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Minutes for 253rd
Registration Board Meeting 1
Minutes for 253rd
Registration Board Meeting held on 05-06th
October, 2015.
Item No. Detail of Item Page No (s)
Item No.I Confirmation of minutes of 252nd
meeting Registration Board
04
Item No.II Cases referred by Pharmacy Services Division
04-13
Item No.III Cases referred by Pharmaceutical Evaluation & Registration Division
14-437
Item No.IV Additional Cases
438-514
Minutes for 253rd
Registration Board Meeting 2
Minutes for 253rd
Meeting Registration Board held on 05-06th
October, 2015.
253rd
meeting of Registration Board was held on 05-06th
October, 2015 in the Committee
Room, M/o National Health Regulation & Coordination. The meeting was chaired by Mr.
Ghulam Rasool Dutani, Director Pharmaceutical Evaluation & Registration Division. The
meeting started with recitation of the Holy Verses. The meeting was attended by the following:-
1. Prof. Dr.Rafi-uz-Zaman Saeed ul Haq
Dean Institute of Pharmacy, University of Lahore,
Islamabad.
Member
2. Lt General (R) Karamat Ahmed Karamat. Member
3. Brig (R). Dr. Muzammil Hasan Najmi,
Associate Dean, Basic Sciences Division,
Foundation Medical University, Rawalpindi
Member
4. Sheikh Sarfraz Ahmad
Deputy Draftsman, M/o Law and Justice
Member
5. Mr. A.Q.Javed Iqbal
Member
6. Dr.Muhammad Khalid Khan
Director Drugs Testing Laboratory
Government of Khyber Pakhtunkhwa, Peshawar
Member
7. Dr.Amanullah Khan
Director Drugs Testing Laboratory
Government of Baluchistan, Quetta
Member
8. Mr.Jamil Anwar
Director Drugs Testing Laboratory
Government of Punjab, Lahore
Member
9. Mr.Ghulam Mujtaba, Assistant Director
Representative of IPO
Member
10. Shaikh Ansar Ahmad
Director Biological Drugs, DRAP
Member
11. Dr.Noor Muhammad Shah
Director MD&MC, DRAP
Member
12. Zeeshan Nazeer Ch
Representative of QA< Division
Member
13. Dr. Obaidullah, Deputy Director General (Reg.I) Secretary/Member
Mr.Jamil Anwar and Mr.Ghulam Mujtaba attended the meeting on 06-10-2015.
Minutes for 253rd
Registration Board Meeting 3
Dr.Masud ur Rehman (DDG Biological), Dr.Tariq Siddique (DDG Regn-II), Zaheer ud
Din M Babar (DDC R.I / R IV), Muhammad Amin (DDC / Incharge, PEC), Zeeshan Nazeer
(DDC QA/ Chairman, QC), Adnan Faisal Saim (DDC QC), Babar Khan (ADC R.II / RIII),
Muneeb Ahmad Cheema (ADC PEC), Salateen Phillips (ADC PEC) and Rana Ahsan ul Haq
(ADC PEC) assisted relevant Directors and Secretary of the Board with agenda.
Shamim Ahmad, Shafiq Ahmad Abbasi, Nadeem Alamgeer and Abuzar Faizy attended
the meeting as observer on behalf of PPMA, Pharma Beauru and PCDA respectively.
Minutes for 253rd
Registration Board Meeting 4
Item No. I: Confirmation of minutes of 252nd
meeting Registration Board.
252nd
meeting of Registration Board was held on 07-08th
September, 2015. Draft minutes
were circulated to all members (who attended the meeting) through e-mail with the request to
forward their comments (if any) within 05 days. No comments have been received on draft
minutes.
Decision: Registration Board approved minutes of 251st Registration Board meeting.
Item No.II: Cases referred by Pharmacy Services Division.
Case No. 01. Tranexamic Acid for the treatment of gastrointestinal bleeding: an
International Randomised, double blind placebo controlled trial.
Haleema Shakur, Project Director, Trials Coordinating Centre, London School of
Hygiene and Tropical Medicine, Keppel Street, London, UK. Prof. Muttiullah Khan & Prof.
Rizwana Chaudhri of Holy Family Hospital, Said Pur Road, Rawalpindi have applied for
approval to conduct the subject trial in Pakistan at various sites. The short title of the trial is
“Haemorrhage Alleviation with Tranexamic Acid – Intestinal system (HALT- IT), trial.
This is a Phase III Clinical trial. List of sites alongwith names of Principal Investigators
has been provided by the Project Director. According to them the trial is an academic
collaboration of hospitals world wide and is being coordinated by the London School of Hygiene
and Tropical Medicine (LSHTM), University of London. As per documents submitted, the
salient features of the trial are as under:-
Aims:-
The HALT-IT trial will determine the effect of early administration of Tranexamic Acid
(TXA) on mortality, morbidity (re-bleeding, non fatal vascular events), blood transfusion,
surgical intervention and health status and patients with acute gastrointestinal bleeding.
Primary Outcome (Expected):-
The primary outcome is death in hospital within 28 days of randomisation (cause-specific
mortality will also be recorded).
Minutes for 253rd
Registration Board Meeting 5
Secondary Outcome (Expected):
a. Re-bleeding
b. Need for surgery or radiological intervention
c. Blood product transfusion
d. Thromboembolic events (deep vein thrombosis, pulmonary embolism, stroke,
myocardial infarction)
e. Other complication (significant cardiac event, sepsis, pneumonia, respiratory
failure, renal failure, liver failure seizures)
f. Patient‟s self care capacity using the Katz Index of Independence in Activities of
Daily Living
g. Days spent in intensive care unit or high dependency unit
Trial Design:
A pragmatic, randomised, double blind, placebo controlled trial among 8,000 patients
with significant gastrointestinal bleeding.
Diagnosis and Inclusion/Exclusion Criteria:
Adults with significant acute upper or lower gastrointestinal bleeding. The diagnosis of
significant bleeding is clinical but may include patients with hypotension, tachycardia, or those
likely to need transfusion, urgent endoscopy or surgery. The fundamental eligibility criterion is
the responsible clinician‟s uncertainty as to whether or not to use Tranexamic Acid in a
particular patient with GI bleeding. If the clinician believes there is a clear indication for, or clear
contraindication to, Tranexamic Acid use, the patient should not be randomised. There are no
pre-specified exclusion criteria.
Test Product, Reference Therapy, Dose and Mode of Administration:
A loading dose of Tranexamic acid (1 gram by intravenous injection) or placebo (sodium
chloride 0.9%) will be given as soon as possible after randomisation, followed by an intravenous
infusion of 3 grams of TXA or placebo (sodium chloride 0.9%) over hours.
Setting:
This trial is coordinated from the London School of Hygiene & Tropical Medicine
Clinical Trials Unit (University of London) and conducted in various hospitals worldwide.
Duration of Treatment and Participation:
Eligible patients should be randomised as soon as possible. The loading dose will be
given immediately after randomisation and the maintenance dose will be given immediately after
the loading dose, over 24 hours. Participation will end at discharge from randomizing hospital,
death or at 28 days post randomisation, whichever occurs first.
Minutes for 253rd
Registration Board Meeting 6
Criteria for Evaluation:
All patients randomly allocated to Tranexamic acid will be compared with those allocated
to placebo, irrespective of whether they received the allocated treatment or not („intention to treat
and analysis).
In the light of prevailing check list for clinical trial applications, the current status of
documents submitted by the applicant as pre-requisites is as follows:-
S. No. Document Remarks
1 Investigator Brochure (s) Yes
2 Final protocol Yes
3 Informed consent and participant
information sheet (Urdu to
English)
Yes
4 Fee No fee has been deposited. The fee for
clinical trial has not been defined under
“Schedule F”. However under the draft
Drugs (Bio-Study) Rules, 2011,
published under S.R.O. 61(1)/2011 dated
13-1-2011 following provision for
clinical trial fee has been given:-
a) Rupee Fifty thousand
(Rs.50000/=) for each principal
investigator in clinical trial.
b) Rupee Fifteen thousand
(Rs.15000/=) for clinical trial
site approval.
5 List of participating counties.
28 countries have been reported to
participate in the trial.
6 Phase of trial. Phase III
7 Quantity of drug / trial material
to be imported on Form 4 under
the Drugs (Import & Export)
Rules, 1976 and application for
import of trial material.
i) Injection Cyklokapron (Tranxamic
Acid), date of Mfg.11-2013
Mfd. By: Pfizer, Kent, UK.
Quantity:- 8000 x 500 mg ampoules,
contained within 1000 packs in a total
of 125 boxes.
ii) Sodium Chloride 0.9% Inj.
date of Mfg.30-07-2014
Mfd. By: South Devon Healthcare
NHS Foundation Trust.
Quantity:- 8000 x 500 mg ampoules,
contained within 1000 packs in a total
of 125 boxes.
iii) Sodium Chloride 0.9% Inj.
date of Mfg.29-06-2014
Minutes for 253rd
Registration Board Meeting 7
Mfd. By: Baxter Healthcare, SA
Quantity:- 2000 x 100 ml bags
Each treatment pack also contains 2 x
sterile 10ml Syringes and 21 FG
needles.
Total amount of trial boxes applied
for import is 250 boxes of trial
treatment.
8 Independent Ethics Committee
(IEC)/Institutional Review
Board (IRB) approval of sites
with complete composition of
committee i.e. names and
designation of members.
Approvals of 05 sites by IRB/Research
Ethics Committee have been provided
with the documents where as request for
approval of 28 sites for conducting trials
has been made to DRAP. The applicants
have also not furnished approval letter
issued by National Bioethics Committee
(NBEC) of Pakistan.
9 CV‟s of the Investigators CVs of 08 PIs have been furnished
whereas the list indicates 30 PIs to
conduct the trial at various sites is given.
10 GMP certificate along with
COPP & free sale certificate of
the investigational product.
The GMP, COPP & Free Sale certificates
of the drug under investigation have not
been provided. The marketing
authorization of the placebo and COA of
the investigational drug have been
furnished only.
11 Pre-clinical/clinical safety
studies
Yes
12 Summary of Protocol Yes
13 Safety and progress report Yes
14 Adverse Event Reporting Form Yes
15 No of patients to be enrolled in
each centre.
8000 patients with diagnosed acute
gastrointestinal bleeding randomised will
be enrolled in participating hospital
selected worldwide. There is no limit to
the maximum number of patients to be
recruited at each site. It has been
estimated that minimum of 20 centres
will join the trial in Pakistan and that on
average 100 participants will be recruited
at each site
16 Name of monitors & clinical
research associate
30 Principle Investigator have been
mentioned to conduct the trial but
consent of only 8 is on record.
17 Evidence of registration in
country of origin.
Not provided, however it has been stated
that the drug is manufactured by Pfizer
Minutes for 253rd
Registration Board Meeting 8
Ltd under marketing authorization #
PL00032/0314 licensed by EMA. COA
of the drug has been provided. COPP is
required.
18 Evidence of registration in
Pakistan.
Not provided, however copy of National
Essential Drugs List of Pakistan has been
referred and as per section information
the drug is a registered in Pakistan under
the name Transamine.
19 Sample of label of the
investigational product / drug.
Yes
20 Duration of trial 04 years
Prima facie this is the case of grant of approval of clinical trial permission to be conducted as per
protocol submitted to the DRAP.
The Principal Investigator has been invited for short presentation regarding the subject title trial
before the Drug Registration Board on 06-10-2015 at 11;30 am.
The case is place before Registration Board for the following:-
i) Approval of the subject clinical trial namely Tranexamic Acid for the treatment of
gastrointestinal bleeding: an International Randomised, double blind placebo
controlled trial. The short title of the trial is “Haemorrhage Alleviation with Tranexamic
Acid – Intestinal system (HALT- IT), trial.
ii) Approval of the presently proposed clinical trial sites. (05 only whose IBR approval is
intact.
iii) Approval of proposed Principal Investigator for above 05 sites.
iv) Approval of fee .
v) Approval of Panel for post approval monitoring of trial sites from DRAP.
vi) Approval of proportionate trial material to be imported each time.
Decision: The case was considered by the Board in its 253rd
meeting held on 6-10-2015. In
the light of presentation made by the trial manager, discussion and
deliberations, the Board decided the matter as under:
i) The clinical trial namely Tranexamic Acid for the treatment of gastrointestinal
bleeding: an International Randomised, double blind placebo controlled trial was
approved in principle. The short title of the trial is “Haemorrhage Alleviation with
Tranexamic Acid – Intestinal system (HALT- IT), trial.
Minutes for 253rd
Registration Board Meeting 9
ii) The Board approved five sites namely Allied Hospital, RMC Rawalpindi; Shifa
International Hospital, Ltd. Islamabad; Post graduate Medical Institute, Lady
Reading Hospital, Peshawar; DHQ Hospital, Khuzdar and DHQ Hospital,
Narowal, whose approvals from IBR are intact.
iii) Principal Investigators namely Dr. Matiullah Mutti, Holy Family Hospital,
Rawalpindi, Dr. Muhammad Umar, Rawalpindi Medical College, Rawalpindi, Dr.
Abdus Salam Khan, Shifa International Hospital, Islamabad, Dr. Aamir Ghafoor
Khan Lady Reading Hospital, Peshwar, Dr. Abdul Wahid DHQ Hospital
khuzdar, Dr. Sajjad, DHQ Hospital, Narowal, whose consents/CVs are intact,
were also approved.
iv) The fee for Clinical trial as proposed in the Bio Study Rules, 2011 was
recommended by the Board for inclusion in Schedule F of the Drugs (Lic, Reg &
Adv) Rules, 1976.
v) Regarding the panel for post approval monitoring of the trial sites, it was decided
that the member of the Registration Board from the concerned Province will head
the panel and the other members from the regional DRAP office or DRAP
Islamabad will associate for such inspection.
vi) Permission for import of proportionate trial material and other regulatory
deficient documents will be considered as per Drugs (Import and Export) Rules,
1976 by competent authority.
Case No. 02 The Efficacy of Varenicline in Achieving Abstinence Among Hookah
Smokers-a Two Arm, Double Blind, Placebo Controlled Study-Funded By
Pfizer (Hookah Trial).
Dr. Raana Zahid, Principal Investigator has sent details of proposed clinical trial of a
chemical “Varenicline” for looking at the efficacy of “Varenicline” in achieving abstinence
among Hookah Smokers-a Two Arm, Double Blind, Placebo Controlled Study-Funded by Pfizer
(Hookah Trial). It has been stated that “The Initiative‟ Pakistan” is a private, non-government
trust organization based at Islamabad, established recently by a group of public health
professionals who are working closely with the University of Leeds and University of York on
tobacco related quantitative and qualitative related research projects. The Pakistan team is
basically an extension of the University of York, UK. Dr. Raana has further informed that the
University of York has successfully implemented and published policy research and Randomized
Controlled Trials.
2. As per documents submitted, the salient features of the trial are as under:-
Minutes for 253rd
Registration Board Meeting 10
Background:
Hookah smoking has increased among youth across the globe including the US, and it
continues as a common and traditional form of smoking tobacco in Pakistan. A range of
behavioral and pharmacological therapies is available to support people in quitting cigarette
smoking; however, little evidence exists on the efficacy of these therapies in achieving
abstinence among hookah smokers.
Research objective:
To assess the efficacy of Varenicline when added to behavioral support for smoking
cessation, by measuring biochemical validated continuous abstinence in hookah smokers.
Design:
A two-arm, double blind, randomised, placebo-controlled, stated to be Phase III trial.
Setting:
At three district hospitals in Punjab, Pakistan (Sargodha, Khushab and Mandi Bahudding)
Participants:
Adults, using hookah (with or without concomitant cigarette, bidi, or other tobacco
smoking) on a daily basis for at least six-months and are willing to quit smoking, will be eligible.
individually randomise 510 participants to one of the two arms of the trial.
Interventions:
Arm 1: Varenicline + Behavioural Support
Arm 2: Placebo + Behavioural support
Measurements:
As per Russell‟s Standard, primary outcome will be continuous abstinence for at least six
months which is bio-chemically verified by a carbon monoxide level of 10 ppm at 5, 12 and 25
weeks post randomisation. Secondary outcomes will include bio-chemically verified point
abstinence at 5, 12 and 25 weeks and any lapses and relapses between the different assessment
points. Tertiary outcomes will include assessment of withdrawal symptom using Mood and
Physical Symptoms Scale (MPSS), smoking dependency using Lebanon Water pipe Dependency
Scale (LWDS-11), and monitoring adverse outcomes.
In the light of prevailing check list for clinical trial applications, the current status of
documents submitted by the applicant as pre-requisites is as follows:-
S. No. Document Remarks
1 Investigator Brochure (s) Yes
2 Final protocol Yes
3 Informed consent and participant
information sheet (Urdu to English)
Yes
Minutes for 253rd
Registration Board Meeting 11
4 Fee The fee for clinical trial has not been
defined under “Schedule F”. However
under the draft Drugs (Bio-Study) Rules,
2011, published under S.R.O. 61(1)/2011
dated 13-1-2011 following provision for
clinical trial fee has been given:-
a) Rupee Fifty thousand (Rs.50000/=) for
each principal investigator in clinical
trial.
b) Rupee Fifteen thousand (Rs.15000/=)
for clinical trial site approval.
The applicant has deposited Rs.5000/=
fee for clinical trial.
5 List of participating counties.
The trial is being conducted in Pakistan
only.
6 Phase of trial. Phase III
7 Quantity of drug / trial material to be
imported on Form 4 under the Drugs
(Import & Export) Rules, 1976 and
application for import of trial material.
i) Varenicline tartrate 0.5mg Tablets.
Quantity:- 2805 tablet units (255
packages having 11 tablets per
package.)
ii) Placebo 0.5mg Tablets.
Quantity:- 2805 tablet units (255
packages having 11 tablets per
package.)
iii) Varenicline Tartrate 1mg Tablets.
Quantity:- 39270 tablet units (255
packages having 154 tablets per
package.)
iv) Placebo 1mg Tablets.
Quantity:- 39270 tablet units (255
packages having 154 tablets per
package.)
8 Independent Ethics Committee
(IEC)/Institutional Review Board (IRB)
approval of sites with complete
composition of committee i.e. names and
designation of members.
Approvals from Independent Ethics
Committee (IEC) / Institutional Review
Board (IRB) of proposed 03 sites have not
been provided with the documents.
However, the applicant has furnished
approval letter issued by National
Bioethics Committee (NBEC) of Pakistan.
9 CV‟s of the Investigators CVs of Chief Investigator, PI and trial
Manager in Pakistan have been furnished.
However the names of research/study
associates/PIs to be involved in trials at
the three proposed sites have not been
provided.
Minutes for 253rd
Registration Board Meeting 12
10 GMP certificate along with COPP & free
sale certificate of the investigational
product.
The GMP, COPP & Free Sale certificates
of the drug under investigation have not
been provided. However it has been stated
that Pfizer USA has been requested to
provide necessary documents and they are
processing our request.
11 Pre-clinical/clinical safety studies Yes
12 Summary of Protocol Yes
13 Safety and progress report Yes
14 Adverse Event Reporting Form Yes
15 No of patients to be enrolled in each
centre.
510 Participants will be enrolled in three
centres of study located at Sargodha,
Khushab and Mandi Bahauddin.
16 Name of monitors & clinical research
associate
The names of research/study
associates/PIs to be involved in trials at
the three proposed sites have not been
disclosed/ provided.
17 Evidence of registration in country of
origin.
Not provided, however it has been stated
that Pfizer USA has been requested to
provide necessary documents and they are
processing their request.
18 Evidence of registration in Pakistan.
Not provided, however as per section
information the drug is registered in
Pakistan.
19 Sample of label of the investigational
product / drug.
Not provided, it has been stated that the
sample of the label will be furnished as
soon as it is ready to be shipped to
Pakistan after receiving the NOC from
DRAP.
20 Duration of trial 02 years
The matter has been referred to the following two experts; however, the opinion of both
of the experts is still awaited:-
i) Dr. Huma Qureshi, Executive Director, PMRC.
ii) Brig. (R)/Dr. Muzammil H. Najmi, Member Registration Board.
Prima facie this is the case of grant of approval of clinical trial permission to be
conducted as per protocol submitted to the DRAP.
The Principal Investigator / Trial Manager has been invited for short presentation
regarding the subject titled trial before the Drug Registration Board 06-10-2015 at 12:30 pm.
The case is placed before the Registration Board for the following:-
Minutes for 253rd
Registration Board Meeting 13
i) Approval of the subject clinical trial namely The Efficacy of Varenicline in
Achieving Abstinence among Hookah Smokers-a Two Arm, Double
Blind, Placebo Controlled Study-Funded By Pfizer (Hookah Trial).
ii) Approval of the presently proposed clinical trial sites subject to provision of
approvals from the IRBs.
iii) Approval of Principal Investigator for each site subject to provision of their CVs and
consent to conduct the trial.
iv) Approval of fee as mentioned above in para 3 (4).
v) Approval of Panel for post approval monitoring of trial sites from DRAP.
vi) Approval of proportionate trial material to be imported each time.
Decision: - The case was considered by the Board in its 253rd
meeting held on 6-10-2015. In the
light of presentation made by the trial manager, discussion and deliberations, the
Board decided the matter as under:
i) The clinical trial namely The Efficacy of Varenicline in Achieving Abstinence
among Hookah Smokers-a Two Arm, Double Blind, Placebo Controlled
Study-Funded By Pfizer (Hookah Trial) was approved by the Board.
ii) The Board approved three proposed sites namely DHQ Hospital, Sargodha,
DHQ Hospital, Mandi Bhauddin and DHQ Hospital, Khushab subject to
provision of approvals from the IRBs. It was also advised to have laison with
teaching Hospital for better conduction/monitoring of the trial/study.
iii) Principal Investigators namely Dr. Raana whose CV is intact was also
approved. Approval of Principal Investigators for the proposed three sites
subject to provision of their CVs and consent to conduct the trial was also
approved.
iv) The fee for Clinical trial as proposed in the Bio Study Rules, 2011 was
recommended by the Board for inclusion in Schedule F of the Drugs (Lic, Reg
& Adv) Rules, 1976.
v) Regarding the panel for post approval monitoring of the trial sites, it was
decided that the member of the Registration Board from the concerned
Province will head the panel and the other members from the regional DRAP
office or DRAP Islamabad will associate for such inspection.
vi) Permission for import of proportionate trial material and other regulatory
deficient documents will be considered as per Drugs (Import and Export)
Rules, 1976 by competent authority.
Minutes for 253rd
Registration Board Meeting 14
Item No.III: Cases referred by Pharmaceutical Evaluation & Registration Division.
A. Registration of Drugs.
Case No.01: Grant of registration of drugs deferred for stability data.
Registration Board in various meetings deferred registration applications of new molecules / formulations for submission of laboratory scale
scientifically rational stability data. Later on Registration Board in its 251st meeting held on 12-13
th August 2015 framed guidelines for submission of
stability data which were communicated to all applicants. The decision of Board is as follows.
“Registration Board deferred the case and advised applicants to provide scientifically rational lab scale data as per requirements decided in the
meeting. However, for the applicants who were previously advised for provision of stability data may provide stability data for testing frequency of at least
0, 3 and 6 months in addition to other requirements approved by Registration Board in instant meeting”.
Stability Study Data Sheet
1.0 Product details:
Product name /Generic
name/Dosage form ABCD 100mg tablets Batch No.
Description of pack
(container closure system)
e.g: 300mg uncoated 10mm off white round tablet
blistered in 250mn PVC, 25mm aluminum foil in a 10x 1
printed unit carton, 100 u/c further packed in a master
shipper.
Batch Size.
Parameters and tests mentioned As per Product Specifications Mfg. Date
Recommended storage
conditions
Short term conditions (Accelerated) 40+ 2C, 75
+5RH
Long term conditions (Real time) 30+ 2C, 65 +5
RH
Exp Date
Minutes for 253rd
Registration Board Meeting 15
Date of initiation &
implementation (API) lot no.
Stability No.
Approval by:
QC Manager:---------------------
QA Manager:---------------------
Production Manager:----------
R&D Manager:-------------------
Assessment frequency (weeks) Initial 1 2 3 4 6 8 12 16 20 24 26
Date of Testing
Mode of testing(F = full, P = Partial testing) F P F P F F F F F F F F
Tests (Physical,
Chemical,
Microbiological)
Acceptance
Criteria
Storage
conditions
(Accelerated)
40oC + 2
oC & 75%RH
+ 5% RH
40oC + 2
oC & 75%RH
+ 5% RH
40oC + 2
oC & 75%RH
+ 5% RH
40oC + 2
oC & 75%RH
+ 5% RH
Sample taken for physical tests =
Sample taken for Chemical tests =
Sample taken for Microbiological tests =
Extra samples (if needed) =
Total Sample size (approx) =
Minutes for 253rd
Registration Board Meeting 16
40oC + 2
oC & 75%RH
+ 5% RH
Analyst signature (after completion of every time line)
Conclusion by QA (after completion of the study):
Assessment frequency (weeks) Initial 1 2 3 4 6 8 12 16 20 24 26
Date of Testing
Mode of testing(F = full, P = Partial testing) F P F P F F F F F F F F
Tests(Physical,
Chemical,
Microbiological)
Acceptance
Criteria
Storage
conditions
(Real Time)
30 C + 2oC,
65% +5% RH
30 C + 2oC,
65% +5% RH
30 C+ 2oC,
65% +5% RH
30 C + 2oC,
65 %+5% RH
30 C+ 2oC,
65% +5% RH
Minutes for 253rd
Registration Board Meeting 17
Analyst signature (after completion of every time line)
Conclusion by QA (after completion of the study):
Documents / Data to be provided by the applicants
Certificate of Analysis of API.
Approval of API by regulatory authority of country of origin or GMP certificate of API manufacturer issued by regulatory authority of
country of origin.
Manufacturer will follow Drug Specification Rules, 1986.
Protocols followed for conduction of stability study and details of tests.
Data of 03 batches will be supported by attested respective documents like chromatograms, laboratory reports, data sheets etc.
Documents confirming import of API etc.
All provided documents will be attested (name, sign and stamp) for ensuring authenticity of data / documents.
Shelf life of two years shall be granted based upon the results 06 month accelerated and real time stability study data.
Commitment to continue real time stability study till assigned shelf life of the product.
Furthermore all applicants have also been called for presentation of their data before the Registration Board. The applicants who have submitted the
stability data has been tabulated below for consideration of Registration Board please.
a. Sofosbuvir 400mg Tablet.
All the applications for registration of Sofosbuvir 400mg Tablet were initially discussed in the 244th
meeting of Registration board
held on 22-23rd
July 2014 wherein the Board decided that in addition to individual dossier deficiencies, every manufacturer will provide
additional data as decided by Registration Board in 240th
meeting for new drug molecule. Later on, Registration Board in its 251st meeting
held on 12-13th
August 2015 framed guidelines for submission of stability data which were communicated to all applicants, who had applied
for registration of the aforesaid drug.
Minutes for 253rd
Registration Board Meeting 18
Registration Board provided an opputunity to all the applicants to present stability data before the Board. 28 applicants provided the
stability data and presented their cases whereas 35 applicants did not provide the same.
Following firms have not submitted stability data but their representatives attended the meeting.
S.No Name Designation & Organization
1. Shaigan Pharmaceuticals (Pvt) Ltd Ghulam Muhammad, (GM, R&D)
2. OBS Pharma, Karachi Mohammad Amjad, Director Industrial Operatoion
3. Rasco Pharma, Lahore Hussnain Raza, Plant manager
4. Dyson Research Lab, Lahore Muhammad Rafique, Quality Control Manager
5. Cirin Pharmaceutical, Hattar Sohail Qaiyum, Quality Control Manager
6. Valor Pharma, Islamabad Asif Iqbal, Quality Control Manager
7. Helix Pharma, Karachi Dr. Obaid Siddiqui, GM Quality Operation
8. Friends Pharma, Lahore Shahid Nadeem, Quality Control Manager
9. Novamed Pharma, Lahore M. Jehangir, Quality Control Manager
10. Saiben Pharma, Muhammad Rafiq, Production Manager
11. Neutro Pharma, Lahore Shahid Niazi, Quality Assurance Manager
12. English Phamaceutical, Lahore Muhammad Nadeem Shahid, Director Operation
13. Schazoo Pharmaceuticals, Lahore Asad Farooq, R&D Manager
14. Rotex Pharma, Islamabad Malik Ikram Shaukat, Quality Control Manager
15. Akson Pharma, Muhammad Azeen, Quality Control Manager
Minutes for 253rd
Registration Board Meeting 19
16. Safron Pharma, Faisalabad Hafiz Muhammad Ibrahim, Quality Control Manager
17. Martin Dow, Karachi Dr. Shafiq ur Rehman,Head of Quality
18. Wilshire Laboratories, Lahore Farhan Qureshi, Quality Assurance Manager
After listening to above representatives, Registration Board advised manufacturers to sumit stability data and other documents as per
requirements decided in 251st meeting of Registration Board. Some manufacturers informed that their cases for permission by DRAP
regarding import of raw materials for the conduction of stability testing are pending. Registration Board deliberated that Quality Assurance
Division has already been advised in 245th
meeting of the Board held on 29-30th
September, 2014 to dispose off cases of raw material import
for conduction of stability studies and product development on priority basis. However keeping in view manufacturer‟s submission, Quality
Assurance Division was again re-iteriated to process such cases on priority without further delay.
Mr. A.Q. Javed Iqbal, Member Registration Board opined that level field should have been provided to all the players and decisions
should be transparent and across the board. He observed that some manufacturers have also been advised to provide clinical trial data.
Registration Board was apprised that in 244th
meeting all applicants were advised to provide following data inaddition to individual dossier
deficiencies:
a. Prescribing information (PI), Patient Information Leaflet (PIL) and Summary of product characteristics (SmPC) as per Approved by
Drug regulatory agencies or authorities of country of origin or FDA, EMA, TGA, Health Canada and MHLW (Japan)
b. Stability Studies conducted under the Zone IV-A conditions as per ICH / WHO guidelines.
c. Clinical Data / Clinical trials
d. Clinical justification
e. International availability specially in FDA, EMA, Health Canada, TGA & MHLW (Japan) of same generic, dosage form & strength
etc.
Minutes for 253rd
Registration Board Meeting 20
Registration Board discussed reference sent by PPMA stating that Registration Board should not grant registrations to Sofosbuvir
400mg Tablets from India as local pharmaceutical manufacturers can manufacture it. A delegation of PPMA led by its Chairman (Mr. Hamid
Raza) also shared same plea before Registration Board. The Board deliberated the request in detail and also discussed that parameters for
grant of registration are safety, efficacy and quality. Registration Board discussed PPMA‟s letter and members were of the view that Import
Policy Order 2012-2015, Ministry of Commerce doesn‟t restrict import of Sofosbuvir 400 mg tablets from India. However, keeping in view
presentation made by PPMA, the Board decided to get opinion of Ministry of Commerce regarding importability of Sofosbuvir 400 mg
tablets from India for updated status as mentioned in PPMA‟s letter.
Registration Board discussed that stability data submitted by the manufacturers will be discussed on case to case basis in presence of
firm‟s representatives. The Board discussed that cases will be evaluated in the light of decision of 251st Registration Board meeting for
requirement of documents and data. Moreover, data should include required pharmacopeial test as applicable to specific dosage form.
Manufacturers who complied aforementioned provisions will be granted registration. Registration Board decided that in order to further
ensure quality of the product and being first generic of new molecule, manufacturer will inform concerned Federal Inspector of Drugs for
taking sample of Active Pharmaceutical Ingredient (used in manufacture of first commercial batch) for test/ analysis from Central Drugs
Laboratory, Karachi before sale of finished product.
Thereafter, Board discussed individual applications of new molecules for which stability data was provided and following decisions
were taken:
Minutes for 253rd
Registration Board Meeting 21
1. SAMI PHARMA, KARACHI
Drug SOFVIR tablets (Sofosbuvir) 400 mg
Source M/s Lauras Labs India
Storage Condition Real Time: 30 C and 75% RH
Accelerated: 40 C and 75% RH
Time Period Real Time: 6 months
Accelerated: 6 months
Frequency 0, 1,2, 3,5, 6 months
Batch Size Batch 1: 300 tab
Batch 2: 410 tab
Batch 3: 410 tab
No. of Batches 03
Sample Size 25 tablets
Meeting Deferred in 244th
and 251st meeting of
Registration Board for stability as per
WHO/ICH guidelines
Batch 1 Accelerated
Parameters Appearance
Disintegration
Time
(in minutes)
Average
weight
(g /tab.)
Dissolutio
n
(%)
Assay
(%)
Specification
White to off white
oval shape tablets,
plain on both sides
Within 30
minutes
1.1742 to
1.2978 NLT 80
NLT 90
and NMT
110
Initial result
White oval shape
tablets, plain on both
sides
6‟:10‟‟ 1.239 100.77 105.91
Minutes for 253rd
Registration Board Meeting 22
After 1
months // 6‟:24‟‟ 1.2341 100.29 104.68
After 3
months // 6:59‟‟ 1.2344 99.23 103.19
After 5
months // 7‟:16‟‟ 1.2347 98.09 102.14
After 6
months // 7‟:25” 1.2355 97.56 100.87
Real Time
Parameters Appearance
Disintegration
Time
(in minutes)
Average weight
(g /tab.) Dissolution
(%)
Assay
(%)
Specification
White to off white
oval shape tablets,
plain on both sides
Within 30
minutes
1.1742 to
1.2978 NLT 80
NLT 90
and NMT
110
Initial result
White oval shape
tablets, plain on both
sides
6‟:10‟‟ 1.239 100.77 105.91
After 3
months // 6‟:19‟‟ 1.240 100.15 104.90
After 5
months // 6:35‟‟ 1.2342 99.65 103.55
After 6
months // 6:49‟‟ 1.2350 98.19 102.12
Minutes for 253rd
Registration Board Meeting 23
Batch 2
Accelerated
Parameters Appearance Disintegration Time
(in minutes)
Average
weight
(g /tab.)
Dissolution
(%)
Assay
(%)
Specification
White to off white
oval shape tablets,
plain on both sides
Within 30
minutes
1.1742 to
1.2978 NLT 80
NLT 90 and
NMT 110
Initial result
White oval shape
tablets, plain on both
sides
6‟:12‟‟ 1.2237 100.60 104.60
After 1
months // 6‟:45‟‟ 1.2239 100.30 103.59
After 3
months // 7‟:08‟‟ 1.2341 99.34 102.97
After 5
months // 8‟:03‟‟ 1.2343 98.92 101.36
After 6
months // 8‟:23‟‟ 1.2353 95.44 100.32
Real Time
Parameters Appearance
Disintegration
Time
(in minutes)
Average
weight
(g /tab.)
Dissolution
(%)
Assay
(%)
Specification
White to off white
oval shape tablets,
plain on both sides
Within 30
minutes
1.1742 to
1.2978 NLT 80
NLT 90
and NMT
110
Initial result White oval shape
tablets, plain on both 6‟:12‟‟ 1.2237 100.60 104.60
Minutes for 253rd
Registration Board Meeting 24
sides
After 3
months // 6‟:25‟‟ 1.2239 100.22 103.79
After 5
months // 6‟:49‟‟ 1.2300 99.75 102.99
After 6
months // 6‟:55‟‟ 1.2309 97.43 102.08
Batch 3 Accelerated
Parameters Appearance
Disintegration
Time
(in minutes)
Average
weight
(g /tab.)
Dissolution
(%)
Assay
(%)
Specification
White to off white oval
shape tablets, plain on both
sides
Within 30
minutes
1.1742 to
1.2978 NLT 80
NLT 90 and
NMT 110
Initial result White oval shape tablets,
plain on both sides 6‟:14‟‟ 1.2382 101.26 105.84
After 1 months // 6‟:25‟‟ 1.2385 100.68 104.40
After 3 months // 6‟:44‟‟ 1.2389 99.18 103.48
After 5 months // 7‟:14‟‟ 1.2391 97.96 102.11
After 6 months // 7‟:34‟‟ 1.2399 95.57 101.84
Real Time
Parameters Appearance
Disintegration
Time
(in minutes)
Average
weight
(g /tab.)
Dissolution
(%)
Assay
(%)
Specification
White to off white oval
shape tablets, plain on both
sides
Within 30 minutes 1.1742 to
1.2978 NLT 80
NLT 90
and NMT
110
Minutes for 253rd
Registration Board Meeting 25
Initial result White oval shape tablets,
plain on both sides 6‟:14‟‟ 1.2382 101.26 105.84
After 3 months // 6‟:20‟‟ 1.2386 100.70 104.75
After 5 months // 6‟:34‟‟ 1.2386 100.18 103.50
After 6 months // 6‟:45‟‟ 1.2390 97.47 101.75
Documents / Data provided by the applicants (M/s Sami, Karachi)
Sr. No. Documents to be provided Status
1. COA of API Yes
2. Approval of API by regulatory authority of country of origin or GMP certificate of API
manufacturer issued by regulatory authority of country of origin.
Yes (Photocopy
provided)
3. Protocols followed for conduction of stability study and details of tests. Yes
4. Data of 03 batches will be supported by attested respective documents like
chromatograms, laboratory reports, data sheets etc.
Yes
5. Documents confirming import of API etc. Yes (By courier)
6. All provided documents will be attested (name, sign and stamp) for ensuring
authenticity of data / documents.
Yes
7. Commitment to continue real time stability study till assigned shelf life of the product. No
Decision: Mr.Shamim Akhter, Director Quality Operations presented the data. Registration Board observed that the stability data
provided by the firm is in accorndace with the guidelines approved by the Board in 251st meeting. Therefore, Board granted
approval of registration of Sofosbuvir 400 mg tablets to the firm. However, manufacturer will inform concerned Federal Inspector of
Drugs for taking sample of Active Pharmaceutical Ingredient (used in manufacture of first commercial batch) for test/ analysis from
Central Drugs Laboratory, Karachi before sale of finished product.
Minutes for 253rd
Registration Board Meeting 26
2. M/s Genix Pharma, Karachi
Drug Sofo tablets (Sofosbuvir) 400 mg
Source Zhejiang Jiangbei, Pharmaceutical Co. Ltd China
Storage Condition Accelerated: 40 C and 75% RH
Real Time: 30°C ± 2°C/65% ± 5% RH)
Time Period 6 months
Frequency 0, 1, 3, 6 months
Batch Size Batch 1 and 2: 225 tabs/ batch
Batch 3: 4985 tabs
No. of Batches 03
Sample Size 20 tablets per test
Meeting Deferred in 244th and 251
st meeting of Registration Board
Batch 1 Accelerated Stability Study (40°C ± 2°C, 75% ± 5% RH)
Product: SOFO 400mg tablet Mfg. Date: 09-2014 Date of Commencement: 12-09-2014
Product Code: NA Exp. Date: 09-2016 Date of Completion: 12-03-2015
Batch No.: TR001 Shelf Life: 2 Years Pack Size: 14‟s
Packaging: HDPE Bottle with Cap, pilfer-proof Specifications No/Version: GENIXQC-SOP-SF-140/00
Reason For Stability: Trial batch for registration purpose and shelf life.
Parameters Assay Dissolution Impurities Disintegration
Time
(minute)
Physical Observation
Specifications Label Claim
400mg/tablet
NLT 80% Unspecified NMT
0.5%
NMT 30
minutes
Oblong yellow biconvex
coated tablets engraved
Minutes for 253rd
Registration Board Meeting 27
Limits
(90%-110%)
Total NMT 1.0% “Genix” on one side plain
on other side.
Intervals
Initial Results 99.19% 99.1% ND 2.39 mins Complies
3rd
month 99.44% 95.5%
Unspecified Impurity
0.034%
Total Impurities
0.034%
2.39 mins Complies
6th month 99.21% 93.9%
Unspecified Impurity
0.182%
Total Impurities
0.182%
2.41 mins Complies
Real Time Stability Study (30°C ± 2°C/65% ± 5% RH)
Product: SOFO 400mg tablet Mfg. Date: 09-2014 Date of Commencement: 12-09-2014
Product Code: NA Exp. Date: 09-2016 Date of Completion: 12-09-2016
Batch No.: TR001 Shelf Life: 2 Years Pack Size: 14‟s
Packaging: HDPE Bottle with Cap, pilfer-proof Specifications No/Version: GENIXQC-SOP-
SF-140/00
Reason For Stability: Trial batch for registration purpose and shelf life.
Parameters Assay Dissolution Impurities Disintegration
Time (minutes)
Physical Observation
Specifications Label Claim
400mg/tablet
NLT 80% Unspecified NMT
0.5%
NMT 30
minutes
Oblong yellow biconvex
coated tablets engraved
Minutes for 253rd
Registration Board Meeting 28
Limits
(90%-110%)
Total NMT 1.0% “Genix” on one side plain
on other side.
Intervals
Initial Results 99.19% 99.1% ND 2.39 mins Complies
3rd
month 99.06% 96.6% ND 2.27 mins Complies
6th month 99.0% 94.0%
Unspecified Impurity
0.186%
Total Impurities
0.186%
2.19 mins
Complies
Batch 2 Accelerated Stability Study (40°C ± 2°C, 75% ± 5% RH)
Product: SOFO 400mg tablet Mfg. Date: 09-2014 Date of Commencement: 12-09-2014
Product Code: NA Exp. Date: 09-2016 Date of Completion: 12-03-2015
Batch No.: TR002 Shelf Life: 2 Years Pack Size: 14‟s
Packaging: HDPE Bottle with
Cap, pilfer-proof Specifications No/Version: GENIXQC-SOP-SF-
140/00
Reason For Stability: Trial batch for registration purpose and shelf life.
Parameters Assay Dissolution Impurities Disintegration
time
Physical Observation
Specifications Label Claim
400mg/tablet
Limits
(90%-110%)
NLT 80% Unspecified NMT
0.5%
Total NMT 1.0%
NMT 30
minutes
Oblong yellow biconvex
coated tablets engraved
“Genix” on one side plain on
other side.
Minutes for 253rd
Registration Board Meeting 29
Intervals↓
Initial Results 101.61% 99.7% ND 2.41 mins Complies
3rd
month 100.68% 96.7%
Unspecified Impurity
0.039%
Total Impurities
0.077%
2.14 mins Complies
6th month 99.0% 94.2%
Unspecified Impurity
0.179%
Total Impurities
0.179%
2.10 mins Complies
Real Time Stability Study (30°C ± 2°C/65% ± 5% RH)
Product: SOFO 400mg tablet Mfg. Date: 09-2014 Date of Commencement: 12-09-2014
Product Code: NA Exp. Date: 09-2016 Date of Completion: 12-09-2016
Batch No.: TR002 Shelf Life: 2 Years Pack Size: 14‟s
Packaging: HDPE Bottle with Cap, pilfer-proof Specifications No/Version: GENIXQC-SOP-
SF-140/00
Reason For Stability: Trial batch for registration purpose and shelf life.
Parameters Assay Dissolution Impurities Disintegration
time
Physical Observation
Specifications Label Claim
400mg/tablet
Limits
NLT 80% Unspecified NMT
0.5%
Total NMT 1.0%
NMT 30
minutes
Oblong yellow biconvex
coated tablets engraved
“Genix” on one side
Minutes for 253rd
Registration Board Meeting 30
(90%-110%) plain on other side.
Intervals↓
Initial Results 101.61% 99.7% ND 2.41 mins Complies
3rd
month 100.24% 96.5%
Unspecified Impurity
0.003%
Total Impurities
0.003%
2.40 mins Complies
6th month 99.70% 92.3%
Unspecified Impurity
0.181%
Total Impurities
0.181%
2.31 mins
Complies
Batch 3 Accelerated Stability Study (40°C ± 2°C/75% ± 5% RH)
Product: SOFOS 400mg tablet Mfg. Date: 02-2015 Date of Commencement: 02-2015
Product Code: NA Exp. Date: 02-2017 Date of Completion: 08-2015
Batch No.: G094 Shelf Life: 2 Years Pack Size: 7‟s
Packaging: HDPE Bottle Specifications No/Version: GENIXQC-SOP-SF-140/00
Batch Size: 4985
Reason For Stability: New products for shelf life estimation.
Parameters Assay Dissolution Impurities Disintegration
time
Physical Observation
Specifications Label Claim
400mg/tablet
Limits
(90%-110%)
NLT 80% Unspecified NMT 0.5%
Total 1.0%
NMT 30
minutes
Oblong yellow biconvex
coated tablets engraved
“Genix” on one side plain
on other side.
Intervals↓
Initial Results 98.09% 95.26 % ND 4.12 minutes Complies
Minutes for 253rd
Registration Board Meeting 31
1st month 100.87% 97.09% ND 2.54 minutes Complies
2nd
month 100.55% 96.55% ND 3.12 minutes Complies
3rd
month 100.47% 93.57% ND 2.23 minutes Complies
4th
month 100.38% 95.98% ND 3.82 minutes Complies
5th
month 99.66% 94.90% ND 2.42 minutes Complies
6th
month 99.26% 92.07% ND 3.26 minutes Complies
Reference Record STR-001/022
Signature
Product: SOFO 400mg tablet Mfg. Date: 09-2014 Date of Commencement: 12-09-2014
Product Code: NA Exp. Date: 09-2016 Date of Completion: 12-09-2016
Batch No.: TR001 Shelf Life: 2 Years Pack Size: 14‟s
Packaging: HDPE Bottle with Cap, pilfer-proof Specifications No/Version: GENIXQC-SOP-
SF-140/00
Reason For Stability: Trial batch for registration purpose and shelf life.
Parameters Assay Dissolution Impurities Disintegration
Time (minutes)
Physical Observation
Specifications Label Claim
400mg/tablet
Limits
(90%-110%)
NLT 80% Unspecified NMT
0.5%
Total NMT 1.0%
NMT 30
minutes
Oblong yellow biconvex
coated tablets engraved
“Genix” on one side plain
on other side.
Intervals
Initial Results 99.19% 99.1% ND 2.39 mins Complies
Minutes for 253rd
Registration Board Meeting 32
3rd
month 99.06% 96.6% ND 2.27 mins Complies
6th month 99.0% 94.0%
Unspecified Impurity
0.186%
Total Impurities
0.186%
2.19 mins
Complies
Real Time Stability Study (30°C ± 2°C/65% ± 5% RH)
Product: SOFOS 400mg tablet Mfg. Date: 02-2015 Date of Commencement: 02-2015
Product Code: NA Exp. Date: 02-2017 Date of Completion: 02-2017
Batch No.: G094 Shelf Life: 2 Years Pack Size: 7‟s
Packaging: HDPE Bottle Specifications No/Version: GENIXQC-SOP-SF-140/00
Batch Size: 4985
Reason For Stability: New products for shelf life estimation.
Parameters Assay Dissolution Impurities Disintegration
Time
Physical Observation
Specifications Label Claim
400mg/tablet
Limits
(90%-110%)
NLT 80% Unspecified NMT 0.5%
Total 1.0%
NMT 30
minutes
Oblong yellow biconvex coated
tablets engraved “Genix” on
one side plain on other side.
Intervals↓
Initial Results 98.09% 95.26 % ND 4.12 minutes Complies
3rd
month 100.58% 95.52% ND 2.27 minutes Complies
6th
month 99.28% 92.16% ND 3.52 minutes Complies
Minutes for 253rd
Registration Board Meeting 33
Reference Record STR-001/04,20 STR-001/04 STR-001/04,20 STR-001/04,20 STR-001/04,20
Signature
Documents / Data provided by the applicant (M/s Genix Pharma, Karachi)
Sr. No. Documents to be provided Status
1. COA of API Yes
2. Approval of API by regulatory authority of country of origin or GMP
certificate of API manufacturer issued by regulatory authority of country of
origin.
Yes
(Copy of GMP certificate
provided)
3. Protocols followed for conduction of stability study and details of tests. Yes
4. Data of 03 batches will be supported by attested respective documents like
chromatograms, laboratory reports, data sheets etc.
Yes (Attested photocopies
provided)
5. Documents confirming import of API etc. Yes (ADC cleared)
6. All provided documents will be attested (name, sign and stamp) for ensuring
authenticity of data / documents.
Yes
7. Commitment to continue real time stability study till assigned shelf life of the
product.
Yes
Decision: Mr. Masood-ur-Rehman, Manager Quality Control presented the data. Registration Board observed that the stability data
provided by the firm is in accorndace with the guidelines approved by the Board in 251st meeting. Therefore, Board granted
approval of registration of Sofosbuvir 400 mg tablets to the firm. However, manufacturer will inform concerned Federal Inspector of
Drugs for taking sample of Active Pharmaceutical Ingredient (used in manufacture of first commercial batch) for test/ analysis from
Central Drugs Laboratory, Karachi before sale of finished product.
Minutes for 253rd
Registration Board Meeting 34
3. M/s Crystolite Pharma, Islamabad
Drug Hepvir tablets (Sofosbuvir) 400 mg
Source M/s Qingdao Fraken, China
Storage Condition Real Time: 30 C and 75% RH
Accelerated: 40 C and 75% RH
Time Period Real Time: 6 months
Accelerated: 6 months
Frequency 0, 1,2, 3,6 months
Batch Size Batch 1: 400 tab
Batch 2: 400 tab
Batch 3: 400 tab
No. of Batches 03
Sample Size 20 tablets
Meeting Deferred in 251st meeting of Registration Board for stability
(AT ACCELERATED CONDITIONS)
Hepvir(Sofosbuvir) 400mg Tablet Batch No.TCP-001 Batch Size 400 Tablets
S.NO TEST SPECIFICATIONS
O Month
02-02-2015
01
Month
02-03-2015
02
Month
02-04-2015
03
Month
04-05-2015
06 Month
04-08-2015
Month
Manufacturing Date 02-2015 Expiry Date 02-2017
Date Of Manufacture 02/02/2015 Sample Size 20 Tablets
Minutes for 253rd
Registration Board Meeting 35
1 Physical Appearance
White, oblongfilm coated tablet with
Crystolite` on one side & plain on
other side.
Complies Complies complies complies complies
2 Identification Sofosbuvir must be positive +ve +ve +ve +ve +ve
3 Disintegration Time NMT 30 minutes 6.15 minutes 6.09 Minutes 6.45minutes 5.55 minutes 6.14 minutes
Average weight of the
tablet 700mg±5.0% 766 769 762 761 769
4 Dissolution NLT 85% in 20 minutes 94.5% 93.8% 95.2% 93.4% 92.5%
4 Assay 90 % to 110 % 100.14 % 99.96% 98.82 % 99.78% 100.63 %
PRODUCT STABILITY TESTING REPORT CONDUCTED AT 40°C ± 2, RH 75 % ± 5
(AT ACCELERATED CONDITIONS)
Hepvir(Sofosbuvir) 400mg Tablet Batch No.TCP-002 Batch Size 400 Tablets
S.NO TEST SPECIFICATIONS O Month
03-03-2015
01
Month
03-04-
2015
02
Month
05-05-
2015
03
Month
03-06-2015
06 Month
03-09-2015
Month
Manufacturing Date 03-2015 Expiry Date 03-2017
Date Of Manufacture 03/03/2015 Sample Size 20 Tablets
Minutes for 253rd
Registration Board Meeting 36
1 Physical Appearance
White, oblongfilm coated tablet with
Crystolite` on one side & Bisected
on other side.
Complies Complies complies complies Complies
2 Identification Sofosbuvir must be positive +ve +ve +ve +ve +ve
3 Disintegration Time NMT 30 minutes 6.23
minutes
6.
45Minutes 6.0minutes 5.55minutes 5.35 minutes
Average weight of the
tablet 700mg±5.0% 766 762 765 768 762
4 Dissolution NLT 85% in 20 minutes 95.5% 93.5% 92.6% 95.0% 92.6%
4 Assay 90 % to 110 % 98.75 % 99.52% 99.43 % 99.82% 99.95%
PRODUCT STABILITY TESTING REPORT CONDUCTED AT 40°C ± 2, RH 75 % ± 5
(AT ACCELERATED CONDITIONS)
Hepvir(Sofosbuvir) 400mg Tablet Batch No.TCP-003 Batch Size Tablets 400
S.NO TEST SPECIFICATIONS
O Month
10-03-2015
01
Month
10-04-2015
02
Month
11-05-
03
Month
10-06-2015
06 Month
10-09-2015
Month
Manufacturing Date 03-2015 Expiry Date 03-2017
Date Of Manufacture 10-03-2015 Sample Size 20 Tablets
Minutes for 253rd
Registration Board Meeting 37
2015
1 Physical Appearance
White, oblongfilm coated tablet with
Crystolite` on one side & Bisected
on other side.
Complies Complies Complies complies complies
2 Identification Sofosbuvir must be positive +ve +ve +ve +ve +ve
3 Disintegration Time NMT 30 minutes 6.10 minutes 6. Minutes 5.55
minutes 6.22 minutes 5.59 minutes
Average weight of the
tablet 700mg±5.0% 769 762 765 764 767
4 Dissolution NLT 85% in 20 minutes 93.5% 96.4% 96.4% 93.2% 95.1%
4 Assay 90 % to 110 % 99.99 % 99.89% 99.92 % 99.82% 99.98 %
PRODUCT STABILITY TESTING REPORT CONDUCTED AT 30°C ± 2, RH 65 % ± 5
ON GOING LONG TERM
(REAL TIME)
Hepvir(Sofosbuvir) 400mg Tablet Batch No.TCP-001 Batch Size Tablets 400
S.NO TEST SPECIFICATIONS
O
Month
02-02-2015
03
Month
04-05-2015
06 month
04-08-2015
09
month
12
month
18
month
24
month
Manufacturing Date 02-2015 Expiry Date 02-2017
Date Of Manufacture 02-02-2015 Sample Size 20 Tablets
Minutes for 253rd
Registration Board Meeting 38
1 Physical Appearance
White, oblong film coated tablet
with Crystolite` on one side &
Bisected on other side.
White,
oblong film
coated tablet
with
Crystolite`
on one side
& Bisected
on other side
White,
oblong film
coated tablet
with
Crystolite`
on one side
& Bisected
on other side
White,
oblong film
coated tablet
with
Crystolite` on
one side &
Bisected on
other side
- - - -
2 Identification Sofosbuvir must be positive +ve +ve- +ve - - - -
3 Disintegration Time NMT 30 minutes 6.20 minutes 6.3minutes 6.54minutes - - - -
4 Dissolution NLT 85% in 20 minutes 96% 96.4% 93.5% - - - -
4 Assay 90 % to 110 % 100.95 % 99.33% 99.59% - - - -
PRODUCT STABILITY TESTING REPORT CONDUCTED AT 30°C ± 2, RH 65 % ± 5 ON GOING LONG TERM
(REAL TIME)
Hepvir(Sofosbuvir) 400mg Tablet Batch No.TCP-002 Batch Size Tablets 400
S.NO TEST SPECIFICATIONS
O
Month
03-03-2015
03
Month
03-06-2015
06
Month
03-09-2015
09
month
12
month
18
month
24
month
1 Physical Appearance
White, oblongfilm coated tablet with
Crystolite` on one side & Bisected
on other side.
White,
oblong film
coated tablet
with
Crystolite`
White,
oblong film
coated tablet
with
Crystolite`
White,
oblong film
coated tablet
with
Crystolite`
- - - -
Manufacturing Date 03-2015 Expiry Date 03-2017
Date Of Manufacture 03-03-2015 Sample Size 20 Tablets
Minutes for 253rd
Registration Board Meeting 39
on one side
& Bisected
on other side
on one side
& Bisected
on other side
on one side
& Bisected
on other side
2 Identification Sofosbuvir must be positive +ve +ve +ve - - - -
3 Disintegration Time NMT 30 minutes 6.20 minutes 6.50 minutes 6.40 minutes - - - -
4 Dissolution NLT 85% in 20 minutes 94.5% 96.8% 94.6% - - - -
4 Assay 90 % to 110 % 100.24% 99.99 % 99.87 % - - - -
PRODUCT STABILITY TESTING REPORT CONDUCTED AT 30°C ± 2, RH 65 % ± 5
ON GOING LONG TERM (REAL TIME)
Hepvir(Sofosbuvir) 400mg Tablet Batch No.TCP-003 Batch Size Tablets 400
S.NO TEST SPECIFICATIONS
O
Month
10-03-2015
03
Month
10-06-2015
06
Month
10-09-2015
09
month
12
month
18
month
24
month
1 Physical Appearance
White, oblongfilm coated tablet with
Crystolite` on one side & Bisected
on other side.
White,
oblong film
coated tablet
with
Crystolite`
on one side
& Bisected
on other side
White,
oblong film
coated tablet
with
Crystolite`
on one side
& Bisected
on other side
White,
oblong film
coated tablet
with
Crystolite`
on one side
& Bisected
on other side
- - - -
Manufacturing Date 03-2015 Expiry Date 03-2017
Date Of Manufacture 10-03-2015 Sample Size 20 Tablets
Minutes for 253rd
Registration Board Meeting 40
2 Identification Sofosbuvir must be positive +ve +ve +ve - - - -
3 Disintegration Time NMT 30 minutes 6.08 minutes 56.20
minutes 6.50 minutes - - - -
Average weight of the
tablet 700mg±5.0% 764 766 769 - - - -
4 Dissolution NLT 85% in 20 minutes 96.5% 93.6% 96.5% - - - -
4 Assay 90 % to 110 % 100.00% 100.07 % 99.89 % - - - -
Documents / Data provided by the applicants (M/s Crystolite, Islamabad)
Sr. No. Documents to be provided Status
1. COA of API Yes
2. Approval of API by regulatory authority of country of origin or GMP certificate of
API manufacturer issued by regulatory authority of country of origin.
Yes (Photocopy
provided)
3. Protocols followed for conduction of stability study and details of tests. Yes
4. Data of 03 batches will be supported by attested respective documents like
chromatograms, laboratory reports, data sheets etc.
Yes
5. Documents confirming import of API etc. Yes (By courier)
6. All provided documents will be attested (name, sign and stamp) for ensuring
authenticity of data / documents.
Yes
7. Commitment to continue real time stability study till assigned shelf life of the product. Yes
Decision: Mr.Amir Raza, Quality Control Manager presented the data. Registration Board observed that the stability data provided
by the firm is in accorndace with the guidelines approved by the Board in 251st meeting. Therefore, Board granted approval of
registration of Sofosbuvir 400 mg tablets to the firm. However, manufacturer will inform concerned Federal Inspector of Drugs for
taking sample of Active Pharmaceutical Ingredient (used in manufacture of first commercial batch) for test/ analysis from Central
Drugs Laboratory, Karachi before sale of finished product.
Minutes for 253rd
Registration Board Meeting 41
4. M/s PharmEvo (Pvt) ltd
Drug Zoval tablets (Sofosbuvir) 400 mg
Source Zhejiang Jiangbei Pharmaceutical Pvt Ltd
Storage Condition Accelerated: 40 C and 75% RH
Real time: 30 C and 75% RH
Time Period Accelerated: 6 months
Real Time: 3 months
Frequency 0, 3, 6 months
Batch Size 400 tablets (Accelerated only)
24500 tablets (Accelerated and RT: 03
months)
No. of Batches 02
Sample Size 200
Batch 1 (Real Time)
Commercial Batch-Long Term Stability Data
Assessment frequency (Months) Initial 1 2 3 6
Date of Testing 03-06-2015 23-07-2015 21-08-2015 21-09-2015
Mode of testing (F=full.) F F F F F Tests (Physical. Chemical) Acceptance Criteria Storage Conditions
(Accelerated)
Appearance Yellow color oblong biconvex
shape film coated tablet plain
from both sides
30◦C ± 2◦C & 75%
RH. ± 5% RH.
Complies Complies Complies Complies
Minutes for 253rd
Registration Board Meeting 42
Identification Positive for Sofosbuvir by
HPLC. The retention time of the
Sample peak in the
chromatogram of the assay
preparation corresponds to that
of the standard preparation as
obtained in the assay.
30◦C ± 2◦C & 75%
RH. ± 5% RH.
Retention time
complies
Retention time
complies
Retention time
complies
Retention time
complies
AVERAGE WEIGHT/TAB 915.0mg ± 5% 30◦C ± 2◦C & 75%
RH. ± 5% RH.
912.7 mg 915.8 mg 921.4 mg 918.4 mg
LENGTH
18.80 – 19.20 mm
30◦C ± 2◦C & 75%
RH. ± 5% RH.
19.14 mm 19.07mm 19.02mm 19.08 mm
WIDTH 8.80 – 9.20 mm 30◦C ± 2◦C & 75%
RH. ± 5% RH.
8.92 mm 9.05 mm 8.96 mm 9.03 mm
THICKNESS 6.30 – 6.90 mm 30◦C ± 2◦C & 75%
RH. ± 5% RH
6.41 mm 6.52 mm 6.49 mm 6.58 mm
DISINTEGRATION NMT 30 mins. 30◦C ± 2◦C & 75%
RH. ± 5% RH
5 mins. 3 mins 4 mins 5 mins
DISSOLUTION
(SOFOSUBVIR )
Not less than 80% after 45
minutes
30◦C ± 2◦C & 75%
RH. ± 5% RH
86.04%
84.78%
95.22%
96.56 %
Assay(SOFOSUBVIR )
(90.0 to 110.0) %
30◦C ± 2◦C & 75%
RH. ± 5% RH
98.45 % 98.53 % 98.32 % 99.37 %
Analyst signature (after completion of every time line)
Conclusion by QA (after completion of the study):
Long term stability study at 300C + 20C and 75% + 5% R.H will be performed for 3 month showed no or little change over time. No significant changes were observed in the physical and
chemical characteristics of the drug product after 3 month.
Accelerated
Commercial Batch-Accelerated Stability Data
Assessment frequency (Months) Initial 1 2 3 6
Date of Testing 03-06-2015 23-07-2015 21-08-2015 21-09-2015
Mode of testing (F=full.) F F F F F
Tests (Physical. Acceptance Criteria Storage Conditions
Minutes for 253rd
Registration Board Meeting 43
Chemical) (Accelerated)
Appearance Yellow color oblong biconvex shape
film coated tablet plain from both
sides
40◦C ± 2◦C & 75%
RH. ± 5% RH.
Complies Complies Complies Complies
Identification Positive for Sofosbuvir by HPLC.
The retention time of the Sample
peak in the chromatogram of the
assay preparation corresponds to that
of the standard preparation as
obtained in the assay.
40◦C ± 2◦C & 75%
RH. ± 5% RH.
Retention time
complies
Retention time
complies
Retention time
complies
Retention time
complies
AVERAGE
WEIGHT/TAB
915.0mg ± 5% 40◦C ± 2◦C & 75%
RH. ± 5% RH.
912.7 mg 914.8 mg 920.1 mg 917.3 mg
LENGTH
18.80 – 19.20 mm
40◦C ± 2◦C & 75%
RH. ± 5% RH.
19.14 mm 19.07mm 19.11mm 19.13 mm
WIDTH 8.80 – 9.20 mm 40◦C ± 2◦C & 75%
RH. ± 5% RH.
8.92 mm 8.97 mm 8.95 mm 8.94 mm
THICKNESS 6.30 – 6.90 mm 40◦C ± 2◦C & 75%
RH. ± 5% RH
6.41 mm 6.48mm 6.43mm 6.47mm
DISINTEGRATION NMT 30 mins. 40◦C ± 2◦C & 75%
RH. ± 5% RH
5 mins. 4 mins 5 mins 3 mins
DISSOLUTION
(SOFOSUBVIR )
Not less than 80% after 45 minutes
40◦C ± 2◦C & 75%
RH. ± 5% RH
86.04% 86.44 % 95.47 % 95.85 %
Assay(SOFOSUBVIR )
(90.0 to 110.0) %
40◦C ± 2◦C & 75%
RH. ± 5% RH
98.45 % 100.92 % 99.49 % 100.05 %
Analyst signature (after completion of every time line)
Conclusion by QA (after completion of the study):
Accelerated stability study at 400C + 20C and 75% + 5% R.H will be performed for 3 month showed no or little change over time. No significant changes were observed in the physical and
chemical characteristics of the drug product after 3 month.
Minutes for 253rd
Registration Board Meeting 44
Batch 2:
Lab Scale Batch-Accelerated Stability Data
Assessment frequency (Months) Initial 3 6 Date of Testing 06-11-2014 10-02-2015 12-05-2015 Mode of testing (F=full.) F F F Tests (Physical.
Chemical) Acceptance Criteria Storage Conditions
(Accelerated)
Appearance Yellow color oblong biconvex
shape film coated tablet plain
from both sides
40◦C ± 2◦C & 75% RH.
± 5% RH. Complies Complies Complies
Identification Positive for Sofosbuvir by
HPLC. The retention time of the
Sample peak in the
chromatogram of the assay
preparation corresponds to that
of the standard preparation as
obtained in the assay.
40◦C ± 2◦C & 75% RH.
± 5% RH. Retention time
complies
Retention time
complies
Retention time complies
AVERAGE
WEIGHT/TAB
915.0mg ± 5% 40◦C ± 2◦C & 75% RH.
± 5% RH. 915.4 mg 915.8 mg 915.1 mg
LENGTH
18.80 – 19.20 mm
40◦C ± 2◦C & 75% RH.
± 5% RH. 19.04 mm 19.07mm 19.02 mm
WIDTH 8.80 – 9.20 mm 40◦C ± 2◦C & 75% RH.
± 5% RH. 9.01 mm 9.05 mm 9.03 mm
THICKNESS 6.30 – 6.90 mm 40◦C ± 2◦C & 75% RH.
± 5% RH 6.60 mm 6.68mm 6.65 mm
DISINTEGRATION NMT 30 mins. 40◦C ± 2◦C & 75% RH.
± 5% RH 4 mins. 6 mins 3 mins
DISSOLUTION
(SOFOSUBVIR )
Not less than 80% after 45
minutes
40◦C ± 2◦C & 75% RH.
± 5% RH
98.39%
93.45%
90.07%
Assay(SOFOSUBVIR )
(90.0 to 110.0) %
40◦C ± 2◦C & 75% RH.
± 5% RH 100.50 % 97.44 % 98.88%
Minutes for 253rd
Registration Board Meeting 45
Analyst signature (after completion of every time line)
Conclusion by QA (after completion of the study):
Accelerated stability study at 400C + 20C and 75% + 5% R.H will be performed for 6 month showed no or little change over time. No significant changes were observed in the
physical and chemical characteristics of the drug product after 6 month.
Documents / Data provided by the applicants (M/s PharmEvo, Karachi)
Sr. No. Documents to be provided Status
1. COA of API Yes (COA for lab scale batch
not provided)
2. Approval of API by regulatory authority of country of origin or GMP
certificate of API manufacturer issued by regulatory authority of country of
origin.
Yes (GMP for lab scale batch
not provided)
3. Protocols followed for conduction of stability study and details of tests. Yes
4. Data of 03 batches will be supported by attested respective documents like
chromatograms, laboratory reports, data sheets etc.
No (Data of two batches
provided)
5. Documents confirming import of API etc. Invoice of 10 kg API provided.
However, invoice of API for lab
scale batch not provided.
6. All provided documents will be attested (name, sign and stamp) for ensuring
authenticity of data / documents.
Yes
7. Commitment to continue real time stability study till assigned shelf life of the
product.
Yes
Decision: Dr.Iftakhar Jafri, Chief Operating Officer presented the data. He also provided attested copies of GMP of API manufacturer,
Certificate of analysis of the material and invoice of API for lab scale batch. Registration Board observed that the stability data provided by
the firm is not in accordance with the guidelines approved by the Board in 251st meeting as firm has provided staility data for 02 batches.
Therefore, case was deferred till the applicant completes the requisite information in respect of stability studies.
Minutes for 253rd
Registration Board Meeting 46
5. M/s Hilton Pharma, Karachi
Drug Sofohil tablets (Sofosbuvir) 400 mg
Source Zheiejiang jianjbi Pharmaceutical Co, Limited
China (200gm)
Wuxi Sigma Chemical Product Co. Ltd, China (01
kg)
Virupaksha Organics, Telangana, India (500gm)
Storage Condition Real Time: 30 C and 65% RH
Accelerated: 40 C and 75% RH
Time Period Real Time: 9 months
Accelerated: 6 months
Frequency 0, 1, 3, 6 months
Batch Size 500 Tablets, 2500 Tablets, 400 Tablets
No. of Batches 03
Sample Size 26 tablets
Meeting Deferred in 244th and 251
st meeting of Registration
Board.
Attributes Tested (Batch 1) Real Time
Batch Number :
SOF-192710-1
Date of Manufacturing:
01-10-2014
Proposed Expiry Date:
2 Years Potency : 400mg / Tablet
Kept on stability :
10-10-2014
Container : Alu Alu Foil Blister
Storage Temperature : 30°C ± 2°C
Storage Humidity : 65% ± 5%
Tested / Analyzed For Specification Limits
RESULTS AT TEST STATIONS
Dates Oct-14 Nov-14 Jan-15 Apr-15 Jul-15
Months Initial 1st 3rd 6th 9th
Minutes for 253rd
Registration Board Meeting 47
Description White, Oblong, film
coated tablets
White, Oblong,
film coated tablets
White, Oblong, film
coated tablets
White, Oblong, film
coated tablets
White, Oblong, film
coated tablets
White, Oblong, film
coated tablets
Assay 90 -- 110 % 100.38% 99.89% 99.59% 99.53% 99.46%
Dissolution NLT 85% (Q+5%) in
20 minutes 98% 98% 98% 95% 95%
Degradation products
GS-606965
GS-331007
GS-566500
GS-607669
GS-607670
Phenol
NMT 0.5%
NMT 0.5%
NMT 0.5%
NMT 0.5%
NMT 0.5%
NMT 0.5%
Not detected
0.09%
0.03%
0.01%
Not detected
Not detected
Not detected
0.09%
0.01%
0.01%
0.043%
Not detected
Not detected
0.05%
0.03%
0.05%
0.083%
Not detected
Not detected
0.05%
0.04%
0.08%
0.123%
Not detected
Not detected
0.04%
0.03%
0.06%
0.118%
Not detected
Unspecified
Degradation Product NMT 0.2% 0.06% 0.06% 0.05% 0.05% 0.07%
Total degradation
product NMT 0.8% 0.32% 0.180% 0.263% 0.293% 0.317%
Accelerated
Batch Number : SOF-192710-1 Date of Manufacturing: 01-10-2014 Proposed Expiry Date: 2 Years
Potency : 400mg / Tablet
Kept on stability : 10-10-2014 Container : Alu Alu Foil Blister
Storage Temperature : 40°C ± 2°C
Storage Humidity : 75% ± 5%
Tested/Analyzed
For
Specification Limits
RESULTS AT TEST STATIONS
Dates Oct-14 Nov-14 Jan-15 Apr-15
Months Initial 1st 3rd 6th
Minutes for 253rd
Registration Board Meeting 48
Description White, Oblong, film
coated tablets
White, Oblong, film
coated tablets
White, Oblong, film
coated tablets
White, Oblong, film
coated tablets
White, Oblong, film coated
tablets
Assay 90 -- 110 % 100.38% 99.51% 98.47% 98.58%
Dissolution NLT 85% (Q+5%) in
20 minutes 98% 98% 98% 94%
Degradation products
GS-606965
GS-331007
GS-566500
GS-607669
GS-607670
Phenol
NMT 0.5%
NMT 0.5%
NMT 0.5%
NMT 0.5%
NMT 0.5%
NMT 0.5%
Not detected
0.09%
0.03%
0.01%
Not detected
Not detected
Not detected
0.07%
0.08%
0.01%
0.01%
Not detected
Not detected
0.02%
0.05%
0.10%
0.113%
Not detected
Not detected
0.05%
0.06%
0.10%
0.211%
Not detected
Unspecified Degradation
Product NMT 0.2% 0.06% 0.06% 0.05% 0.04%
Total degradation product NMT 0.8% 0.32% 0.230% 0.333% 0.461%
Attributes Tested (Batch 2) Real Time
Batch Number :
SOF-194312-2
Date of Manufacturing:
31-12-2014
Proposed Expiry Date:
2 Years Potency : 400mg / Tablet
Kept on stability :
09-01-2015
Container : Alu Alu Foil Blister
Storage Temperature : 30°C ± 2°C
Storage Humidity : 65% ± 5%
Tested / Analyzed For Specification Limits
RESULTS AT TEST STATIONS
Dates Dec-14 Apr-15 Jul-15
Months Initial 3rd 6th
Minutes for 253rd
Registration Board Meeting 49
Description White, Oblong, film coated
tablets
White, Oblong, film coated
tablets
White, Oblong, film coated
tablets White, Oblong, film coated tablets
Assay 90 -- 110 % 100.04% 99.53% 99.46%
Dissolution NLT 85% (Q+5%) in 20
minutes 95% 94% 93%
Degradation products
GS-606965
GS-331007
GS-566500
GS-607669
GS-607670
Phenol
NMT 0.5%
NMT 0.5%
NMT 0.5%
NMT 0.5%
NMT 0.5%
NMT 0.5%
Not detected
Not detected
Not detected
0.01%
0.03%
Not detected
Not detected
0.01%
Not detected
Not detected
0.048%
Not detected
Not detected
0.01%
Not detected
Not detected
0.05%
Not detected
Unspecified Degradation
Product NMT 0.2% 0.045% 0.044% 0.040%
Total degradation product NMT 0.8% 0.085% 0.102% 0.101%
Accelerated
Batch Number :
SOF-194312-2
Date of Manufacturing:
31-12-2014
Proposed Expiry Date:
2 Years Potency : 400mg / Tablet
Kept on stability :
09-01-2015
Container : Alu Alu Foil Blister
Storage Temperature : 40°C ± 2°C
Storage Humidity : 75% ± 5%
Tested / Analyzed For Specification Limits
RESULTS AT TEST STATIONS
Dates Dec-14 Apr-15 Jul-15
Months Initial 3rd 6th
Minutes for 253rd
Registration Board Meeting 50
Description White, Oblong, film coated
tablets
White, Oblong, film coated
tablets
White, Oblong, film coated
tablets White, Oblong, film coated tablets
Assay 90 -- 110 % 100.04% 99.91% 98.83%
Dissolution NLT 85% (Q+5%) in 20
minutes 95% 94% 92%
Degradation products
GS-606965
GS-331007
GS-566500
GS-607669
GS-607670
Phenol
NMT 0.5%
NMT 0.5%
NMT 0.5%
NMT 0.5%
NMT 0.5%
NMT 0.5%
Not detected
Not detected
Not detected
0.01%
0.03%
Not detected
Not detected
0.02%
Not detected
0.03%
0.101%
Not detected
Not detected
0.01%
Not detected
0.01%
0.103%
Not detected
Unspecified Degradation
Product NMT 0.2% 0.045% 0.054% 0.048%
Total degradation product NMT 0.8% 0.085% 0.205% 0.204%
Attributes Tested (Batch 3) Real Time
Batch Number :
SOF-194612-3
Date of Manufacturing:
17.04.2015
Proposed Expiry Date:
2 Years Potency : 400mg / Tablet
Kept on stability :
20.04.2015 Container : Alu Alu Foil Blister Storage Temperature : 30°C ± 2°C Storage Humidity : 65% ± 5%
Tested / Analyzed For Specification Limits
RESULTS AT TEST STATIONS
Dates Dec-14 Apr-15
Months Initial 3rd
Description White, Oblong, film coated tablets White, Oblong, film coated tablets White, Oblong, film coated tablets
Minutes for 253rd
Registration Board Meeting 51
Assay 90 -- 110 % 100.62% 100.40%
Dissolution NLT 85% (Q+5%) in 20 minutes 100% 99%
Degradation products
GS-606965
GS-331007
GS-566500
GS-607669
GS-607670
Phenol
NMT 0.5%
NMT 0.5%
NMT 0.5%
NMT 0.5%
NMT 0.5%
NMT 0.5%
Not detected
Not detected
Not detected
Not detected
Not detected
Not detected
Not detected
Not detected
Not detected
Not detected
Not detected
Not detected
Unspecified Degradation Product NMT 0.2% Not detected Not detected
Total degradation product NMT 0.8% Not detected Not detected
Accelerated
Batch Number :
SOF-194612-3
Date of Manufacturing:
17.04.2015
Proposed Expiry Date:
2 Years Potency : 400mg / Tablet
Kept on stability :
20.04.2015 Container : Alu Alu Foil Blister Storage Temperature : 40°C ± 2°C Storage Humidity : 75% ± 5%
Tested / Analyzed For Specification Limits
RESULTS AT TEST STATIONS
Dates Dec-14 Apr-15
Months Initial 3rd
Description White, Oblong, film coated tablets White, Oblong, film coated tablets White, Oblong, film coated tablets
Assay 90 -- 110 % 100.62% 99.70%
Minutes for 253rd
Registration Board Meeting 52
Dissolution NLT 85% (Q+5%) in 20 minutes 100% 99%
Degradation products
GS-606965
GS-331007
GS-566500
GS-607669
GS-607670
Phenol
NMT 0.5%
NMT 0.5%
NMT 0.5%
NMT 0.5%
NMT 0.5%
NMT 0.5%
Not detected
Not detected
Not detected
Not detected
Not detected
Not detected
Not detected
Not detected
Not detected
Not detected
Not detected
Not detected
Unspecified Degradation Product NMT 0.2% Not detected Not detected
Total degradation product NMT 0.8% Not detected Not detected
Documents / Data provided by the applicants
(M/s Hilton Pharma, Karachi)
Sr. No. Documents to be provided Status
1. COA of API Yes
2. Approval of API by regulatory authority of country
of origin or GMP certificate of API manufacturer
issued by regulatory authority of country of origin.
Yes
3. Protocols followed for conduction of stability study
and details of tests.
Yes
Minutes for 253rd
Registration Board Meeting 53
4. Data of 03 batches will be supported by attested
respective documents like chromatograms,
laboratory reports, data sheets etc.
Yes
5. Documents confirming import of API etc. Invoices of three batches from three different sources
provided.
500 gram from India (ADC Cleared).
200 gram & 01 Kg from China (custom cleared)
6. All provided documents will be attested (name, sign
and stamp) for ensuring authenticity of data /
documents.
Yes
7. Commitment to continue real time stability study till
assigned shelf life of the product.
Yes
Decision: Mr.Saleem Riaz, Director technical presented the data. He explained that firm has pre-qualified M/s Virupaksha Organics,
Telangana, India as API source and manufactured 03 laboratory scale batches and submitted real time and accelerated stability data for
about 05 months and 15 days. Registration Board observed that the stability data provided by the firm is not in accordance with the
guidelines approved by the Board in 251st meeting as firm has provided staility data for 02 batches. Therefore, case was deferred till the
applicant completes the requisite information in respect of stability studies.
Minutes for 253rd
Registration Board Meeting 54
6. M/s Genome Pharma, Hattar
Drug CHC tablets (Sofosbuvir) 400 mg
Source M/s Beijing Baiao Pharma, China
Storage Condition Real Time: 30 C and 75% RH
Accelerated: 40 C and 75% RH
Time Period Real Time: 6 months
Accelerated: 6 months
Frequency 0, 1,2, 3,6 months
Batch Size Batch 1: 400 tab
Batch 2: 400 tab
Batch 3: 400 tab
No. of Batches 03
Meeting Deferred in 244th
and 251st meeting of
Registration Board for stability
Stability Study Data Sheet
1.0 Product details:
Product name /Generic
name/Dosage form CHC-400mg (Sofosbuvir) Tablets Batch No. T-001
Description of pack
(container closure system)
28 Tablets in Alu Alu Blister Packed in Card Board Unit
Carton. Batch Size. 400 Tablets
Parameters and tests mentioned As per Product Specifications (Genome Spec‟s) Mfg. Date 07-03-2015
Recommended storage conditions Short term conditions (Accelerated) 40+ 2C, 75 +5RH Exp Date 06-03-2017
Date of initiation & implementation 08-03-2015 (API) lot no.
Sofosbuvir
Minutes for 253rd
Registration Board Meeting 55
Batch No 20150201
Stability No. ST/GP/CHC-001 Source Beijing baiao
Pharmaceuticals Co. Ltd
Accelerated
Tests Specifications
Results: Frequency/Date
0 Month 1 Month 2 Months 3 Months 6 Months
08-03-2015 08-04-2015 08-05-2015 08-06-2015 08-09-2015
Description
White to off-white oblong
unscored biconvex film
coated tablets
Off-white Off-white Off-white Off-white Off-white
Identification Sofosbuvir must be positive Complies Complies Complies Complies Complies
D.T NMT 30 minutes 04minutes 04minutes 04minutes 05minutes 07 minutes
Dissolution NLT 80%(Q) in 45minutes 95.46% 95.38% 95.29% 95.21% 93.87%
Assay 90.0% - 110% 100.43% 100.19% 100.10% 100.15% 99.95 %
Tested by QC Analyst
Sample taken for physical tests = 24 Tabs
Sample taken for Chemical tests = 104 Tabs
Sample taken for Microbiological tests = N/A
Extra samples (if needed) = N/A
Total Sample size (approx) = 128 Tabs
Minutes for 253rd
Registration Board Meeting 56
Checked by QC Manager
1.0 Product details:
Product name /Generic
name/Dosage form CHC-400mg (Sofosbuvir) Tablets Batch No. T-002
Description of pack
(container closure system)
28 Tablets in Alu Alu Blister Packed in Card Board Unit
Carton. Batch Size. 400 Tablets
Parameters and tests mentioned As per Product Specifications (Genome Spec‟s) Mfg. Date 10-03-2015
Recommended storage conditions Short term conditions (Accelerated) 40+ 2C, 75 +5RH Exp Date 09-03-2017
Date of initiation & implementation 11-03-2015 (API) lot no.
Sofosbuvir
Batch No 20150201
Stability No. ST/GP/CHC-002 Source Beijing baiao
Pharmaceuticals Co. Ltd
Accelerated
Tests Specifications Results: Frequency/Date
Sample taken for physical tests = 24 Tabs
Sample taken for Chemical tests = 104 Tabs
Sample taken for Microbiological tests = N/A
Extra samples (if needed) = N/A
Total Sample size (approx) = 128 Tabs
Minutes for 253rd
Registration Board Meeting 57
0 Month 1 Month 2 Months 3 Months 6 Months
11-03-2015 11-04-2015 11-05-2015 11-06-2015 11-09-2015
Description
White to off-white oblong
unscored biconvex film
coated tablets
Off-white Off-white Off-white Off-white Off-white
Identification Sofosbuvir must be positive Complies Complies Complies Complies Complies
D.T NMT 30 minutes 03minutes 03minutes 04minutes 04minutes 06minutes
Dissolution NLT 80%(Q) in 45minutes 96.01% 95.82% 95.75% 95.72% 94.85%
Assay 90.0% - 110% 100.75% 100.69% 100.61% 100.43% 99.96%
Tested by QC Analyst
Checked by QC Manager
Product name /Generic
name/Dosage form CHC-400mg (Sofosbuvir) Tablets Batch No. T-003
Description of pack
(container closure system)
28 Tablets in Alu Alu Blister Packed in Card Board Unit
Carton. Batch Size. 400 Tablets
Parameters and tests mentioned As per Product Specifications (Genome Spec‟s) Mfg. Date 17-03-2015
Recommended storage conditions Short term conditions (Accelerated) 40+ 2C, 75 +5RH Exp Date 16-03-2017
Date of initiation & implementation 18-03-2015 (API) lot no.
Sofosbuvir
Minutes for 253rd
Registration Board Meeting 58
Batch No 20150201
Stability No. ST/GP/CHC-003 Source Beijing baiao
Pharmaceuticals Co. Ltd
Tests Specifications
Results: Frequency/Date
0 Month 1 Month 2 Months 3 Months 6 Months
18-03-2015 18-04-2015 18-05-2015 18-06-2015 18-09-2015
Description
White to off-white oblong
unscored biconvex film
coated tablets
Off-white Off-white Off-white Off-white Off-white
Identification Sofosbuvir must be positive Complies Complies Complies Complies Complies
D.T NMT 30 minutes 06minutes 06minutes 06minutes 07minutes 08 minutes
Dissolution NLT 80%(Q) in 45minutes 98.73% 98.65% 98.62% 98.58% 95.22%
Assay 90.0% - 110% 99.23% 99.22% 99.21% 99.19% 99.0 %
Sample taken for physical tests = 24 Tabs
Sample taken for Chemical tests = 104 Tabs
Sample taken for Microbiological tests = N/A
Extra samples (if needed) = N/A
Total Sample size (approx) = 128 Tabs
Minutes for 253rd
Registration Board Meeting 59
Tested by QC Analyst
Checked by QC Manager
Stability Study Data Sheet
1.0 Product details:
Product name /Generic
name/Dosage form CHC-400mg (Sofosbuvir) Tablets Batch No. T-001
Description of pack
(container closure system)
28 Tablets in Alu Alu Blister Packed in Card Board Unit
Carton. Batch Size. 400 Tablets
Parameters and tests mentioned As per Product Specifications (Genome Spec‟s) Mfg. Date 07-03-2015
Recommended storage conditions Long term conditions (Real Time) 30+ 2C, 65 +5RH Exp Date 06-03-2017
Date of initiation & implementation 08-03-2015 (API) lot no.
Sofosbuvir
Batch No 20150201
Stability No. ST/GP/CHC-001 Source Beijing baiao
Pharmaceuticals Co. Ltd
Sample taken for physical tests = 36 Tabs
Sample taken for Chemical tests = 156 Tabs
Sample taken for Microbiological tests = N/A
Extra samples (if needed) = N/A
Total Sample size (approx) = 192 Tabs
Minutes for 253rd
Registration Board Meeting 60
Tests Specifications
Results: Frequency/Date
0 Month 3 Months 6 Months 9 Months 12 Months 18 Months 24 Months
08-03-2015 08-06-2015 08-09-2015 08-12-2015 08-03-2016 08-09-2016 08-03-2017
Description
White to off-white oblong
unscored biconvex film
coated tablets
Off-white Off-white Off-white
Identification Sofosbuvir must be
positive Complies Complies Complies
D.T NMT 30 minutes 04minutes 04minutes 04minutes
Dissolution NLT 80%(Q) in 45minutes 95.46% 95.37% 94.65%
Assay 90.0% - 110% 100.43% 100.23% 100.21%
Tested by QC Analyst
Checked by QC Manager
Stability Study Data Sheet
1.0 Product details:
Product name /Generic
name/Dosage form CHC-400mg (Sofosbuvir) Tablets Batch No. T-002
Description of pack
(container closure system)
28 Tablets in Alu Alu Blister Packed in Card Board Unit
Carton. Batch Size. 400 Tablets
Parameters and tests mentioned As per Product Specifications (Genome Spec‟s) Mfg. Date 10-03-2015
Minutes for 253rd
Registration Board Meeting 61
Recommended storage conditions Long term conditions (Real Time) 30+ 2C, 65 +5RH Exp Date 09-03-2017
Date of initiation & implementation 11-03-2015 (API) lot no.
Sofosbuvir
Batch No 20150201
Stability No. ST/GP/CHC-002 Source Beijing baiao
Pharmaceuticals Co. Ltd
Tests Specifications
Results: Frequency/Date
Initial 3 Months 6 Months 9 Months 12 Months 18 Months 24 Months
11-03-2015 11-06-2015 11-09-2015 11-12-2015 11-03-2016 11-09-2016 11-03-2017
Description
White to off-white oblong
unscored biconvex film
coated tablets
Off-white Off-white Off-white
Identification Sofosbuvir must be
positive Complies Complies Complies
D.T NMT 30 minutes 03minutes 03minutes 03minutes
Dissolution NLT 80%(Q) in 45minutes 96.01% 96.28 % 95.08%
Sample taken for physical tests = 36 Tabs
Sample taken for Chemical tests = 156 Tabs
Sample taken for Microbiological tests = N/A
Extra samples (if needed) = N/A
Total Sample size (approx) = 192 Tabs
Minutes for 253rd
Registration Board Meeting 62
Assay 90.0% - 110% 100.75% 100.51% 100.46%
Tested by QC Analyst
Checked by QC Manager
Stability Study Data Sheet
1.0 Product details:
Product name /Generic
name/Dosage form CHC-400mg (Sofosbuvir) Tablets Batch No. T-003
Description of pack
(container closure system)
28 Tablets in Alu Alu Blister Packed in Card Board Unit
Carton. Batch Size. 400 Tablets
Parameters and tests mentioned As per Product Specifications (Genome Spec‟s) Mfg. Date 17-03-2015
Recommended storage conditions Long term conditions (Real Time) 30+ 2C, 65 +5RH Exp Date 16-03-2017
Date of initiation & implementation 18-03-2015 (API) lot no.
Sofosbuvir
Batch No 20150201
Stability No. ST/GP/CHC-003 Source Beijing baiao
Pharmaceuticals Co. Ltd
Sample taken for physical tests = 36 Tabs
Sample taken for Chemical tests = 156 Tabs
Sample taken for Microbiological tests = N/A
Extra samples (if needed) = N/A
Total Sample size (approx) = 192 Tabs
Minutes for 253rd
Registration Board Meeting 63
Tests Specifications
Results: Frequency/Date
0 Month 3 Months 6 Months 9 Months 12 Months 18 Months 24 Months
18-03-2015 18-06-2015 18-09-2015 18-12-2015 18-03-2016 18-09-2016 18-03-2017
Description
White to off-white oblong
unscored biconvex film
coated tablets
Off-white Off-white Off-white
Identification Sofosbuvir must be
positive Complies Complies Complies
D.T NMT 30 minutes 06minutes 06minutes 06minutes
Dissolution NLT 80%(Q) in 45minutes 98.73% 98.64% 98.58%
Assay 90.0% - 110% 99.23% 99.21% 99.18%
Tested by QC Analyst
Checked by QC Manager
Minutes for 253rd
Registration Board Meeting 64
Documents / Data provided by the applicants (M/s Genome Pharma, Hattar)
Sr. No. Documents to be provided Status
1. COA of API Yes
2. Approval of API by regulatory authority of country of origin or GMP
certificate of API manufacturer issued by regulatory authority of country of
origin.
Yes (Photocopy provided)
3. Protocols followed for conduction of stability study and details of tests. Yes
4. Data of 03 batches will be supported by attested respective documents like
chromatograms, laboratory reports, data sheets etc.
Yes
5. Documents confirming import of API etc. Yes
(ADC cleared)
6. All provided documents will be attested (name, sign and stamp) for ensuring
authenticity of data / documents.
Yes
7. Commitment to continue real time stability study till assigned shelf life of the
product.
No
Decision: Mr. Bakht Zameen, Quality Assurance Manager presented the data. Registration Board observed that the stability data
provided by the firm is in accorndace with the guidelines approved by the Board in 251st meeting. Therefore, Board granted
approval of registration of Sofosbuvir 400 mg tablets to the firm. However, manufacturer will inform concerned Federal Inspector of
Drugs for taking sample of Active Pharmaceutical Ingredient (used in manufacture of first commercial batch) for test/ analysis from
Central Drugs Laboratory, Karachi before sale of finished product.
Minutes for 253rd
Registration Board Meeting 65
7. M/s High-Q Pharma, Karachi
Drug Basovir tablets (Sofosbuvir) 400 mg
Source M/s Jiang Xi Synergy Pharma, China
Storage Condition Real Time: 30 C and 65% RH
Accelerated: 40 C and 75% RH
Time Period Real Time: 6 months
Accelerated: 6 months
Frequency 0, 1,2, 3,6 months
Batch Size 60 tablets per batch
No. of Batches 03
Meeting Deferred in 244th
and 251st meeting of
Registration Board for stability
Stability Data for BASOVIR (Sofosbuvir) 400 mg Tablets
Stability Program Number: STP-048-013
Batch Size: 60 Tablets
Batch Number: TRBBSV-001
Real Time
Test Initial
1
(Month)
3
(Month)
6
(Month)
Description
Complies
Complies
Complies
Complies
Minutes for 253rd
Registration Board Meeting 66
Stability Data for BASOVIR (Sofosbuvir) 400 mg Tablets
Stability Program Number: STP-048-013
Batch Size: 60 Tablets
Batch Number: TRBBSV-002
Real Time
Sofosbuvir
by HPLC
(% Label Claim)
101.1
100.9
100.4
100.1
Dissolution
By U.V
94,97,93,
98,101,95
X = 96%
98,102,97
94,98,96
X = 97.5%
99,96,101
93,95,97
X = 96.8%
98,97,99
95,97,94
X = 96.6%
Test
Initial
1
(Month)
3
(Month)
6
(Month)
Description
Complies
Complies
Complies
Complies
Sofosbuvir
by HPLC
(% Label Claim)
100.8
99.9
99.4
99.1
Dissolution
By U.V
96,99,94
94,99,97
X = 96.5%
97,99,96
92,96,97
X = 96%
97,97,95
92,96,94
X = 95%
94,96,94
93,96,95
X = 95%
Minutes for 253rd
Registration Board Meeting 67
Stability Data for BASOVIR (Sofosbuvir) 400 mg Tablets
Stability Program Number: STP-048-013
Batch Size: 60 Tablets
Batch Number: TRBBSV-003
Real Time
Test Initial
1
(Month)
3
(Month)
6
(Month)
Description
Complies
Complies
Complies
Complies
Sofosbuvir
by HPLC
(% Label Claim)
100.9
100.8
100.2
100.0
Dissolution
By U.V
98,99,97
98,97,99
X = 98%
100,95,99,
95,95,97
X = 97%
96,95,97
96,94,93
X = 95%
99,94,92
93,93,95
X = 94%
Minutes for 253rd
Registration Board Meeting 68
Stability Data for BASOVIR (Sofosbuvir) 400 mg Tablets
Stability Program Number: STP-048-013
Batch Size: 60 Tablets
Batch Number: TRBBSV-001
Accelerated
Test
Initial
1
(Month)
3
(Month)
6
(Month)
Description
Complies
Complies
Complies
Complies
Sofosbuvir
by HPLC
(% Label Claim)
101.1
100.9
99.6
97.7
Dissolution
By U.V
94,97,93,
98,101,95
X = 96%
94,93,95
97,98,94
X = 95%
97,98,92
91,94,92
X = 94%
95,95,97
92,95,93
X = 94%
Minutes for 253rd
Registration Board Meeting 69
Stability Data for BASOVIR (Sofosbuvir) 400 mg Tablets
Stability Program Number: STP-048-013
Batch Size: 60 Tablets
Batch Number: TRBBSV-002
Accelerated
Test
Initial
1
(Month)
3
(Month)
6
(Month)
Description
Complies
Complies
Complies
Complies
Sofosbuvir
by HPLC
(% Label Claim)
100.8
101.1
99.2
97.3
Dissolution
By U.V
96,99,94
94,99,97
X = 96.5%
99,95,96
97,95,99
X = 96.8%
99,97,94
93,95,94
X = 95%
95,96,92
95,93,94
X = 94%
Minutes for 253rd
Registration Board Meeting 70
Stability Data for BASOVIR (Sofosbuvir) 400 mg Tablets
Stability Program Number: STP-048-013
Batch Size: 60 Tablets
Batch Number: TRBBSV-003
Accelerated
Test
Initial
1
(Month)
3
(Month)
6
(Month)
Description
Complies
Complies
Complies
Complies
Sofosbuvir
by HPLC
(% Label Claim)
100.9
100.2
99.4
98.1
Dissolution
By U.V
98,99,97
98,97,99
X = 98%
96,97,99
95,94,95
X = 96%
97,95,97
95,96,96
X = 96%
97,95,94
92,95,96
X = 95%
Minutes for 253rd
Registration Board Meeting 71
Documents / Data provided by the applicantsm (M/s High-Q Pharma, Karachi)
Sr. No. Documents to be provided Status
1. COA of API Yes
2. Approval of API by regulatory authority of country of origin or GMP
certificate of API manufacturer issued by regulatory authority of country of
origin.
Yes (Photocopy provided)
3. Protocols followed for conduction of stability study and details of tests. Yes
4. Data of 03 batches will be supported by attested respective documents like
chromatograms, laboratory reports, data sheets etc.
Yes
5. Documents confirming import of API etc. Yes
(ADC cleared)
6. All provided documents will be attested (name, sign and stamp) for ensuring
authenticity of data / documents.
Yes
7. Commitment to continue real time stability study till assigned shelf life of the
product.
Yes
Decision: No representative of the firm appeared to discuss the data. Registration Board observed that the stability data provided by the
firm is not in accordance with the guidelines approved by the Board in 251st meeting as firm has provided staility data for 02 batches and
clarification is also required regarding number of talets manufactured in a batch and tests performed for staility studies. Therefore, case
was deferred till the applicant completes the requisite information in respect of stability studies.
Minutes for 253rd
Registration Board Meeting 72
8. GLOBAL PHARMA ISLAMABAD
Drug VIRO-C tablets (Sofosbuvir) 400 mg
Source Sulli Pharma Tech, China
Storage Condition Accelerated: 40 C and 75% RH
Real Time: 30 C and 65% RH
Time Period Accelerated: 6 months
Real Time: 6 months
Frequency 0, 1, 3, 6 months
Batch Size Batch I: 100 tabs
Batch II: 100 tab
Batch III: 250 tabs
No. of Batches 03
Sample Size 400 tablets
Meeting Deferred in 244th
and 251st meeting of
Registration Board for stability as per
WHO/ICH guidelines
ACCELERATED STABILITY STUDY REPORT
Product name / Generic
Name / Dosage form
Viro C Tablets 400mg (Sofosbuvir) Batch No. B#T-004
Description of pack (Container
closure system)
19mm oblong, Biconvex, Off White Coated
Tablets, Packed in HDPE-Bottles with Child
resistant closure & Slicagel Bag.
Batch Size 250 Tablets
Minutes for 253rd
Registration Board Meeting 73
Parameters and tests mentioned As per Product Specifications (Accelerated)
Mfg. Date Dec - 2014
Recommended storage conditions
Short term conditions (Accelerated) 40 +- 2C,
75+-5RH
Long term conditions (Real Time) 30 +
-2C,
65+
-5RH
Exp Date Nov - 2016
Date of initiation
& implementation
17/12/2014
API Lot No. 0049CT29183/2014
Stability No. 15/R&D/135
Approval by : QC Manager:......................................
QA Manager:......................................
Production Manager:...........................
R&D Manager:....................................
Assessment frequency (week) Initial (0) 1 2 3 4 6 8 12 16 20 24 26
Date of Testing
16-12--
2014
16-03-
2015
16-06-
2015
Mode of testing (F = Full, P = Partial testing)F F P F P F F F F F F F F
Sample taken for physical test = 20 Tablets
Sample taken for Chemical Test = 20 Tablets
Sample taken for Microbiological tests = NA
Extra samples (If Needed) = NA Tot al Sample size 40 x2 = 80 Tab
Minutes for 253rd
Registration Board Meeting 74
Tests(Physical,
Chemical
Microbiological)
Acceptance
Criteria
Storage
Condition
(Accelerated)
Apperance
19mm oblong, biconvex, Off
White Coated
400
C+-20
C 75%
RH+
-5%RH
Complies Complies Complies
Dissolution NLT 75% 40
0
C+-20
C 75% RH+
-5%RH
98.7% 96.2% 95.9%
Identification Positive
400C
+-2
0C 75%
RH+
-5%RH
Positive Positive Positive
Assay 90-110% 400C
+-20C 75% RH
+-
5%RH
101.3% 103.3 103.5%
Analyst signature (after completion of every time line
Tablets
Conclusion by QA (After completion of the study
ACCELERATED STABILITY STUDY REPORT
Product name / Generic Name / Dosage form
Viro C Tablets 400mg (Sofosbuvir) Batch No. B#T-005
Description of pack (Container
closure system)
19mm oblong, Biconvex, Off White
Coated Tablets, Packed in HDPE-
Bottles with Child resistant closure &
Slicagel Bag.
Batch Size 100 Tablets
Parameters and tests mentioned
As per Product Specifications
(Accelerated)
Mfg. Date Dec - 2014
Minutes for 253rd
Registration Board Meeting 75
Recommended storage conditions
Short term conditions (Accelerated) 40
+- 2C, 75+-5RH
Long term conditions (Real Time) 30 +
-2C, 65+
-5RH
Exp Date Nov - 2016
Date of initiation & implementation 17/12/2014
API Lot No.
0049CT2918
3/2014
Stability No. 15/R&D/136
Approval by : QC Manager:......................................
QA Manager:......................................
Production Manager:...........................
R&D Manager:....................................
Assessment frequency (week) Initial (0) 1 2 3 4 6 8 12 16 20 24 26
Date of Testing
17-12-
2014
17-03-
2015
17-06-
2015
Mode of testing (F = Full, P = Partial testing)F F P F P F F F F F F F F
Tests(Physical,
Chemical
Microbiological)
Acceptance
Criteria
Storage
Condition
(Accelerated)
Apperance
19mm oblong,
biconvex, Off
White Coated
400
C+-20
C 75%
RH+
-5%RH
Complies Complies Complies
Dissolution NLT 75% 40
0
C+-20
C 75% RH+
-5%RH
97.7% 96.0% 95.7%
Sample taken for physical test = 10 Tablets
Sample taken for Chemical Test = 10 Tablets
Sample taken for Microbiological tests = NA
Extra samples (If Needed) = NA Tot al Sample size 20 x2 = 40 Tab
Minutes for 253rd
Registration Board Meeting 76
Identification Positive
400C
+-2
0C 75%
RH+
-5%RH
Positive Positive Positive
Assay 90-110% 400C
+-20C 75% RH
+-
5%RH
100.10% 103.5% 103.4%
Analyst signature (after completion of every time line Tablets
Conclusion by QA (After completion of the study
ACCELERATED STABILITY STUDY REPORT
Product name / Generic Name / Dosage form
Viro C Tablets 400mg (Sofosbuvir) Batch No. B#T-006
Description of pack (Container
closure system)
19mm oblong, Biconvex, Off White
Coated Tablets, Packed in HDPE-
Bottles with Child resistant closure &
Slicagel Bag.
Batch Size 100 Tablets
Parameters and tests mentioned
As per Product Specifications
(Accelerated)
Mfg. Date Dec - 2014
Recommended storage conditions
Short term conditions (Accelerated) 40
+- 2C, 75+-5RH
Long term conditions (Real Time) 30 +
-2C, 65+
-5RH
Exp Date Nov - 2016
Minutes for 253rd
Registration Board Meeting 77
Date of initiation &implementation
17/12/2014
API Lot No.
0049CT2918
3/2014
Stability No. 15/R&D/137
Approval by : QC Manager:......................................
QA Manager:......................................
Production Manager:...........................
R&D Manager:....................................
Assessment frequency (week) Initial (0) 1 2 3 4 6 8 12 16 20 24 26
Date of Testing
17-12--
2014
17-03-
2015
16-06-
2015
Mode of testing (F = Full, P = Partial testing)F F P F P F F F F F F F F
Tests(Physical,
Chemical
Microbiological)
Acceptance
Criteria
Storage
Condition
(Accelerated)
Apperance
19mm oblong,
biconvex, Off White Coated
400
C+-20
C 75%
RH+
-5%RH
Complies Complies Complies
Dissolution NLT 75% 40
0
C+-20
C 75% RH+
-5%RH
98.7% 95.8% 95.9%
Identification Positive 400C
+-2
0C 75% Positive Positive Positive
Sample taken for physical test = 10 Tablets
Sample taken for Chemical Test = 10 Tablets
Sample taken for Microbiological tests = NA
Extra samples (If Needed) = NA Tot al Sample size 20 x2 = 40 Tab
Minutes for 253rd
Registration Board Meeting 78
RH+
-5%RH
Assay 90-110% 400C
+-20C 75% RH
+-
5%RH
100.60% 104.5% 103.9%
Analyst signature (after completion of every time line Tablets
Conclusion by QA (After completion of the study
REAL TIME STABILITY STUDY REPORT
Product name / Generic
Name / Dosage form
Viro C Tablets 400mg (Sofosbuvir) Batch No. B#T-004
Description of pack (Container
closure system)
19mm oblong, Biconvex, Off White
Coated Tablets, Packed in HDPE-
Bottles with Child resistant closure &
Slicagel Bag.
Batch Size 100 Tablets
Parameters and tests mentioned
As per Product Specifications (Real
Time)
Mfg. Date Dec - 2014
Recommended storage conditions
Short term conditions (Accelerated) 40
+- 2C, 75+-5RH
Long term conditions (Real Time) 30 +
-2C, 65+
-5RH
Exp Date Nov - 2016
Date of initiation
& implementation
17/12/2014
API Lot No.
0049CT2918
3/2014
Minutes for 253rd
Registration Board Meeting 79
Stability No. 15/R&D/138
Approval by : QC Manager:......................................
QA Manager:......................................
Production Manager:...........................
R&D Manager:....................................
Assessment frequency (week) Initial (0) 1 2 3 4 6 8 12 16 20 24 26
Date of Testing
16-12--
2014
16-03-
2015
16-06-
2015
Mode of testing (F = Full, P = Partial testing)F F P F P F F F F F F F F
Tests(Physical,
Chemical
Microbiological)
Acceptance
Criteria
Storage
Condition
(Real
Time)
Apperance
19mm oblong, biconvex, Off
White Coated
300
C+-20
C
65% RH+
-5%RH
Complies Complies Complies
Dissolution NLT 75%
300
C+-20
C
65% RH+
-5%RH
98.7% 94.9% 94.9%
Identification Positive
300
C+-20
C
65% RH+
-5%RH
Positive Positive Positive
Assay 90-110% 300
C+-20
C 101.33% 103.54% 100.50%
Sample taken for physical test = 20 Tablets
Sample taken for Chemical Test = 20 Tablets
Sample taken for Microbiological tests = NA
Extra samples (If Needed) = NA Total Sample size 40 x3 = 120 Tab
Minutes for 253rd
Registration Board Meeting 80
65% RH+
-5%RH
Analyst signature (after completion of every time line
Tablets
Conclusion by QA (After completion of the study
REAL TIME STABILITY STUDY REPORT
Product name / Generic
Name / Dosage form
Viro C Tablets 400mg (Sofosbuvir) Batch No. B#T-005
Description of pack (Container
closure system)
19mm oblong, Biconvex, Off White
Coated Tablets, Packed in HDPE-
Bottles with Child resistant closure &
Slicagel Bag.
Batch Size 100 Tablets
Parameters and tests mentioned
As per Product Specifications (Real
Time)
Mfg. Date Dec - 2014
Recommended storage conditions
Short term conditions (Accelerated) 40
+- 2C, 75+-5RH
Long term conditions (Real Time) 30 +
-2C, 65+
-5RH
Exp Date Nov - 2016
Date of initiation
& implementation
17/12/2014
API Lot No.
0049CT2918
3/2014
Stability No. 15/R&D/139
Minutes for 253rd
Registration Board Meeting 81
Appro val by : QC Manager:......................................
QA Manager:......................................
Production Manager:...........................
R&D Manager:....................................
Assessment frequency (week) Initial (0) 1 2 3 4 6 8 12 16 20 24 26
Date of Testing
16-12--
2014
16-03-
2015
16-06-
2015
Mode of testing (F = Full, P = Partial testing)F F P F P F F F F F F F F
Tests(Physical,
Chemical
Microbiological)
Acceptance
Criteria
Storage
Condition
(Real
Time)
Apperance
19mm oblong,
biconvex, Off
White Coated
300
C+-20
C
65% RH+
-5%RH
Complies Complies Complies
Dissolution NLT 75%
300
C+-20
C
65% RH+
-5%RH
97.7% 94.6% 94.2%
Identification Positive
300
C+-20
C
65% RH+
-5%RH
Positive Positive Positive
Assay 90-110%
300
C+-20
C
65% RH+
-5%RH
101.10% 100.14% 100.09%
Sample taken for physical test = 10 Tablets
Sample taken for Chemical Test = 10 Tablets
Sample taken for Microbiological tests = NA
Extra samples (If Needed) = NA Tot al Sample size 20 x3 = 60 Tab
Minutes for 253rd
Registration Board Meeting 82
Analyst signature (after completion of every time line
Tablets
Conclusion by QA (After completion of the study
REAL TIME STABILITY STUDY REPORT
Product name / Generic Name / Dosage form
Viro C Tablets 400mg (Sofosbuvir) Batch No. B#T-006
Description of pack (Container
closure system)
19mm oblong, Biconvex, Off White
Coated Tablets, Packed in HDPE-
Bottles with Child resistant closure &
Slicagel Bag.
Batch Size 100 Tablets
Parameters and tests mentioned As per Product Specifications (Real
Time) Mfg. Date Dec - 2014
Recommended storage conditions
Short term conditions (Accelerated) 40
+- 2C, 75+-5RH
Long term conditions (Real Time) 30 +
-2C, 65+
-5RH
Exp Date Nov - 2016
Date of initiation & implementation 17/12/2014
API Lot No.
0049CT2918
3/2014
Stability No. 15/R&D/140
Appro val by : QC Manager:...................................... Sample take n for physical test = 10 Tablets
Sample take n for Chemical Test = 10 Tablets
Sample take n for Microbiological tests = NA
Extra samples (If Needed) = NA Tot al Sample size 20 x3 = 60 Tab
Minutes for 253rd
Registration Board Meeting 83
QA Manager:......................................
Production Manager:...........................
R&D Manager:....................................
Assessment frequency (week) Initial (0) 1 2 3 4 6 8 12 16 20 24 26
Date of Testing
16-12--
2014
16-03-
2015
16-06-
2015
Mode of testing (F = Full, P = Partial testing)F F P F P F F F F F F F F
Tests(Physical,
Chemical
Microbiological)
Acceptance
Criteria
Storage
Condition
(Real
Time)
Apperance
19mm oblong,
biconvex, Off
White Coated
300
C+-20
C
65% RH+
-5%RH
Complies Complies Complies
Dissolution NLT 75%
300
C+-20
C
65% RH+
-5%RH
98.7% 95.4% 95.9%
Identification Positive
300
C+-20
C
65% RH+
-5%RH
Positive Positive Positive
Assay 90-110%
300
C+-20
C
65% RH+
-5%RH
100.60% 100.54% 100.35%
Analyst signature (after completion of every time line
Tablets
Conclusion by QA (After completion of the study
Minutes for 253rd
Registration Board Meeting 84
Documents / Data provided by the applicants
Global Pharma, Islamabad
Sr. No. Documents to be provided Status
1. COA of API Yes
2. Approval of API by regulatory authority of country of origin or GMP
certificate of API manufacturer issued by regulatory authority of country of
origin.
Yes
3. Protocols followed for conduction of stability study and details of tests. Yes
4. Data of 03 batches will be supported by attested respective documents like
chromatograms, laboratory reports, data sheets etc.
Yes
5. Documents confirming import of API etc. Yes (ADC cleared)
6. All provided documents will be attested (name, sign and stamp) for ensuring
authenticity of data / documents.
Partially attested
7. Commitment to continue real time stability study till assigned shelf life of the
product.
Yes
Decision: Mr.Zamir-ul-Hussan and Mr.Anis Iqbal presented the data. Registration Board observed that the stability data provided
by the firm is in accorndace with the guidelines approved by the Board in 251st meeting. Therefore, Board granted approval of
registration of Sofosbuvir 400 mg tablets to the firm. However, manufacturer will inform concerned Federal Inspector of Drugs for
taking sample of Active Pharmaceutical Ingredient (used in manufacture of first commercial batch) for test/ analysis from Central
Drugs Laboratory, Karachi before sale of finished product.
Minutes for 253rd
Registration Board Meeting 85
9. CCL PHARMA ISLAMABAD
Drug Sofos tablets (Sofosbuvir) 400 mg
Source Jianxi Synergy Pharma, China
Storage Condition Accelerated: 40 C and 75% RH
Real Time: 30 C and 65% RH
Time Period Accelerated: 6 months
Real Time: 6 months
Frequency 0, 3, 6 months
Batch Size Batch I: 400 tabs
Batch II: 400 tab
Batch III: 400 tabs
No. of Batches 03
Sample Size 360 tablets
Meeting Deferred in 244th
and 251st meeting of
Registration Board for stability as per
WHO/ICH guidelines
Stability Study Data Sheet
1.0 Product details:
Product name /Generic
name/Dosage form
Sofos tablets 400mg
Sofosbuvir Batch No. T1 / 15
Description of pack
(container closure system)
1260mg film coated, with 19.8mm length, pink oblong
biconvex tablet blistered in 265mm Alu-Alu, in 3x10‟s tablet
packed in printed unit carton along with leaflet.
Batch Size. 400 tablets
Minutes for 253rd
Registration Board Meeting 86
Parameters and tests mentioned In House Mfg. Date 02-2015
Recommended storage conditions
Short term conditions (Accelerated) 40°C±2°C,
75% ±5%RH
Long term conditions (Real time) 30°C ± 2°C,
75% ±5 %RH
Exp Date 01-2017
Date of initiation & implementation 10-02-2015 (API) lot no. YF 20150123
Stability No. 024
Assessment frequency (Months) Initial 1 2 3 4 6 8 12 16 20 24 26
Date of Testing 10-2-15 - - 10-5-15 - 10-8-15
Mode of testing(F = full, P = Partial testing) F F F F F F F F F F F F
Tests (Physical,
Chemical,
Microbiological)
Acceptance
Criteria
Storage
conditions
(Accelerated)
Description
Pink Oblong
Biconvex film
coated Tablet
40oC ± 2
oC &
75%RH ± 5% RH Complies
- - Complies Complies
Dissolution NLT 75% of
Sofosbuvir
40oC ± 2
oC &
75%RH ± 5% RH 95.29%
- - 93.63% 90.58%
Sample taken for physical tests = 30 tabs.
Sample taken for Chemical tests = 90 tabs.
Extra samples (if needed) = NA
Total Sample size (approx) = 120tabs.
Minutes for 253rd
Registration Board Meeting 87
dissolved in
45min
Identification of
Sofosbuvir
Retention time
of standard
and sample
should be
comparable
40oC ± 2
oC &
75%RH ± 5% RH
Complies
- - Complies
Complies
Assay of
Sofosbuvir 90-110%
40oC ± 2
oC &
75%RH ± 5% RH 103.97%
- - 100.15% 99.13%
Analyst signature (after completion of every time line)
Conclusion by QA (after completion of the study):
Assessment frequency (Months) Initial 1 2 3 4 6 8 12 16 20 24 26
Date of Testing 10-2-15 - - 10-5-15 - 10-8-15
Mode of testing(F = full, P = Partial testing) F F F F F F F F F F F F
Tests(Physical,
Chemical,
Microbiological)
Acceptance
Criteria
Storage
conditions
(Real Time)
Description
Pink Oblong
Biconvex film
coated Tablet
30 oC ± 2
oC,
75%RH ± 5% RH Complies
- - Complies Complies
Dissolution
NLT 75% of
Sofosbuvir
dissolved in
45min
30 oC ± 2
oC,
75%RH ±5% RH 95.29%
- - 94.68% 91.47%
Identification of Retention time 30 oC ± 2
oC, Complies
Minutes for 253rd
Registration Board Meeting 88
Sofosbuvir
of standard
and sample
should be
comparable
75%RH ± 5% RH - - Complies Complies
Assay of
Sofosbuvir 90-110%
30 oC ± 2
oC,
75%RH ± 5% RH 103.97%
- - 103.87% 101.51%
Analyst signature (after completion of every time line)
Conclusion by QA (after completion of the study):
Stability Study Data Sheet
1.0 Product details:
Product name /Generic
name/Dosage form
Sofos tablets 400mg
Sofosbuvir
Batch No. T2 / 15
Description of pack
(container closure system)
1260mg film coated, with 19.8mm length, Pink oblong
biconvex tablet blistered in 265mm Alu-Alu, in 3x10‟s tablet
packed in printed unit carton along with leaflet.
Batch Size. 400 tablets
Parameters and tests mentioned In House Mfg. Date 02-2015
Recommended storage conditions
Short term conditions (Accelerated) 40°C±2°C,
75% ±5%RH
Long term conditions (Real time) 30°C ±2C,
75% ±5 %RH
Exp Date 01-2017
Minutes for 253rd
Registration Board Meeting 89
Date of initiation & implementation 16-02-2015 (API) lot no. YF 20150123
Stability No. 028
Sample taken for physical tests = 30 tabs.
Sample taken for Chemical tests = 90 tabs.
Extra samples (if needed) = NA
Total Sample size (approx) = 120 tabs.
Minutes for 253rd
Registration Board Meeting 90
Assessment frequency (Months) Initial 1 2 3 4 6 8 12 16 20 24 26
Date of Testing 16-2-15 - - 16-5-15 - 16-8-15
Mode of testing(F = full, P = Partial testing) F F F F F F F F F F F F
Tests (Physical,
Chemical,
Microbiological)
Acceptance
Criteria
Storage
conditions
(Accelerated)
Description
Pink Oblong
Biconvex film
coated Tablet
40oC ± 2
oC &
75%RH ± 5% RH Complies
- - Complies Complies
Dissolution
NLT 75% of
Sofosbuvir
dissolved in
45min
40oC ± 2
oC &
75%RH ± 5% RH 96.75%
- - 93.85% 90.69%
Identification of
Sofosbuvir
Retention time
of standard
and sample
should be
comparable
40oC ± 2
oC &
75%RH ± 5% RH
Complies
- - Complies Complies
Assay of
Sofosbuvir 90-110%
40oC ± 2
oC &
75%RH ± 5% RH 103.93%
- - 100.15% 99.07%
Analyst signature (after completion of every time line)
Conclusion by QA (after completion of the study):
Minutes for 253rd
Registration Board Meeting 91
Assessment frequency (Months) Initial 1 2 3 4 6 8 12 16 20 24 26
Date of Testing 16-2-15 - - 16-5-15 - 16-8-15
Mode of testing(F = full, P = Partial testing) F F F F F F F F F F F F
Tests(Physical,
Chemical,
Microbiological)
Acceptance
Criteria
Storage
conditions
(Real Time)
Description
Pink Oblong
Biconvex film
coated Tablet
30 oC ± 2
oC,
75%RH ± 5% RH Complies
- - Complies Complies
Dissolution
NLT 75% of
Sofosbuvir
dissolved in
45min
30 oC ± 2
oC,
75%RH ±5% RH 96.75%
- - 95.51% 93.77%
Identification of
Sofosbuvir
Retention time
of standard
and sample
should be
comparable
30 oC ± 2
oC,
75%RH ± 5% RH
Complies
- -
Complies
Complies
Assay of
Sofosbuvir 90-110%
30 oC ± 2
oC,
75%RH ± 5% RH 103.93%
- - 103.32% 102.03%
Analyst signature (after completion of every time line)
Conclusion by QA (after completion of the study):
Minutes for 253rd
Registration Board Meeting 92
Stability Study Data Sheet
1.0 Product details:
Product name /Generic
name/Dosage form
Sofos tablets 400mg
Sofosbuvir Batch No. T3 / 15
Description of pack
(container closure system)
1260mg film coated, with 19.8mm length, Pink oblong
biconvex tablet blistered in 265mm Alu-Alu, in 3x10‟s tablet
packed in printed unit carton along with leaflet.
Batch Size. 400 tablets
Parameters and tests mentioned In House Mfg. Date 02-2015
Recommended storage conditions
Short term conditions (Accelerated) 40°C± 2°C,
75%±5%RH
Long term conditions (Real time) 30°C±2°C,
75%±5 %RH
Exp Date 01-2017
Date of initiation & implementation 22-02-2015 (API) lot no.
YF 20150123
Stability No. 038
Sample taken for physical tests = 30 tabs.
Sample taken for Chemical tests = 90 tabs.
Extra samples (if needed) = NA
Total Sample size (approx) = 120 tabs.
Minutes for 253rd
Registration Board Meeting 93
Assessment frequency (Months) Initial 1 2 3 4 6 8 12 16 20 24 26
Date of Testing 22-2-15 - - 22-5-15 - 22-8-15
Mode of testing(F = full, P = Partial testing) F F F F F F F F F F F F
Tests (Physical,
Chemical,
Microbiological)
Acceptance
Criteria
Storage
conditions
(Accelerated)
Description
Pink Oblong
Biconvex film
coated Tablet
40oC ± 2
oC &
75%RH ± 5% RH Complies
- - Complies Complies
Dissolution
NLT 75% of
sofosbuvir
dissolved in
45min
40oC ± 2
oC &
75%RH ± 5% RH 94.76%
- - 91.13% 89.84%
Identification of
Sofosbuvir
Retention time
of standard
and sample
should be
comparable
40oC ± 2
oC &
75%RH ± 5% RH Complies
- - Complies Complies
Assay of
Sofosbuvir 90-110%
40oC ± 2
oC & 75%RH
± 5% RH 103.29%
- - 99.52% 98.98%
Analyst signature (after completion of every time line)
Conclusion by QA (after completion of the study):
Minutes for 253rd
Registration Board Meeting 94
Assessment frequency (Months) Initial 1 2 3 4 6 8 12 16 20 24 26
Date of Testing 22-2-15 - - 22-5-15 - 22-8-15
Mode of testing(F = full, P = Partial testing) F F F F F F F F F F F F
Tests(Physical,
Chemical,
Microbiological)
Acceptance
Criteria
Storage
conditions
(Real Time)
Description
Pink Oblong
Biconvex film
coated Tablet
30 oC ± 2
oC,
75%RH ± 5% RH Complies
- - Complies Complies
Dissolution
NLT 75% of
Sofosbuvir
dissolved in
45min
30 oC ± 2
oC,
75%RH ± 5% RH 94.76%
- - 93.51% 91.28%
Identification of
Sofosbuvir
Retention time
of standard
and sample
should be
comparable
30 oC ± 2
oC,
75%RH ± 5% RH Complies
- - Complies Complies
Assay of
Sofosbuvir 90-110%
30 oC ± 2
oC,
75%RH ± 5% RH 103.29%
- - 101.76% 100.85%
Analyst signature (after completion of every time line)
Conclusion by QA (after completion of the study):
Minutes for 253rd
Registration Board Meeting 95
Documents / Data provided by the applicant
(M/s CCL Pharma, Lahore)
Sr. No. Documents to be provided Status
1. COA of API Yes
2. Approval of API by regulatory authority of country of origin or GMP
certificate of API manufacturer issued by regulatory authority of country of
origin.
Yes
3. Protocols followed for conduction of stability study and details of tests. Yes
4. Data of 03 batches will be supported by attested respective documents like
chromatograms, laboratory reports, data sheets etc.
No (raw data not attested)
5. Documents confirming import of API etc. Yes
(By courier)
6. All provided documents will be attested (name, sign and stamp) for ensuring
authenticity of data / documents.
Partially attested
7. Commitment to continue real time stability study till assigned shelf life of the
product.
Yes
Decision: Mr.Umer Saleem and Shahid Anwar presented the data. Registration Board observed that the stability data provided by
the firm is in accorndace with the guidelines approved by the Board in 251st meeting. Therefore, Board granted approval of
registration of Sofosbuvir 400 mg tablets to the firm. However, manufacturer will inform concerned Federal Inspector of Drugs for
taking sample of Active Pharmaceutical Ingredient (used in manufacture of first commercial batch) for test/ analysis from Central
Drugs Laboratory, Karachi before sale of finished product.
Minutes for 253rd
Registration Board Meeting 96
10. M/s Getz Pharma, Karachi
Drug Sofviget tablets (Sofosbuvir) 400 mg
Source Beijing Kawin Technology Share-Holding Co.
Ltd, China
Storage Condition Real Time: 30 C and 75% RH
Accelerated: 40 C and 75% RH
Time Period Real Time: 6 months
Accelerated: 6 months
Frequency 0, 3, 6 months
Two batches: six months
one batch : three months
Batch Size Not provided
No. of Batches 03
Sample Size Not provided
Meeting Deferred in 244th
and 251st meeting of
Registration Board for stability studies
Stability Study Data Sheet Product Details:
Product Name / Generic
name / Dosage form Sofviget (Sofosbuvir) Tablets 400mg Batch No. 262DS01
Description of pack
(container closure system)
400mg Yellow colored oblong shaped film coated
tablets, packed in 28 x 1 HDPE bottle, further packed
in secondary carton. Batch Size. 400 tablets
Parameters and test
mentioned
Appearance: Yellow colored oblong shaped film
coated tablets, both sides plain.
Disintegration Time: Not more than 30 minutes. Mfg. Date September 2014
Minutes for 253rd
Registration Board Meeting 97
Identification: The retention time of the major
peak in the chromatogram of the
Assay preparation corresponds to
that of the Standard preparation as
obtained in the Assay.
Dissolution: Not less than 75% (Q); (Q + 5% =
80%)
Assay: (90.0 – 110.0)%
Total Aerobic Not more than 1000 cfu/gm
Microbial Count:
Total Yeast & Mold Not more than 100 cfu/gm
Count:
Escherichia coli: Must be absent / 10gm
Recommended storage
conditions
Accelerated condition: 40°C ± 2°C & 75% ± 5%RH
Real time condition: 30°C ± 2°C & 75% ± 5%RH Exp. Date September 2016
Date of initiation &
Implementation September 2014 (API) lot no. HM174C00520140812
Stability No. FS-837
Sample taken for physical tests = 40
Sample taken for Chemical tests =
Sample taken for Microbiological tests = 10
Extra samples (if needed) = -
Total Sample size (approx) = 50
Minutes for 253rd
Registration Board Meeting 98
Assessment frequency (weeks) Initial 1 2 3 4 6 9 12 16 20 24 36
Date of Testing Sep-14 Dec-14 Mar-15
Mode of testing (F = full, P = Partial testing) F P F P F F F F F F F F
Tests (Physical,
Chemical,
Microbiological) Acceptance Criteria
Storage
conditions
(Accelerated)
Appearance Yellow colored oblong shaped film coated
tablets, both sides plain.
Complies
40°C ± 2°C &
75% ± 5%RH - - Complies - Complies
Disintegration Time
Not more than 30 minutes.
1 min
40°C ± 2°C & 75% ± 5%RH
- - 2 min - 2 min
Identification
The retention time of
the major peak in the
chromatogram of the Assay preparation
corresponds to that of
the Standard preparation as obtained in the
Assay.
Complies
40°C ± 2°C & 75% ± 5%RH
- - Complies - Complies
Dissolution Not less than 75% (Q); (Q + 5% = 80%)
91.801%
40°C ± 2°C &
75% ± 5%RH - - 91.040% - 96.749%
Assay (90.0 – 110.0)%
96.057%
40°C ± 2°C & 75% ± 5%RH
- - 97.295% - 96.760%
Total Aerobic
Microbial Count
Not more than 1000 cfu/gm
40°C ± 2°C &
75% ± 5%RH 0.00
cfu/g - - - -
0.00
cfu/g
Total Yeast &
Mold Count
Not more than 100
cfu/gm 40°C ± 2°C & 75% ± 5%RH
0.00
cfu/g - - - -
0.00
cfu/g
Escherichia coli Must be absent / 10gm 40°C ± 2°C & 75% ± 5%RH
Complies - - - - Complies
Analyst signature
Conclusion by QA
Minutes for 253rd
Registration Board Meeting 99
Assessment frequency (weeks) Initial 1 2 3 4 6 9 12 16 20 24 36
Date of Testing Sep-14 Dec-14 Mar-15 Jun-15
Mode of testing (F = full, P = Partial testing) F P F P F F F F F F F F
Tests (Physical,
Chemical,
Microbiological) Acceptance Criteria
Storage
conditions
(Accelerated)
Appearance Yellow colored oblong shaped film coated
tablets, both sides plain.
Complies
30°C ± 2°C &
75% ± 5%RH - - Complies - Complies Complies
Disintegration Time
Not more than 30 minutes.
1 min
30°C ± 2°C & 75% ± 5%RH
- - 1 min - 2 min 1 min
Identification
The retention time of
the major peak in the
chromatogram of the Assay preparation
corresponds to that of
the Standard preparation as obtained in the
Assay.
Complies
30°C ± 2°C & 75% ± 5%RH
- - Complies - Complies Complies
Dissolution Not less than 75% (Q); (Q + 5% = 80%)
91.801%
30°C ± 2°C &
75% ± 5%RH - - 96.670% - 96.626% 90.819%
Assay (90.0 – 110.0)%
96.057%
30°C ± 2°C & 75% ± 5%RH
- - 97.480% - 96.475% 101.054%
Total Aerobic
Microbial Count
Not more than 1000 cfu/gm
30°C ± 2°C &
75% ± 5%RH 0.00
cfu/g - - - - - -
Total Yeast &
Mold Count
Not more than 100
cfu/gm 30°C ± 2°C & 75% ± 5%RH
0.00
cfu/g - - - - - -
Escherichia coli Must be absent / 10gm 30°C ± 2°C & 75% ± 5%RH
Complies - - - - - --
Analyst signature
Conclusion by QA
Minutes for 253rd
Registration Board Meeting 100
Stability Study Data Sheet Product Details:
Product Name / Generic
name / Dosage form Sofviget (Sofosbuvir) Tablets 400mg Batch No. 262DS02
Description of pack
(container closure system)
400mg Yellow colored oblong shaped film coated
tablets, packed in 28 x 1 HDPE bottle, further packed
in secondary carton. Batch Size. 325 tablets
Parameters and test
mentioned
Appearance: Yellow colored oblong shaped film
coated tablets, both sides plain.
Disintegration Time: Not more than 30 minutes.
Identification: The retention time of the major
peak in the chromatogram of the
Assay preparation corresponds to
that of the Standard preparation as
obtained in the Assay.
Dissolution: Not less than 75% (Q); (Q + 5% =
80%)
Assay: (90.0 – 110.0)%
Total Aerobic Not more than 1000 cfu/gm
Microbial Count:
Total Yeast & Mold Not more than 100 cfu/gm
Count:
Escherichia coli: Must be absent / 10gm
Mfg. Date December 2014
Recommended storage
conditions
Accelerated condition: 40°C ± 2°C & 75% ± 5%RH
Real time condition: 30°C ± 2°C & 75% ± 5%RH Exp. Date December 2016
Date of initiation &
Implementation December 2014 (API) lot no. HM174C00520140812
Stability No. FS-879
Sample taken for physical tests = 40
Sample taken for Chemical tests =
Sample taken for Microbiological tests = 10
Minutes for 253rd
Registration Board Meeting 101
Extra samples (if needed) = -
Total Sample size (approx) = 50
Assessment frequency (weeks) Initial 1 2 3 4 6 9 12 16 20 24 36
Date of Testing Dec-14 Mar-15 Jun-15
Mode of testing (F = full, P = Partial testing) F P F P F F F F F F F F
Tests (Physical,
Chemical,
Microbiological) Acceptance Criteria
Storage
conditions
(Accelerated)
Appearance Yellow colored oblong shaped film coated tablets,
both sides plain.
Complies
40°C ± 2°C & 75%
± 5%RH - - Complies - Complies
Disintegration Time Not more than 30 minutes.
5 min
40°C ± 2°C & 75%
± 5%RH - - 3 min - 5 min
Identification
The retention time of the
major peak in the chromatogram of the
Assay preparation
corresponds to that of the Standard preparation as
obtained in the Assay.
Complies
40°C ± 2°C & 75% ± 5%RH
- - Complies - Complies
Dissolution Not less than 75% (Q); (Q
+ 5% = 80%)
93.879%
40°C ± 2°C & 75%
± 5%RH - - 97.105% - 97.038%
Assay (90.0 – 110.0)%
95.822%
40°C ± 2°C & 75%
± 5%RH - - 97.830% - 97.754%
Minutes for 253rd
Registration Board Meeting 102
Total Aerobic
Microbial Count
Not more than 1000
cfu/gm 40°C ± 2°C & 75%
± 5%RH 0.00 cfu/g - - - -
0.00
cfu/g
Total Yeast & Mold
Count Not more than 100 cfu/gm 40°C ± 2°C & 75%
± 5%RH 0.00 cfu/g - - - -
0.00
cfu/g
Escherichia coli Must be absent / 10gm 40°C ± 2°C & 75% ± 5%RH
Complies - - - - Complies
Analyst signature
Conclusion by QA
Minutes for 253rd
Registration Board Meeting 103
Assessment frequency (weeks) Initial 1 2 3 4 6 9 12 16 20 24 36
Date of Testing Dec-14 Mar-15 Jun-15
Mode of testing (F = full, P = Partial testing) F P F P F F F F F F F F
Tests (Physical,
Chemical,
Microbiological) Acceptance Criteria
Storage
conditions
(Accelerated)
Appearance
Yellow colored oblong
shaped film coated
tablets, both sides plain.
Complies
30°C ± 2°C & 75% ± 5%RH
- - Complies - Complies
Disintegration
Time
Not more than 30
minutes.
5 min
30°C ± 2°C & 75% ± 5%RH
- - 3 min - 5 min
Identification
The retention time of
the major peak in the
chromatogram of the
Assay preparation
corresponds to that of
the Standard preparation as obtained in the
Assay.
Complies
30°C ± 2°C &
75% ± 5%RH - - Complies - Complies
Dissolution Not less than 75% (Q);
(Q + 5% = 80%)
93.879%
30°C ± 2°C &
75% ± 5%RH - - 96.238% - 94.805%
Assay (90.0 – 110.0)%
95.822%
30°C ± 2°C & 75% ± 5%RH
- - 97.895% - 99.785%
Total Aerobic
Microbial Count
Not more than 1000
cfu/gm 30°C ± 2°C &
75% ± 5%RH 0.00
cfu/g - - - - -
Total Yeast &
Mold Count
Not more than 100
cfu/gm 30°C ± 2°C & 75% ± 5%RH
0.00
cfu/g - - - - -
Escherichia coli Must be absent / 10gm 30°C ± 2°C & 75% ± 5%RH
Complies - - - - -
Analyst signature
Conclusion by QA
Minutes for 253rd
Registration Board Meeting 104
Stability Study Data Sheet Product Details:
Product Name / Generic
name / Dosage form Sofviget (Sofosbuvir) Tablets 400mg Batch No. 262DS03
Description of pack
(container closure system)
400mg Yellow colored oblong shaped film coated
tablets, packed in 28 x 1 HDPE bottle, further packed
in secondary carton. Batch Size. 325 tablets
Parameters and test
mentioned
Appearance: Yellow colored oblong shaped film
coated tablets, both sides plain.
Disintegration Time: Not more than 30 minutes.
Identification: The retention time of the major
peak in the chromatogram of the
Assay preparation corresponds to
that of the Standard preparation as
obtained in the Assay.
Dissolution: Not less than 75% (Q); (Q + 5% =
80%)
Assay: (90.0 – 110.0)%
Total Aerobic Not more than 1000 cfu/gm
Microbial Count:
Total Yeast & Mold Not more than 100 cfu/gm
Count:
Escherichia coli: Must be absent / 10gm
Mfg. Date April 2015
Recommended storage
conditions
Accelerated condition: 40°C ± 2°C & 75% ± 5%RH
Real time condition: 30°C ± 2°C & 75% ± 5%RH Exp. Date April 2016
Date of initiation &
Implementation April 2015 (API) lot no. 2141206
Stability No. FS-056-15
Sample taken for physical tests = 40
Minutes for 253rd
Registration Board Meeting 105
Sample taken for Chemical tests =
Sample taken for Microbiological tests = 10
Extra samples (if needed) = -
Total Sample size (approx) = 50
Assessment frequency (weeks) Initial 1 2 3 4 6 9 12 16 20 24 36
Date of Testing Apr-15 Aug-15
Mode of testing (F = full, P = Partial testing) F P F P F F F F F F F F
Tests (Physical,
Chemical,
Microbiological) Acceptance Criteria
Storage
conditions
(Accelerated)
Appearance
Yellow colored oblong
shaped film coated
tablets, both sides plain.
Complies
40°C ± 2°C & 75% ± 5%RH
- - Complies
Disintegration
Time
Not more than 30
minutes.
2 min
40°C ± 2°C & 75% ± 5%RH
- - 3 min
Identification
The retention time of the major peak in the
chromatogram of the
Assay preparation corresponds to that of
the Standard preparation
as obtained in the
Assay.
Complies
40°C ± 2°C &
75% ± 5%RH - - Complies
Dissolution Not less than 75% (Q);
(Q + 5% = 80%)
93.804%
40°C ± 2°C &
75% ± 5%RH - - 88.759%
Assay (90.0 – 110.0)%
97.798%
40°C ± 2°C & 75% ± 5%RH
- - 96.231%
Minutes for 253rd
Registration Board Meeting 106
Total Aerobic
Microbial Count
Not more than 1000
cfu/gm 40°C ± 2°C & 75% ± 5%RH
0.00
cfu/g - - -
Total Yeast &
Mold Count
Not more than 100
cfu/gm 40°C ± 2°C & 75% ± 5%RH
0.00
cfu/g - - -
Escherichia coli Must be absent / 10gm 40°C ± 2°C & 75% ± 5%RH
Complies - - -
Analyst signature
Conclusion by QA
Assessment frequency (weeks) Initial 1 2 3 4 6 9 12 16 20 24 36
Date of Testing Apr-15 Aug-15
Mode of testing (F = full, P = Partial testing) F P F P F F F F F F F F
Tests (Physical,
Chemical,
Microbiological) Acceptance Criteria
Storage
conditions
(Accelerated)
Appearance
Yellow colored oblong
shaped film coated
tablets, both sides plain.
Complies
30°C ± 2°C & 75% ± 5%RH
- - Complies
Disintegration
Time
Not more than 30
minutes.
2 min
30°C ± 2°C & 75% ± 5%RH
- - 2 min
Identification
The retention time of
the major peak in the
chromatogram of the Assay preparation
corresponds to that of
the Standard preparation as obtained in the
Assay.
Complies
30°C ± 2°C &
75% ± 5%RH - - Complies
Dissolution Not less than 75% (Q);
(Q + 5% = 80%)
93.804%
30°C ± 2°C &
75% ± 5%RH - - 91.359%
Assay (90.0 – 110.0)%
97.798%
Minutes for 253rd
Registration Board Meeting 107
30°C ± 2°C &
75% ± 5%RH - - 100.691%
Total Aerobic
Microbial Count
Not more than 1000
cfu/gm 30°C ± 2°C &
75% ± 5%RH 0.00
cfu/g - - -
Total Yeast &
Mold Count
Not more than 100
cfu/gm 30°C ± 2°C & 75% ± 5%RH
0.00
cfu/g - - -
Escherichia coli Must be absent / 10gm 30°C ± 2°C & 75% ± 5%RH
Complies - - -
Analyst signature
Conclusion by QA
Documents / Data provided by the applicants (M/s Getz Pharma, Karachi)
Sr. No. Documents to be provided Status
1. COA of API Yes
2. Approval of API by regulatory authority of country of origin or GMP
certificate of API manufacturer issued by regulatory authority of country of
origin.
Yes
3. Protocols followed for conduction of stability study and details of tests. Yes
4. Data of 03 batches will be supported by attested respective documents like
chromatograms, laboratory reports, data sheets etc.
Yes
(Third batch : 3months
data)
5. Documents confirming import of API etc. Yes (ADC cleared)
6. All provided documents will be attested (name, sign and stamp) for ensuring
authenticity of data / documents.
Yes
7. Commitment to continue real time stability study till assigned shelf life of the
product.
Yes
Decision: Mr. Sultan Ghani, Director QA submitted up dated stability data for 3rd
batch. Registration Board observed that the stability data
provided by the firm for 3rd
batch is not for 06 months and thus not in accordance with the guidelines approved by the Board in 251st
meeting. Therefore, case was deferred till the applicant completes the requisite information in respect of stability studies
Minutes for 253rd
Registration Board Meeting 108
11. M/s AGP, Karachi
(Manufactured by: M/s Mylan Laboratories, Ltd, F4 &F 12, MIDC, Malegaon, Sinnar, Nashik-422113, Maharahtra, India.)
Firm M/s AGP, Karachi
Drug Myhep 400mg
Source M/s Mylan Laboratories, India
Storage Condition Accelerated and Real Time (Zone IV-A)
Time Period 06 Months
Frequency 03 Months Interval
Batch Size 18000
No. of Batches 03
Sample Size 9660 tablets
Meeting M-251st
Scanned copy (Notarized) of sole agency agreement provided.
MYLAN LABORATORIES LIMITED
F-4 & F-12, Malegaon MIDC, Sinnar,
Nashik - 422 113, Maharashtra, India.
ACCELERATED STORAGE CONDITION - STABILITY STUDY DATA Product Sofosbuvir Tablets 400 mg Market REXP
Strength 400mg Batch Size 18000 Tablets
Batch No. 2008369 Pack 28'S HDPE
Mfg. Date Jan-2015 Protocol No. EBSP-SFB000T-001 -00
Exp. Date Dec-2016 STPNo. FPPSFB151R
Date In Jan 23,2015 Stability Site Mylan Laboratories Ltd. Nashik
Storage Condition 40°C ± 2°C /75% ± 5% RH Batch Type Exhibit
S. Test(s) Specification 0Day(s) 1Month(s) 3Month(s) 5Month(s) 6Month(s)
Minutes for 253rd
Registration Board Meeting 109
No. MLNEST1501031 MLNEST1501669 MLNEST1503609 MLNEST1506170 MLNEST1507169
1 Description
Yellow colored, capsule
shaped biconvex beveled
edge film coated tablet
debossed with "SF400"
on one side of the tablet and "M" on the other
side.
Yellow colored, capsule
shaped biconvex beveled
edge film coated tablet
debossed with "SF400"
on one side of the tablet and "M" on the other
side.
Yellow colored, capsule
shaped biconvex beveled
edge film coated tablet
debossed with "SF400"
on one side of the tablet and "M" on the other
side.
Yellow colored, capsule
shaped biconvex beveled
edge film coated tablet
debossed with "SF400"
on one side of the tablet and "M" on the other
side.
Yellow colored, capsule
shaped biconvex beveled
edge film coated tablet
debossed with "SF400"'
on one side of the tablet and "M" on the other
side.
Yellow colored, capsule
shaped biconvex beveled
edge film coated tablet
debossed with "SF400"
on one side of the tablet and "M" on the other
side.
2 Assay (By HPLC)
360.00 - 420.00 mg/tablet 90.0- 105.0%
w/w
In mg:402.46 mg
In % : 100.6 % w/w
In mg:400.61 mg
In % : 100.2 % w/w
In mg:409.83 mg
In % : 102.5 % w/w
In mg:402.43 mg
In % : 100.6% w/w
In mg:405.37 mg
In % : 101.3 % w/w
3 Dissolution (By UV) Not less than 80% (Q =
75%) in 15 minutes.
Min:96 %
Max:98 % Avg: 97 %
Min:97 %
Max:98 % Avg: 97 %
Min:95 %
Max:96 % Avg: 95 %
4 Dissolution Profile
(By UV)
Not less than 80% (Q =
75%) in 15 minutes.
Min:96 %
Max:98 % Avg: 97 %
Min:97 %
Max:99 % Avg: 98 %
5 Related
(Long term Storage Conditions) S.
No. Test(s) Specification
0Day(s)
MLNEST1501031
3Month(s)
MLNEST1503610
6Month(s)
MLNEST1507170
1 Description
Yellow colored, capsule shaped
biconvex beveled edge film
coated tablet debossed with
"SF400" on one side of the tablet
and "M" on the other side.
Yellow colored, capsule shaped
biconvex beveled edge film
coated tablet debossed with
"SF400" on one side of the tablet
and "M" on the other side.
Yellow colored, capsule shaped
biconvex beveled edge film
coated tablet debossed with
"SF400" on one side of the tablet
and "M" on the other side.
Yellow colored, capsule shaped
biconvex beveled edge film
coated tablet debossed with
"SF400" on one side of the tablet
and "M" on the other side.
2 Assay (By HPLC) 360.00 - 420.00 mg/tablet 90.0 -
105.0% w/w
In mg:402.46 mg
In % : 100.6% w/w
In mg:410.68 mg
In % : 102.7 % w/w
In mg:404.43 mg
In % : 101.1 % w/w
3 Dissolution (By UV) Not less than 80% (Q = 75%) in
15 minutes.
Min:96 %
Max:98 %
Avg: 97 %
-- --
4 Dissolution Profile (By UV) Not less than 80% (Q = 75%) in
15 minutes. --
Min:95 %
Max:97 %
Avg: 96 %
Min:98 %
Max:99 %
Avg: 98 %
5 Related Substances (By
Minutes for 253rd
Registration Board Meeting 110
MYLAN LABORATORIES LIMITED F-4 & F-12, Malegaon MIDC, Sinnar,
Nashik - 422 113, Maharashtra, India.
ACCELERATED STORAGE CONDITION - STABILITY STUDY DATA Product Sofosbuvir Tablets 400 mg Market REXP
Strength 400mg Batch Size 18000 Tablets
Batch No. 2008370 Pack 28'S HDPE
Mfg. Date Jan-2015 Protocol No. EBSP-SFB000T-001 -00
Exp. Date Dec-2016 STP No. FPPSFB151R
Date In Jan 23, 2015 Stability Site Mylan Laboratories Ltd. Nashik
Storage Condition 40°C ± 2°C 175% ± 5% RH Batch Type Exhibit
S.
No. Test(s) Specification
0Day(s)
MLNEST1501032
1Month(s)
MLNEST1501670
3Month(s)
MLNEST1503611
5Month(s)
MLNEST1506171
6Month(s)
MLNEST1507171
1 Description
Yellow colored, capsule
shaped biconvex beveled
edge film coated tablet
debossed with "SF400"
on one side of the tablet
and "M" on the other
side.
Yellow colored, capsule
shaped biconvex beveled
edge film coated tablet
debossed with "SF400"
on one side of the tablet
and "M" on the other
side.
Yellow colored, capsule
shaped biconvex beveled
edge film coated tablet
debossed with "SF400"
on one side of the tablet
and "M" on the other
side.
Yellow colored, capsule
shaped biconvex beveled
edge film coated tablet
debossed with "SF400"
on one side of the tablet
and "M" on the other
side.
Yellow colored, capsule
shaped biconvex beveled
edge film coated tablet
debossed with "SF400"
on one side of the tablet
and "M" on the other
side.
Yellow colored, capsule
shaped biconvex beveled
edge film coated tablet
debossed with "SF400"
on one side of the tablet
and "M" on the other
side.
2 Assay (By HPLC)
360.00 - 420.00
mg/tablet 90.0 - 105.0%
w/w
In mg:405.50 mg
In % : 101.4 % w/w
In mg:400.54 mg
In % : 100.1 % w/w
In mg:410.99 mg
In % : 102.7% w/w
In mg:400.27 mg
In % : 100.1 % w/w
In mg:409.42 mg
In % : 102.4% w/w
3 Dissolution (By
UV)
Not less than 80% (Q =
75%) in 15 minutes.
Min:99 %
Max: 100%
Avg : 99 %
Min:97 %
Max:98 %
Avg: 98 %
Min:94 %
Max:96 %
Avg: 95 %
4 Dissolution Profile
(By UV)
Not less than 80% (Q =
75%) in 15 minutes.
Min:97 %
Max:99 %
Avg: 98 %
Min:97 %
Max:98 %
Avg: 98 %
5 Related
Minutes for 253rd
Registration Board Meeting 111
(Long Term Storage Conditions)
S.
No. Test(s) Specification
0Day(s)
MLNEST1501032
3Month(s)
MLNEST1503612
6Month(s)
MLNEST1507172
1 Description
Yellow colored, capsule shaped
biconvex beveled edge film coated
tablet debossed with "SF400" on
one side of the tablet and "M" on
the other side.
Yellow colored, capsule shaped
biconvex beveled edge film coated
tablet debossed with "SF400" on
one side of the tablet and "M" on
the other side.
Yellow colored, capsule shaped
biconvex beveled edge film coated
tablet debossed with "SF400" on
one side of the tablet and "M" on
the other side.
Yellow colored, capsule shaped
biconvex beveled edge film coated
tablet debossed with "SF400" on
one side of the tablet and "M" on
the other side.
2 Assay (By HPLC) 360.00 - 420.00 mg/tablet 90.0 -
105.0% w/w
In mg:405.50 mg
In % : 101.4 % w/w
In mg:413.67 mg
In % : 103.4 % w/w
In mg:407.25 mg
In % : 101.8% w/w
3 Dissolution (By
UV)
Not less than 80% (Q = 75%) in 15
minutes.
Min:99 %
Max: 100%
Avg: 99 %
4 Dissolution Profile (By UV) Not less than 80% (Q = 75%) in 15
minutes.
Min:97 %
Max:98 %
Avg: 97 %
Min:97 %
Max:99 %
Avg: 99 %
5 Related
Substances (By
MYLAN LABORATORIES LIMITED F-4 & F-12, Malegaon MIDC, Sinnar,
Nashik - 422 113, Maharashtra, India. ACCELERATED STORAGE CONDITION - STABILITY STUDY DATA
Product Sofosbuvir Tablets 400 mg Market REXP
Strength 400mg Batch Size 18000 Tablets
Batch No. 8032429 Pack 28'S HDPE
Mfg. Date Jan-2015 Protocol No. EBSP-SFB000T-001 -00
Exp. Date Dec-2016 STP No. FPPSFB151R
Date In Jan 23, 2015 Stability Site Mylan Laboratories Ltd. Nashik
Storage Condition 40°C ± 2°C /75% ± 5% RH Batch Type Exhibit
S.
No. Test(s) Specification
0Day(s)
MLNEST1501030
1Month(s)
MLNEST1501668
3Month(s)
MLNEST1503607
5Month(s)
MLNEST1506169
6Month(s)
MLNEST1507167
1 Description Yellow colored, capsule Yellow colored, capsule Yellow colored, capsule Yellow colored, capsule Yellow colored, capsule Yellow colored, capsule
Minutes for 253rd
Registration Board Meeting 112
shaped biconvex beveled
edge film coated tablet
debossed with "SF400"
on one side of the tablet
and "M" on the other
side.
shaped biconvex beveled
edge film coated tablet
debossed with "SF400"
on one side of the tablet
and "M" on the other
side.
shaped biconvex beveled
edge film coated tablet
debossed with "SF400"
on one side of the tablet
and "M" on the other
side.
shaped biconvex beveled
edge film coated tablet
debossed with "SF400"
on one side of the tablet
and "M" on the other
side.
shaped biconvex beveled
edge film coated tablet
debossed with "SF400"
on one side of the tablet
and "M" on the other
side.
shaped biconvex beveled
edge film coated tablet
debossed with "SF400"
on one side of the tablet
and "M" on the other
side.
2 Assay (By HPLC)
360.00 - 420.00
mg/tablet 90.0 - 105.0%
w/w
In mg:402.60 mg
In % : 100.7 % w/w
In mg:402.35 mg
In % : 100.6 % w/w
In mg:404.12 mg
In % : 101.0 % w/w
In mg:401.94 mg
In % : 100.5 % w/w
In mg:403.73 mg
In % : 100.9 % w/w
3 Dissolution (By
UV)
Not less than 80% (Q =
75%) in 15 minutes.
Min:94 %
Max:95 %
Avg: 95 %
Min:97 %
Max:98 %
Avg: 97 %
--
Min:94 %
Max:96 %
Avg: 95 %
--
4 Dissolution Profile
(By UV)
Not less than 80% (Q =
75%) in 15 minutes. -- --
Min:94 %
Max:98 %
Avg: 96 %
--
Min:98 %
Max:99 %
Avg: 99 %
5 Related
(Long Term Storage Conditions) S.
No. Test(s) Specification
0Day(s)
MLNEST1501030
3Month(s)
MLNEST1503607 6Month(s) MLNEST1507168
1 Description
Yellow colored, capsule shaped
biconvex beveled edge film
coated tablet debossed with
"SF400" on one side of the tablet
and "M" on the other side.
Yellow colored, capsule shaped
biconvex beveled edge film
coated tablet debossed with
"SF400" on one side of the tablet
and "M" on the other side.
Yellow colored, capsule shaped
biconvex beveled edge film
coated tablet debossed with
"SF400" on one side of the tablet
and "M" on the other side.
Yellow colored, capsule shaped
biconvex beveled edge film
coated tablet debossed with
"SF400" on one side of the tablet
and "M" on the other side.
2 Assay (By HPLC) 360.00 - 420.00 mg/tablet 90.0 -
105.0% w/w
In mg:402.60 mg
In % : 100.7% w/w
In mg:410.08 mg
In % : 102.5 % w/w
In mg:402.32 mg
In % : 100.6 % w/w
3 Dissolution (By UV) Not less than 80% (Q = 75%) in
15 minutes.
Min:94 %
Max:95 %
Avg: 95 %
-- --
Minutes for 253rd
Registration Board Meeting 113
4 Dissolution Profile (By UV) Not less than 80% (Q = 75%) in
15 minutes. --
Min:94 %
Max:98 %
Avg: 96 %
Min:98 %
Max:99 %
Avg: 99 %
5 Related Substances (By
Documents / Data provided by the applicant (M/s AGP, Karachi )
Sr. No. Documents to be provided Status
1. COA of API Yes
2. Approval of API by regulatory authority of country of origin or GMP certificate of
API manufacturer issued by regulatory authority of country of origin.
Yes (M/s Mylan
Laboratories, India)
3. Protocols followed for conduction of stability study and details of tests. Yes
4. Data of 03 batches will be supported by attested respective documents like
chromatograms, laboratory reports, data sheets etc.
Yes
5. Documents confirming import of API etc. NA (Imported as FPP)
6. All provided documents will be attested (name, sign and stamp) for ensuring
authenticity of data / documents.
Yes
7. Commitment to continue real time stability study till assigned shelf life of the
product.
Yes
Decision: Mr.Qamar Nafees, Director QA of the firm presented that M/s Mylan Laboratories Limited is a licensee of M/s Gillead
Laboratories (innovator of the product) and product has been developed after complete technology transfer from aforementioned company.
Moreover, M/s AGP has additionally provided bio-equivalence studies and data has been presented with registration dossier. Registration
Board discuused reference sent by PPMA for not granting registrations to Sofosbuvir 400mg Tablets from India as local pharmaceutical
manufacturers can manufacture it. The Board deliberated the request in detail and also discussed that parameters for grant of registration
are safety, efficacy and quality and application by M/s AGP qualifies for approval / grant of registration. Members were also of the view that
Import Policy Order 2012-2015, Ministry of Commerce don’t restrict import of Sofosbuvir 400 mg tablets from India. However, keeping in
view presentation made by PPMA, the Board decided to get opinion of Ministry of Commerce regarding importability of Sofosbuvir 400 mg
tablets from India for updated status as mentioned in PPMA’s letter.
Minutes for 253rd
Registration Board Meeting 114
12. TABROS PHARMA KARACHI
Drug VIBRENTAL tablets (Sofosbuvir) 400 mg
Source M/s Xiamen Halosyntech China
Storage Condition Real Time: 30 C and 75% RH
Accelerated: 40 C and 75% RH
Time Period Real Time: 6 months
Accelerated: 6 months
Frequency 0, 1,2, 3, 6 months
Batch Size 166/ batch
No. of Batches 03
Meeting Deferred in 244th
and 251st meeting of
Registration Board for stability
STABILITY STUDY PROTOCOL
1.0 Product details:
Product name / Genric
name/Dosage form VIBRENTA TABLET (Sofosbuvir Tablet) Batch No. EXP-001
Description of pack
(container closure system)
400mg Film Coated white oblong tablet blistered in Alu-
alu foil packed in prined unit carton. Batch Size 166 Tablets
Parameters and tests
mentioned As per Product Specifications Mfg. Date Nov-2014
Recommended storage
conditions
Short term condictions (Accelerated) 40± 2°C, 75±5% RH
Long term condictions (Real Time) 30± 2°C, 65±5% RH Exp. Date Oct-2016
Date of initiation & 05/11/14 (API) Lot no. 141001
Minutes for 253rd
Registration Board Meeting 115
implementation
Stability No. TAB-RND-001/14
Sample taken for physical tests = 50 Tablets
Sample taken for Chemical tests = 50 Tablets
Sample taken for Microbiological
tests = N/A
Extra Samples (if needed) = 100 Tablets
Total Sample size (approx) = 200 Tablets
STABILITY STUDY DATA SHEET
1.0 Product details:
Product name / Genric
name/Dosage form VIBRENTA TABLET (Sofosbuvir Tablet) Batch No. EXP-001
Description of pack
(container closure system)
400mg Film Coated white oblong tablet blistered in Alu-alu foil
packed in prined unit carton. Batch Size 1000 Tablets
Parameters and tests
mentioned As per Product Specifications Mfg. Date Nov-2014
Recommended storage Short term condictions (Accelerated) 40± 2°C, 75±5% Exp. Date Oct-2016
Minutes for 253rd
Registration Board Meeting 116
conditions RH
Long term condictions (Real Time) 30± 2°C, 65±5% RH
Date of initiation &
implementation 05/11/14 (API) Lot no. 141001
Stability No. TAB-RND-001/14
Sample taken for physical tests = 50 Tablets
Sample taken for Chemical tests = 50 Tablets
Sample taken for Microbiological
tests = N/A
Extra Samples (if needed) = 100 Tablets
Total Sample size (approx) = 200 Tablets
Assessment frequency (Months) Initial 1 2 3 4 6 8 12 16 20 24 26
Date of Testing Nov-14 Dec-14 Jan-15 Feb-15 May-15
Mode of Testing (F = full, P = Partial testing) F P F P F F F F F F F F
Tests Acceptance
Criteria
Storage
conditions
(Accelerated)
(Physical,
Chemical,
Microbiological)
Minutes for 253rd
Registration Board Meeting 117
Appearance
White film
coated oblong
Tablet
40°C± 2°C &
75%±5% RH Comply
Comply Comply Comply Comply
Average
Weight 615.0 mg ±
5.0% 40°C± 2°C &
75%±5% RH 625 mg
624 mg 623 mg 626 mg 625 mg
Disintegration
Time
NMT 30
Minutes
40°C± 2°C &
75%±5% RH 4:10
4:20 3:55 4:26 4:50
Dissolution
Test NLT 80.0%
40°C± 2°C &
75%±5% RH 86.68%
96.46% 94.19% 96.79% 97.18%
Assay
(Sofosbuvir)
(Sofosbuvir)
90.0% ---
110.0%
40°C± 2°C &
75%±5% RH 100.22%
100.35% 100.01% 100.12% 99.20%
Analyst signature (after completion of every
time line)
Conclusion by QA (after completion of the study):
Stability studies of Sofosbuvir (400mg) Vibrenta Tablet was conduct in Accelerated conditions (40±2°C) & RH 75±5%. The product found stable for 6 Months
Minutes for 253rd
Registration Board Meeting 118
Assessment frequency (Months) Initial 1 2 3 4 6 8 12 16 20 24 26
Date of Testing Nov-14 Feb-15 May-
15
Mode of Testing (F = full, P = Partial testing) F P F P F F F F F F F F
Tests Acceptance
Criteria
Storage
conditions
(Real Time)
(Physical,
Chemical,
Microbiological)
Appearance
White film
coated oblong
Tablet
30°C± 2°C &
65%±5% RH
Compl
y
Compl
y
Compl
y
Average
Weight 615.0 mg ±
5.0% 30°C± 2°C &
65%±5% RH 625 mg
624 mg 623
mg
Disintegration
Time
NMT 30
Minutes
30°C± 2°C &
65%±5% RH 4:01
3:55 4:15
Dissolution
Test NLT 80.0%
30°C± 2°C &
65%±5% RH 86.68%
85.10% 84.11
%
Assay
(Sofosbuvir)
(Sofosbuvir)
90.0% ---
110.0%
30°C± 2°C &
65%±5% RH
100.22
%
100.02
%
89.90
%
Minutes for 253rd
Registration Board Meeting 119
Analyst signature (after completion of every time
line)
Conclusion by QA (after completion of the study):
Stability studies of Sofosbuvir (400mg) Vibrenta Tablet was conduct in Real Time conditions (30±2°C) & RH 65±5%. The product found stable for 6
Months
STABILITY STUDY PROTOCOL
1.0 Product details:
Product name / Generic
name/Dosage form VIBRENTA TABLET (Sofosbuvir Tablet) Batch No. EXP-002
Description of pack
(container closure system)
400mg Film Coated white oblong tablet blistered in Alu-
alu foil packed in prined unit carton. Batch Size 1000 Tablets
Parameters and tests
mentioned As per Product Specifications Mfg. Date Nov-2014
Recommended storage
conditions
Short term condictions (Accelerated) 40± 2°C, 75±5%
RH
Long term condictions (Real Time) 30± 2°C, 65±5%
RH
Exp. Date Oct-2016
Date of initiation &
implementation 05/11/14 (API) Lot no. 141001
Stability No. TAB-RND-002/14
Minutes for 253rd
Registration Board Meeting 120
Sample taken for physical tests = 50 Tablets
Sample taken for Chemical tests = 50 Tablets
Sample taken for Microbiological
tests = N/A
Extra Samples (if needed) = 100 Tablets
Total Sample size (approx) = 200 Tablets
STABILITY STUDY DATA SHEET 1.0 Product details:
Product name / Generic
name/Dosage form VIBRENTA TABLET (Sofosbuvir Tablet) Batch No. EXP-002
Description of pack
(container closure system)
400mg Film Coated white oblong tablet blistered in Alu-
alu foil packed in printed unit carton. Batch Size 1000 Tablets
Parameters and tests
mentioned As per Product Specifications Mfg. Date Nov-2014
Recommended storage
conditions
Short term condictions (Accelerated) 40± 2°C, 75±5%
RH
Long term condictions (Real Time) 30± 2°C, 65±5%
RH
Exp. Date Oct-2016
Minutes for 253rd
Registration Board Meeting 121
Date of initiation &
implementation 05/11/14 (API) Lot no. 141001
Stability No. TAB-RND-002/14
Sample taken for physical tests = 50 Tablets
Sample taken for Chemical tests = 50 Tablets
Sample taken for Microbiological
tests = N/A
Extra Samples (if needed) = 100 Tablets
Total Sample size (approx) = 200 Tablets
Assessment frequency (Months) Initial 1 2 3 4 6 8 12 1
6
2
0
2
4
2
6
Date of Testing Nov-14 Dec-14 Jan-15 Feb-15 May-
15
Mode of Testing (F = full, P = Partial
testing) F P F P F F F F F F F F
Tests Acceptan
ce
Storage
conditions
(Physical, Chemical, Microbiological)
Minutes for 253rd
Registration Board Meeting 122
Criteria (Accelerat
ed)
Appearance
White
film
coated
oblong
Tablet
40°C±
2°C &
75%±5%
RH
Compl
y
Compl
y
Compl
y
Compl
y
Comp
ly
Average Weight 615.0 mg
± 5.0%
40°C±
2°C &
75%±5%
RH
624
mg
625
mg
620
mg
621
mg
626
mg
Disintegration Time NMT 30
Minutes
40°C±
2°C &
75%±5%
RH
4:03
4:35 4:44 4:28 4:11
Dissolution Test NLT
80.0%
40°C±
2°C &
75%±5%
RH
88.10
%
95.36
%
94.21
%
96.33
%
96.67
%
Assay
(Sofosbuvir)
(Sofosbuv
ir)
90.0% ---
110.0%
40°C±
2°C &
75%±5%
RH
101.18
%
100.69
%
100.70
%
100.27
%
99.10
%
Analyst signature (after completion of
every time line)
Conclusion by QA (after completion of
the study):
Stability studies of Sofosbuvir (400mg)
Vibrenta Tablet was conduct in
Accelerated conditions (40±2°C) & RH
Minutes for 253rd
Registration Board Meeting 123
75±5%. The product found stable for 6
Months
Assessment frequency (Months) Initial 1 2 3 4 6 8 12 16 20 24 26
Date of Testing Nov-14 Feb-15 May-15
Mode of Testing (F = full, P = Partial testing) F P F P F F F F F F F F
Tests Acceptance
Criteria
Storage
conditions
(Real Time)
(Physical,
Chemical,
Microbiological)
Appearance
White film
coated oblong
Tablet
30°C± 2°C &
65%±5% RH Comply
Comply Comply
Average
Weight 615.0 mg ±
5.0% 30°C± 2°C &
65%±5% RH 624 mg
623 mg 625 mg
Disintegration
Time
NMT 30
Minutes
30°C± 2°C &
65%±5% RH 4:03
3:50 4:02
Dissolution
Test NLT 80.0%
30°C± 2°C &
65%±5% RH 88.10%
87.22% 86.12%
Minutes for 253rd
Registration Board Meeting 124
Assay
(Sofosbuvir)
(Sofosbuvir)
90.0% ---
110.0%
30°C± 2°C &
65%±5% RH 101.18%
101.00% 99.98%
Analyst signature (after completion of every
time line)
Conclusion by QA (after completion of the study):
Stability studies of Sofosbuvir (400mg) Vibrenta Tablet was conduct in Real Time conditions (30±2°C) & RH 65±5%. The product found stable for 6 Months
STABILITY STUDY PROTOCOL Product details:
Product name / Generic
name/Dosage form VIBRENTA TABLET (Sofosbuvir Tablet) Batch No. EXP-003
Description of pack
(container closure system)
400mg Film Coated white oblong tablet blistered in Alu-alu foil
packed in printed unit carton. Batch Size 1000 Tablets
Parameters and tests
mentioned As per Product Specifications Mfg. Date Nov-2014
Recommended storage
conditions
Short term conditions (Accelerated) 40± 2°C, 75±5% RH
Long term conditions (Real Time) 30± 2°C, 65±5% RH Exp. Date Oct-2016
Date of initiation &
implementation 05/11/14 (API) Lot no. 141001
Stability No. TAB-RND-003/14
Minutes for 253rd
Registration Board Meeting 125
Sample taken for physical tests = 50 Tablets
Sample taken for Chemical tests = 50 Tablets
Sample taken for Microbiological
tests = N/A
Extra Samples (if needed) = 100 Tablets
Total Sample size (approx) = 200 Tablets
STABILITY STUDY DATA SHEET
1.0 Product details:
Product name / Generic
name/Dosage form VIBRENTA TABLET (Sofosbuvir Tablet) Batch No. EXP-003
Description of pack
(container closure system)
400mg Film Coated white oblong tablet blistered in Alu-alu foil
packed in printed unit carton. Batch Size 1000 Tablets
Parameters and tests mentioned As per Product Specifications Mfg. Date Nov-2014
Recommended storage conditions Short term conditions (Accelerated) 40± 2°C, 75±5% RH
Long term conditions (Real Time) 30± 2°C, 65±5% RH Exp. Date Oct-2016
Date of initiation &
implementation 05/11/14 (API) Lot no. 141001
Stability No. TAB-RND-003/14
Minutes for 253rd
Registration Board Meeting 126
Sample taken for physical tests = 50 Tablets
Sample taken for Chemical tests = 50 Tablets
Sample taken for Microbiological tests = N/A
Extra Samples (if needed) = 100 Tablets
Total Sample size (approx) = 200 Tablets
Assessment frequency (Months) Initial 1 2 3 4 6 8 12 16 20 24 26
Date of Testing Nov-14 Dec-14 Jan-15 Feb-15 May-
15
Mode of Testing (F = full, P = Partial testing) F P F P F F F F F F F F
Tests
Acceptance
Criteria
Storage
conditions
(Accelerated)
(Physical,
Chemical,
Microbiological
)
Appearance
White film
coated oblong
Tablet
40°C± 2°C &
75%±5% RH
Compl
y
Compl
y
Compl
y
Compl
y
Compl
y
Average 615.0 mg ± 40°C± 2°C & 625 mg
Minutes for 253rd
Registration Board Meeting 127
Weight 5.0% 75%±5% RH 624.5
mg 625 mg 623 mg
624
mg
Disintegration
Time
NMT 30
Minutes
40°C± 2°C &
75%±5% RH 4:02
4:25 4:55 4:01 4:19
Dissolution
Test NLT 80.0%
40°C± 2°C &
75%±5% RH
88.10
%
95.16% 94.15
%
97.13
%
98.06
%
Assay
(Sofosbuvir)
(Sofosbuvir)
90.0% ---
110.0%
40°C± 2°C &
75%±5% RH
100.67
%
100.48
%
100.48
%
100.06
%
99.19
%
Analyst signature (after completion of every
time line)
Conclusion by QA (after completion of the study):
Stability studies of Sofosbuvir (400mg) Vibrenta Tablet was conduct in Accelerated conditions (40±2°C) & RH 75±5%. The product found stable for
6 Months
Assessment frequency (weeks) Initial 1 2 3 4 6 8 12 16 20 24 26
Date of Testing
Mode of Testing (F = full, P = Partial testing) F P F P F F F F F F F F
Tests Acceptance Storage
Minutes for 253rd
Registration Board Meeting 128
(Physical,
Chemical,
Microbiological)
Criteria conditions
(Real Time)
Appearance
White film
coated oblong
Tablet
30°C± 2°C &
65%±5% RH
Compl
y
Compl
y
Compl
y
Average
Weight 615.0 mg ±
5.0% 30°C± 2°C &
65%±5% RH 625 mg
624 mg 622
mg
Disintegration
Time
NMT 30
Minutes
30°C± 2°C &
65%±5% RH 4:20
4:13 4:32
Dissolution
Test NLT 80.0%
30°C± 2°C &
65%±5% RH 88.10%
87.13% 85.47
%
Assay
(Sofosbuvir)
(Sofosbuvir)
90.0% ---
110.0%
30°C± 2°C &
65%±5% RH
100.67
%
100.53
%
99.76
%
Analyst signature (after completion of every time
line)
Conclusion by QA (after completion of the study):
Stability studies of Sofosbuvir (400mg) Vibrenta Tablet was conduct in Real Time conditions (30±2°C) & RH 65±5%. The product found stable for 6
Months
Minutes for 253rd
Registration Board Meeting 129
Documents / Data provided by the applicants
M/s Tabros, Karachi
Sr. No. Documents to be provided Status
1. COA of API Yes
2. Approval of API by regulatory authority of country of origin or GMP
certificate of API manufacturer issued by regulatory authority of country of
origin.
No (GMP certificate of the
manufacturer is different
from the COA provided/
API imported)
Firm submitted that Ximen
Halosyntech China is
located in Benbhu BBCA
Tushan Pharmaceutical
China, who is GMP owner
and contract manufacturing
for plant for Xiamen.
Xiamen has contract
manufacturing with
Bengbbu Tushan
.
3. Protocols followed for conduction of stability study and details of tests. Yes
Minutes for 253rd
Registration Board Meeting 130
4. Data of 03 batches will be supported by attested respective documents like
chromatograms, laboratory reports, data sheets etc.
Yes
5. Documents confirming import of API etc. Only 200 grams of API
imported (By courier).
Quantity of API does not
relate to the claimed batch
size.
6. All provided documents will be attested (name, sign and stamp) for ensuring
authenticity of data / documents.
Yes
7. Commitment to continue real time stability study till assigned shelf life of the
product.
Yes
Decision: Mr.Faisal Abbas, Quality Assurance Manager appeared befor Registration Board and clarified that M/s Ximen
Halosyntech China is located in Benbhu, China and Benbhu Tushan Pharmaceutical China is GMP owner and contract
manufacturing for plant for Xiamen. He aprovided COA and GMP certificate for manufacturer of the API i.e. Benbhu Tushan
Pharmaceutical China. He further informed that batch size of 1000 tablets per batch was mentioned mistakenly in earlier stability
data. The actual btach size is 166 tablets per batch and submitted copy of revised data of the batch. Keeping in view data submitted,
Registration Board granted approval of registration of Sofosbuvir 400 mg tablets to the firm. However, manufacturer will inform
concerned Federal Inspector of Drugs for taking sample of Active Pharmaceutical Ingredient (used in manufacture of first
commercial batch) for test/ analysis from Central Drugs Laboratory, Karachi before sale of finished product.
Minutes for 253rd
Registration Board Meeting 131
13. GLITZ PHARMA ISLAMABAD
Drug Sofosvir tablets (Sofosbuvir) 400 mg
Source M/s Jianxi Synergy Pharma, China
Storage Condition Real Time: 30 C and 65% RH
Accelerated: 40 C and 75% RH
Time Period Real Time: 6 months
Accelerated: 6 months
Frequency 0, 1,2, 3 months
Batch Size 1. 1500 2. 500, 3. 500 batch
No. of Batches 03
Meeting Deferred in 244th
and 251st meeting of
Registration Board for stability
Minutes for 253rd
Registration Board Meeting 132
Product Details
Product name/ Generic name/
Dosage form Sofosvir (Sofosbuvir) 400mg Tablets Batch No TT-01
Description of pack
(container closure system) Blister Pack Bat size 1500 Tablets
Parameters and tests
mentioned Description, Identification, Disintegration, Dissolution & Assay Mfg. Date 07-2015
Recommended storage
conditions
Short term conditions (Accelerated) 40◦C ±2
◦C, 75%±5% RH
Long term conditions (Real Time) 30◦C ±2
◦C, 65%±5% RH
Exp. Date 07-2017
Date of initiation &
implementation 01-07-2015 (API) Lot No YF20150401
Stability No. Doc. No.: GP / QC / SSP / 001
Sample taken for Physical tests = (6+6) = 12 Tablets
Sample taken for Chemical tests = 20 Tablets
Sample taken for Microbiological tests =N.A
Extra Samples if needed = 5
Total sample size (approx) = 37 Tablets per test
Minutes for 253rd
Registration Board Meeting 133
Accelerated Stability Study Data Sheet
Assessment frequency (weeks) Initial After 01 month After 02
months After 03 months After 06 months
Date of Testing 01-07-15 01-08-15 01-09-15 01-10-15 01-01-16
Mode of testing (F= full, P= partial) F P F P F P F P F P
Tests (Physical,
Chemical,
Microbiological)
Acceptance
Criteria
Storage
Conditions
(Accelerated)
Description
Oblong
shape white
color tablets
40◦C ±2◦C,
75%±5%
Complies Complies Complies Continue
Identification Positive for
Sofosbuvir
40◦C ±2◦C,
75%±5%
Positive Positive Positive Continue
Disintegration NMT 30
min
40◦C ±2◦C,
75%±5%
12 min 12.5 min 12.6 min Continue
Dissolution
NLT 85 %
in 30
minutes
40◦C ±2◦C,
75%±5%
98.16 % 97.78% 97.46% Continue
Assay
NLT 90.0%
and NMT
110.0%
40◦C ±2◦C,
75%±5%
101.15% 100.20 % 99.97 % Continue
Analyst Signature (after completion of every time
line)
Conclusion by QA (after completion of the study)
Minutes for 253rd
Registration Board Meeting 134
Real Time Stability Study Data Sheet
Assessment frequency (weeks) Initial After 03 months After 06 months After 09 months
Date of Testing 01-07-15 01-10-15 01-01-16 01-04-16
Mode of testing (F= full, P= partial) F P F P F P F P
Tests (Physical,
Chemical,
Microbiological)
Acceptance Criteria
Storage
Conditions
(Accelerated)
Description Oblong shape white
color tablets
30◦C ±2◦C,
65%±5%
Complies Continue
Identification Positive for
Sofosbuvir
30◦C ±2◦C,
65%±5%
Positive Continue
Disintegration NMT 30 min
30◦C ±2◦C,
65%±5%
12.5 min Continue
Dissolution NLT 85 % in 30
minutes
30◦C ±2◦C,
65%±5%
98.16 % Continue
Assay NLT 90.0% and
NMT 110.0%
30◦C ±2◦C,
65%±5%
101.05 % Continue
Analyst Signature (after completion of every time line)
Conclusion by QA (after completion of the study)
Minutes for 253rd
Registration Board Meeting 135
Real Time Stability Study Data Sheet
Post Expiry 01 Year Stability Study
Assessment frequency (weeks) After 12 months After 18 months After 24
months
After 30
months
After 36 months
Date of Testing 01-07-16 01-01-17 01-07-
17
Mode of testing (F= full, P= partial) F P F P F P F P F P
Tests (Physical,
Chemical,
Microbiological)
Acceptance
Criteria
Storage
Conditions
(Accelerated)
Description
30◦C ±2◦C,
65%±5%
Identification
30◦C ±2◦C,
65%±5%
Uniformity of dosage units
30◦C ±2◦C,
65%±5%
Disintegration
30◦C ±2◦C,
65%±5%
Dissolution
30◦C ±2◦C,
65%±5%
Assay
30◦C ±2◦C,
65%±5%
Analyst Signature (after completion of every time line)
Conclusion by QA (after completion of the study)
Minutes for 253rd
Registration Board Meeting 136
Product Details
Product name/ Generic name/
Dosage form Sofosvir (Sofosbuvir) 400mg Tablets Batch No TT-02
Description of pack
(container closure system) Blister Pack Bat size 500 Tablets
Parameters and tests
mentioned Description, Identification, Disintegration, Dissolution & Assay Mfg. Date 07-2015
Recommended storage
conditions
Short term conditions (Accelerated) 40◦C ±2
◦C, 75%±5% RH
Long term conditions (Real Time) 30◦C ±2
◦C, 65%±5% RH
Exp. Date 07-2017
Date of initiation &
implementation 01-07-2015 (API) Lot No YF20150401
Stability No. Doc. No.: GP / QC / SSP / 001
Sample taken for Physical tests = (6+6) = 12
Sample taken for Chemical tests = 20
Sample taken for Microbiological tests = N.A
Extra Samples if needed = 5
Total sample size (Approx) = 37 Tablets Per Test
Minutes for 253rd
Registration Board Meeting 137
Accelerated Stability Study Data Sheet
Assessment frequency (weeks) Initial After 01 month After 02 months After 03 months After 06 months
Date of Testing 01-07-15 01-08-15 01-09-15 01-10-15 01-01-
16
Mode of testing (F= full, P= partial) F P F P F P F P F P
Tests (Physical,
Chemical,
Microbiological)
Acceptance
Criteria
Storage
Conditions
(Accelerated)
Description
Oblong
shape white
color tablets
40◦C ±2◦C,
75%±5%
Complies Complies Complies Continue
Identification Positive for
Sofosbuvir
40◦C ±2◦C,
75%±5%
Positive Positive Positive Continue
Disintegration NMT 30
min
40◦C ±2◦C,
75%±5%
12.1 min 12.5 min 12.6 min Continue
Dissolution
NLT 85 %
in 30
minutes
40◦C ±2◦C,
75%±5%
97.13% 97.78% 97.46% Continue
Assay
NLT 90.0%
and NMT
110.0%
40◦C ±2◦C,
75%±5%
101.22% 100.20 % 100.97 % Continue
Analyst Signature (after completion of every time
line)
Conclusion by QA (after completion of the study)
Minutes for 253rd
Registration Board Meeting 138
Real Time Stability Study Data Sheet
Assessment frequency (weeks) Initial After 03 months After 06 months After 09 months
Date of Testing 01-07-15 01-10-15 01-01-16 01-04-16
Mode of testing (F= full, P= partial) F P F P F P F P
Tests (Physical,
Chemical,
Microbiological)
Acceptance Criteria
Storage
Conditions
(Accelerated)
Description Oblong shape white
color tablets
30◦C ±2◦C,
65%±5%
Complies Continue
Identification Positive for
Sofosbuvir
30◦C ±2◦C,
65%±5%
Positive Continue
Disintegration NMT 30 min
30◦C ±2◦C,
65%±5%
12.5 min Continue
Dissolution NLT 85 % in 30
minutes
30◦C ±2◦C,
65%±5%
97.13 % Continue
Assay NLT 90.0% and
NMT 110.0%
30◦C ±2◦C,
65%±5%
101.05 % Continue
Analyst Signature (after completion of every time line)
Conclusion by QA (after completion of the study)
Minutes for 253rd
Registration Board Meeting 139
Real Time Stability Study Data Sheet
Post Expiry 01 Year Stability Study
Assessment frequency (weeks) After 12 months After 18 months After 24 months After 30 months After 36 months
Date of Testing 01-07-16 01-01-17 01-07-17
Mode of testing (F= full, P= partial) F P F P F P F P F P
Tests (Physical,
Chemical,
Microbiological)
Acceptance Criteria Storage
Conditions
(Accelerated)
Description
30◦C ±2◦C,
65%±5%
Identification
30◦C ±2◦C,
65%±5%
Uniformity of
dosage units
30◦C ±2◦C,
65%±5%
Disintegration
30◦C ±2◦C,
65%±5%
Dissolution
30◦C ±2◦C,
65%±5%
Assay
30◦C ±2◦C,
65%±5%
Analyst Signature (after completion of every time line)
Conclusion by QA (after completion of the study)
Minutes for 253rd
Registration Board Meeting 140
Product Details
Product name/ Generic name/
Dosage form Sofosvir (Sofosbuvir) 400mg Tablets Batch No TT-03
Description of pack
(container closure system) Blister Pack Bat size 500 Tablets
Parameters and tests
mentioned Description, Identification, Disintegration, Dissolution & Assay Mfg. Date 07-2015
Recommended storage
conditions
Short term conditions (Accelerated) 40◦C ±2
◦C, 75%±5% RH
Long term conditions (Real Time) 30◦C ±2
◦C, 65%±5% RH
Exp. Date 07-2017
Date of initiation &
implementation 01-07-2015 (API) Lot No YF20150401
Stability No. Doc. No.: GP / QC / SSP / 001
Sample taken for Physical tests = (6+6) = 12
Sample taken for Chemical tests = 20
Sample taken for Microbiological tests = N.A
Extra Samples if needed = 5
Total sample size (Approx) = 37 Tablets per test
Minutes for 253rd
Registration Board Meeting 141
Accelerated Stability Study Data Sheet
Assessment frequency (weeks) Initial After 01 month After 02 months After 03 months After 06 months
Date of Testing 01-07-15 01-08-15 01-09-15 01-10-15 01-01-
16
Mode of testing (F= full, P= partial) F P F P F P F P F P
Tests (Physical,
Chemical,
Microbiological)
Acceptance
Criteria
Storage
Conditions
(Accelerated)
Description
Oblong
shape white
color tablets
40◦C ±2◦C,
75%±5%
Complies Complies Complies Continue
Identification Positive for
Sofosbuvir
40◦C ±2◦C,
75%±5%
Positive Positive Positive Continue
Disintegration NMT 30
min
40◦C ±2◦C,
75%±5%
12.4 min 11.9 min 12.4 min Continue
Dissolution
NLT 85 %
in 30
minutes
40◦C ±2◦C,
75%±5%
96.06 % 94.78 % 94.89 % Continue
Assay
NLT 90.0%
and NMT
110.0%
40◦C ±2◦C,
75%±5%
100.56 % 100.20 % 100.04 % Continue
Analyst Signature (after completion of every time
line)
Conclusion by QA (after completion of the study)
Minutes for 253rd
Registration Board Meeting 142
Real Time Stability Study Data Sheet
Assessment frequency (weeks) Initial After 03 months After 06 months After 09 months
Date of Testing 01-07-15 01-10-15 01-01-16 01-04-16
Mode of testing (F= full, P= partial) F P F P F P F P
Tests (Physical,
Chemical,
Microbiological)
Acceptance Criteria
Storage
Conditions
(Accelerated)
Description Oblong shape white
color tablets
30◦C ±2◦C,
65%±5%
Complies Continue
Identification Positive for
Sofosbuvir
30◦C ±2◦C,
65%±5%
Positive Continue
Disintegration NMT 30 min
30◦C ±2◦C,
65%±5%
12.7 min Continue
Dissolution NLT 85 % in 30
minutes
30◦C ±2◦C,
65%±5%
96.06 % Continue
Assay NLT 90.0% and
NMT 110.0%
30◦C ±2◦C,
65%±5%
100.56 % Continue
Analyst Signature (after completion of every time line)
Conclusion by QA (after completion of the study)
Continued…
Minutes for 253rd
Registration Board Meeting 143
Real Time Stability Study Data Sheet
Post Expiry 01 Year Stability Study
Assessment frequency (weeks) After 12 months After 18 months After 24 months After 30 months After 36 months
Date of Testing 01-07-16 01-01-17 01-07-17
Mode of testing (F= full, P= partial) F P F P F P F P F P
Tests (Physical,
Chemical,
Microbiological)
Acceptance
Criteria
Storage
Conditions
(Accelerated)
Description
30◦C ±2◦C,
65%±5%
Identification
30◦C ±2◦C,
65%±5%
Uniformity of
dosage units
30◦C ±2◦C,
65%±5%
Disintegration
30◦C ±2◦C,
65%±5%
Dissolution
30◦C ±2◦C,
65%±5%
Assay
30◦C ±2◦C,
65%±5%
Analyst Signature (after completion of every time
line)
Conclusion by QA (after completion of the study)
Minutes for 253rd
Registration Board Meeting 144
Accelerated Stability Study Data Sheet
Assessment frequency (weeks) Initial After 01 month After 02 months After 03 months After 06 months
Date of Testing 01-07-15 01-08-15 01-09-15 01-10-15 01-01-16
Mode of testing (F= full, P= partial) F P F P F P F P F P
Tests (Physical,
Chemical,
Microbiological)
Acceptance
Criteria
Storage Conditions
(Accelerated)
Description
Oblong shape
white color
tablets
40◦C ±2◦C,
75%±5%
Complies Complies Complies Continue
Identification Positive for
Sofosbuvir
40◦C ±2◦C,
75%±5%
Positive Positive Positive Continue
Disintegration NMT 30 min
40◦C ±2◦C,
75%±5%
12 min 12.5 min 12.6 min Continue
Dissolution NLT 85 % in
30 minutes
40◦C ±2◦C,
75%±5%
98.16 % 97.78% 97.46% Continue
Assay
NLT 90.0%
and NMT
110.0%
40◦C ±2◦C,
75%±5%
101.15% 100.20 % 99.97 % Continue
Analyst Signature (after completion of every time line)
Conclusion by QA (after completion of the study)
Minutes for 253rd
Registration Board Meeting 145
Real Time Stability Study Data Sheet
Assessment frequency (weeks) Initial After 03 months After 06 months After 09 months
Date of Testing 01-07-15 01-10-15 01-01-16 01-04-16
Mode of testing (F= full, P= partial) F P F P F P F P
Tests (Physical,
Chemical,
Microbiological)
Acceptance Criteria
Storage
Conditions
(Accelerated)
Description Oblong shape white
color tablets
30◦C ±2◦C,
65%±5%
Complies Continue
Identification Positive for
Sofosbuvir
30◦C ±2◦C,
65%±5%
Positive Continue
Disintegration NMT 30 min
30◦C ±2◦C,
65%±5%
12.5 min Continue
Dissolution NLT 85 % in 30
minutes
30◦C ±2◦C,
65%±5%
98.16 % Continue
Assay NLT 90.0% and
NMT 110.0%
30◦C ±2◦C,
65%±5%
101.05 % Continue
Analyst Signature (after completion of every time line)
Conclusion by QA (after completion of the study)
Minutes for 253rd
Registration Board Meeting 146
Real Time Stability Study Data Sheet
Post Expiry 01 Year Stability Study
Assessment frequency (weeks) After 12 months After 18 months After 24 months After 30 months After 36 months
Date of Testing 01-07-16 01-01-17 01-07-17
Mode of testing (F= full, P= partial) F P F P F P F P F P
Tests (Physical,
Chemical,
Microbiological)
Acceptance
Criteria
Storage
Conditions
(Accelerated)
Description
30◦C ±2◦C,
65%±5%
Identification
30◦C ±2◦C,
65%±5%
Uniformity of dosage
units
30◦C ±2◦C,
65%±5%
Disintegration
30◦C ±2◦C,
65%±5%
Dissolution
30◦C ±2◦C,
65%±5%
Assay 30◦C ±2◦C,
65%±5%
Analyst Signature (after completion of every time
line)
Conclusion by QA (after completion of the study)
Minutes for 253rd
Registration Board Meeting 147
Documents / Data provided by the applicants
M/s Glitz, Islamabad
Sr. No. Documents to be provided Status
1. COA of API Yes
2. Approval of API by regulatory authority of country of origin or GMP
certificate of API manufacturer issued by regulatory authority of country of
origin.
No
3. Protocols followed for conduction of stability study and details of tests. Yes
4. Data of 03 batches will be supported by attested respective documents like
chromatograms, laboratory reports, data sheets etc.
No
5. Documents confirming import of API etc. No
6. All provided documents will be attested (name, sign and stamp) for ensuring
authenticity of data / documents.
Yes
7. Commitment to continue real time stability study till assigned shelf life of the
product.
No
Decision: Mr. Kiramatullah, Quality Control manager presented the data. The Board observed that the stability data provided by the firm
is not in accordance with the guidelines approved by the Board in 251st meeting as firm has not provided approval of API by regulatory
authority of country of origin or GMP certificate of API manufacturer issued by regulatory authority of country of origin, data of 03
batches will be supported by attested respective documents like chromatograms, laboratory reports, data sheets and commitment to
continue real time stability study till assigned shelf life of the product. Therefore, case was deferred till the applicant completes the requisite
information in respect of stability studies.
Minutes for 253rd
Registration Board Meeting 148
14. M/s Shrooq Pharma, Lahore
Drug Sofvir tablets (Sofosbuvir) 400 mg
Source Virupaksha Organics Ltd. India
Storage Condition Accelerated: 40 C and 75% RH
Time Period Accelerated: 6 months
Frequency 0, 1,2, 3, 4,5, 6 months
Batch Size 400/ batch
No. of Batches 03
Sample Size 30 tablets
Meeting Deferred in 244th and 251
st meeting of Registration
Board
Attributes Tested (Batch 1)
Accelerated: 40 C and 75% RH
Sr.
No.
Attribute Specifications Results
(Initial)
Results
(1
months)
Results
(2
months)
Results
(3
months)
Results
(4
months)
Results
(6
months)
1. Appearance White
colored
oblong
shaped film
coated tablets
Complied Complied Complied Complied Complied Complied
2. Identification +ve +ve +ve +ve +ve +ve +ve
3. Disintegration
time (mins)
NMT 30 mins 6 6 6 7 6 6
4. Average Wt 685 mg ± Complied Complied Complied Complied Complied Complied
Minutes for 253rd
Registration Board Meeting 149
5.0%
5. Assay % 90-110% 99% 99% 99% 99% 99% 99%
Attributes Tested (Batch 2) Accelerated: 40 C and 75% RH
Sr.
No.
Attribute Specifications Results
(Initial)
Results
(1
months)
Results
(2
months)
Results
(3
months)
Results
(4
months)
Results
(6
months)
1. Appearance White
colored
oblong
shaped film
coated tablets
Complied Complied Complied Complied Complied Complied
2. Identification +ve +ve +ve +ve +ve +ve +ve
3. Disintegration
time (mins)
NMT 30 mins 6 6 6 7 6 6
4. Average Wt 685 mg ±
5.0%
Complied Complied Complied Complied Complied Complied
5. Assay % 90-110% 99% 99% 99% 99% 99% 99%
Attributes Tested (Batch 3) Accelerated: 40 C and 75% RH
Sr.
No.
Attribute Specifications Results
(Initial)
Results
(1
months)
Results
(2
months)
Results
(3
months)
Results
(4
months)
Results
(6
months)
1. Appearance White
colored
oblong
shaped film
coated tablets
Complied Complied Complied Complied Complied Complied
2. Identification +ve +ve +ve +ve +ve +ve +ve
3. Disintegration
time (mins)
NMT 30 mins 6 6 6 7 6 6
4. Average Wt 685 mg ± Complied Complied Complied Complied Complied Complied
Minutes for 253rd
Registration Board Meeting 150
5.0%
5. Assay % 90-110% 99% 99% 99% 99% 99% 99%
Documents / Data provided by the applicant (M/s Shrooq Pharma, Lahore)
Sr. No. Documents to be provided Status
1. COA of API Yes
2. Approval of API by regulatory authority of country of origin or GMP
certificate of API manufacturer issued by regulatory authority of country of
origin.
No
3. Protocols followed for conduction of stability study and details of tests. Yes
4. Data of 03 batches will be supported by attested respective documents like
chromatograms, laboratory reports, data sheets etc.
Data of only accelerated
stability studies provided
5. Documents confirming import of API etc. Yes (By courier)
6. All provided documents will be attested (name, sign and stamp) for ensuring
authenticity of data / documents.
Yes
7. Commitment to continue real time stability study till assigned shelf life of the
product.
Yes
Decision: Mr. Gulsher Zaidi, Import Manager presented the data before Registration Board. The Board observed that the stability data
provided by the firm is not in accordance with the guidelines approved by the Board in 251st meeting as firm has not provided approval of
API by regulatory authority of country of origin or GMP certificate of API manufacturer issued by regulatory authority of country of origin
and real time stability data of 03 batches along with attested respective documents like chromatograms, laboratory reports, data sheets.
Therefore, case was deferred till the applicant completes the requisite information in respect of stability studies.
Minutes for 253rd
Registration Board Meeting 151
15. M/s Macter International Karachi
Drug Sofomac tablets (Sofosbuvir) 400 mg
Source Xiamen halosyntech Limited China
Storage Condition Accelerated: 40 C and 75% RH
Real Time: 30°C ± 2°C/65% ± 5% RH)
Time Period 6 months
Frequency 0,1,3,6 months
Batch Size Batch I: 350 Tablets
Batch II: 350Tablets
Batch III: 2125 tabs
No. of Batches 03
Sample Size 196
Meeting Deferred in 244th
and 251st meeting of
Registration Board
Product: Sofomac 400mg Tablets Storage Condition: 30˚C + 2˚C & 65% + 5% RH
Batch / Lot # S001 Mfg. Date: Feb-14
Pack Size: 14's & 28's Expiry Date: Feb-16
Packaging Material: Bottle, Cap, Label, Unit carton &
Leaflet Storage period: Initial, 3 & 6 months
Test for Finished product Specifications Initial 3 Months 6 Months
Minutes for 253rd
Registration Board Meeting 152
Physical Appearance Elongated film coated tablet complies complies complies
Disintegration time NMT 30 minutes 8 min 8 min 9 min
Dissolution NLT 75% 92.32% 91.65% 90.78%
Assay Sofosbuvir
90- 110% 102.11% 101.68% 100.94%
Batch 2
Product: Sofomac 400mg Tablets Storage Condition: 30˚C + 2˚C & 65% + 5% RH
Batch / Lot # S002 Mfg. Date: Feb-14
Pack Size: 14's & 28's Expiry Date: Feb-16
Packaging Material: Bottle, Cap, Label, Unit carton &
Leaflet Storage period: Initial, 3 & 6 months
Test for Finished product Specifications Initial 3 Months 6 Months
Physical Appearance Elongated film coated tablet complies complies complies
Disintegration time NMT 30 minutes 7 min 7 min 8 min
Dissolution NLT 75% 93.11% 92.63% 91.82%
Assay Sofosbuvir
90- 110% 102.81% 102.35% 101.66%
Minutes for 253rd
Registration Board Meeting 153
Batch 3
Product: Sofomac 400mg Tablets Storage Condition: 30˚C + 2˚C & 65% + 5% RH
Batch / Lot # S003 Mfg. Date: Feb-14
Pack Size: 14's & 28's Expiry Date: Feb-16
Packaging Material: Bottle, Cap, Label, Unit carton &
Leaflet Storage period: Initial, 3 & 6 months
Test for Finished product Specifications Initial 3 Months 6 Months
Physical Appearance Elongated film coated tablet complies complies complies
Disintegration time NMT 30 minutes 8 min 9 min 9 min
Dissolution NLT 75% 92.64% 91.82% 90.94%
Assay Sofosbuvir
90- 110% 103.34% 102.75% 101.88%
Product: Sofomac 400mg Tablets Storage Condition: 40˚C + 2˚C & 75% + 5% RH
Batch / Lot # S001 Mfg. Date: Feb-14
Pack Size: 14's & 28's Expiry Date: Feb-16
Minutes for 253rd
Registration Board Meeting 154
Packaging Material: Bottle, Cap, Label, Unit carton &
Leaflet Storage
period: Initial, 3 & 6 months
Test for Finished product Specifications Initial 3 Months 6 Months
Physical Appearance Elongated film coated tablet complies complies complies
Disintegration time NMT 30 minutes 8 min 9 min 9 min
Dissolution NLT 75% 92.32% 91.45% 90.67%
Assay Sofosbuvir
90- 110% 102.11% 101.53% 100.75%
Batch 2
Product: Sofomac 400mg Tablets Storage Condition: 40˚C + 2˚C & 75% + 5% RH
Batch / Lot # S002 Mfg. Date: Feb-14
Pack Size: 14's & 28's Expiry Date: Feb-16
Packaging Material: Bottle, Cap, Label, Unit carton &
Leaflet Storage
period: Initial, 3 & 6 months
Test for Finished product Specifications Initial 3 Months 6 Months
Physical Appearance Elongated film coated tablet complies complies complies
Minutes for 253rd
Registration Board Meeting 155
Disintegration time NMT 30 minutes 7 min 8 min 9 min
Dissolution NLT 75% 93.11% 92.32% 91.41%
Assay Sofosbuvir
90- 110% 102.81% 102.21% 101.34%
Batch 3
Product: Sofomac 400mg Tablets Storage Condition: 40˚C + 2˚C & 75% + 5% RH
Batch / Lot # S003 Mfg. Date: Feb-14
Pack Size: 14's & 28's Expiry Date: Feb-16
Packaging Material: Bottle, Cap, Label, Unit carton &
Leaflet Storage
period: Initial, 3 & 6 months
Test for Finished product Specifications Initial 3 Months 6 Months
Physical Appearance Elongated film coated tablet complies complies complies
Disintegration time NMT 30 minutes 8 min 9 min 10 min
Dissolution NLT 75% 92.64% 91.71% 90.74%
Assay Sofosbuvir
90- 110% 103.34% 102.55% 101.61%
Minutes for 253rd
Registration Board Meeting 156
Documents / Data provided by the applicant
(M/s Macter Pharma, Karachi)
Sr. No. Documents to be provided Status
1. COA of API Yes
2. Approval of API by regulatory authority of country of origin or GMP
certificate of API manufacturer issued by regulatory authority of country of
origin.
No
3. Protocols followed for conduction of stability study and details of tests. Yes
4. Data of 03 batches will be supported by attested respective documents like
chromatograms, laboratory reports, data sheets etc.
No (Chromatograms and
related data not provided)
5. Documents confirming import of API etc. No
6. All provided documents will be attested (name, sign and stamp) for ensuring
authenticity of data / documents.
Yes
7. Commitment to continue real time stability study till assigned shelf life of the
product.
Yes
Decision: Dr.Salman Zaidi, Director Technical appeared befor Registration Board and clarified that M/s Ximen Halosyntech China
is located in Benbhu, China and Benbhu Tushan Pharmaceutical China is GMP owner and contract manufacturing for plant for
Xiamen. He aprovided COA and GMP certificate for manufacturer of the API i.e. Benbhu Tushan Pharmaceutical China. He also
provided raw data and documents confirming import of API by courier. Keeping in view data submitted, Registration Board granted
approval of registration of Sofosbuvir 400 mg tablets to the firm. However, manufacturer will inform concerned Federal Inspector of
Drugs for taking sample of Active Pharmaceutical Ingredient (used in manufacture of first commercial batch) for test/ analysis from
Central Drugs Laboratory, Karachi before sale of finished product.
Minutes for 253rd
Registration Board Meeting 157
16. M/s Welmark Pharma, Hattar
Drug Sofomark (Sofosbuvir) 400mg
Source Jiangxi Synergy Pharmaceutical Co., Ltd. China
(For trial purpose)
Storage
Conditions
Real Time: 30oC + 2
oC and 65% + 5% RH
Accelerated: 40oC + 2
oC and 75% + 5%RH
Time Period Real Time: 6 months
Accelerated: 6 months
Frequency 0, 1, 3, 6 months
0, 3, 6 months
Batch Size 50 tablets, 50 tablets
No. of Batches 02 (T1 and T2)
Sample Size 20 Tablets
Meeting Deferred in 244 and 251 meeting
Attributes Tested - Batch# T1
Product: Sofomark 400mg tablet Mfg. Date: 02 - 2015 Date of Commencement: 11-02-
2015
Product Code: N/A Exp. Date: 01 - 2017 Date of Completion: 11-08-2015
Batch#: T1 Shelf Life: 2 Years Pack Size: 7's
Packaging Material: HDPE Bottle
with cap, Silica dessicant, Leaflet,
Unit Carton
Storage Period: Initial, 1, 3 & 6 months
S.No Attribute Specifications Results
(Initial)
Results
(1 month)
Results
(3 months)
Results
(6 months)
1. Appearance White colored
oblong shaped
film coated
tablets
RT:
Complied
Acc:
Complied
RT:
Complied
Acc:
Complied
RT:
Complied
Acc:
Complied
RT:
Complied
Acc:
Complied
2. Identification Must be Positive Positive Positive Positive Positive
Minutes for 253rd
Registration Board Meeting 158
3. Dissolution NLT 85% RT: 99%
Acc: 97%
RT: 99%
Acc: 99%
RT: 99%
Acc: 99%
RT: 99%
Acc: 95%
4. Disintegration
time
NMT 30
minutes
RT: 7 min
Acc: 7 min
RT: 7 min
Acc: 7 min
RT: 7 min
Acc: 8 min
RT: 7 min
Acc: 9 min
5. Total
Degradation
Product
NMT 0.8% RT:
Complied
Acc:
Complied
RT:
Complied
Acc:
Complied
RT:
Complied
Acc:
Complied
RT:
Complied
Acc:
Complied
6. Assay% 90-110% RT: 103%
Acc: 103%
RT: 102%
Acc: 102%
RT: 102%
Acc: 101%
RT: 100%
Acc: 99%
Attributes Tested - Batch# T2
Product: Sofomark 400mg tablet Mfg. Date: 02 - 2015 Date of Commencement: 16-02-2015
Product Code: N/A Exp. Date: 01 - 2017 Date of Completion: 16-08-2015
Batch#: T2 Shelf Life: 2 Years Pack Size: 7's
Packaging Material: HDPE Bottle
with cap, Silica dessicant, Leaflet,
Unit Carton
Storage: Initial, 3 & 6 months
S.No. Attribute Specifications Results (Initial) Results
(3 months)
Results
(6 months)
1. Appearance White colored
oblong shaped
film coated
tablets
RT: Complied
Acc: Complied
RT: Complied
Acc: Complied
RT: Complied
Acc: Complied
2. Identification Must be Positive Positive Positive Positive
3. Dissolution NLT 85% RT: 99%
Acc: 97%
RT: 99%
Acc: 99%
RT: 99%
Acc: 94%
4. Disintegration
Time
NMT 30 minutes RT: 7 min
Acc: 7 min
RT: 7 min
Acc: 7 min
RT: 8 min
Acc: 10 min
5. Total NMT 0.8% RT: Complied RT: Complied RT: Complied
Minutes for 253rd
Registration Board Meeting 159
Degradation
Product
Acc: Complied Acc: Complied Acc: Complied
6. Assay% 90-110% RT: 103%
Acc: 103%
RT: 102%
Acc: 100%
RT: 102%
Acc: 98.8%
Documents / Data provided by the applicant
(M/s Welmark Pharma, Hattar)
Sr. No. Documents to be provided Status
1. COA of API Yes
2. Approval of API by regulatory authority of country of origin or GMP
certificate of API manufacturer issued by regulatory authority of country of
origin.
No
3. Protocols followed for conduction of stability study and details of tests. No
4. Data of 03 batches will be supported by attested respective documents like
chromatograms, laboratory reports, data sheets etc.
No
5. Documents confirming import of API etc. Yes (By courier)
6. All provided documents will be attested (name, sign and stamp) for ensuring
authenticity of data / documents.
Photocopies provided
7. Commitment to continue real time stability study till assigned shelf life of the
product.
No
Decision: Mr. Muhammad Muneer, Quality Control Manager presented the data before Registration Board. The Board observed that the
stability data provided by the firm is not in accordance with the guidelines approved by the Board in 251st meeting as firm has not provided
approval of API by regulatory authority of country of origin or GMP certificate of API manufacturer issued by regulatory authority of
country of origin, protocols followed for conduction of stability study and details of tests, data of 03 batches along with attested respective
documents like chromatograms, laboratory reports, data sheets and Commitment to continue real time stability study till assigned shelf life
of the product . Therefore, case was deferred till the applicant completes the requisite information in respect of stability studies.
Minutes for 253rd
Registration Board Meeting 160
17. M/ s Searle Company Ltd Karachi
Firm M/ s Searle Company Ltd Karachi
Drug Sobvi 400mg
Source Beijing Huikang Bouyan China
Storage Condition 40C, 75±5RH,
30C, 75±5RH
Time Period 0,3,6,9
Frequency 03 Months Interval
Batch Size
No. of Batches 03
Sample Size
Meeting M-244th
and 249th
Stability Data Report
Product Name: SOBVI 400mg TABLETS Ref. # 3651/A Packaging: Alu / Alu Blister
(Sofosbuvir)
B.No. 14 PD-080/A Mfg.Date: 10-2014
Shelf Life: 2Years Exp. Date: 10-2016
Test Specifications Initial 03 Month 06 Month 09 Month
Ambient Ambient Ambient
Description
Yellow colored, biconvex, oblong shaped,
film coated tablets, engraved breakline on
one side and plain on other side.
Complies Complies Complies Complies
Assay
(Sofosbuvir)
400mg /tab
90% to 110% of L.C 101.72% 101.69% 101.92% 102.01%
Minutes for 253rd
Registration Board Meeting 161
Disintegration Time NMT 30 mins 2 mins 2 mins 4 mins 3 mins
Dissolution test NLT 80% released in 60 minutes 90.56% 90.73% 93.58% 102.31%
Ambient Condition: 30ºC + 2ºC / 65% RH + 5% RH
Product Name: SOBVI 400mg TABLETS Ref. # 3651/A Packaging: Alu / Alu Blister
(Sofosbuvir)
B.No. 14 PD-080/A Mfg.Date: 10-2014
Shelf Life: 2Years Exp. Date: 10-2016
Test Specifications Initial 03 Month 06 Months
Accelerated condition Accelerated condition
Description
Yellow colored, biconvex, oblong
shaped, film coated tablets,
engraved breakline on one side
and plain on other side.
Complies Complies Complies
Assay
(Sofosbuvir)
400mg /tab
90% to 110% of L.C 101.72% 101.70% 101.95%
Disintegration Time NMT 30 mins 2 mins 3 mins 3 mins
Dissolution test NLT 80% released in 60 minutes 90.56% 91.58% 95.88%
Minutes for 253rd
Registration Board Meeting 162
Accelerated Condition: 40ºC + 2ºC / 75% + 5% RH
Product Name: SOBVI 400mg TABLETS Ref. # 3651/B Packaging: Alu / Alu Blister
(Sofosbuvir)
B.No. 14 PD-080/B Mfg.Date: 10-2014
Shelf Life: 2Years Exp. Date: 10-2016
Test Specifications Initial 03 Month 06 Month 09 Month
Ambient Ambient Ambient
Description
Yellow colored, biconvex, oblong shaped,
film coated tablets, engraved breakline on
one side and plain on other side.
Complies Complies Complies Complies
Assay
(Sofosbuvir)
400mg /tab
90% to 110% of L.C 101.85% 101.37% 101.25% 100.88%
Disintegration Time NMT 30 mins 2 mins 2 mins 2 mins 4 mins
Dissolution test NLT 80% released in 60 minutes 91.77% 91.72% 95.61% 98.45%
Ambient Condition: 30ºC + 2ºC / 65% RH + 5% RH
Product Name: SOBVI 400mg TABLETS Ref. # 3651/B Packaging: Alu / Alu Blister
(Sofosbuvir)
B.No. 14 PD-080/B Mfg.Date: 10-2014
Shelf Life: 2Years Exp. Date: 10-2016
Test Specifications Initial 03 Month 06 Months
Accelerated condition Accelerated condition
Minutes for 253rd
Registration Board Meeting 163
Description
Yellow colored, biconvex, oblong
shaped, film coated tablets, engraved
breakline on one side and plain on other
side.
Complies Complies Complies
Assay
(Sofosbuvir)
400mg /tab
90% to 110% of L.C 101.85% 101.72% 101.36%
Disintegration Time NMT 30 mins 2 mins 4 mins 3 mins
Dissolution test NLT 80% released in 60 minutes 91.77% 90.69% 94.82%
Accelerated Condition: 40ºC + 2ºC / 75% + 5% RH
Product Name: SOBVI 400mg TABLETS Ref. # 3651/C Packaging: Alu / Alu Blister
(Sofosbuvir)
B.No. 14 PD-080/C Mfg.Date: 10-2014
Shelf Life: 2Years Exp. Date: 10-2016
Test Specifications Initial 03 Month 06 Month 09 Month
Ambient Ambient Ambient
Description
Yellow colored, biconvex, oblong shaped,
film coated tablets, engraved breakline on
one side and plain on other side.
Complies Complies Complies Complies
Assay
(Sofosbuvir)
400mg /tab
90% to 110% of L.C 101.68% 101.56% 101.36% 99.33%
Disintegration Time NMT 30 mins 2 mins 2 mins 2 mins 3 mins
Minutes for 253rd
Registration Board Meeting 164
Dissolution test NLT 80% released in 60 minutes 92.34% 91.70% 93.47% 98.83%
Ambient Condition: 30ºC + 2ºC / 65% RH + 5% RH
Product Name: SOBVI 400mg TABLETS Ref. # 3651/C Packaging: Alu / Alu Blister
(Sofosbuvir)
B.No. 14 PD-080/C Mfg.Date: 10-2014
Shelf Life: 2Years Exp. Date: 10-2016
Test Specifications Initial 03 Month 06 Months
Accelerated condition Accelerated condition
Description
Yellow colored, biconvex, oblong
shaped, film coated tablets, engraved
breakline on one side and plain on
other side.
Complies Complies Complies
Assay
(Sofosbuvir)
400mg /tab
90% to 110% of L.C 101.68% 101.34% 100.58%
Disintegration Time NMT 30 mins 2 mins 4 mins 3 mins
Dissolution test NLT 80% released in 60 minutes 92.34% 90.33% 94.35%
Accelerated Condition: 40ºC + 2ºC / 75% + 5% RH
Documents / Data provided by the applicant
(M/s Searl Pharma, Karachi)
Sr. No. Documents to be provided Status
Minutes for 253rd
Registration Board Meeting 165
1. COA of API Yes
2. Approval of API by regulatory authority of country of origin or GMP
certificate of API manufacturer issued by regulatory authority of country of
origin.
Yes
3. Protocols followed for conduction of stability study and details of tests. Yes
4. Data of 03 batches will be supported by attested respective documents like
chromatograms, laboratory reports, data sheets etc.
Yes
5. Documents confirming import of API etc. Yes (by courier)
200gms
6. All provided documents will be attested (name, sign and stamp) for ensuring
authenticity of data / documents.
Yes
7. Commitment to continue real time stability study till assigned shelf life of the
product.
Yes
Decision: Mr.Anwar Jamal presented the data. Registration Board observed that the stability data provided by the firm is in
accorndace with the guidelines approved by the Board in 251st meeting. Therefore, Board granted approval of registration of
Sofosbuvir 400 mg tablets to the firm. However, manufacturer will inform concerned Federal Inspector of Drugs for taking sample
of Active Pharmaceutical Ingredient (used in manufacture of first commercial batch) for test/ analysis from Central Drugs
Laboratory, Karachi before sale of finished product.
Minutes for 253rd
Registration Board Meeting 166
18. M/s Wilson Pharmaceuticals Islamabad
Drug Saferon Tablets 400mg
Source Virupaksha organics Limited, India
Storage Condition Accelerated: 40 C and 75% RH
Real Time: 30 C and 65% RH
Time Period 6 months
Frequency 0,3,6 months
Batch Size 500 tablets
No. of Batches 3
Sample Size 424 x 3
Meeting 244& 251
ACCELERATED STABILITY STUDY
Product Name: Saferon Tablets Batch #: 01
Composition:Each Tablet Contains Batch Size: 500 tablets
Sofosbuvir----400mg
Mfg. Date: 12-2014 Exp. Date: 12-2016
Storage Condition: 40º C ± 2º 75% RH ± 5%RH Frequency: 0, 3, 6 months
Type of Container / Packaging: Alu-Alu/Alu-PVC Strip
Minutes for 253rd
Registration Board Meeting 167
Remarks: After the period of 6 months accelerated stability study, no change in physical & chemical characters observed.
ACCELERATED STABILITY STUDY
Product Name: Saferon Tablets Batch #: 02
Composition:Each Tablet Contains Batch Size: 500 tablets
Sofosbuvir----400mg
Mfg. Date: 12-2014 Exp. Date: 12-2016
Storage Condition: 40º C ± 2º 75% RH ± 5%RH Frequency: 0, 3, 6 months
Type of Container / Packaging: Alu-Alu/Alu-PVC Strip
Test
Performed
Internal /Standard
Specification
RESULTS
Initial at the time of
Mfg.(Zero)
After
03 months
After
06 months
Physical
Appearance Film coated tablets Complies Complies Complies
Identification
Sample profile
corresponds to that of
standard
Complies Complies Complies
Disintegration
Time NMT 30 minutes 7: 00 minutes 7:00 minutes 6:00 minutes
Dissolution
NLT 75% 95.59% 94.45% 93.57%
Assay
90-110% 105.72% 105.21% 105.11%
Minutes for 253rd
Registration Board Meeting 168
Remarks: After the period of 6 months accelerated stability study, no change in physical & chemical characters observed.
ACCELERATED STABILITY STUDY
Product Name: Saferon Tablets Batch #: 03
Composition:Each Tablet Contains Batch Size: 500 tablets
Sofosbuvir----400mg
Mfg. Date: 12-2014 Exp. Date: 12-2016
Test
Performed
Internal /Standard
Specification
RESULTS
Initial at the time of
Mfg.(Zero) After
03months
After
06months
Physical
Appearance Film coated tablets Complies Complies Complies
Identification
Sample profile
corresponds to that of
standard
Complies Complies Complies
Disintegration
Time NMT 30 minutes 8:00 minutes 7:02 minutes 6:02 minutes
Dissolution
NLT 75% 94.80% 94.35% 94.13%
Assay
90-110% 105.43% 105.14% 105.00%
Minutes for 253rd
Registration Board Meeting 169
Storage Condition: 40º C ± 2º 75% RH ± 5%RH Frequency: 0, 3, 6 months
Type of Container / Packaging: Alu-Alu/Alu-PVC Strip
Remarks: After the period of 6 months accelerated stability study, no change in physical & chemical characters observed.
Test
Performed
Internal /Standard
Specification
RESULTS
Initial at the time of
Mfg.(Zero) After
03 months
After
06 months
Physical
Appearance Film coated tablets Complies Complies Complies
Identification
Sample profile
corresponds to that of
standard
Complies Complies Complies
Disintegration
Time NMT 30 minutes 6:00 minutes 7:02 minutes 6:02 minutes
Dissolution
NLT 75% 95.54% 95.18% 95.02%
Assay
90-110% 105.99% 105.44% 105.27%
Minutes for 253rd
Registration Board Meeting 170
LONG TERM STABILITY STUDY
Product Name: Saferon Tablets Batch #: 01
Composition:Each Tablet Contains Batch Size: 500 tablets
Sofosbuvir----400mg
Mfg. Date: 12-2014 Exp. Date: 12-2016
Storage Condition: 30º C ± 2º 65% RH ± 5%RH Frequency: 0, 3, 6,9 months
Type of Container / Packaging: Alu-Alu/Alu-PVC Strip
Test
Performed
Internal /Standard
Specification
RESULTS
Initial at the time of
Mfg.(Zero) After
03 months
After
06months
After
09 months
Physical
Appearance Film coated tablets Complies Complies Complies Complies
Identification
Sample profile
corresponds to that of
standard
Complies Complies Complies Complies
Disintegration
Time NMT 30 minutes 7:00 minutes 6:02 minutes 7:02 minutes 7:01 minutes
Dissolution
NLT 75% 95.59% 95.18% 93.95% 93.43%
Assay
90-110% 105.72% 105.41% 105.06% 104.33%
Minutes for 253rd
Registration Board Meeting 171
Remarks: After the period of 9 months long term stability study, no change in physical & chemical characters observed.
LONG TERM STABILITY STUDY
Product Name: Saferon Tablets Batch #: 02
Composition:Each Tablet Contains Batch Size: 500 tablets
Sofosbuvir----400mg
Mfg. Date: 12-2014 Exp. Date: 12-2016
Storage Condition: 30º C ± 2º 65% RH ± 5%RH Frequency: 0, 3, 6,9 months
Type of Container / Packaging: Alu-Alu/Alu-PVC Strip
Test
Performed
Internal /Standard
Specification
RESULTS
Initial at the time of
Mfg.(Zero) After
03 months
After
06months
After
09 months
Physical
Appearance Film coated tablets Complies Complies Complies Complies
Identification
Sample profile
corresponds to that of
standard
Complies Complies Complies Complies
Disintegration
Time NMT 30 minutes 8:00 minutes 7:02 minutes 7:02 minutes 7:01 minutes
Dissolution
NLT 75% 94.80% 94.51% 94.12% 93.75%
Minutes for 253rd
Registration Board Meeting 172
Remarks: After the period of 9 months long term stability study, no change in physical & chemical characters observed.
LONG TERM STABILITY STUDY
Product Name: Saferon Tablets Batch #: 03
Composition:Each Tablet Contains Batch Size: 500 tablets
Sofosbuvir----400mg
Mfg. Date: 12-2014 Exp. Date: 12-2016
Storage Condition: 30º C ± 2º 65% RH ± 5%RH Frequency: 0, 3, 6,9 months
Type of Container / Packaging: Alu-Alu/Alu-PVC Strip
Assay
90-110% 105.43% 105.20% 105.00% 104.25%
Test
Performed
Internal /Standard
Specification
RESULTS
Initial at the time of
Mfg.(Zero) After
03 months
After
06months
After
09 months
Physical
Appearance Film coated tablets Complies Complies Complies Complies
Identification
Sample profile
corresponds to that of
standard
Complies Complies Complies Complies
Minutes for 253rd
Registration Board Meeting 173
Remarks: After the period of 9 months long term stability study, no change in physical & chemical characters observed.
Documents / Data provided by the applicant (M/s Wilson Pharma, Islamabad)
Sr. No. Documents to be provided Status
1. COA of API Yes
2. Approval of API by regulatory authority of country of origin or GMP
certificate of API manufacturer issued by regulatory authority of country of
origin.
Yes
3. Protocols followed for conduction of stability study and details of tests. Yes
4. Data of 03 batches will be supported by attested respective documents like
chromatograms, laboratory reports, data sheets etc.
Yes
5. Documents confirming import of API etc. Yes (Courier)
6. All provided documents will be attested (name, sign and stamp) for ensuring
authenticity of data / documents.
Yes
7. Commitment to continue real time stability study till assigned shelf life of the
product.
Yes
Decision: Mr.Tipu Sultan Akram presented the data. Registration Board observed that the stability data provided by the firm is in
accorndace with the guidelines approved by the Board in 251st meeting. Therefore, Board granted approval of registration of
Sofosbuvir 400 mg tablets to the firm. However, manufacturer will inform concerned Federal Inspector of Drugs for taking sample
of Active Pharmaceutical Ingredient (used in manufacture of first commercial batch) for test/ analysis from Central Drugs
Laboratory, Karachi before sale of finished product.
Disintegration
Time NMT 30 minutes 6:00 minutes 6:02minutes 7:02 minutes 7:00 minutes
Dissolution
NLT 75% 95.54% 95.30% 95.05% 94.66%
Assay
90-110% 105.99% 105.55% 105.13% 104.19%
Minutes for 253rd
Registration Board Meeting 174
19. M/s Werrick Pharmaceuticals Islamabad
Drug Cell-tab Tablets 400mg
Source Virupaksha organics Limited, India
Storage Condition Accelerated: 40 C and 75% RH
Real Time: 30 C and 65% RH
Time Period 6 months
Frequency 0,3,6 months
Batch Size 500 tablets
No. of Batches 3
Sample Size 424 x 3
Meeting 244& 251
ACCELERATED STABILITY STUDY
Product Name: Cell-Tab Tablets Batch #: 01
Composition:Each Tablet Contains Batch Size: 500 tablets
Sofosbuvir----400mg
Mfg. Date: 12-2014 Exp. Date: 12-2016
Storage Condition: 40º C ± 2º 75% RH ± 5%RH Frequency: 0, 3, 6 months
Type of Container / Packaging: Alu-Alu/Alu-PVC Strip
Test
Performed
Internal /Standard
Specification
RESULTS
Minutes for 253rd
Registration Board Meeting 175
Remarks: After the period of 6 months accelerated stability study, no change in physical & chemical characters observed.
ACCELERATED STABILITY STUDY
Product Name: Cell-Tab Tablets Batch #: 02
Composition:Each Tablet Contains Batch Size: 500 tablets
Sofosbuvir----400mg
Mfg. Date: 12-2014 Exp. Date: 12-2016
Storage Condition: 40º C ± 2º 75% RH ± 5%RH Frequency: 0, 3, 6 months
Type of Container / Packaging: Alu-Alu/Alu-PVC Strip
Initial at the time of
Mfg.(Zero) After
03months
After
06 months
Physical
Appearance Film coated tablets Complies Complies Complies
Identification
Sample profile
corresponds to that of
standard
Complies Complies Complies
Disintegration
Time NMT 30 minutes 7:00 minutes 8:00 minutes 7:00 minutes
Dissolution
NLT 75% 93.59% 92.45% 90.57%
Assay
90-110%
105.72%
105.21% 105.11%
Minutes for 253rd
Registration Board Meeting 176
Remarks: After the period of 6 months accelerated stability study, no change in physical & chemical characters observed.
ACCELERATED STABILITY STUDY
Product Name: Cell-Tab Tablets Batch #: 03
Composition:Each Tablet Contains Batch Size: 500 tablets
Sofosbuvir----400mg
Test
Performed
Internal /Standard
Specification
RESULTS
Initial at the time of
Mfg.(Zero) After
03 months
After
06 months
Physical
Appearance Film coated tablets Complies Complies Complies
Identification
Sample profile
corresponds to that of
standard
Complies Complies Complies
Disintegration
Time NMT 30 minutes 8:00 minutes 7:01 minutes 8 :01minutes
Dissolution
NLT 75% 94.66% 94.35% 94.19%
Assay
90-110%
105.50%
105.27% 105.13%
Minutes for 253rd
Registration Board Meeting 177
Mfg. Date: 12-2014 Exp. Date: 12-2016
Storage Condition: 40º C ± 2º 75% RH ± 5%RH Frequency: 0, 3, 6 months
Type of Container / Packaging: Alu-Alu/Alu-PVC Strip
Remarks: After the period of 6 months accelerated stability study, no change in physical & chemical characters observed.
Test
Performed
Internal /Standard
Specification
RESULTS
Initial at the time of
Mfg.(Zero) After
03 months
After
06 months
Physical
Appearance Film coated tablets Complies Complies Complies
Identification
Sample profile
corresponds to that of
standard
Complies Complies Complies
Disintegration
Time NMT 30 minutes 7:00 minutes 6:01 minutes 7:01 minutes
Dissolution
NLT 75% 93.88% 93.59% 93.11%
Assay
90-110%
105.95%
105.50% 105.25%
Minutes for 253rd
Registration Board Meeting 178
LONG TERM STABILITY STUDY
Product Name: Cell-Tab Tablets Batch #: 01
Composition:Each Tablet Contains Batch Size: 500 tablets
Sofosbuvir----400mg
Mfg. Date: 12-2014 Exp. Date: 12-2016
Storage Condition: 30º C ± 2º 65% RH ± 5%RH Frequency: 0, 3, 6,9 months
Type of Container / Packaging: Alu-Alu/Alu-PVC Strip
Test
Performed
Internal /Standard
Specification
RESULTS
Initial at the time of
Mfg.(Zero) After
03 months
After
06 months
After
09 months
Physical
Appearance Film coated tablets Complies Complies Complies Complies
Identification
Sample profile
corresponds to that of
standard
Complies Complies Complies Complies
Disintegration
Time NMT 30 minutes 7:00minutes 6:00 minutes 7:00minutes 7:01minutes
Dissolution
NLT 75% 93.59% 92.19% 91.00% 91.80%
Assay
90-110% 105.72% 105.30% 105.15% 104.95%
Minutes for 253rd
Registration Board Meeting 179
Remarks:After the period of 9 months long term stability study, no change in physical & chemical characters observed.
LONG TERM STABILITY STUDY
Product Name: Cell-Tab Tablets Batch #: 02
Composition:Each Tablet Contains Batch Size: 500 tablets
Sofosbuvir----400mg
Mfg. Date: 12-2014 Exp. Date: 12-2016
Storage Condition: 30º C ± 2º 65% RH ± 5%RH Frequency: 0, 3, 6,9 months
Type of Container / Packaging: Alu-Alu/Alu-PVC Strip
Test
Performed
Internal /Standard
Specification
RESULTS
Initial at the time of
Mfg.(Zero) After
03 months
After
06months
After
09 months
Physical
Appearance Film coated tablets Complies Complies Complies Complies
Identification
Sample profile
corresponds to that of
standard
Complies Complies Complies Complies
Disintegration
Time NMT 30 minutes 8:00minutes 6:01 minutes 7:01 minutes 7:00 minutes
Dissolution
NLT 75% 94.66% 94.41% 94.00% 93.52%
Minutes for 253rd
Registration Board Meeting 180
Remarks: After the period of 9 months long term stability study, no change in physical & chemical characters observed.
LONG TERM STABILITY STUDY
Product Name: Cell-Tab Tablets Batch #: 03
Composition:Each Tablet Contains Batch Size: 500 tablets
Sofosbuvir----400mg
Mfg. Date: 12-2014 Exp. Date: 12-2016
Storage Condition: 30º C ± 2º 65% RH ± 5%RH Frequency: 0, 3, 6,9 months
Type of Container / Packaging: Alu-Alu/Alu-PVC Strip
Assay
90-110% 105.50% 105.28% 105.01% 104.34%
Test
Performed
Internal /Standard
Specification
RESULTS
Initial at the time of
Mfg.(Zero) After
03 months
After
06 months
After
09 months
Physical
Appearance Film coated tablets Complies Complies Complies Complies
Identification
Sample profile
corresponds to that of
standard
Complies Complies Complies Complies
Disintegration
Time NMT 30 minutes 7:00 minutes 6:01minutes 7:02minutes 7:02minutes
Minutes for 253rd
Registration Board Meeting 181
Remarks: After the period of 9 months long term stability study, no change in physical & chemical characters observed.
Documents / Data provided by the applicant (M/s Werrick Pharma, Islamabad)
Sr. No. Documents to be provided Status
1. COA of API Yes
2. Approval of API by regulatory authority of country of origin or GMP
certificate of API manufacturer issued by regulatory authority of country of
origin.
Yes
3. Protocols followed for conduction of stability study and details of tests. Yes
4. Data of 03 batches will be supported by attested respective documents like
chromatograms, laboratory reports, data sheets etc.
Yes
5. Documents confirming import of API etc. Yes (Courier)
6. All provided documents will be attested (name, sign and stamp) for ensuring
authenticity of data / documents.
Yes
7. Commitment to continue real time stability study till assigned shelf life of the
product.
Yes
Decision: Mr.Tipu Sultan Akram presented the data. Registration Board observed that the stability data provided by the firm is in
accorndace with the guidelines approved by the Board in 251st meeting. Therefore, Board granted approval of registration of Sofosbuvir
400 mg tablets to the firm. However, manufacturer will inform concerned Federal Inspector of Drugs for taking sample of Active
Pharmaceutical Ingredient (used in manufacture of first commercial batch) for test/ analysis from Central Drugs Laboratory, Karachi
before sale of finished product.
Dissolution
NLT 75% 93.88% 93.35% 93.10% 92.88%
Assay
90-110% 105.95% 105.49% 105.23% 105.00%
Minutes for 253rd
Registration Board Meeting 182
20. M/s Scottmann Pharmaceuticals Islamabad
Drug HEPALDI Tablets 400mg
Source Virupaksha organics Limited, India
Storage Condition Accelerated: 40 C and 75% RH
Real Time: 30 C and 65% RH
Time Period 6 months
Frequency 0,3,6 months
Batch Size 500 tablets
No. of Batches 3
Sample Size 424 x 3
Meeting 252
LONG TERM STABILITY STUDY
Product Name: Hepaldi Tablets Batch #: 01
Composition: Each Tablet Contains Batch Size: 500 tablets
Sofosbuvir----400mg
Mfg. Date: 11-2014 Exp. Date: 11-2016
Storage Condition: 30º C ± 2º 65% RH ± 5%RH Frequency: 0, 3, 6, 9 months
Type of Container / Packaging: Alu-Alu/Alu-PVC Strip
Minutes for 253rd
Registration Board Meeting 183
Remarks: After the period of 9 months long term stability study, no change in physical & chemical characters observed.
ACCELERATED STABILITY STUDY Product Name: Hepaldi Tablets Batch #: 01
Composition: Each Tablet Contains Batch Size: 500 tablets
Sofosbuvir----400mg
Mfg. Date: 11-2014 Exp. Date: 11-2016
Storage Condition: 40º C ± 2º 75% RH ± 5%RH Frequency: 0, 3, 6months
Type of Container / Packaging: Alu-Alu/Alu-PVC Strip
Test
Performed
Internal /Standard
Specification
RESULTS
Initial at the time of
Mfg.(Zero) After
03 months
After
06 months
After
09 months
Physical
Appearance Film coated tablets Complies Complies Complies Complies
Identification
Sample profile
corresponds to that of
standard
Complies Complies Complies Complies
Disintegration
Time NMT 30 minutes 6:00 minutes 7:01 minutes 7:01 minutes 6:01 minutes
Dissolution
NLT 75% 93.59% 93.37% 92.95% 92.54%
Assay
90-110% 104.74% 104.45% 104.20 104.00%
Minutes for 253rd
Registration Board Meeting 184
Remarks: After the period of 6 months accelerated stability study, no change in physical & chemical characters observed.
Test
Performed
Internal /Standard
Specification
RESULTS
Initial at the time of
Mfg.(Zero) After
03 months
After
06months
Physical
Appearance Film coated tablets Complies Complies Complies
Identification
Sample profile
corresponds to that of
standard
Complies Complies Complies
Disintegration
Time NMT 30 minutes 6:00 minutes 8:00 minutes 7:00 minutes
Dissolution
NLT 75% 93.59% 93.11% 92.40%
Assay
90-110% 104.74% 104.54% 104.30%
Minutes for 253rd
Registration Board Meeting 185
LONG TERM STABILITY STUDY
Product Name: Hepaldi Tablets Batch #: 02
Composition: Each Tablet Contains Batch Size: 500 tablets
Sofosbuvir----400mg
Mfg. Date: 11-2014 Exp. Date: 11-2016
Storage Condition: 30º C ± 2º 65% RH ± 5%RH Frequency: 0, 3, 6,9 months
Type of Container / Packaging: Alu-Alu/Alu-PVC Strip
Test
Performed
Internal /Standard
Specification
RESULTS
Initial at the time of
Mfg.(Zero) After
03 months
After
06 months
After
09 months
Physical
Appearance Film coated tablets Complies Complies Complies Complies
Identification
Sample profile
corresponds to that of
standard
Complies Complies Complies Complies
Disintegration
Time NMT 30 minutes 7:00 minutes 6:01 minutes 7:01minutes 8:01minutes
Dissolution
NLT 75% 94.46% 94.13% 93.85% 93.27%
Assay
90-110% 104.88% 104.66% 104.42% 104.22%
Minutes for 253rd
Registration Board Meeting 186
Remarks: After the period of 9 months long term stability study, no change in physical & chemical characters observed.
ACCELERATED STABILITY STUDY
Product Name: Hepaldi Tablets Batch #: 02
Composition: Each Tablet Contains Batch Size: 500 tablets
Sofosbuvir----400mg
Mfg. Date: 11-2014 Exp. Date: 11-2016
Storage Condition: 40º C ± 2º 75% RH ± 5%RH Frequency: 0, 3, 6 months
Type of Container / Packaging: Alu-Alu/Alu-PVC Strip
Test
Performed
Internal /Standard
Specification
RESULTS
Initial at the time of
Mfg.(Zero) After
03 months
After
06months
Physical
Appearance Film coated tablets Complies Complies Complies
Identification
Sample profile
corresponds to that of
standard
Complies Complies Complies
Disintegration
Time NMT 30 minutes 7:00 minutes 7:00 minutes 7:01 minutes
Minutes for 253rd
Registration Board Meeting 187
Remarks: After the period of 6 months accelerated stability study, no change in physical & chemical characters observed.
LONG TERM STABILITY STUDY
Product Name: Hepaldi Tablets Batch #: 03
Composition: Each Tablet Contains Batch Size: 500 tablets
Sofosbuvir----400mg
Mfg. Date: 11-2014 Exp. Date: 11-2016
Storage Condition: 30º C ± 2º 65% RH ± 5%RH Frequency: 0, 3, 6, 9 months
Type of Container / Packaging: Alu-Alu/Alu-PVC Strip
Dissolution
NLT 75% 94.46% 94.05% 93.75%
Assay
90-110% 104.88% 104.49% 104.30%
Test
Performed
Internal /Standard
Specification
RESULTS
Initial at the time of
Mfg.(Zero) After
03 months
After
06 months
After
09months
Physical
Appearance Film coated tablets Complies Complies Complies Complies
Minutes for 253rd
Registration Board Meeting 188
Remarks: After the period of 9 months long term stability study, no change in physical & chemical characters observed.
ACCELERATED STABILITY STUDY
(ICH GUIDELINE)
Product Name: Hepaldi Tablets Batch #: 03
Composition: Each Tablet Contains Batch Size: 500 tablets
Sofosbuvir----400mg
Mfg. Date: 11-2014 Exp. Date: 11-2016
Storage Condition: 40º C ± 2º 75% RH ± 5%RH Frequency: 0, 3, 6 months
Type of Container / Packaging: Alu-Alu/Alu-PVC Strip
Identification
Sample profile
corresponds to that of
standard
Complies Complies Complies Complies
Disintegration
Time NMT 30 minutes 6:00 minutes 7:01 minutes 6:01 minutes 7:01 minutes
Dissolution
NLT 75% 95.55% 95.12% 94.87% 94.29%
Assay
90-110% 104.68% 104.45% 104.21% 104.09%
Minutes for 253rd
Registration Board Meeting 189
Remarks: After the period of 6 months accelerated stability study, no change in physical & chemical characters observed.
Documents / Data provided by the applicant
(M/s Scottman Pharma, Islamabad)
Sr. No. Documents to be provided Status
1. COA of API Yes
2. Approval of API by regulatory authority of country of origin or GMP
certificate of API manufacturer issued by regulatory authority of country of
origin.
Yes
Test
Performed
Internal /Standard
Specification
RESULTS
Initial at the time of
Mfg.(Zero) After
03 months
After
06months
Physical
Appearance Film coated tablets Complies Complies Complies
Identification
Sample profile
corresponds to that of
standard
Complies Complies Complies
Disintegration
Time NMT 30 minutes 6:00 minutes 8:00 minutes 7:01 minutes
Dissolution
NLT 75% 95.55% 95.41% 95.25%
Assay
90-110% 104.68% 104.41% 104.25%
Minutes for 253rd
Registration Board Meeting 190
3. Protocols followed for conduction of stability study and details of tests. Yes
4. Data of 03 batches will be supported by attested respective documents like
chromatograms, laboratory reports, data sheets etc.
Yes
5. Documents confirming import of API etc. Yes (Courier)
6. All provided documents will be attested (name, sign and stamp) for ensuring
authenticity of data / documents.
Yes
7. Commitment to continue real time stability study till assigned shelf life of the
product.
Yes
Decision: Mr.Tipu Sultan Akram presented the data. Registration Board observed that the stability data provided by the firm is in
accorndace with the guidelines approved by the Board in 251st meeting. Therefore, Board granted approval of registration of
Sofosbuvir 400 mg tablets to the firm. However, manufacturer will inform concerned Federal Inspector of Drugs for taking sample
of Active Pharmaceutical Ingredient (used in manufacture of first commercial batch) for test/ analysis from Central Drugs
Laboratory, Karachi before sale of finished product.
Minutes for 253rd
Registration Board Meeting 191
21. M/s Max Pharmaceuticals Islamabad
Drug Sofavir tablets (Sofosbuvir) 400 mg
Source Changzou Pharmaceutical Factory Co. Ltd
China
Storage Condition Accelerated: 40 C and 75% RH
Real Time: 30°C ± 2°C/65% ± 5% RH)
Time Period 6 months
Frequency 0, 1, 3, 6 months
Batch Size Batch I: 500 Tablets
Batch II: 1000 Tablets
Batch III: 900 tabs
No. of Batches 03
Sample Size 10 packs
Meeting Deferred in 244th
and 251st meeting of
Registration Board
Stability study Report
Product Name/ Generic
Name/ Dosage Form
Sofavir (Sofosbuvir) 400mg
Tablet Batch No. 15T01
Description of pack
Oblong shaped film coated
tablets filled in pet bottle &
packed in carton Batch Size 500 Tablets
Parameter and test
mentioned As per Product specification
Manufacturing
Date 01-2015
Recommended storage
conditions
Short term condition (Accelerated) 40°C ± 2, RH 75 % ± 5
Long term condition (Real Time) 30°C ± 2, RH 65 % ± 5 Expiry Date 01-2017
Minutes for 253rd
Registration Board Meeting 192
Assessment frequency (week) Initial (0) 1 2 3 4 6 8 12 16 20 24 26
Date of Testing 23/01/2015 23/04/2015 23/07/2015
Mode of testing (F = Full, P = Partial testing)F P F P F F F F F F F F
Tests(Physical,
Chemical,
Microbiological)
Acceptance
Criteria
Storage
Condition
(Accelerated)
Appearance 19mm oblong,
Off White Coated
Tablets
400C+-20C
75% RH +-5%RH Complies Complies Complies
Identification Sofosbuvir must
be Positive
400C+-20C
75% RH +-5%RH Positive Positive Positive
Disintegration time NMT 30minuts 400C+-20C
75% RH +-5%RH 13 Minutes 14 Minutes 14Minutes
Dissolution NLT 75% 400C+-20C
75% RH +-5%RH 94% 92% 89%
Assay 90-110% 400C+-20C
75% RH +-5%RH 100.4% 99.5% 98.7%
Analyst signature (after completion of every time line)
Date of initiation &
implementation 13-01-2015 API lot NO. 150503
Stability No. 15SOFO-STB-01 Date of
Storage 20-01-2015
Sample taken for Physical testing =04
Sample taken for Chemical testing =04
Sample taken for Microbial testing =NA
Sample taken Extra =02
Total sample size = 10packs
Minutes for 253rd
Registration Board Meeting 193
Conclusion by QC (After completion of the study):
Above data shows that the results of all the physical and chemical parameters are within limits during 6 months accelerated stability studies. So
the product is stable.
Assessment frequency (week) Initial (0) 1 2 3 4 6 8 12 16 20 24 26
Date of Testing 23/01/2015 23/04/2015 23/07/2015
Mode of testing (F = Full, P = Partial testing)F P F P F F F F F F F F
Tests(Physical,
Chemical,
Microbiological)
Acceptance
Criteria
Storage
Condition
(Real Time)
Appearance 19mm oblong,
Off White Coated
Tablets
300C+-20C
65% RH +-
5%RH Complies Complies Complies
Identification Sofosbuvir must
be Positive
300C+-20C
65% RH +-
5%RH Positive Positive Positive
Disintegration time NMT 30minuts
300C+-20C
65% RH +-
5%RH 13 Minutes 13 Minutes 14Minutes
Dissolution NLT 75% 300C+-20C
65% RH +-
5%RH
94% 94% 93%
Assay 90-110%
300C+-20C
65% RH +-
5%RH
100.4% 100% 99.8%
Analyst signature (after completion of every time line)
Conclusion by QC (After completion of the study):
Above data shows that the results of all the physical and chemical parameters are within limits during 6 months accelerated stability studies. So
the product is stable.
Minutes for 253rd
Registration Board Meeting 194
Sample taken for Physical testing =04
Sample taken for Chemical testing =04
Sample taken for Microbial testing =NA
Sample taken Extra =02
Total sample size = 10packs
Assessment frequency (week) Initial (0) 1 2 3 4 6 8 12 16 20 24 26
Date of Testing 23/01/2015 23/04/2015 23/07/2015
Mode of testing (F = Full, P = Partial testing)F P F P F F F F F F F F
Tests(Physical,
Chemical,
Microbiological)
Acceptance
Criteria
Storage
Condition
(Accelerated)
Product Name/ Generic Name/
Dosage Form Sofavir (Sofosbuvir) 400mg Tablet Batch No. 15T02
Description of pack Oblong shaped film coated tablets filled in pet bottle &
packed in carton Batch Size 1000 Tablets
Parameter and test mentioned As per Product specification Manufacturing Date 01-2015
Recommended storage conditions
Short term condition (Accelerated) 40°C ± 2, RH 75 % ± 5
Long term condition (Real Time) 30°C ± 2, RH 65 % ± 5
Expiry Date 01-2017
Date of initiation &
implementation 15-01-2015 API lot NO. 150503
Stability No. 15SOFO-STB-02 Date of Storage 25-01-2015
Minutes for 253rd
Registration Board Meeting 195
Appearance 19mm oblong,
Off White Coated
Tablets
400C+-20C
75% RH +-5%RH Complies Complies Complies
Identification Sofosbuvir must
be Positive
400C+-20C
75% RH +-5%RH Positive Positive Positive
Disintegration time NMT 30minuts 400C+-20C
75% RH +-5%RH 14 Minutes 14 Minutes 14Minutes
Dissolution NLT 75% 400C+-20C
75% RH +-5%RH 92% 91% 88%
Assay 90-110% 400C+-20C
75% RH +-5%RH 101% 100.2% 99.8%
Analyst signature (after completion of every time line)
Conclusion by QC (After completion of the study):
Above data shows that the results of all the physical and chemical parameters are within limits during 6 months accelerated stability studies. So
the product is stable.
Assessment frequency (week) Initial (0) 1 2 3 4 6 8 12 16 20 24 26
Date of Testing 23/01/2015 23/04/2015 23/07/2015
Mode of testing (F = Full, P = Partial testing)F P F P F F F F F F F F
Tests(Physical,
Chemical,
Microbiological)
Acceptance
Criteria
Storage
Condition
(Real Time)
Appearance 19mm oblong,
Off White Coated
Tablets
300C+-20C
65% RH +-
5%RH Complies Complies Complies
Identification Sofosbuvir must
be Positive
300C+-20C
65% RH +-
5%RH Positive Positive Positive
Disintegration time NMT 30minuts 300C+-20C
65% RH +-14 Minutes 13 Minutes 13Minutes
Minutes for 253rd
Registration Board Meeting 196
5%RH
Dissolution NLT 75% 300C+-20C
65% RH +-
5%RH
92% 92% 91%
Assay 90-110%
300C+-20C
65% RH +-
5%RH
101% 99.8% 100%
Analyst signature (after completion of every time line)
Conclusion by QC (After completion of the study):
Above data shows that the results of all the physical and chemical parameters are within limits during 6 months accelerated stability studies. So
the product is stable.
Sample taken for Physical testing =04
Sample taken for Chemical testing =04
Product Name/ Generic Name/
Dosage Form Sofavir (Sofosbuvir) 400mg Tablet Batch No. 15T03
Description of pack Oblong shaped film coated tablets filled in pet bottle &
packed in carton Batch Size 900 Tablets
Parameter and test mentioned As per Product specification Manufacturing
Date 01-2015
Recommended storage
conditions
Short term condition (Accelerated) 40°C ± 2, RH 75 % ± 5
Long term condition (Real Time) 30°C ± 2, RH 65 % ± 5
Expiry Date 01-2017
Date of initiation &
implementation 20-01-2015 API lot NO. 150503
Stability No. 15SOFO-STB-03 Date of Storage 25-01-2015
Minutes for 253rd
Registration Board Meeting 197
Sample taken for Microbial testing =NA
Sample taken Extra =02
Total sample size = 10packs
Assessment frequency (week) Initial (0) 1 2 3 4 6 8 12 16 20 24 26
Date of Testing 23/01/2015 23/04/2015 23/07/2015
Mode of testing (F = Full, P = Partial testing)F P F P F F F F F F F F
Tests(Physical,
Chemical,
Microbiological)
Acceptance
Criteria
Storage
Condition
(Accelerated)
Appearance 19mm oblong,
Off White Coated
Tablets
400C+-20C
75% RH +-5%RH Complies Complies Complies
Identification Sofosbuvir must
be Positive
400C+-20C
75% RH +-5%RH Positive Positive Positive
Disintegration time NMT 30minuts 400C+-20C
75% RH +-5%RH 13 Minutes 13 Minutes 14Minutes
Dissolution NLT 75% 400C+-20C
75% RH +-5%RH 95% 93% 90%
Assay 90-110% 400C+-20C
75% RH +-5%RH 100.5% 99.3% 98.6%
Analyst signature (after completion of every time line)
Conclusion by QC (After completion of the study):
Above data shows that the results of all the physical and chemical parameters are within limits during 6 months accelerated stability studies. So
the product is stable.
Minutes for 253rd
Registration Board Meeting 198
Assessment frequency (week) Initial (0) 1 2 3 4 6 8 12 16 20 24 26
Date of Testing 23/01/2015 23/04/2015 23/07/2015
Mode of testing (F = Full, P = Partial testing)F P F P F F F F F F F F
Tests(Physical,
Chemical,
Microbiological)
Acceptance
Criteria
Storage
Condition
(Real Time)
Appearance 19mm oblong,
Off White Coated
Tablets
300C+-20C
65% RH +-
5%RH Complies Complies Complies
Identification Sofosbuvir must
be Positive
300C+-20C
65% RH +-
5%RH Positive Positive Positive
Disintegration time NMT 30minuts
300C+-20C
65% RH +-
5%RH 13 Minutes 13 Minutes 12Minutes
Dissolution NLT 75% 300C+-20C
65% RH +-
5%RH
95% 94% 94%
Assay 90-110%
300C+-20C
65% RH +-
5%RH
100.5% 99.6% 100%
Analyst signature (after completion of every time line)
Conclusion by QC (After completion of the study):
Above data shows that the results of all the physical and chemical parameters are within limits during 6 months accelerated stability studies. So
the product is stable.
Minutes for 253rd
Registration Board Meeting 199
Documents / Data provided by the applicant (M/s Max Pharmaceuticals Islamabad)
Sr. No. Documents to be provided Status
1. COA of API Yes
2. Approval of API by regulatory authority of country of
origin or GMP certificate of API manufacturer issued by
regulatory authority of country of origin.
Yes
3. Protocols followed for conduction of stability study and
details of tests.
Yes
4. Data of 03 batches will be supported by attested
respective documents like chromatograms, laboratory
reports, data sheets etc.
Yes
5. Documents confirming import of API etc.
Yes (by courier)
6. All provided documents will be attested (name, sign and
stamp) for ensuring authenticity of data / documents.
Yes
7. Commitment to continue real time stability study till
assigned shelf life of the product.
Yes
Decision: Mr.Riaz, Quality Control Manager presented the data. Registration Board observed that the stability data provided by the
firm is in accorndace with the guidelines approved by the Board in 251st meeting. Therefore, Board granted approval of registration
of Sofosbuvir 400 mg tablets to the firm. However, manufacturer will inform concerned Federal Inspector of Drugs for taking
sample of Active Pharmaceutical Ingredient (used in manufacture of first commercial batch) for test/ analysis from Central Drugs
Laboratory, Karachi before sale of finished product.
Minutes for 253rd
Registration Board Meeting 200
22. M/s Biogen Pharma Islamabad
Drug Sofbugen tablets (Sofosbuvir) 400 mg
Source Not submitted
Storage Condition Accelerated: 40 C and 75% RH
Real Time: 30°C ± 2°C/65% ± 5% RH)
Time Period 5 months accelerated
6months real time
Frequency 0, 1,2 3, 4,5,6 months (Accelerated)
0,3,6 (Real Time)
Batch Size Batch I: 1000 Packs
Batch II: 1000 Packs
Batch III: 1000 Packs
No. of Batches 03
Sample Size Nil
Meeting Deferred in 244th
and 251st meeting of
Registration Board
Minutes for 253rd
Registration Board Meeting 201
Documents / Data provided by the applicant
(M/s Biogen Pharma Islamabad)
Sr. No. Documents to be provided Status
1. COA of API No
2. Approval of API by regulatory authority of country of
origin or GMP certificate of API manufacturer issued by
regulatory authority of country of origin.
No
3. Protocols followed for conduction of stability study and
details of tests.
No
4. Data of 03 batches will be supported by attested
respective documents like chromatograms, laboratory
reports, data sheets etc.
No
5. Documents confirming import of API etc. No
6. All provided documents will be attested (name, sign and
stamp) for ensuring authenticity of data / documents.
No
7. Commitment to continue real time stability study till
assigned shelf life of the product.
No
Decision: Mr.Khalid Qayyum, Quality Control Manager appeared for presentation of data. Registration Board observed that the stability
data provided by the firm was not in accordance with the guidelines approved by the board finalized in 251st meeting. Therefore, case was
deferred till the applicant completes the requisite information in respect of stability studies.
Minutes for 253rd
Registration Board Meeting 202
22. M/s Valor Pharma Islamabad
Drug HEPAVIR tablets (Sofosbuvir) 400 mg
Source Not submitted
Storage Condition Accelerated: 40 C and 75% RH
Time Period 5 months accelerated
6months real time
Frequency 0,2 ,4 ,6 months (Accelerated)
Batch Size Nil
No. of Batches 01
Sample Size Nil
Meeting Deferred in 244th
and 251st meeting of
Registration Board
Documents / Data provided by the applicant
(M/s Valor Pharma Islamabad)
Sr. No. Documents to be provided Status
1. COA of API No
2. Approval of API by regulatory authority of country of
origin or GMP certificate of API manufacturer issued by
regulatory authority of country of origin.
No
3. Protocols followed for conduction of stability study and
details of tests.
No
4. Data of 03 batches will be supported by attested No
Minutes for 253rd
Registration Board Meeting 203
respective documents like chromatograms, laboratory
reports, data sheets etc.
5. Documents confirming import of API etc. No
6. All provided documents will be attested (name, sign and
stamp) for ensuring authenticity of data / documents.
No
7. Commitment to continue real time stability study till
assigned shelf life of the product.
No
Decision: Mr. Asif Iqbal, Quality Control Manage appeared for presentation of data. Registration Board observed that the stability data
provided by the firm was not in accordance with the guidelines approved by the board finalized in 251st meeting. Therefore, case was
deferred till the applicant completes the requisite information in respect of stability studies.
Minutes for 253rd
Registration Board Meeting 204
23. M/s Everest Pharmaceuticals Islamabad
Drug Ledisovir tablets (Ledipasvir 90 mg +
Sofosbuvir) 400 mg
Source Ruyuan HEC Pharm Co. China
Storage Condition Accelerated: 40 C and 75% RH
Real Time: 30°C ± 2°C/65% ± 5% RH)
30°C ± 2°C/75% ± 5% RH
Time Period 6 months
Frequency 0, 1,2 3,4, 6, 8,12,16,20,24,26 weeks
0,3,6 months
Batch Size Batch I: 500 Tablets
Batch II: 2000 Tablets
Batch III: 2000 tabs
No. of Batches 03
Sample Size 3212 tablets
Meeting Deferred in 251st meeting of Registration
Board
Remarks Latest GMP inspection report is not provided,
However the firm has submitted that they have
requested FID Islamabad four times dated 21-
03-15, 26-03-15, 14-04-15 & 27-04-15 for
conduction of GMP inspection and for this
purpose they have submitted 5000/- as per
DRAP requirement.
Minutes for 253rd
Registration Board Meeting 205
Stability Study Data Sheet
Product name /Generic name/Dosage
form
LEDISOVIR 90mg /400 mg Tablets /Ledipasvir+Sofosbuvir/Tablets Batch No. X.01.01/15
Description of pack
( container closure system)
13mm Round white film coated tablets, plain ,blistered in 260mm aluminum foil in a 14x 2 printed unit
carton, 200u/c further packed in master shipper. Batch
Size.
500 Tablets
Parameters and test mentioned As product Specifications provided Mfg. Date 01/15
Recommended storage condition
Short term conditions (Accelerated ) 40± 2C, 75±5 RH
(Study duration 26 weeks ,with study name,Initial (0 Time),Week-1, Week-2, Week-3, Week-4,
Week-6, Week-8, Week-12, Week-16, Week-20, Week-24, Week-26
Long term conditions (Real Time) 30± 2C, 65±5 RH
(Study duration 26 weeks ,with study name,Initial (0 Time),Week-1, Week-2, Week-3, Week-4,
Week-6, Week-8, Week-12, Week-16, Week-20, Week-24, Week-26
In addition (already completed and submitted to DRAP)
Stability Study
(Proposed)
Storage
Conditions
Study
Duration
Study
Name
(Long Term)
25 ⁰C /60% RH
30 ⁰C /75% RH
30 ⁰C /65% RH
40 ⁰C /75% RH
24 months
24 months
24 months
6 months
S1
S2
S3
S4
(Accelerated/Open Dish) 25 ⁰C /60% RH
30 ⁰C /75% RH
45 days
45 days
S5
S6
(Accelerated/Stress)
50 ⁰C /Ambient 25 ⁰C /80% RH
5 ⁰C
45 days
45 days
45 days
S7
S8
S9
Stability Study (Proposed) Storage
Conditions
Study
Duration
Study Name
Short term conditions (Accelerated ) 40± 2C, 75±5
RH
0 months
3 months
0 months
3 months
Exp Date
01/17 (as
per
calculation
of
Accelerated
Stability
Study)
Minutes for 253rd
Registration Board Meeting 206
6 mon hs 6 months
Long t rm conditions (Real Time) 30± 2C, 65±5 RH
0 months
3 months
6 months
0 months
3 months
6 months
Respective documents, Assay Reports document No.(EP/QC/QR/010),Analytical Report Products document No.
(EP/QC/QR/008), Stability summary document No. (EV-QR-DRAP-ST-030), Photometric Report Instrument
generated, Spectrum of Standard solution Instrument generated, Spectrum of Sample solution Instrument generated,
Stability study Data document No.(EP/QC/QR/033),Chromatogram of Standard Solution and Sample Solution , duly
sign and stamp are attached.
Date of
initiation &
implementation
Storage
Conditions
Study
Duration
Study Name Date of
Initiation
Date of Completion
25 ⁰C /60% RH
30 ⁰C /75% RH
30 ⁰C /65% RH
40 ⁰C /75% RH
24 months
24 months
24 months
6 months
S-1
S-2
S-3
S-4
07-01-2015
08-01-2015
09-01-2015
10-01-2015
07-01-2017 (study of 06 Months 07-07-2015 completed) continue….
08-01-2017 (study of 06 Months 08-07-2015 completed) continue….
09-01-2017(study of 06 Months 09-07-2015 completed) continue….
10-07-2015 (study of 06 Months completed)
25 ⁰C /60% RH
30 ⁰C /75% RH
45 days
45 days
S-5
S-6
12-01-2015
13-01-2015
26-02-2015 (study of 45 days completed)
27-02-2015 (study of 45 days completed)
50 ⁰C /Ambient
25 ⁰C /80% RH
5 ⁰C
45 days
45 days
45 days
S-7
S-8
S-9
14-01-2015
15-01-2015
16-01-2015
28-02-2015 (study of 45 days completed)
01-03-2015 (study of 45 days completed)
02-03-2015 (study of 45 days completed)
Initial (0 Time)
Initial (0 Time)
(API)lot
no.
A15070018-01
Minutes for 253rd
Registration Board Meeting 207
40± 2C, 75±5 RH
Week-1
Week-2
Week-3
Week-4
Week-6
Week-8
Week-12
Week-16
Week-20
Week-24
Week-26
Week-1
Week-2
Week-3
Week-4
Week-6
Week-8
Week-12
Week-16
Week-20
Week-24
Week-26
07-01-2015
08-07-2015 (study of 26 weeks completed)
30± 2C, 65±5 RH
Initial (0 Time)
Week-1
Week-2
Week-3
Week-4
Week-6
Week-8
Week-12
Week-16
Week-20
Week-24
Week-26
Initial (0 Time)
Week-1
Week-2
Week-3
Week-4
Week-6
Week-8
Week-12
Week-16
Week-20
Week-24
Week-26
07-01-2015 08-07-2015 (study of 26 weeks completed)
40± 2C, 75±5 RH
0 months
3 months
6 months
0 months
3 months
6 months 07-01-2015 07-07-2015 (study of 06 Month completed)
30± 2C, 65±5 RH
0 months
3 months
6 months
0 months
3 months
6 months 07-01-2015 07-07-2015 (study of 06 Month completed)
Minutes for 253rd
Registration Board Meeting 208
Approval by:
QC Manager: ---------------------
QA Manager: ---------------------
Product Manager: ---------------
R&D Manager: -------------------
Stability No. Following 13 Stability studies of SOVIR 400mg Tablets Batch No. X.01.01/15 are conducted, out of which only
3 studies S-1,S-2,S-3 are continue and will be completed on 06-08-2016 remaining all are completed. Short term conditions (Accelerated ) at 40± 2C, 75±5 RH of 26 weeks
Long term conditions (Real Time) at 30± 2C, 65±5 RH of 26 weeks
Long term conditions (Real Time) at 25 ⁰C /60% RH of 24 Months
Long term conditions (Real Time) at 30 ⁰C /75% RH of 24 Months
Long term conditions (Real Time) at 30 ⁰C /65% RH of 24 Months
Long term conditions (Real Time) at 40 ⁰C /75% RH of 06 Months
(Accelerated/Open Dish) 25 ⁰C /60% RH of 45 Days
(Accelerated/Open Dish) at 30 ⁰C /75% RH of 45 Days
(Accelerated/Stress) at 50 ⁰C /Ambient of 45 Days
(Accelerated/Stress) at 25 ⁰C /80% RH of 45 Days
(Accelerated/Stress) at 5 ⁰C of 45 Days
Short term conditions (Accelerated ) at 40± 2C, 75±5 RH of 06 Months
Long term conditions (Real Time) at 30± 2C, 65±5 RH of 06 Months
Sample taken for physical test = 285 Tablets
Sample taken for chemical test = 195 Tablets
Extra sample = 11 Tablets
Total Sample size (approx ) = 491 Tablets
Minutes for 253rd
Registration Board Meeting 209
Stability Study Data Sheet
Product name /Generic name/Dosage
form
LEDISOVIR 90mg /400 mg Tablets /Ledipasvir+Sofosbuvir/Tablets Batch No. P.01.01/15
Description of pack
( container closure system)
13mm Round white film coated tablets, plain ,blistered in 260mm aluminum foil in a 14x 2 printed unit
carton, 200u/c further packed in master shipper. Batch
Size.
2000
Tablets
Parameters and test mentioned As product Specifications provided Mfg. Date 01/15
Recommended storage condition
Short term conditions (Accelerated ) 40± 2C, 75±5 RH
(Study duration 26 weeks ,with study name,Initial (0 Time),Week-1, Week-2, Week-3, Week-4,
Week-6, Week-8, Week-12, Week-16, Week-20, Week-24, Week-26
Long term conditions (Real Time) 30± 2C, 65±5 RH
(Study duration 26 weeks ,with study name,Initial (0 Time),Week-1, Week-2, Week-3, Week-4,
Week-6, Week-8, Week-12, Week-16, Week-20, Week-24, Week-26
In addition (already completed and submitted to DRAP)
Stability Study
(Proposed)
Storage
Conditions
Study
Duration
Study
Name
(Long Term)
25 ⁰C /60% RH
30 ⁰C /75% RH
30 ⁰C /65% RH
40 ⁰C /75% RH
24 months
24 months
24 months
6 months
S1
S2
S3
S4
(Accelerated/Open Dish) 25 ⁰C /60% RH
30 ⁰C /75% RH
45 days
45 days
S5
S6
(Accelerated/Stress)
50 ⁰C /Ambient 25 ⁰C /80% RH
5 ⁰C
45 days
45 days
45 days
S7
S8
S9
Stability Study (Proposed) Storage
Conditions
Study
Duration
Study Name
Short term conditions (Accelerated ) 40± 2C, 75±5
RH
0 months
3 months
6 months
0 months
3 months
6 months
Exp Date
01/17 (as
per
calculation
of
Accelerated
Stability
Study)
Minutes for 253rd
Registration Board Meeting 210
Long term conditions (Real Time) 30± 2C, 65±5 RH
0 months
3 months
6 months
0 months
3 months
6 months
Respective documents, Assay Reports document No.(EP/QC/QR/010),Analytical Report Products document No.
(EP/QC/QR/008), Stability summary document No. (EV-QR-DRAP-ST-030), Photometric Report Instrument
generated, Spectrum of Standard solution Instrument generated, Spectrum of Sample solution Instrument generated,
Stability study Data document No.(EP/QC/QR/033),Chromatogram of Standard Solution and Sample Solution , duly
sign and stamp are attached.
Date of
initiation &
implementation
Storage
Conditions
Study
Duration
Study Name Date of
Initiation
Date of Completion
25 ⁰C /60% RH
30 ⁰C /75% RH
30 ⁰C /65% RH
40 ⁰C /75% RH
24 months
24 months
24 months
6 months
S-10
S-11
S-12
S-13
14-01-2015
15-01-2015
16-01-2015
17-01-2015
14-01-2017 (study of 06 Months 14-07-2015 completed) continue….
15-01-2017 (study of 06 Months 15-07-2015 completed) continue….
16-01-2017(study of 06 Months 16-07-2015 completed) continue….
17-07-2015 (study of 06 Months completed)
25 ⁰C /60% RH
30 ⁰C /75% RH
45 days
45 days
S-14
S-15
19-01-2015
20-01-2015
08-03-2015 (study of 45 days completed)
09-03-2015 (study of 45 days completed)
50 ⁰C /Ambient
25 ⁰C /80% RH
5 ⁰C
45 days
45 days
45 days
S-16
S-17
S-18
21-01-2015
22-01-2015
23-01-2015
10-03-2015 (study of 45 days completed)
11-03-2015 (study of 45 days completed)
12-03-2015 (study of 45 days completed)
40± 2C, 75±5 RH
Initial (0 Time)
Week-1
Week-2
Week-3
Week-4
Week-6
Week-8
Week-12
Week-16
Week-20
Week-24
Week-26
Initial (0 Time)
Week-1
Week-2
Week-3
Week-4
Week-6
Week-8
Week-12
Week-16
Week-20
Week-24
Week-26
17-01-2015
18-07-2015 (study of 26 weeks completed)
(API)lot
no.
A15070018-01
Minutes for 253rd
Registration Board Meeting 211
30± 2C, 65±5 RH
Initial (0 Time)
Week-1
Week-2
Week-3
Week-4
Week-6
Week-8
Week-12
Week-16
Week-20
Week-24
Week-26
Initial (0 Time)
Week-1
Week-2
Week-3
Week-4
Week-6
Week-8
Week-12
Week-16
Week-20
Week-24
Week-26
17-01-2015 18-07-2015 (study of 26 weeks completed)
40± 2C, 75±5 RH
0 months
3 months
6 months
0 months
3 months
6 months 17-01-2015 17-07-2015 (study of 06 Month completed)
30± 2C, 65±5 RH
0 months
3 months
6 months
0 months
3 months
6 months 17-01-2015 17-07-2015 (study of 06 Month completed)
Stability No. Following 13 Stability studies of SOVIR 400mg Tablets Batch No. P.01.01/15 are conducted, out of which only 3
studies S-1,S-2,S-3 are continue and will be completed on 06-08-2016 remaining all are completed. Short term conditions (Accelerated ) at 40± 2C, 75±5 RH of 26 weeks
Long term conditions (Real Time) at 30± 2C, 65±5 RH of 26 weeks
Long term conditions (Real Time) at 25 ⁰C /60% RH of 24 Months
Long term conditions (Real Time) at 30 ⁰C /75% RH of 24 Months
Long term conditions (Real Time) at 30 ⁰C /65% RH of 24 Months
Long term conditions (Real Time) at 40 ⁰C /75% RH of 06 Months
(Accelerated/Open Dish) 25 ⁰C /60% RH of 45 Days
(Accelerated/Open Dish) at 30 ⁰C /75% RH of 45 Days
Minutes for 253rd
Registration Board Meeting 212
Approval by:
QC Manager: ---------------------
QA Manager: ---------------------
Product Manager: ---------------
R&D Manager: -------------------
Stability Study Data Sheet
(Accelerated/Stress) at 50 ⁰C /Ambient of 45 Days
(Accelerated/Stress) at 25 ⁰C /80% RH of 45 Days
(Accelerated/Stress) at 5 ⁰C of 45 Days
Short term conditions (Accelerated ) at 40± 2C, 75±5 RH of 06 Months
Long term conditions (Real Time) at 30± 2C, 65±5 RH of 06 Months
Sample taken for physical test = 988 Tablets
Sample taken for chemical test = 290 Tablets
Extra sample = 31 Tablets
Total Sample size (approx ) = 1309 Tablets
Product name /Generic name/Dosage
form
LEDISOVIR 90mg /400 mg Tablets /Ledipasvir+Sofosbuvir/Tablets Batch No. P.02.01/15
Description of pack
( container closure system)
13mm Round white film coated tablets, plain ,blistered in 260mm aluminum foil in a 14x 2 printed unit
carton, 200u/c further packed in master shipper. Batch
Size.
2000
Tablets
Parameters and test mentioned As product Specifications provided Mfg. Date 01/15
Minutes for 253rd
Registration Board Meeting 213
Recommended storage condition
Short term conditions (Accelerated ) 40± 2C, 75±5 RH
(Study duration 26 weeks ,with study name,Initial (0 Time),Week-1, Week-2, Week-3, Week-4,
Week-6, Week-8, Week-12, Week-16, Week-20, Week-24, Week-26
Long term conditions (Real Time) 30± 2C, 65±5 RH
(Study duration 26 weeks ,with study name,Initial (0 Time),Week-1, Week-2, Week-3, Week-4,
Week-6, Week-8, Week-12, Week-16, Week-20, Week-24, Week-26
In addition (already completed and submitted to DRAP)
Stability Study
(Proposed)
Storage
Conditions
Study
Duration
Study
Name
(Long Term)
25 ⁰C /60% RH
30 ⁰C /75% RH
30 ⁰C /65% RH
40 ⁰C /75% RH
24 months
24 months
24 months
6 months
S1
S2
S3
S4
(Accelerated/Open Dish) 25 ⁰C /60% RH
30 ⁰C /75% RH
45 days
45 days
S5
S6
(Accelerated/Stress)
50 ⁰C /Ambient 25 ⁰C /80% RH
5 ⁰C
45 days
45 days
45 days
S7
S8
S9
Stability Study (Proposed) Storage
Conditions
Study
Duration
Study Name
Short term conditions (Accelerated ) 40± 2C, 75±5
RH
0 months
3 months
6 months
0 months
3 months
6 months
Long term conditions (Real Time) 30± 2C, 65±5 RH
0 months
3 months
6 months
0 months
3 months
6 months
Respective documents, Assay Reports document No.(EP/QC/QR/010),Analytical Report Products document No.
(EP/QC/QR/008), Stability summary document No. (EV-QR-DRAP-ST-030), Photometric Report Instrument
generated, Spectrum of Standard solution Instrument generated, Spectrum of Sample solution Instrument generated,
Stability study Data document No.(EP/QC/QR/033),Chromatogram of Standard Solution and Sample Solution , duly
sign and stamp are attached.
Exp Date
01/17 (as
per
calculation
of
Accelerated
Stability
Study)
Minutes for 253rd
Registration Board Meeting 214
Date of
initiation &
implementation
Storage
Conditions
Study
Duration
Study Name Date of
Initiation
Date of Completion
25 ⁰C /60% RH
30 ⁰C /75% RH
30 ⁰C /65% RH
40 ⁰C /75% RH
24 months
24 months
24 months
6 months
S-19
S-20
S-21
S-22
24-01-2015
26-01-2015
27-01-2015
28-01-2015
24-01-2017 (study of 06 Months 24-07-2015 completed) continue….
26-01-2017 (study of 06 Months 15-07-2015 completed) continue….
27-01-2017(study of 06 Months 16-07-2015 completed) continue….
28-07-2015 (study of 06 Months completed)
25 ⁰C /60% RH
30 ⁰C /75% RH
45 days
45 days
S-23
S-24
29-01-2015
30-01-2015
18-03-2015 (study of 45 days completed)
30-03-2015 (study of 45 days completed)
50 ⁰C /Ambient
25 ⁰C /80% RH
5 ⁰C
45 days
45 days
45 days
S-25
S-26
S-27
31-01-2015
02-01-2015
03-01-2015
31-03-2015 (study of 45 days completed)
02-03-2015 (study of 45 days completed)
03-03-2015 (study of 45 days completed)
40± 2C, 75±5 RH
Initial (0 Time)
Week-1
Week-2
Week-3
Week-4
Week-6
Week-8
Week-12
Week-16
Week-20
Week-24
Week-26
Initial (0 Time)
Week-1
Week-2
Week-3
Week-4
Week-6
Week-8
Week-12
Week-16
Week-20
Week-24
Week-26
24-01-2015
11-07-2015 (study of 26 weeks completed)
30± 2C, 65±5 RH
Initial (0 Time)
Week-1
Week-2
Week-3
Week-4
Week-6
Week-8
Week-12
Week-16
Initial (0 Time)
Week-1
Week-2
Week-3
Week-4
Week-6
Week-8
Week-12
Week-16
24-01-2015 11-07-2015 (study of 26 weeks completed)
(API)lot
no.
A15070018-01
Minutes for 253rd
Registration Board Meeting 215
Approval by:
QC Manager: ---------------------
Week-20
Week-24
Week-26
Week-20
Week-24
Week-26
40± 2C, 75±5 RH
0 months
3 months
6 months
0 months
3 months
6 months 24-01-2015 24-07-2015 (study of 06 Month completed)
30± 2C, 65±5 RH
0 months
3 months
6 months
0 months
3 months
6 months 24-01-2015 24-07-2015 (study of 06 Month completed)
Stability No. Following 13 Stability studies of SOVIR 400mg Tablets Batch No. P.02.01/15 are conducted, out of which only 3
studies S-1,S-2,S-3 are continue and will be completed on 06-08-2016 remaining all are completed. Short term conditions (Accelerated ) at 40± 2C, 75±5 RH of 26 weeks
Long term conditions (Real Time) at 30± 2C, 65±5 RH of 26 weeks
Long term conditions (Real Time) at 25 ⁰C /60% RH of 24 Months
Long term conditions (Real Time) at 30 ⁰C /75% RH of 24 Months
Long term conditions (Real Time) at 30 ⁰C /65% RH of 24 Months
Long term conditions (Real Time) at 40 ⁰C /75% RH of 06 Months
(Accelerated/Open Dish) 25 ⁰C /60% RH of 45 Days
(Accelerated/Open Dish) at 30 ⁰C /75% RH of 45 Days
(Accelerated/Stress) at 50 ⁰C /Ambient of 45 Days
(Accelerated/Stress) at 25 ⁰C /80% RH of 45 Days
(Accelerated/Stress) at 5 ⁰C of 45 Days
Short term conditions (Accelerated ) at 40± 2C, 75±5 RH of 06 Months
Long term conditions (Real Time) at 30± 2C, 65±5 RH of 06 Months
Minutes for 253rd
Registration Board Meeting 216
QA Manager: ---------------------
Product Manager: ---------------
R&D Manager: -------------------
Documents / Data provided by the applicant (M/s Everest Pharmaceuticals Islamabad)
Sr. No. Documents to be provided Status
1. COA of API Yes
2. Approval of API by regulatory authority of country of origin or GMP
certificate of API manufacturer issued by regulatory authority of country of
origin.
Yes
3. Protocols followed for conduction of stability study and details of tests. Yes
4. Data of 03 batches will be supported by attested respective documents like
chromatograms, laboratory reports, data sheets etc.
Yes
5. Documents confirming import of API etc. Yes (by courier)
6. All provided documents will be attested (name, sign and stamp) for
ensuring authenticity of data / documents.
Yes
7. Commitment to continue real time stability study till assigned shelf life of
the product.
Yes
Decision: Mr.Muhammad Usman, CEO presented the data. He informed that firm has requested DRAP, Islamabad four times dated 21-03-
15, 26-03-15, 14-04-15 and 27-04-15 for conduction of GMP inspection and also deposited fee Rs5000/- as per DRAP’s requirement.
Registration Board inquired from representative of QA & LT Division about GMP status of the manufacturer. GMP inspection report was
presented before the Board on 06.10.2015 and tablet section was found satifactoy. Registration Board observed that the stability data
provided by the firm is in accordance with the recommendations of the Board finalized in 251st meeting. Therefore, Board granted approval
of registration of Ledipasvir 90 mg + Sofosbuvir 400 mg tablets to the firm. However, manufacturer will inform concerned Federal
Inspector of Drugs for taking sample of Active Pharmaceutical Ingredient (used in manufacture of first commercial batch) for test/ analysis
from Central Drugs Laboratory, Karachi before sale of finished product.
Sample taken for physical test = 1021 Tablets
Sample taken for chemical test = 364 Tablets
Extra sample = 27 Tablets
Total Sample size (approx ) = 1412 Tablets
Minutes for 253rd
Registration Board Meeting 217
24. M/s Everest Pharmaceuticals Islamabad
Drug Sovir tablets (Sofosbuvir) 400 mg
Source Ruyuan HEC Pharm Co. China
Storage Condition Accelerated: 40 C and 75% RH
Real Time: 30°C ± 2°C/65% ± 5% RH)
30°C ± 2°C/75% ± 5% RH
Time Period 6 months
Frequency 0, 1,2 3,4, 6, 8,12,16,20,24,26 weeks
0,3,6 months
Batch Size Batch I: 500 Tablets
Batch II: 2125 Tablets
Batch III: 2125 tabs
No. of Batches 03
Sample Size 3126 tablets
Meeting Deferred in 244th
and 251st meeting of
Registration Board
Remarks Latest GMP inspection report is not
provided, However the firm has submitted
that they have requested FID Islamabad
four times dated 21-03-15, 26-03-15, 14-
04-15 & 27-04-15 for conduction of GMP
inspection and for this purpose they have
submitted 5000/- as per DRAP
requirement.
Firm has submitted letters of two
prescribers. Their comments are as under:
Minutes for 253rd
Registration Board Meeting 218
Prof. Dr. Zafar Iqbal (Ex-Professor of
Medicine Pincipal Sheikh Khalifa Bin
Zayed Medical & Dental College, Lahore
“ Sofosbuvir (Sovir) 400mg along with
Ribavarin (dose adjustment according to
weight of patient) was prescribed to 20
cases of chroniv liver disease. These patiets
were either ineligible to receive interferon
therapy or were Interferon non responders.
The treatment was initiated after propper
pproval of IRB (Institutional Review
Board) of Gujranwala Medical College and
informed consnet. Fourteen patients have
completed four weeks of treatment and
have achieved RVR according to real time
PCR technology. Sofosbuvir ( Sovir) has
proven efficacy and tolerability in these
patients fof Chronic Liver Disease. It will
be a valuable addition to be used in patients
of Chronic Liver Disease.
Prof. Dr. Aftab Mohsin, Profesor of
Medicine, Principal Gujranwala Medical
College.
“In view of urgent need of SOFOSBUVIR
for patients of chronic Hepatitis C, an
approval was sought form IRB of GMC to
be used, as life saving measure in selected
patients of chronic Hepatitis C. Sofosbuvir
(Sovir) tablet along with Ribavirin was
given in 20 cases of chronic hepatitis C,
Minutes for 253rd
Registration Board Meeting 219
who had advanced cirrhosis. They were
either non responder to pegylated interferon
or ineligible for interferon therapy. In all
the cases the drug was well tolerated at
week 1 & week 2 of follow up. The RVR
results will be carried out after completion
of )4 weeks treatmet, done in the end of
March 2015In case of good response on
RVR it will be a valuable addition to be
used in selected cases of Chronic Hepatitis
C”.
The firm has submitted the letter of Doc
Sanjiv Sehgal, Dir Transplant
Hepatology,Medenta , The Medi City,
Gurguan Dehli India stating that use of
Sovir 400 mg tablet in chronic Hepatitis C
three patients with improve outcome and
well toleartetd safety profile.
Minutes for 253rd
Registration Board Meeting 220
Stability Study Data Sheet
Product name /Generic name/Dosage
form
SOVIR 400 mg Tablets /Sofosbuvir/Tablets Batch No. X.01.08/14
Description of pack
( container closure system)
13mm Round white film coated tablets, plain ,blistered in 260mm aluminum foil in a 14x 2 printed unit
carton, 200u/c further packed in master shipper. Batch
Size.
500 Tablets
Parameters and test mentioned As product Specifications provided Mfg. Date 08/14
Recommended storage condition
Short term conditions (Accelerated ) 40± 2C, 75±5 RH
(Study duration 26 weeks ,with study name,Initial (0 Time),Week-1, Week-2, Week-3, Week-4,
Week-6, Week-8, Week-12, Week-16, Week-20, Week-24, Week-26
Long term conditions (Real Time) 30± 2C, 65±5 RH
(Study duration 26 weeks ,with study name,Initial (0 Time),Week-1, Week-2, Week-3, Week-4,
Week-6, Week-8, Week-12, Week-16, Week-20, Week-24, Week-26
In addition (already completed and submitted to DRAP)
Stability Study
(Proposed)
Storage
Conditions
Study
Duration
Study
Name
(Long Term)
25 ⁰C /60% RH
30 ⁰C /75% RH
30 ⁰C /65% RH
40 ⁰C /75% RH
24 months
24 months
24 months
6 months
S1
S2
S3
S4
(Accelerated/Open Dish) 25 ⁰C /60% RH
30 ⁰C /75% RH
45 days
45 days
S5
S6
(Accelerated/Stress)
50 ⁰C /Ambient 25 ⁰C /80% RH
5 ⁰C
45 days
45 days
45 days
S7
S8
S9
Exp Date
08/16 (as
per
calculation
of
Accelerated
Stability
Study)
Minutes for 253rd
Registration Board Meeting 221
Stability Study (Proposed) Storage
Conditions
Study
Duration
Study Name
Short term conditions (Accelerated ) 40± 2C, 75±5
RH
0 months
3 months
6 months
0 months
3 months
6 months
Long term conditions (Rea Time) 30± 2C, 65±5 RH
0 months
3 months
6 months
0 months
3 months
6 months
Respective documents, Assay Reports document No.(EP/QC/QR/010),Analytical Report Products document No.
(EP/QC/QR/008), Stability summary document No. (EV-QR-DRAP-ST-030), Photometric Report Instrument
generated, Spectrum of Standard solution Instrument generated, Spectrum of Sample solution Instrument generated,
Stability study Data document No.(EP/QC/QR/033),Chromatogram of Standard Solution and Sample Solution , duly
sign and stamp are attached.
Date of
initiation &
implementation
Storage
Conditions
Study
Duration
Study Name Date of
Initiation
Date of Completion
25 ⁰C /60% RH
30 ⁰C /75% RH
30 ⁰C /65% RH
40 ⁰C /75% RH
24 months
24 months
24 months
6 months
S-1
S-2
S-3
S-4
06-08-2014
06-08-2014
06-08-2014
06-08-2014
06-08-2016(study of 12 Months 06-08-2015 completed) continue….
06-08-2016(study of 12 Months 06-08-2015 completed) continue….
06-08-2016(study of 12 Months 06-08-2015 completed) continue….
06-02-2015 (study of 06 Months completed)
25 ⁰C /60% RH
30 ⁰C /75% RH
45 days
45 days
S-5
S-6
06-08-2014
20-09-2014
21-09-2014 (study of 45 days completed)
04-10-2014 (study of 45 days completed)
50 ⁰C /Ambient
25 ⁰C /80% RH
5 ⁰C
45 days
45 days
45 days
S-7
S-8
S-9
06-08-2014
06-10-2014
06-08-2014
21-09-2014 (study of 45 days completed)
20-11-2014 (study of 45 days completed)
21-09-2014 (study of 45 days completed)
Initial (0 Time)
Week-1
Initial (0 Time)
Week-1
(API)lot
no.
A15070018-01
Minutes for 253rd
Registration Board Meeting 222
40± 2C, 75±5 RH
Week-2
Week-3
Week-4
Week-6
Week-8
Week-12
Week-16
Week-20
Week-24
Week-26
Week-2
Week-3
Week-4
Week-6
Week-8
Week-12
Week-16
Week-20
Week-24
Week-26
04-08-2014
02-02-2015 (study of 26 weeks completed)
30± 2C, 65±5 RH
Initial (0 Time)
Week-1
Week-2
Week-3
Week-4
Week-6
Week-8
Week-12
Week-16
Week-20
Week-24
Week-26
Initial (0 Time)
Week-1
Week-2
Week-3
Week-4
Week-6
Week-8
Week-12
Week-16
Week-20
Week-24
Week-26
04-08-2014 02-02-2015 (study of 26 weeks completed)
40± 2C, 75±5 RH
0 months
3 months
6 months
0 months
3 months
6 months 04-08-2014 04-02-2015 (study of 06 Month completed)
30± 2C, 65±5 RH
0 months
3 months
6 months
0 months
3 months
6 months 04-08-2014 04-02-2015 (study of 06 Month completed)
Minutes for 253rd
Registration Board Meeting 223
Approval by:
QC Manager: ---------------------
QA Manager: ---------------------
Product Manager: ---------------
R&D Manager: -------------------
Stability No. Following 13 Stability studies of SOVIR 400mg Tablets Batch No. X.01.08/14 are conducted, out of which only
3 studies S-1,S-2,S-3 are continue and will be completed on 06-08-2016 remaining all are completed. Short term conditions (Accelerated ) at 40± 2C, 75±5 RH of 26 weeks
Long term conditions (Real Time) at 30± 2C, 65±5 RH of 26 weeks
Long term conditions (Real Time) at 25 ⁰C /60% RH of 24 Months
Long term conditions (Real Time) at 30 ⁰C /75% RH of 24 Months
Long term conditions (Real Time) at 30 ⁰C /65% RH of 24 Months
Long term conditions (Real Time) at 40 ⁰C /75% RH of 06 Months
(Accelerated/Open Dish) 25 ⁰C /60% RH of 45 Days
(Accelerated/Open Dish) at 30 ⁰C /75% RH of 45 Days
(Accelerated/Stress) at 50 ⁰C /Ambient of 45 Days
(Accelerated/Stress) at 25 ⁰C /80% RH of 45 Days
(Accelerated/Stress) at 5 ⁰C of 45 Days
Short term conditions (Accelerated ) at 40± 2C, 75±5 RH of 06 Months
Long term conditions (Real Time) at 30± 2C, 65±5 RH of 06 Months
Sample taken for physical test = 279 Tablets
Sample taken for chemical test = 202 Tablets
Extra sample = 17 Tablets
Total Sample size (approx ) = 499 Tablets
Minutes for 253rd
Registration Board Meeting 224
Stability Study Data Sheet
Product name /Generic name/Dosage
form
SOVIR 400 mg Tablets /Sofosbuvir/Tablets Batch No. P.01.08/14
Description of pack
( container closure system)
13mm Round white film coated tablets, plain ,blistered in 260mm aluminum foil in a 14x 2 printed unit
carton, 200u/c further packed in master shipper. Batch
Size.
2125
Tablets
Parameters and test mentioned As product Specifications provided Mfg. Date 08/14
Recommended storage condition
Short term conditions (Accelerated ) 40± 2C, 75±5 RH
(Study duration 26 weeks ,with study name,Initial (0 Time),Week-1, Week-2, Week-3, Week-4,
Week-6, Week-8, Week-12, Week-16, Week-20, Week-24, Week-26
Long term conditions (Real Time) 30± 2C, 65±5 RH
(Study duration 26 weeks ,with study name,Initial (0 Time),Week-1, Week-2, Week-3, Week-4,
Week-6, Week-8, Week-12, Week-16, Week-20, Week-24, Week-26
In addition (already completed and submitted to DRAP)
Stability Study
(Proposed)
Storage
Conditions
Study
Duration
Study
Name
(Long Term)
25 ⁰C /60% RH
30 ⁰C /75% RH
30 ⁰C /65% RH
40 ⁰C /75% RH
24 months
24 months
24 months
6 months
S1
S2
S3
S4
(Accelerated/Open Dish) 25 ⁰C /60% RH
30 ⁰C /75% RH
45 days
45 days
S5
S6
(Accelerated/Stress)
50 ⁰C /Ambient 25 ⁰C /80% RH
5 ⁰C
45 days
45 days
45 days
S7
S8
S9
Exp Date
08/16 (as
per
calculation
of
Accelerated
Stability
Study)
Minutes for 253rd
Registration Board Meeting 225
Stability Study (Proposed) Storage
Conditions
Study
Duration
Study Name
Short term conditions (Accelerated ) 40± 2C, 75±5
RH
0 months
3 months
6 months
0 months
3 months
6 months
Long term conditions (Real Time) 30± 2C, 65±5 RH
0 months
3 months
6 months
0 months
3 months
6 months
Respective documents, Assay Reports document No.(EP/QC/QR/010),Analytical Report Products document No.
(EP/QC/QR/008), Stability summary document No. (EV-QR-DRAP-ST-030), Photometric Report Instrument
generated, Spectrum of Standard solution Instrument generated, Spectrum of Sample solution Instrument generated,
Stability study Data document No.(EP/QC/QR/033),Chromatogram of Standard Solution and Sample Solution , duly
sign and stamp are attached.
Date of
initiation &
implementation
Storage
Conditions
Study
Duration
Study Name Date of
Initiation
Date of Completion
25 ⁰C /60% RH
30 ⁰C /75% RH
30 ⁰C /65% RH
40 ⁰C /75% RH
24 months
24 months
24 months
6 months
S-10
S-11
S-12
S-13
06-08-2014
06-08-2014
06-08-2014
06-08-2014
06-08-2016(study of 12 Months 06-08-2015 completed) continue….
06-08-2016(study of 12 Months 06-08-2015 completed) continue….
06-08-2016(study of 12 Months 06-08-2015 completed) continue….
06-02-2015 (study of 06 Months completed)
25 ⁰C /60% RH
30 ⁰C /75% RH
45 days
45 days
S-14
S-15
06-08-2014
20-09-2014
21-09-2014 (study of 45 days completed)
04-10-2014 (study of 45 days completed)
50 ⁰C /Ambient
25 ⁰C /80% RH
5 ⁰C
45 days
45 days
45 days
S-16
S-17
S-18
06-08-2014
06-10-2014
06-08-2014
21-09-2014 (study of 45 days completed)
20-11-2014 (study of 45 days completed)
21-09-2014 (study of 45 days completed)
40± 2C, 75±5 RH
Initial (0 Time)
Week-1
Week-2
Week-3
Week-4
Week-6
Initial (0 Time)
Week-1
Week-2
Week-3
Week-4
Week-6
06-08-2014 04-02-2015 (study of 26 weeks completed)
(API)lot
no.
A15070018-01
Minutes for 253rd
Registration Board Meeting 226
Week-8
Week-12
Week-16
Week-20
Week-24
Week-26
Week-8
Week-12
Week-16
Week-20
Week-24
Week-26
30± 2C, 65±5 RH
Initial (0 Time)
Week-1
Week-2
Week-3
Week-4
Week-6
Week-8
Week-12
Week-16
Week-20
Week-24
Week-26
Initial (0 Time)
Week-1
Week-2
Week-3
Week-4
Week-6
Week-8
Week-12
Week-16
Week-20
Week-24
Week-26
06-08-2014 04-02-2015 (study of 26 weeks completed)
40± 2C, 75±5 RH
0 months
3 months
6 months
0 months
3 months
6 months 06-08-2014 06-02-2015 (study of 06 Month completed)
30± 2C, 65±5 RH
0 months
3 months
6 months
0 months
3 months
6 months 06-08-2014 06-02-2015 (study of 06 Month completed)
Minutes for 253rd
Registration Board Meeting 227
Approval by:
QC Manager: ---------------------
QA Manager: ---------------------
Product Manager: ---------------
R&D Manager: -------------------
Stability No. Following 13 Stability studies of SOVIR 400mg Tablets Batch No. P.01.08/14 are conducted, out of which only 3
studies S-1,S-2,S-3 are continue and will be completed on 06-08-2016 remaining all are completed. Short term conditions (Accelerated ) at 40± 2C, 75±5 RH of 26 weeks
Long term conditions (Real Time) at 30± 2C, 65±5 RH of 26 weeks
Long term conditions (Real Time) at 25 ⁰C /60% RH of 24 Months
Long term conditions (Real Time) at 30 ⁰C /75% RH of 24 Months
Long term conditions (Real Time) at 30 ⁰C /65% RH of 24 Months
Long term conditions (Real Time) at 40 ⁰C /75% RH of 06 Months
(Accelerated/Open Dish) 25 ⁰C /60% RH of 45 Days
(Accelerated/Open Dish) at 30 ⁰C /75% RH of 45 Days
(Accelerated/Stress) at 50 ⁰C /Ambient of 45 Days
(Accelerated/Stress) at 25 ⁰C /80% RH of 45 Days
(Accelerated/Stress) at 5 ⁰C of 45 Days
Short term conditions (Accelerated ) at 40± 2C, 75±5 RH of 06 Months
Long term conditions (Real Time) at 30± 2C, 65±5 RH of 06 Months
Sample taken for physical test = 918 Tablets
Sample taken for chemical test = 321 Tablets
Extra sample = 24 Tablets
Total Sample size (approx ) = 1263 Tablets
Minutes for 253rd
Registration Board Meeting 228
Stability Study Data Sheet
Product name /Generic name/Dosage
form
SOVIR 400 mg Tablets /Sofosbuvir/Tablets Batch No. P.02.08/14
Description of pack
( container closure system)
13mm Round white film coated tablets, plain ,blistered in 260mm aluminum foil in a 14x 2 printed unit
carton, 200u/c further packed in master shipper. Batch
Size.
2125
Tablets
Parameters and test mentioned As product Specifications provided Mfg. Date 08/14
Recommended storage condition
Short term conditions (Accelerated ) 40± 2C, 75±5 RH
(Study duration 26 weeks ,with study name,Initial (0 Time),Week-1, Week-2, Week-3, Week-4,
Week-6, Week-8, Week-12, Week-16, Week-20, Week-24, Week-26
Long term conditions (Real Time) 30± 2C, 65±5 RH
(Study duration 26 weeks ,with study name,Initial (0 Time),Week-1, Week-2, Week-3, Week-4,
Week-6, Week-8, Week-12, Week-16, Week-20, Week-24, Week-26
In addition (already completed and submitted to DRAP)
Stability Study
(Proposed)
Storage
Conditions
Study
Duration
Study
Name
(Long Term)
25 ⁰C /60% RH
30 ⁰C /75% RH
30 ⁰C /65% RH
40 ⁰C /75% RH
24 months
24 months
24 months
6 months
S1
S2
S3
S4
(Accelerated/Open Dish) 25 ⁰C /60% RH
30 ⁰C /75% RH
45 days
45 days
S5
S6
(Accelerated/Stress)
50 ⁰C /Ambient 25 ⁰C /80% RH
5 ⁰C
45 days
45 days
45 days
S7
S8
S9
Exp Date
08/16 (as
per
calculation
of
Accelerated
Stability
Study)
Minutes for 253rd
Registration Board Meeting 229
Stability Study (Proposed) Storage
Conditions
Study
Duration
Study Name
Short term conditions (Accelerated ) 40± 2C, 75±5
RH
0 months
3 months
6 months
0 months
3 months
6 months
Long term conditions (Real Time) 30± 2C, 65±5 RH
0 months
3 months
6 months
0 months
3 months
6 months
Respective documents, Assay Reports document No.(EP/QC/QR/010),Analytical Report Products document No.
(EP/QC/QR/008), Stability summary document No. (EV-QR-DRAP-ST-030), Photometric Report Instrument
generated, Spectrum of Standard solution Instrument generated, Spectrum of Sample solution Instrument generated,
Stability study Data document No.(EP/QC/QR/033),Chromatogram of Standard Solution and Sample Solution , duly
sign and stamp are attached.
Date of
initiation &
implementation
Storage
Conditions
Study
Duration
Study Name Date of
Initiation
Date of Completion
25 ⁰C /60% RH
30 ⁰C /75% RH
30 ⁰C /65% RH
40 ⁰C /75% RH
24 months
24 months
24 months
6 months
S-19
S-20
S-21
S-22
08-08-2014
08-08-2014
08-08-2014
08-08-2014
08-08-2016(study of 12 Months 06-08-2015 completed) continue….
08-08-2016(study of 12 Months 06-08-2015 completed) continue….
08-08-2016(study of 12 Months 06-08-2015 completed) continue….
08-02-2015 (study of 06 Months completed)
25 ⁰C /60% RH
30 ⁰C /75% RH
45 days
45 days
S-23
S-24
08-08-2014
20-09-2014
23-09-2014 (study of 45 days completed)
04-10-2014 (study of 45 days completed)
50 ⁰C /Ambient
25 ⁰C /80% RH
5 ⁰C
45 days
45 days
45 days
S-25
S-26
S-27
08-08-2014
06-10-2014
08-08-2014
23-09-2014 (study of 45 days completed)
20-11-2014 (study of 45 days completed)
23-09-2014 (study of 45 days completed)
40± 2C, 75±5 RH
Initial (0 Time)
Week-1
Week-2
Week-3
Week-4
Initial (0 Time)
Week-1
Week-2
Week-3
Week-4
08-08-2014 06-02-2015 (study of 26 weeks completed)
(API)lot
no.
A15070018-01
Minutes for 253rd
Registration Board Meeting 230
Week-6
Week-8
Week-12
Week-16
Week-20
Week-24
Week-26
Week-6
Week-8
Week-12
Week-16
Week-20
Week-24
Week-26
30± 2C, 65±5 RH
Initial (0 Time)
Week-1
Week-2
Week-3
Week-4
Week-6
Week-8
Week-12
Week-16
Week-20
Week-24
Week-26
Initial (0 Time)
Week-1
Week-2
Week-3
Week-4
Week-6
Week-8
Week-12
Week-16
Week-20
Week-24
Week-26
08-08-2014 06-02-2015 (study of 26 weeks completed)
40± 2C, 75±5 RH
0 months
3 months
6 months
0 months
3 months
6 months 08-08-2014 09-02-2015 (study of 06 Month completed)
30± 2C, 65±5 RH
0 months
3 months
6 months
0 months
3 months
6 months 08-08-2014 09-02-2015 (study of 06 Month completed)
Minutes for 253rd
Registration Board Meeting 231
Approval by:
QC Manager: ---------------------
QA Manager: ---------------------
Product Manager: ---------------
R&D Manager: -------------------
Stability No. Following 13 Stability studies of SOVIR 400mg Tablets Batch No. P.02.08/14 are conducted, out of which only 3
studies S-1,S-2,S-3 are continue and will be completed on 06-08-2016 remaining all are completed. Short term conditions (Accelerated ) at 40± 2C, 75±5 RH of 26 weeks
Long term conditions (Real Time) at 30± 2C, 65±5 RH of 26 weeks
Long term conditions (Real Time) at 25 ⁰C /60% RH of 24 Months
Long term conditions (Real Time) at 30 ⁰C /75% RH of 24 Months
Long term conditions (Real Time) at 30 ⁰C /65% RH of 24 Months
Long term conditions (Real Time) at 40 ⁰C /75% RH of 06 Months
(Accelerated/Open Dish) 25 ⁰C /60% RH of 45 Days
(Accelerated/Open Dish) at 30 ⁰C /75% RH of 45 Days
(Accelerated/Stress) at 50 ⁰C /Ambient of 45 Days
(Accelerated/Stress) at 25 ⁰C /80% RH of 45 Days
(Accelerated/Stress) at 5 ⁰C of 45 Days
Short term conditions (Accelerated ) at 40± 2C, 75±5 RH of 06 Months
Long term conditions (Real Time) at 30± 2C, 65±5 RH of 06 Months
Sample taken for physical test = 897 Tablets
Sample taken for chemical test = 448 Tablets
Extra sample = 19 Tablets
Total Sample size (approx ) = 1364 Tablets
Minutes for 253rd
Registration Board Meeting 232
Documents / Data provided by the applicant
(M/s Everest Pharmaceuticals Islamabad)
Sr. No. Documents to be provided Status
1. COA of API Yes
2. Approval of API by regulatory authority of country of
origin or GMP certificate of API manufacturer issued by
regulatory authority of country of origin.
Yes
3. Protocols followed for conduction of stability study and
details of tests.
Yes
4. Data of 03 batches will be supported by attested
respective documents like chromatograms, laboratory
reports, data sheets etc.
Yes
5. Documents confirming import of API etc. Yes (by courier)
6. All provided documents will be attested (name, sign and
stamp) for ensuring authenticity of data / documents.
Yes
7. Commitment to continue real time stability study till
assigned shelf life of the product.
Yes
Decision: Mr.Muhammad Usman, CEO presented the data. He informed that firm has requested DRAP, Islamabad four times dated
21-03-15, 26-03-15, 14-04-15 and 27-04-15 for conduction of GMP inspection and also deposited fee Rs5000/- as per DRAP’s
requirement. Registration Board inquired from representative of QA & LT Division about GMP status of the manufacturer. GMP
inspection report was presented before the Board on 06.10.2015 and tablet section was found satifactoy. Registration Board observed
that the stability data provided by the firm is in accordance with the recommendations of the Board finalized in 251st meeting.
Therefore, Board granted approval of registration of Sofosbuvir 400 mg tablets to the firm. However, manufacturer will inform
concerned Federal Inspector of Drugs for taking sample of Active Pharmaceutical Ingredient (used in manufacture of first
commercial batch) for test/ analysis from Central Drugs Laboratory, Karachi before sale of finished product.
Minutes for 253rd
Registration Board Meeting 233
25. M/s Novartis Pharma Karachi (M/s Strides Acrolabs India)
Brand Name
Composition
Pharmacological group
Manufacturer
Type of Form
Date & Diary
Fee
Demanded price & Pack
size
Manufactured by Remarks
VIRSO Tablets 400mg
Each film coated tablets
contains:
Sofosbuvir…..400mg
Antiviral
Form-5A
Dy No 181, dated 25-08-15
50000/-
38000/- per 28‟s bottle
M/s Strides Arco Lab Ltd,
36/7, Suraj Ajakkanahaali,
Indalavadi, Cross Anekal,
Taluka Banglore, India.
Copy of CoPP submitted.
Firm submitted that original
Copp is in process of
legalization.
Drug VIRSO Tablets 400mg
Source M/s Sequent Scientific Limited India
Storage Condition Accelerated: 40 C and 75% RH
Real Time: 30 C and 65% RH
Real time : 30 C and 75% RH
Time Period 6 months
Frequency 0,1,2,3,6 months (Acc)
0,3,6 months (Real time)
Batch Size 5000 tablets/ batch
Minutes for 253rd
Registration Board Meeting 234
No. of Batches 3
Sample Size Nil
Meeting 252
product Sofosbuvir tablets 40mg batch size 5000 tablets stability condition 40⁰c±2⁰c/75% ±5%RH
batch no 2004488-007 mfg. location Strides Bangalore
mfg. date Dec-2014 mfg. for Optimization batch Orientation Not applicable
expr date Nov-2016 date of incubation 14.01.2015
Primary Packaging material:-Plastic container- [1OOCC][Round] [Screw] [White opaque HOPE container}(Extra heavy weight) induction sealing
HS 130-35 liner][printed as unsealed for your Protection], Desiccant-(1g Silica gel sac:hetJIL:42.67 x w:19mrn [Tyvek Sachet][Text printed as
1'DO NOT EAT"'[REEL FOR'1J[STRIP PAXI[MULTISORBT, Polyester coil- Pharmaceutical grade polyester coil:9GM/YARD (10cm)
Pack size HDPE Container -28‟s
Version No: R0 API Source/B No:- Sequent Scientific Limited / 12RD14/SFB/20
Period
Test
Description Water
content
limit for
information
only
Dissolution
limit: NLT
80.0% (Q) of
labeled amount
of Sofosbuvir
should dissolved
in 15 min
Gs-
686965
limit:
NMT
0.50%
Gs-
331007
limit:
NMT
0.50%
Gs-
566500
limit:
NMT
0.50%
Gs-
607669
limit:
NMT
0.50%
Gs-
607670
limit:
NMT
0.50%
Phenol
limit:
NMT
0.50%
any
unspecified
degradation
product
limit: NMT
0.20%
total
impurities
limit NMT
0.8%
assay by HPLC
each film coated
tablet contains
Sofosbuvir 400mg
limit:376.00mg to
420.00mg (94.0%
to 105.00% of label
claim)
Reference A.R
No.
Initial Yellow colored
capsule shaped
bevel edged film
coated tablets
debossed with
"400" on one
side and plain
on other side
2.03% BQL 0.04% BQL BQL BQL BQL BQL 0.02% 0.06% 399.2mg (99.8%) 1080/FD/1500004
1 M Yellow coloured
capsule shaped
bevel edged film
coated tablets
debossed with
"400" on one
side and plain
on other side
1.70% BQL BQL BQL BQL BQL BQL BQL 0.02% 0.02% 400.4mg (100.1%) 1080/FD/1500185
2M Yellow colored 1.75% BQL BQL BQL BQL BQL BQL BQL 0.02% 0.02% 397.6mg (99.4%) 1080/FD/1500245
Minutes for 253rd
Registration Board Meeting 235
capsule shaped
bevel edged film
coated tablets
debossed with
"400" on one
side and plain
on other side
3M Yellow colored
capsule shaped
bevel edged film
coated tablets
debossed with
"400" on one
side and plain
on other side
2.45% BQL BQL BQL BQL BQL BQL BQL 0.05% 0.05% 400.00mg (100.0%) 1080/FD/1500491
product Sofosbuvir tablets 40mg batch size 5000 tablets stability condition 40⁰c±2⁰c/75%
±5%RH batch no 2004488-007 mfg. location Strides Bangalore
mfg. date Dec-2014 mfg. for Optimization batch Orientation Not applicable
expr date Nov-2016 date of incubation 14.01.2015
Primary Packaging material:-Plastic container- [1OOCC][Round] [Screw] [White opaque HOPE container}(Extra heavy weight) induction sealing HS 130-
35 liner][printed as unsealed for your Protection], Desiccant-(1g Silica gel sac:hetJIL:42.67 x w:19mrn [Tyvek Sachet][Text printed as 1'DO NOT
EAT"'[REEL FOR'1J[STRIP PAXI[MULTISORBT, Polyester coil- Pharmaceutical grade polyester coil:9GM/YARD (10cm)
Pack size HDPE Container -
28‟s
Version No: R0 API Source/B No:- Sequent Scientific Limited / 12RD14/SFB/20
Period
Test
Description Water
content
limit for
information
only
Dissolution
limit: NLT
80.0% (Q) of
labeled amount
of Sofosbuvir
should
dissolved in 15
min
Gs-
686965
limit
:NMT
0.50%
Gs-
331007
limit:
NMT
0.50%
Gs-
566500
limit:
NMT
0.50%
Gs-
607669
limit:
NMT
0.50%
Gs-
607670
limit:
NMT
0.50%
Phenol
limit:
NMT
0.50%
any
unspecified
degradation
product limit:
NMT 0.20%
total
impurities
limit NMT
0.8%
assay by HPLC
each film coated
tablet contains
Sofosbuvir 400mg
limit:376.00mg to
420.00mg (94.0%
to 105.00% of label
claim)
Reference
A.R No.
6M Yellow colored
capsule shaped bevel
edged film coated
tablets debossed with
2.17% 90.5 - 91.9% BQL BQL BQL BQL BQL BQL 0.02% 0.02% 399.6mg
(99.9%)
1080/SS/
1500978
Minutes for 253rd
Registration Board Meeting 236
"400" on one side
and plain on other
side
product Sofosbuvir tablets 40mg batch size 5000 tablets stability condition 40⁰c±2⁰c/75% ±5%RH
batch no 2004488-008 mfg. location Strides Bangalore
mfg. date Dec-2014 mfg. for Optimization batch Orientation Not applicable
expr date Nov-2016 date of incubation 14.01.2015
Primary Packaging material:-Plastic container- [1OOCC][Round] [Screw] [White opaque HOPE container}(Extra heavy weight) induction sealing
HS 130-35 liner][printed as unsealed for your Protection], Desiccant-(1g Silica gel sac:hetJIL:42.67 x w:19mrn [Tyvek Sachet][Text printed as
1'DO NOT EAT"'[REEL FOR'1J[STRIP PAXI[MULTISORBT, Polyester coil- Pharmaceutical grade polyester coil:9GM/YARD (10cm)
Pack size HDPE Container -28‟s
Version No: R0 API Source/B No:- Sequent Scientific Limited / 12RD14/SFB/20
Period
Test
Description Water
content
limit for
information
only
Dissolution
limit: NLT
80.0% (Q)
of labeled
amount of
Sofosbuvir
should
dissolved in
15 min
Gs-
686965
limit
:NMT
0.50%
Gs-
331007
limit:
NMT
0.50%
Gs-
566500
limit:
NMT
0.50%
Gs-
607669
limit:
NMT
0.50%
Gs-
607670
limit:
NMT
0.50%
Phenol
limit:
NMT
0.50%
any
unspecified
degradation
product
limit: NMT
0.20%
total
impurities
limit NMT
0.8%
assay by HPLC
each film coated
tablet contains
Sofosbuvir 400mg
limit:376.00mg to
420.00mg (94.0%
to 105.00% of
label claim)
Reference A.R
No.
Initial Yellow colored
capsule shaped
bevel edged film
coated tablets
debossed with "400"
on one side and
plain on other side
1.96% 94.6-98.6% BQL BQL BQL BQL BQL BQL 0.03% 0.05% 400.8mg (100.2%) 1080/ss/1500005
1 M Yellow coloured
capsule shaped
bevel edged film
coated tablets
debossed with "400"
on one side and
plain on other side
1.55% 91.5-95.9% BQL BQL BQL BQL BQL BQL 0.02% 0.02% 400.4mg (100.0%) 1080/ss/1500186
2M Yellow colored
capsule shaped
bevel edged film
coated tablets
1.60% 100.8-
102.3%
BQL BQL BQL BQL BQL BQL 0.02% 0.02% 406.4mg (101.6%) 1080/ss/1500246
Minutes for 253rd
Registration Board Meeting 237
debossed with "400"
on one side and
plain on other side
3M Yellow colored
capsule shaped
bevel edged film
coated tablets
debossed with "400"
on one side and
plain on other side
2.04% 92.5-95.8% BQL BQL BQL BQL BQL BQL 0.05% 0.05% 407.30mg
(101.8%)
1080/ss/1500495
product Sofosbuvir tablets 40mg batch size 5000 tablets stability condition 40⁰c±2⁰c/75% ±5%RH
batch no 2004488-008 mfg. location Strides Bangalore
mfg. date Dec-2014 mfg. for Optimization batch Orientation Not applicable
expr date Nov-2016 date of incubation 14.01.2015
Primary Packaging material:-Plastic container- [1OOCC][Round] [Screw] [White opaque HOPE container}(Extra heavy weight) induction
sealing HS 130-35 liner][printed as unsealed for your Protection], Desiccant-(1g Silica gel sac:hetJIL:42.67 x w:19mrn [Tyvek Sachet][Text
printed as 1'DO NOT EAT"'[REEL FOR'1J[STRIP PAXI[MULTISORBT, Polyester coil- Pharmaceutical grade polyester coil:9GM/YARD
(10cm)
Pack size HDPE Container -28‟s
Version No: R0 API Source/B No:- Sequent Scientific Limited / 12RD14/SFB/20
Period
Test
Description Water
content
limit for
information
only
Dissolution
limit: NLT
80.0% (Q)
of labeled
amount of
Sofosbuvir
should
dissolved in
15 min
Gs-
686965
limit
:NMT
0.50%
Gs-
331007
limit:
NMT
0.50%
Gs-
566500
limit:
NMT
0.50%
Gs-
607669
limit:
NMT
0.50%
Gs-
607670
limit:
NMT
0.50%
Phenol
limit:
NMT
0.50%
any
unspecified
degradation
product
limit: NMT
0.20%
total
impurities
limit NMT
0.8%
assay by HPLC
each film coated
tablet contains
Sofosbuvir 400mg
limit:376.00mg to
420.00mg (94.0%
to 105.00% of
label claim)
Reference A.R No.
6M Yellow colored
capsule shaped
bevel edged film
coated tablets
debossed with
"400" on one side
and plain on other
side
2.11% 90.1-95.3% BQL BQL BQL BQL BQL BQL 0.02% 0.02% 400.4mg
(100.1%)
1080/SS+O52/1500797
Minutes for 253rd
Registration Board Meeting 238
product Sofosbuvir tablets 40mg batch size 5000 tablets stability condition 40⁰c±2⁰c/75% ±5%RH
batch no 2004488-009 mfg. location Strides Bangalore
mfg. date Dec-2014 mfg. for Optimization batch Orientation Not applicable
expr date Nov-2016 date of incubation 14.01.2015
Primary Packaging material:-Plastic container- [1OOCC][Round] [Screw] [White opaque HOPE container}(Extra heavy weight) induction sealing
HS 130-35 liner][printed as unsealed for your Protection], Desiccant-(1g Silica gel sac:hetJIL:42.67 x w:19mrn [Tyvek Sachet][Text printed as
1'DO NOT EAT"'[REEL FOR'1J[STRIP PAXI[MULTISORBT, Polyester coil- Pharmaceutical grade polyester coil:9GM/YARD (10cm)
Pack size HDPE Container -28‟s
Version No: R0 API Source/B No:- Sequent Scientific Limited / 12RD14/SFB/20
Period
Test
Description Water
content
limit for
information
only
Dissolution
limit: NLT
80.0% (Q)
of labeled
amount of
Sofosbuvir
should
dissolved in
15 min
Gs-
686965
limit
:NMT
0.50%
Gs-
331007
limit:
NMT
0.50%
Gs-
566500
limit:
NMT
0.50%
Gs-
607669
limit:
NMT
0.50%
Gs-
607670
limit:
NMT
0.50%
Phenol
limit:
NMT
0.50%
any
unspecified
degradation
product
limit: NMT
0.20%
total
impurities
limit NMT
0.8%
assay by HPLC
each film coated
tablet contains
Sofosbuvir 400mg
limit:376.00mg to
420.00mg (94.0%
to 105.00% of
label claim)
Reference A.R No.
Initial Yellow colored
capsule shaped
bevel edged film
coated tablets
debossed with "400"
on one side and
plain on other side
1.80% 93.5-95.5% BQL BQL BQL BQL BQL BQL 0.01% 0.01% 403.6MG
(100.9%)
1080/FD/1500006
1 M Yellow coloured
capsule shaped
bevel edged film
coated tablets
debossed with "400"
on one side and
plain on other side
1.63% 93.1-96.3% BQL BQL BQL BQL BQL BQL 0.02% 0.02% 402.4MG
(100.6%)
1080/SS/2500187
2M Yellow colored
capsule shaped
bevel edged film
coated tablets
debossed with "400"
on one side and
plain on other side
1.64% 97.9-
102.2%
BQL BQL BQL BQL BQL BQL 0.02% 0.02% 406.4MG
(101.6%)
1080/SS/1500247
Minutes for 253rd
Registration Board Meeting 239
3M Yellow colored
capsule shaped
bevel edged film
coated tablets
debossed with "400"
on one side and
plain on other side
1.82% 90.3-93.9% BQL BQL BQL BQL BQL BQL 0.05% 0.05% 401.6mg (100.4%) 1080/SS/1500499
Product Sofosbuvir tablets 40mg batch size 5000 tablets stability condition 40⁰c±2⁰c/75% ±5%RH
batch no 2004488-009 mfg. location Strides Bangalore
mfg. date Dec-2014 mfg. for Optimization batch Orientation Not applicable
expr date Nov-2016 date of incubation 14.01.2015
Primary Packaging material:-Plastic container- [1OOCC][Round] [Screw] [White opaque HOPE container}(Extra heavy weight) induction
sealing HS 130-35 liner][printed as unsealed for your Protection], Desiccant-(1g Silica gel sac:hetJIL:42.67 x w:19mrn [Tyvek Sachet][Text
printed as 1'DO NOT EAT"'[REEL FOR'1J[STRIP PAXI[MULTISORBT, Polyester coil- Pharmaceutical grade polyester coil:9GM/YARD
(10cm)
Pack size HDPE Container -28‟s
Version No: R0 API Source/B No:- Sequent Scientific Limited / 12RD14/SFB/20
Period
Test
Description Water
content
limit for
information
only
Dissolution
limit: NLT
80.0% (Q)
of labeled
amount of
Sofosbuvir
should
dissolved in
15 min
Gs-
686965
limit
:NMT
0.50%
Gs-
331007
limit:
NMT
0.50%
Gs-
566500
limit:
NMT
0.50%
Gs-
607669
limit:
NMT
0.50%
Gs-
607670
limit:
NMT
0.50%
Phenol
limit:
NMT
0.50%
any
unspecified
degradation
product
limit: NMT
0.20%
total
impurities
limit NMT
0.8%
assay by HPLC
each film coated
tablet contains
Sofosbuvir 400mg
limit:376.00mg to
420.00mg (94.0%
to 105.00% of
label claim)
Reference A.R No.
6M Yellow colored
capsule shaped
bevel edged film
coated tablets
debossed with
"400" on one side
and plain on other
side
1.99% 94.1-96.1% BQL BQL BQL BQL BQL BQL 0.02% 0.02% 398.4mg (99.6%) 1080/SS+O52/1500986
Product Sofosbuvir tablets 40mg batch size 5000 tablets stability condition 30⁰c±2⁰c/65% ±5%RH
batch no 2004488-007 mfg. location Strides Bangalore
mfg. date Dec-2014 mfg. for Optimization batch Orientation Not applicable
expr date Nov-2016 date of incubation 14.01.2015
Minutes for 253rd
Registration Board Meeting 240
Primary Packaging material:-Plastic container- [1OOCC][Round] [Screw] [White opaque HOPE container}(Extra heavy weight) induction sealing HS
130-35 liner][printed as unsealed for your Protection], Desiccant-(1g Silica gel sac:hetJIL:42.67 x w:19mrn [Tyvek Sachet][Text printed as 1'DO
NOT EAT"'[REEL FOR'1J[STRIP PAXI[MULTISORBT, Polyester coil- Pharmaceutical grade polyester coil:9GM/YARD (10cm)
Pack size HDPE Container -28‟s
Version No: R0 API Source/B No:- Sequent Scientific Limited / 12RD14/SFB/20
Period
Test
Description water
content limit
: for
information
only
Water content
limit for
information only
Dissolu
tion
limit:
NLT
80.0%
(Q) of
labeled
amount
of
Sofosbu
vir
should
dissolve
d in 15
min
Gs-
686965
limit:
NMT
0.50%
Gs-
331007
limit:
NMT
0.50%
Gs-
566500
limit:
NMT
0.50%
Gs-
60766
9 limit:
NMT
0.50%
Gs-607670
limit: NMT
0.50%
Phenol limit:
NMT 0.50%
any
unspecified
degradation
product
limit: NMT
0.20%
total
impurities
limit NMT
0.8%
assay by HPLC
each film
coated tablet
contains
Sofosbuvir
400mg
limit:376.00mg
to 420.00mg
(94.0% to
105.00% of
label claim)
Initial Yellow colored
capsule shaped bevel
edged film coated
tablets debossed with
"400" on one side and
plain on other side
2.03% 94.1-98.4% BQL BQL BQL BQL BQL BQL 0.01% 0.06% 399.2mg
(99.8%)
1080/FD/15000
06
3 M Yellow coloured
capsule shaped bevel
edged film coated
tablets debossed with
"400" on one side and
plain on other side
3.79% 88.0-91.1% BQL BQL BQL BQL BQL BQL 0.06% 0.06% 401.2mg
(100.3%)
1080/SS/25001
87
6M Yellow colored
capsule shaped bevel
edged film coated
tablets debossed with
"400" on one side and
plain on other side
2.19% 88.9-94.8% BQL BQL BQL BQL BQL BQL 0.02% 0.02% 396.0mg
(99.0%)
1080/SS/15002
47
product Sofosbuvir tablets 40mg batch size 5000 tablets stability condition 30⁰c±2⁰c/75% ±5%RH
Minutes for 253rd
Registration Board Meeting 241
batch no 2004488-007 mfg. location Strides Bangalore
mfg. date Dec-2014 mfg. for Optimization batch Orientation Not applicable
expr date Nov-2016 date of incubation 14.01.2015
Primary Packaging material:-Plastic container- [1OOCC][Round] [Screw] [White opaque HOPE container}(Extra heavy weight) induction sealing HS
130-35 liner][printed as unsealed for your Protection], Desiccant-(1g Silica gel sac:hetJIL:42.67 x w:19mrn [Tyvek Sachet][Text printed as 1'DO
NOT EAT"'[REEL FOR'1J[STRIP PAXI[MULTISORBT, Polyester coil- Pharmaceutical grade polyester coil:9GM/YARD (10cm)
Pack size HDPE Container -28‟s
Version No: R0 API Source/B No:- Sequent Scientific Limited / 12RD14/SFB/20
Period
Test
Description Water
content limit
for
information
only
Dissolution
limit: NLT
80.0% (Q) of
labeled amount
of Sofosbuvir
should dissolved
in 15 min
Gs-
686965
limit:
NMT
0.50%
Gs-
331007
limit:
NMT
0.50%
Gs-
566500
limit:
NMT
0.50%
Gs-
607669
limit:
NMT
0.50%
Gs-
60767
0 limit:
NMT
0.50%
Phenol
limit: NMT
0.50%
any
unspecified
degradation
product limit:
NMT 0.20%
total
impurities
limit NMT
0.8%
assay by
HPLC each
film coated
tablet
contains
Sofosbuvir
400mg
limit:376.00
mg to
420.00mg
(94.0% to
105.00% of
label claim)
Reference A.R
No.
Initial Yellow colored
capsule shaped bevel
edged film coated
tablets debossed with
"400" on one side and
plain on other side
2.03% 94.1-98.4% BQL 0.04% BQL BQL BQL BQL 0.02% 0.06% 399.2mg
(99.8%)
1080/FD/15000
06
3 M Yellow coloured
capsule shaped bevel
edged film coated
tablets debossed with
"400" on one side and
plain on other side
2.59% 88.1-90.5% BQL BQL BQL BQL BQL BQL 0.05% 0.05% 402.4mg
(100.6%)
1080/SS/25001
87
6M Yellow colored
capsule shaped bevel
edged film coated
tablets debossed with
"400" on one side and
plain on other side
2.38% 89.9-93.3% BQL BQL BQL BQL BQL BQL 0.02% 0.02% 397.2mg
(99.3%)
1080/SS/15002
47
Minutes for 253rd
Registration Board Meeting 242
product Sofosbuvir tablets 40mg batch size 5000 tablets stability condition 30⁰c±2⁰c/65% ±5%RH
batch no 2004488-008 mfg. location Strides Bangalore
mfg. date Dec-2014 mfg. for Optimization batch Orientation Not applicable
expr date Nov-2016 date of incubation 14.01.2015
Primary Packaging material:-Plastic container- [1OOCC][Round] [Screw] [White opaque HOPE container}(Extra heavy weight) induction sealing HS
130-35 liner][printed as unsealed for your Protection], Desiccant-(1g Silica gel sac:hetJIL:42.67 x w:19mrn [Tyvek Sachet][Text printed as 1'DO
NOT EAT"'[REEL FOR'1J[STRIP PAXI[MULTISORBT, Polyester coil- Pharmaceutical grade polyester coil:9GM/YARD (10cm)
Pack size HDPE Container -28‟s
Version No: R0 API Source/B No:- Sequent Scientific Limited / 12RD14/SFB/20
Period
Test
Description Water
content limit
for
information
only
Dissolution
limit: NLT
80.0% (Q) of
labeled amount
of Sofosbuvir
should dissolved
in 15 min
Gs-
686965
limit:
NMT
0.50%
Gs-
331007
limit:
NMT
0.50%
Gs-
566500
limit:
NMT
0.50%
Gs-
607669
limit:
NMT
0.50%
Gs-
60767
0 limit:
NMT
0.50%
Phenol
limit: NMT
0.50%
any
unspecified
degradation
product limit:
NMT 0.20%
total
impurities
limit NMT
0.8%
assay by
HPLC each
film coated
tablet
contains
Sofosbuvir
400mg
limit:376.00
mg to
420.00mg
(94.0% to
105.00% of
label claim)
Reference A.R
No.
Initial Yellow colored
capsule shaped bevel
edged film coated
tablets debossed with
"400" on one side and
plain on other side
1.96% 94.6-98.6% BQL BQL BQL BQL BQL BQL 0.03% 0.05% 400.8mg
(100.2%)
1080/FD/15000
05
3 M Yellow coloured
capsule shaped bevel
edged film coated
tablets debossed with
"400" on one side and
plain on other side
2.39% 93.7-95.1% BQL BQL BQL BQL BQL BQL 0.05% 0.05% 403.2mg
(100.8%)
1080/SS/15004
93
6M Yellow colored
capsule shaped bevel
edged film coated
tablets debossed with
"400" on one side and
1.95% 90.0-93.3% BQL BQL BQL BQL BQL BQL 0.02% 0.02% 385.6mg
(96.4%)
1080/SS/15009
82
Minutes for 253rd
Registration Board Meeting 243
product Sofosbuvir tablets 40mg batch size 5000 tablets stability condition 30⁰c±2⁰c/75% ±5%RH
batch no 2004488-008 mfg. location Strides Bangalore
mfg. date Dec-2014 mfg. for Optimization batch Orientation Not applicable
expr date Nov-2016 date of incubation 14.01.2015
Primary Packaging material:-Plastic container- [1OOCC][Round] [Screw] [White opaque HOPE container}(Extra heavy weight) induction sealing HS
130-35 liner][printed as unsealed for your Protection], Desiccant-(1g Silica gel sac:hetJIL:42.67 x w:19mrn [Tyvek Sachet][Text printed as 1'DO
NOT EAT"'[REEL FOR'1J[STRIP PAXI[MULTISORBT, Polyester coil- Pharmaceutical grade polyester coil:9GM/YARD (10cm)
Pack size HDPE Container -28‟s
Version No: R0 API Source/B No:- Sequent Scientific Limited / 12RD14/SFB/20
Period
Test
Description Water
content limit
for
information
only
Dissolution
limit: NLT
80.0% (Q) of
labeled amount
of Sofosbuvir
should dissolved
in 15 min
Gs-
686965
limit:
NMT
0.50%
Gs-
331007
limit:
NMT
0.50%
Gs-
566500
limit:
NMT
0.50%
Gs-
607669
limit:
NMT
0.50%
Gs-
60767
0 limit:
NMT
0.50%
Phenol
limit: NMT
0.50%
any
unspecified
degradation
product limit:
NMT 0.20%
total
impurities
limit NMT
0.8%
assay by
HPLC each
film coated
tablet
contains
Sofosbuvir
400mg
limit:376.00
mg to
420.00mg
(94.0% to
105.00% of
label claim)
Reference A.R
No.
Initial Yellow colored
capsule shaped bevel
edged film coated
tablets debossed with
"400" on one side and
plain on other side
1.96% 94.6-98.6% BQL BQL BQL BQL BQL BQL 0.03% 0.05% 400.8mg
(100.2%)
1080/FD/15000
05
3 M Yellow coloured
capsule shaped bevel
edged film coated
tablets debossed with
"400" on one side and
plain on other side
1.91% 91.8-95.6% BQL BQL BQL BQL BQL BQL 0.05% 0.05% 400.0mg
(100.0%)
1080/SS/15004
94
6M Yellow colored
capsule shaped bevel
edged film coated
tablets debossed with
1.91% 89.3-93.6% BQL BQL BQL BQL BQL BQL 0.02% 0.02% 383.2mg
(95.8%)
1080/SS/15009
81
plain on other side
Minutes for 253rd
Registration Board Meeting 244
"400" on one side and
plain on other side
product Sofosbuvir tablets 40mg batch size 5000 tablets stability condition 30⁰c±2⁰c/65% ±5%RH
batch no 2004488-009 mfg. location Strides Bangalore
mfg. date Dec-2014 mfg. for Optimization batch Orientation Not applicable
expr date Nov-2016 date of incubation 14.01.2015
Primary Packaging material:-Plastic container- [1OOCC][Round] [Screw] [White opaque HOPE container}(Extra heavy weight) induction sealing HS
130-35 liner][printed as unsealed for your Protection], Desiccant-(1g Silica gel sac:hetJIL:42.67 x w:19mrn [Tyvek Sachet][Text printed as 1'DO
NOT EAT"'[REEL FOR'1J[STRIP PAXI[MULTISORBT, Polyester coil- Pharmaceutical grade polyester coil:9GM/YARD (10cm)
Pack size HDPE Container -28‟s
Version No: R0 API Source/B No:- Sequent Scientific Limited / 12RD14/SFB/20
Period
Test
Description Water
content limit
for
information
only
Dissolution
limit: NLT
80.0% (Q) of
labeled amount
of Sofosbuvir
should dissolved
in 15 min
Gs-
686965
limit:
NMT
0.50%
Gs-
331007
limit:
NMT
0.50%
Gs-
566500
limit:
NMT
0.50%
Gs-
607669
limit:
NMT
0.50%
Gs-
60767
0 limit:
NMT
0.50%
Phenol
limit: NMT
0.50%
any
unspecified
degradation
product limit:
NMT 0.20%
total
impurities
limit NMT
0.8%
assay by
HPLC each
film coated
tablet
contains
Sofosbuvir
400mg
limit:376.00
mg to
420.00mg
(94.0% to
105.00% of
label claim)
Reference A.R
No.
Initial Yellow colored
capsule shaped bevel
edged film coated
tablets debossed with
"400" on one side and
plain on other side
1.80% 93.5-95.5% BQL BQL BQL BQL BQL BQL 0.01% 0.01% 403.6mg
(100.9%)
1080/FD/15000
06
3 M Yellow coloured
capsule shaped bevel
edged film coated
tablets debossed with
"400" on one side and
plain on other side
2.12% 90.7-94.2% BQL BQL BQL BQL BQL BQL 0.05% 0.05% 400.0mg
(100.0%)
1080/SS/15004
97
6M Yellow colored
capsule shaped bevel
edged film coated
2.38% 93.4-95.3% BQL BQL BQL BQL BQL BQL 0.02% 0.02% 400.4mg
(100.1%)
1080/SS/15009
84
Minutes for 253rd
Registration Board Meeting 245
tablets debossed with
"400" on one side and
plain on other side
product Sofosbuvir tablets 40mg batch size 5000 tablets stability condition 30⁰c±2⁰c/75% ±5%RH
batch no 2004488-009 mfg. location Strides Bangalore
mfg. date Dec-2014 mfg. for Optimization batch Orientation Not applicable
expr date Nov-2016 date of incubation 14.01.2015
Primary Packaging material:-Plastic container- [1OOCC][Round] [Screw] [White opaque HOPE container}(Extra heavy weight) induction sealing HS
130-35 liner][printed as unsealed for your Protection], Desiccant-(1g Silica gel sac:hetJIL:42.67 x w:19mrn [Tyvek Sachet][Text printed as 1'DO
NOT EAT"'[REEL FOR'1J[STRIP PAXI[MULTISORBT, Polyester coil- Pharmaceutical grade polyester coil:9GM/YARD (10cm)
Pack size HDPE Container -28‟s
Version No: R0 API Source/B No:- Sequent Scientific Limited / 12RD14/SFB/20
Period
Test
Description Water
content limit
for
information
only
Dissolution
limit: NLT
80.0% (Q) of
labeled amount
of Sofosbuvir
should dissolved
in 15 min
Gs-
686965
limit:
NMT
0.50%
Gs-
331007
limit:
NMT
0.50%
Gs-
566500
limit:
NMT
0.50%
Gs-
607669
limit:
NMT
0.50%
Gs-
60767
0 limit:
NMT
0.50%
Phenol
limit: NMT
0.50%
any
unspecified
degradation
product limit:
NMT 0.20%
total
impurities
limit NMT
0.8%
assay by
HPLC each
film coated
tablet
contains
Sofosbuvir
400mg
limit:376.00
mg to
420.00mg
(94.0% to
105.00% of
label claim)
Reference A.R
No.
Initial Yellow colored
capsule shaped bevel
edged film coated
tablets debossed with
"400" on one side and
plain on other side
1.80% 93.5-95.5% BQL BQL BQL BQL BQL BQL 0.01% 0.01% 403.6mg
(100.9%)
1080/FD/15000
06
3 M Yellow coloured
capsule shaped bevel
edged film coated
tablets debossed with
"400" on one side and
plain on other side
1.88% 90.8-93.3% BQL BQL BQL BQL BQL BQL 0.05% 0.05% 389.2mg
(97.3%)
1080/SS/15004
98
6M Yellow colored
capsule shaped bevel
1.93% 94.3-97.4% BQL BQL BQL BQL BQL BQL 0.02% 0.02% 400.0mg
(100.0%)
1080/SS/15009
85
Minutes for 253rd
Registration Board Meeting 246
edged film coated
tablets debossed with
"400" on one side and
plain on other side
product Sofosbuvir tablets 40mg batch size 5000 tablets stability condition 25⁰c±2⁰c/60% ±5%RH
batch no 2004488-007 mfg. location Strides Bangalore
mfg. date Dec-2014 mfg. for Optimization batch Orientation Not applicable
expr date Nov-2016 date of incubation 14.01.2015
Primary Packaging material:-Plastic container- [1OOCC][Round] [Screw] [White opaque HOPE container}(Extra heavy weight) induction sealing HS
130-35 liner][printed as unsealed for your Protection], Desiccant-(1g Silica gel sac:hetJIL:42.67 x w:19mrn [Tyvek Sachet][Text printed as 1'DO
NOT EAT"'[REEL FOR'1J[STRIP PAXI[MULTISORBT, Polyester coil- Pharmaceutical grade polyester coil:9GM/YARD (10cm)
Pack size HDPE Container -28‟s
Version No: R0 API Source/B No:- Sequent Scientific Limited / 12RD14/SFB/20
Period
Test
Description Water
content limit
for
information
only
Dissolution
limit: NLT
80.0% (Q) of
labeled amount
of Sofosbuvir
should dissolved
in 15 min
Gs-
686965
limit:
NMT
0.50%
Gs-
331007
limit:
NMT
0.50%
Gs-
566500
limit:
NMT
0.50%
Gs-
607669
limit:
NMT
0.50%
Gs-
60767
0 limit:
NMT
0.50%
Phenol
limit: NMT
0.50%
any
unspecified
degradation
product limit:
NMT 0.20%
total
impurities
limit NMT
0.8%
assay by
HPLC each
film coated
tablet
contains
Sofosbuvir
400mg
limit:376.00
mg to
420.00mg
(94.0% to
105.00% of
label claim)
Reference A.R
No.
Initial Yellow colored
capsule shaped bevel
edged film coated
tablets debossed with
"400" on one side and
plain on other side
2.03% 94.1-98.4% BQL 0.04% BQL BQL BQL BQL 0.02% 0.06% 399.2mg
(99.8%)
1080/FD/15000
04
3 M Yellow coloured
capsule shaped bevel
edged film coated
tablets debossed with
"400" on one side and
plain on other side
2.36% 90.2-94.0% BQL BQL BQL BQL BQL BQL 0.06% 0.06% 385.6mg
(96.4%)
1080/SS/15004
88
6M Yellow colored 2.00% 89.2-93.8% BQL BQL BQL BQL BQL BQL 0.02% 0.02% 397.2mg 1080/SS/15009
Minutes for 253rd
Registration Board Meeting 247
capsule shaped bevel
edged film coated
tablets debossed with
"400" on one side and
plain on other side
(99.3%) 76
product Sofosbuvir tablets 40mg batch size 5000 tablets stability condition 25⁰c±2⁰c/60% ±5%RH
batch no 2004488-008 mfg. location Strides Bangalore
mfg. date Dec-2014 mfg. for Optimization batch Orientation Not applicable
expr date Nov-2016 date of incubation 14.01.2015
Primary Packaging material:-Plastic container- [1OOCC][Round] [Screw] [White opaque HOPE container}(Extra heavy weight) induction sealing HS
130-35 liner][printed as unsealed for your Protection], Desiccant-(1g Silica gel sac:hetJIL:42.67 x w:19mrn [Tyvek Sachet][Text printed as 1'DO
NOT EAT"'[REEL FOR'1J[STRIP PAXI[MULTISORBT, Polyester coil- Pharmaceutical grade polyester coil:9GM/YARD (10cm)
Pack size HDPE Container -28‟s
Version No: R0 API Source/B No:- Sequent Scientific Limited / 12RD14/SFB/20
Period
Test
Description Water
content limit
for
information
only
Dissolution
limit: NLT
80.0% (Q) of
labeled amount
of Sofosbuvir
should dissolved
in 15 min
Gs-
686965
limit:
NMT
0.50%
Gs-
331007
limit:
NMT
0.50%
Gs-
566500
limit:
NMT
0.50%
Gs-
607669
limit:
NMT
0.50%
Gs-
60767
0 limit:
NMT
0.50%
Phenol
limit: NMT
0.50%
any
unspecified
degradation
product limit:
NMT 0.20%
total
impurities
limit NMT
0.8%
assay by
HPLC each
film coated
tablet
contains
Sofosbuvir
400mg
limit:376.00
mg to
420.00mg
(94.0% to
105.00% of
label claim)
Reference A.R
No.
Initial Yellow colored
capsule shaped bevel
edged film coated
tablets debossed with
"400" on one side and
plain on other side
1.96% 94.6-98.6% BQL BQL BQL BQL BQL BQL 0.03% 0.05% 400.8mg
(100.2%)
1080/FD/15000
05
3 M Yellow coloured
capsule shaped bevel
edged film coated
tablets debossed with
"400" on one side and
2.18% 92.5-94.0% BQL BQL BQL BQL BQL BQL 0.05% 0.05% 393.6mg
(98.4%)
1080/SS/15004
92
Minutes for 253rd
Registration Board Meeting 248
product Sofosbuvir tablets 40mg batch size 5000 tablets stability condition 25⁰c±2⁰c/60% ±5%RH
batch no 2004488-009 mfg. location Strides Bangalore
mfg. date Dec-2014 mfg. for Optimization batch Orientation Not applicable
expr date Nov-2016 date of incubation 14.01.2015
Primary Packaging material:-Plastic container- [1OOCC][Round] [Screw] [White opaque HOPE container}(Extra heavy weight) induction sealing HS
130-35 liner][printed as unsealed for your Protection], Desiccant-(1g Silica gel sac:hetJIL:42.67 x w:19mrn [Tyvek Sachet][Text printed as 1'DO
NOT EAT"'[REEL FOR'1J[STRIP PAXI[MULTISORBT, Polyester coil- Pharmaceutical grade polyester coil:9GM/YARD (10cm)
Pack size HDPE Container -28‟s
Version No: R0 API Source/B No:- Sequent Scientific Limited / 12RD14/SFB/20
Period
Test
Description Water
content limit
for
information
only
Dissolution
limit: NLT
80.0% (Q) of
labeled amount
of Sofosbuvir
should dissolved
in 15 min
Gs-
686965
limit:
NMT
0.50%
Gs-
331007
limit:
NMT
0.50%
Gs-
566500
limit:
NMT
0.50%
Gs-
607669
limit:
NMT
0.50%
Gs-
60767
0 limit:
NMT
0.50%
Phenol
limit: NMT
0.50%
any
unspecified
degradation
product limit:
NMT 0.20%
total
impurities
limit NMT
0.8%
assay by
HPLC each
film coated
tablet
contains
Sofosbuvir
400mg
limit:376.00
mg to
420.00mg
(94.0% to
105.00% of
label claim)
Reference A.R
No.
Initial Yellow colored
capsule shaped bevel
edged film coated
tablets debossed with
"400" on one side and
plain on other side
1.80% 93.5-95.5% BQL BQL BQL BQL BQL BQL 0.01% 0.01% 403.6mg
(100.9%)
1080/FD/15000
06
3 M Yellow coloured
capsule shaped bevel
2.02% 90.3-93.0% BQL BQL BQL BQL BQL BQL 0.05% 0.05% 395.6mg
(98.9%)
1080/SS/15004
96
plain on other side
6M Yellow colored
capsule shaped bevel
edged film coated
tablets debossed with
"400" on one side and
plain on other side
1.95% 91.2-92.6% BQL BQL BQL BQL BQL BQL 0.02% 0.02% 389.6mg
(97.4%)
1080/SS/15009
80
Minutes for 253rd
Registration Board Meeting 249
edged film coated
tablets debossed with
"400" on one side and
plain on other side
6M Yellow colored
capsule shaped bevel
edged film coated
tablets debossed with
"400" on one side and
plain on other side
2.25% 93.2-95.2% BQL BQL BQL BQL BQL BQL 0.07% 0.15% 395.2mg
(98.8%)
1080/SS/15009
83
Documents / Data provided by the applicant
(M/s Novartis Pharma, Karachi)
Sr. No. Documents to be provided Status
1. COA of API Yes
2. Approval of API by regulatory authority of country of origin or GMP
certificate of API manufacturer issued by regulatory authority of country of
origin.
Yes (copy GMP issued by
TGA is submitted)
3. Protocols followed for conduction of stability study and details of tests. Yes
4. Data of 03 batches will be supported by attested respective documents like
chromatograms, laboratory reports, data sheets etc.
Yes ( raw data is not
submitted)
5. Documents confirming import of API etc. NA
6. All provided documents will be attested (name, sign and stamp) for ensuring
authenticity of data / documents.
No
7. Commitment to continue real time stability study till assigned shelf life of the
product.
Yes
Decision: Registration Board deferred as firm has not provided legalized COPP.
Minutes for 253rd
Registration Board Meeting 250
26. M/s Ferozsons Lab Nowshera
(Harvoni tablets imported from M/s Gilead Sciences USA)
Brand Name
Composition
Pharmacological group
Manufacturer
Type of Form
Date & Diary, Fee
Demanded MRP & Pack
size
Manufactured by Remarks
Harvoni Tablets
Each film coated tablets
contains:
Sofosbuvir…..400mg
Ledipasvir…..90mg
Antiviral
Form-5A
Dy No 90, dated 30-07-15
50000/-
43095/- per 28‟s bottle
Manufactured by:
M/s Patheon Inc., 2100
Syntex Court, Mississauga,
Ontario, L5N 7K9, Canada.
Repacked and batch release
by:
M/s Gilead Sciences
Limited, IDA Business &
Technology Park,
Carrigtohill, County Cork,
Ireland.
Product license holder:
M/s Gilead Sciences inc. 333
Lakeside Drive, Foster City,
CA, 94404, USA.
M/s Gilead Sciences
submitted that they have
proposed registration of
alternative trade dress (white
colored) of Harvoni. This
will safeguard the diversion
of Harvoni Tablets intended
for Pakistan to higher
income countries. Harvoni
tablets sold to higher income
countries are orange colored
and alternative trade dress
proposed for Pakistan is
white.
The USFDA COPP
submitted by the firm states
that the product is licensed
in USA but not actually in
market. The justification of
the firm in this regard is
mentioned above.
Minutes for 253rd
Registration Board Meeting 251
Drug (Ledipasvir/ Sofosbuvir 90/400mg tablets)
Source Sofosbuvir: ST Pharm Gyeonggi, South Korae
Ledipasvir: Yuhan Chemicals, South Korea
Storage Condition Accelerated: 40 C and 75% RH
Real Time: 30 C and 75% RH
Time Period 6 months and 6months (White colored tablets)
6 months and 24 months (Orange colored
tablets)
Frequency 0,3,6, (white colored tablets)
0,3,6,9,12,24 months (Orange colored tablets)
Batch Size One batch of 65 Kg ( white colored)
Five batches of 120 Kg ( orange colored)
No. of Batches 6
Sample Size Nil
Meeting 252
Remarks M/s Gileads Science submitted that white
tablets differ from orange tablets only in color
of film coating while maintaining the same
quantitative composition of tablet core, hence
stability data generated on orange tablets are
representative and suitable to support the
storage condition and shelf life.
Sofosbuvir 400 mg/Ledipasvir 90 mg Tablets - Lot DK1307B1
Mfg Site: Patheon, TRO (Mississauga, Ontario, Canada) Batch Size: 66 kg
Mfg Date: October 2013 Fill Quantity: 28 tablets per bottle
Minutes for 253rd
Registration Board Meeting 252
Timepoint
T=0
3 Mo
6 Mo
Appearance
Conf
Conf
Conf
Water Content
2.4
2.2
2.3
Strength (SOF)
99.6
99.2
97.9
Total Deg. (SOF)
0.0
0.0
0.0
Strength (LDV)
99.4
99.5
98.6
Total Deg. (LDV)
0.1
0.1
0.1
Disso (SOF) mean at 30 min
97
97
98
Disso (LDV) mean at 30 min
95
95
96
Fill/Pkg Site: Patheon, TRO (Mississauga, Ontario, Canada)
Fill/Pkg Date: October 2013
Study Init. Date:
Study Duration:
Dec 10, 2013
60 Months
API Lot/Mfg:
Filler:
Desiccant:
Cap: Bottle:
Sofosbuvir, GS-7977(7)6-12002, GS-7977(7)-6-12004, and GS-7977(7)-6-12005 ( ST Pharm, Gyeonggi-do, South Korea)
Ledipasvir solid dispersion, lot 19WG06-50.HE00001 (Hovione, Ireland), sources from GS-5885-03 drug substance, lot PP-1015-
2001 ( Yuhan Chemicals, Inc., Ansan-Shi, Kyuonggi-do, South Korea)
RM-1071, Polyester fiber (coil), 9 gram/yard (Carolina Absorbent Cotton Co.)
RM-11490, 1 gram, Canister with Silica Gel, Labeled (Without Patent No.) (Süd Chemie)
RM-1460, Child Resistant, Polypropylene 38-400 Finish, White, Tekni-Plex HS 130 Innerseal (unprinted), pictorial (Van
Blarcom) RM-1686, 100 mL, White, 38-400 Finish, HDPE, Gilead Debossing, “.050” min. wall (Drug Plastics)
Condition: 30 °C/75% RH Test
Minutes for 253rd
Registration Board Meeting 253
Timepoint
T=0
3 Mo
6 Mo
LD
V
Total Deg. (LDV)
0.1
0.1
0.1
Unspecified LDV related deg
Conf
Conf
Conf
GS-459666
0.14
0.14
0.15
SO
F
Total Deg. (SOF)
0.0
0.0
0.0
Unspecified SOF related deg
Conf
Conf
Conf
GS-606965
GS-331007
GS-566500
GS-607669
GS-607670
Phenol
Condition: 30 °C/75% RH
Test
Sofosbuvir 400 mg/Ledipasvir 90 mg Tablets - Lot DK1307B1
Mfg Site: Patheon, TRO (Mississauga, Ontario, Canada) Batch Size: 66 kg
Mfg Date: October 2013 Fill Quantity: 28 tablets per bottle
Fill/Pkg Site: Patheon, TRO (Mississauga, Ontario, Canada)
Fill/Pkg Date: October 2013
Study Init. Date:
Study Duration:
Dec 10, 2013
6 Months
API Lot/Mfg:
Minutes for 253rd
Registration Board Meeting 254
Timepoint
T=0
1 Mo
3 Mo
6 Mo
Appearance
Conf
Conf
Conf
Conf
Water Content
2.4
2.2
2.1
2.4
Strength (SOF)
99.6
99.9
99.3
98.4
Total Deg. (SOF)
0.0
0.0
0.0
0.0
Strength (LDV)
99.4
100.8
99.4
98.9
Total Deg. (LDV)
0.1
0.2
0.1
0.2
Disso (SOF) mean at 30 min
97
99
98
98
Disso (LDV) mean at 30 min
95
96
96
97
Filler:
Desiccant:
Cap: Bottle:
Sofosbuvir, GS-7977(7)6-12002, GS-7977(7)-6-12004, and GS-7977(7)-6-12005 ( ST Pharm, Gyeonggi-do, South Korea)
Ledipasvir solid dispersion, lot 19WG06-50.HE00001 (Hovione, Ireland), sources from GS-5885-03 drug substance, lot PP-1015-
2001 ( Yuhan Chemicals, Inc., Ansan-Shi, Kyuonggi-do, South Korea)
RM-1071, Polyester fiber (coil), 9 gram/yard (Carolina Absorbent Cotton Co.)
RM-11490, 1 gram, Canister with Silica Gel, Labeled (Without Patent No.) (Süd Chemie)
RM-1460, Child Resistant, Polypropylene 38-400 Finish, White, Tekni-Plex HS 130 Innerseal (unprinted), pictorial (Van
Blarcom) RM-1686, 100 mL, White, 38-400 Finish, HDPE, Gilead Debossing, “.050” min. wall (Drug Plastics)
Condition: 40 °C/75% RH Test
Minutes for 253rd
Registration Board Meeting 255
Timepoint
T=0
1 Mo
3 Mo
6 Mo
LD
V
Total Deg. (LDV)
0.1
0.2
0.1
0.2
Unspecified LDV related deg
Conf
Conf
Conf
Conf
GS-459666
0.14
0.15
0.14
0.15
SO
F
Total Deg. (SOF)
0.0
0.0
0.0
0.0
Unspecified SOF related deg
Conf
Conf
Conf
Conf
GS-606965
GS-331007
GS-566500
GS-607669
GS-607670
trace
Phenol
Condition: 40 °C/75% RH
Test
Decision: Mr.Baqar Hasan, Director presented the data. Registration Board observed that
the registration application was according to Form-5A and stability data provided by the
firm was in accordance with the recommendations of the board finalized in 251st meeting.
Therefore, Board granted approval of registration of Sofosbuvir 400/ Ledipasvir 90 mg
tablets to the firm.
Minutes for 253rd
Registration Board Meeting 256
b. Other molecules / formulations:
27. M/s Brookes Pharma, Karachi
Drug Tomex (Dexmedetomidine) Injection 2 ml
Storage Condition Accelerated: 40 C and 75% RH
Real Time: 30 C and 65% RH
Time Period Accelerated: 6 months
Frequency 0, 1,2, 3, 4,5, 6 months
Batch Size 10 L
No. of Batches 1
Sample Size 39 ampoules
Meeting Deferred in 245th meeting of Registration Board for
stability data as per WHO/ICH guidelines
Accelerated: 40 0 C+2
0C, RH 75+ 5 %
Batch
No.
Period Appearanc
e
(Liquid)
Color
(Colorless
)
Clarity pH
(4.5 – 7.0)
Assay of
Dexmedeto
midine
Related
Substances
(Known: NMT 0.1
%)
(unknown; NMT
0.1 %)
Enantiomeric
Impurity
NMT : 1.0 %
Bacterial
Endotoxin
Test
NMT (79.04
EU/ml )
Sterility Test
(Passes test)
FD/
C1410
Initial Complies Complies Clear 5.85 99.16 % 0.0064% Complies Less than
79.04EU/ml Passes test
FD/
C1410
1st
months
Complies Complies Clear 6.68 97.18 % Not Detected Complies
- -
Minutes for 253rd
Registration Board Meeting 257
FD/
C1410
2nd
Months
Complies Complies Clear 5.93 97.73 Not Detected
Complies
- -
FD/
C1410
3rd
Months
Complies Complies
Clear
6.20 99.12 Not Detected
Complies
- -
FD/
C1410
6th
Months
Complies
Complies
Clear
5.86 95.50 Not Detected
Complies
Less than
79.04EU/ml
Passes test
Real Time: 30 C and 65% RH
Batch
No.
Period Appearanc
e
(Liquid)
Color
(Colorless)
Clarity pH
(4.5 – 7.0)
Assay of
Dexmedeto
midine
Related
Substances
(Known: NMT 0.1
%)
(unknown; NMT
0.1 %)
Enantiomeri
c
Impurity
NMT : 1.0
%
Bacterial
Endotoxin
Test
NMT (79.04
EU/ml )
Sterility Test
(Passes test)
FD/
C1410
Initial Complies Complies Clear 5.85 99.16 % 0.0064% Complies Less than
79.04EU/ml Passes test
FD/
C1410
1st
months
Complies Complies Clear 6.64 97.84 % Not Detected Complies
- -
FD/
C1410
2nd
Months
Complies Complies Clear 5.05 97.80 Not Detected
Complies
- -
Minutes for 253rd
Registration Board Meeting 258
FD/
C1410
3rd
Months
Complies Complies
Clear
6.42 98.35 Not Detected
Complies
- -
FD/
C1410
6th
Months
Complies
Complies
Clear
5.83 94.48 Not Detected
Complies
Less than
79.04EU/ml
Passes test
Cis-Curon Injection (Cis-AtracuriumBesylate) 5 ml
Storage Condition Accelerated: 25 C and 60% RH
Real Time: 2-8 C
Time Period 6 months
Frequency 0, 1,2, 3, 6 months
Batch Size 10 L
No. of Batches 1
Sample Size 29 ampoules
Meeting Deferred in 245th meeting of Registration Board
Accelerated: 25 C and 60% RH
Batch No. Period
Physical
Characteristics
(Colorless to
slighty yellow
or greenish
yellow clear
Clarity Identification
Assay of
Cis-
Atricurium
(as
besylate)
(90-115%)
pH
(3.25-
3.65)
Bacterial
Endotoxin
Test
NMT (79.04
EU/ml )
Sterility Test
(Passes test)
Minutes for 253rd
Registration Board Meeting 259
solution )
FD/E1420 Initial Complies Complies Complies 110.02% 3.35
Less than
79.04EU/ml Passes test
FD/E1420 1st Month Complies Complies Complies 105.75% 3.45 - -
FD/E1420 2nd Month Complies Complies Complies 100.75% 3.5 - -
FD/E1420 3rd Month Complies Complies Complies 99.44% 3.54 - -
FD/E1420 6th Month Complies Complies Complies 92.50% 3.61
Less than
79.04EU/ml
Passes test
Significant change noticed in assay of product
Real Time: 2-8 C
FD/E1420 2- 8°C Initial Complies Complies Complies 110.02% 3.35
Less than
79.04EU/ml Passes test
FD/E1420 2- 8°C
1st
Month Complies Complies Complies 108.32% 3.43 - -
FD/E1420 2- 8°C
2nd
Month Complies Complies Complies 109.40% 3.48 - -
FD/E1420 2- 8°C
3rd
Month Complies Complies Complies 106.77% 3.52 - -
FD/E1420 2- 8°C
6th
Month Complies Complies Complies 107.34% 3.55
Less than
79.04EU/ml
Passes test
Minutes for 253rd
Registration Board Meeting 260
Documents / Data provided by the applicant
(M/s Brookes Pharma, Karachi)
Sr. No. Documents to be provided Status
1. COA of API Yes
2. Approval of API by regulatory authority of country of origin or GMP
certificate of API manufacturer issued by regulatory authority of country of
origin.
No
3. Protocols followed for conduction of stability study and details of tests. Yes
4. Data of 03 batches will be supported by attested respective documents like
chromatograms, laboratory reports, data sheets etc.
No. Documents for one
batch of each product
provided
5. Documents confirming import of API etc. Yes
6. All provided documents will be attested (name, sign and stamp) for ensuring
authenticity of data / documents.
Yes
7. Commitment to continue real time stability study till assigned shelf life of the
product.
Yes
Decision: Dr.Arif Siddique, Director presented the data with Registration Board. It was observed that the stability data provided
by the firm is not in accorndace with the guidelines approved by the Board in 251st meeting. Therefore, case was deferred till the
applicant completes the requisite information in respect of stability studies.
Minutes for 253rd
Registration Board Meeting 261
28. M/s Global Pharmaceutical, Islamabad
Drug Dlanz Capsule 30 mg
Dlanz Capsule 60 mg
Storage Condition Accelerated: 40 C and 75% RH
Real Time: 30 C and 65% RH
Time Period 12 months and 20 months
Frequency 0,3,6,9,12,20 months
Batch Size 10000 Caps
No. of Batches 03
Sample Size 50 packs per batch
Meeting Registration Board approved the products.
However, the Board advised concerned P E & R
Division and Incharge, PEC to evaluate submitted
stability studies of Zone IVA of Dexlansoprazole
30 & 60mg Capsule. Registration Board authorized
its Chairman for subsequent approval for issuance
of registration letter.
(246 meeting of registration board)
Remarks Assay conducted on spectrophotometer
Minutes for 253rd
Registration Board Meeting 262
Stability Study Data Sheet
1.0 Product Detail:
Product Name /Generic
Name / Dosage Form D-LANZ 30mg (Dexlansoprazole) Batch No B#T-023
Description of Pack
(Container closure
System)
Almost White Spherical DDR Pellets 17% filled “EHG Capsule”
size
„4‟ with Cap Green & body Yellow, Blister In Alu-Alu Aluminum
Foil, 7‟s Packed in Printed Unit Carton along with leaflet.
Batch Size 10000 Caps
Parameter and tests
Mentioned As Per in house specification Mfg.Date Aug-2013
Recommended storage
Condition
Accelerated conditions (Accelerated Stability)
40°±2°C, and 75% ±5% RH (Accelerated Stability) Exp Date July 2015
Date of Completion
& implementation 12/02/2015 API lot NO DLP0113
Stability No 15/R & D /135
Approval by:
QC Manager…………………………………………………..
QA Manager…………………………………………………..
Production Manager………………………………………
R & D Manager………………………………………………
Sample taken for physical test = 100 Capsules
Sample taken for Chemical test = 100 Capsules
Sample taken for Microbiological Test = N/A
Extra Sample (if Needed) = N/A
Total Sample Size 200x3 = 600 Capsules
Minutes for 253rd
Registration Board Meeting 263
Assessment Frequency (Month) Initial (0) 1 2 3 4 6 9 11 20
Date of Testing 10/08/2013 10/11/2013 10/02/2014 10/05/2014
Mode of Testing (F = Full, P= Partial testing) F P F P F F
Tests (Physical, Chemical Microbiological)
Acceptance Criteria
Storage Condition
(Acce)
Appearance
White Spherical Pellets filled in EHG Capsule Size 4
40°±2°C, 75% RH ±5% RH
Complies Complies Complies
Dissolution
0.1 N HCL After 2 hours NMT 10%
3.50% 2.90% 2.90%
Buffer pH7.0
After 1 hours NMT 10% After 3 hours NMT 10%
40°±2°C, 75% RH ±5% RH
49.0% 96.9 %
51.7% 92.8 %
47.1% 92.3 %
Identification Positive
40°±2°C, 75% RH ±5% RH
Positive Positive Positive
Assay of Dexlansprazole
90.0-110.0%
40°±2°C, 75% RH ±5% RH
106.32% 105.02% 100.00%
Analyst signature (after completion of every time line)
Conclusion by QA (after completion of the study)
Minutes for 253rd
Registration Board Meeting 264
Stability Study Data Sheet
1.0 Product Detail:
Product Name /Generic
Name / Dosage Form D-LANZ 30mg (Dexlansoprazole) Batch No B#T-024
Description of Pack
(Container closure
System)
Almost White Spherical DDR Pellets 17% filled “EHG Capsule”
size
„4‟ with Cap Green & body Yellow, Blister In Alu-Alu Aluminum
Foil, 7‟s Packed in Printed Unit Carton along with leaflet.
Batch Size 10000 Caps
Parameter and tests
Mentioned As Per in house specification Mfg.Date Aug-2013
Recommended storage
Condition
Accelerated conditions (Accelerated Stability)
40°±2°C, and 75% ±5% RH (Accelerated Stability) Exp Date July 2015
Date of Completion
& implementation 15/02/2015 API Lot No DLP0113
Stability No 15/R & D /135
Approval by:
QC Manager…………………………………………………..
QA Manager…………………………………………………..
Production Manager………………………………………
R & D Manager………………………………………………
Sample taken for physical test = 100 Capsules
Sample taken for Chemical test = 100 Capsules
Sample taken for Microbiological Test = N/A
Extra Sample (if Needed) = N/A
Total Sample Size 200x3 = 600 Capsules
Minutes for 253rd
Registration Board Meeting 265
Assessment Frequency (Month) Initial (0) 1 2 3 4 6 9 11 20
Date of Testing 10/08/2013 10/11/2013 10/02/2014 10/05/2014
Mode of Testing (F = Full, P= Partial testing) F P F P F F
Tests (Physical, Chemical Microbiological)
Acceptance Criteria
Storage Condition
(Acce)
Appearance
White Spherical Pellets filled in EHG Capsule Size 4
40°±2°C, 75% RH ±5% RH
Complies Complies Complies
Dissolution
0.1 N HCL After 2 hours NMT 10%
4.39% 2.43% 3.50%
Buffer pH7.0
After 1 hours NMT 10% After 3 hours NMT 10%
40°±2°C, 75% RH ±5% RH
48.7% 91.4 %
52.2% 94.7%
48.0%
90.20%
Identification Positive
40°±2°C, 75% RH ±5% RH
Positive Positive Positive
Assay of Dexlansprazole
90.0-110.0%
40°±2°C, 75% RH ±5% RH
105.56% 104.52% 102.27%
Analyst signature (after completion of every time line)
Conclusion by QA (after completion of the study)
Minutes for 253rd
Registration Board Meeting 266
Stability Study Data Sheet
1.0 Product Detail:
Product Name /Generic
Name / Dosage Form D-LANZ 30mg (Dexlansoprazole) Batch No B#T-0771
Description of Pack
(Container closure
System)
Almost White Spherical DDR Pellets 17% filled “EHG Capsule”
size
„4‟ with Cap Green & body Yellow, Blister In Alu-Alu Aluminum
Foil, 7‟s Packed in Printed Unit Carton along with leaflet.
Batch Size 10000 Caps
Parameter and tests
Mentioned As Per in house specification Mfg.Date Aug-2013
Recommended storage
Condition
Accelerated conditions (Accelerated Stability)
40°±2°C, and 75% ±5% RH (Accelerated Stability) Exp Date July 2015
Date of Completion
& implementation 15/02/2015 API Lot No DLP0113
Stability No 15/R & D /135
Approval by:
QC Manager…………………………………………………..
QA Manager…………………………………………………..
Production Manager………………………………………
R & D Manager………………………………………………
Sample taken for physical test = 100 Capsules
Sample taken for Chemical test = 100 Capsules
Sample taken for Microbiological Test = N/A
Extra Sample (if Needed) = N/A
Total Sample Size 200x3 = 600 Capsules
Minutes for 253rd
Registration Board Meeting 267
Assessment Frequency (Month) Initial (0) 1 2 3 4 6 9 11 20
Date of Testing 10/08/2013 10/11/2013 10/02/2014 10/05/2014
Mode of Testing (F = Full, P= Partial testing) F P F P F F
Tests (Physical, Chemical Microbiological)
Acceptance Criteria
Storage Condition
(Acce)
Appearance
White Spherical Pellets filled in EHG Capsule Size 4
40°±2°C, 75% RH ±5% RH
Complies Complies Complies
Dissolution
0.1 N HCL After 2 hours NMT 10% 2.7% 2.0% 2.9%
Buffer pH7.0
After 1 hours NMT 10% After 3 hours NMT 10%
40°±2°C, 75% RH ±5% RH
51.4% 96.3%
49.0% 92.4%
50.0% 90.3%
Identification Positive
40°±2°C, 75% RH ±5% RH
Positive Positive Positive
Assay of Dexlansprazole
90.0-110.0%
40°±2°C, 75% RH ±5% RH
105.31% 103.6% 102.2%
Analyst signature (after completion of every time line)
Conclusion by QA (after completion of the study)
Minutes for 253rd
Registration Board Meeting 268
Stability Study Data Sheet
1.0 Product Detail:
Product Name /Generic
Name / Dosage Form D-LANZ 60mg (Dexlansoprazole) Batch No B#T-017
Description of Pack
(Container closure
System)
Almost White Spherical DDR Pellets 17% filled “EHG Capsule”
size
„1‟ with Cap Green & body Yellow, Blister In Alu-Alu Aluminum
Foil, 7‟s Packed in Printed Unit Carton along with leaflet.
Batch Size 10000 Caps
Parameter and tests
Mentioned As Per in house specification Mfg.Date Aug-2013
Recommended storage
Condition
Accelerated conditions (Accelerated Stability)
40°±2°C, and 75% ±5% RH (Accelerated Stability) Exp Date July 2015
Date of Completion
& implementation 10/05/2015 API Lot No DLP0113
Stability No 15/R & D /135
Approval by:
QC Manager…………………………………………………..
QA Manager…………………………………………………..
Production Manager………………………………………
R & D Manager………………………………………………
Sample taken for physical test = 100 Capsules
Sample taken for Chemical test = 100 Capsules
Sample taken for Microbiological Test = N/A
Extra Sample (if Needed) = N/A
Total Sample Size 200x3 = 600 Capsules
Minutes for 253rd
Registration Board Meeting 269
Assessment Frequency (Month) Initial (0) 1 2 3 4 6 9 11 20
Date of Testing 10/08/2013 10/11/2013 10/02/2014 10/05/2014
Mode of Testing (F = Full, P= Partial testing) F P F P F F
Tests (Physical, Chemical Microbiological)
Acceptance Criteria
Storage Condition
(Acce)
Appearance
White Spherical Pellets filled in EHG Capsule Size 4
40°±2°C, 75% RH ±5% RH
Complies Complies Complies
Dissolution
0.1 N HCL After 2 hours NMT 10% 2.7% 2.0% 2.9%
Buffer pH7.0
After 1 hours NMT 10% After 3 hours NMT 10%
40°±2°C, 75% RH ±5% RH
51.4% 96.3%
49.0% 92.4%
50.0% 90.3%
Identification Positive
40°±2°C, 75% RH ±5% RH
Positive Positive Positive
Assay of Dexlansprazole
90.0-110.0%
40°±2°C, 75% RH ±5% RH
105.08% 104.84% 103.6%
Analyst signature (after completion of every time line)
Conclusion by QA (after completion of the study)
Minutes for 253rd
Registration Board Meeting 270
Stability Study Data Sheet
1.0 Product Detail:
Product Name /Generic
Name / Dosage Form D-LANZ 60mg (Dexlansoprazole) Batch No B#T-018
Description of Pack
(Container closure
System)
Almost White Spherical DDR Pellets 17% filled “EHG Capsule”
size
„1‟ with Cap Green & body Yellow, Blister In Alu-Alu Aluminum
Foil, 7‟s Packed in Printed Unit Carton along with leaflet.
Batch Size 10000 Caps
Parameter and tests
Mentioned As Per in house specification Mfg.Date Aug-2013
Recommended storage
Condition
Accelerated conditions (Accelerated Stability)
40°±2°C, and 75% ±5% RH (Accelerated Stability) Exp Date July 2015
Date of Completion
& implementation 10/05/2015 API Lot No DLP0113
Stability No 15/R & D /135
Approval by:
QC Manager…………………………………………………..
QA Manager…………………………………………………..
Production Manager………………………………………
R & D Manager………………………………………………
Sample taken for physical test = 100 Capsules
Sample taken for Chemical test = 100 Capsules
Sample taken for Microbiological Test = N/A
Extra Sample (if Needed) = N/A
Total Sample Size 200x3 = 600 Capsules
Minutes for 253rd
Registration Board Meeting 271
Assessment Frequency (Month) Initial (0) 1 2 3 4 6 9 11 20
Date of Testing 10/08/2013 10/11/2013 10/02/2014 10/05/2014
Mode of Testing (F = Full, P= Partial testing) F P F P F F
Tests (Physical, Chemical Microbiological)
Acceptance Criteria
Storage Condition
(Acce)
Appearance
White Spherical Pellets filled in EHG Capsule Size 4
40°±2°C, 75% RH ±5% RH
Complies Complies Complies
Dissolution
0.1 N HCL After 2 hours NMT 10% 3.5% 2.9% 2.9%
Buffer pH7.0
After 1 hours NMT 10% After 3 hours NMT 10%
40°±2°C, 75% RH ±5% RH
49.0% 96.9%
51.7% 92.8%
47.1% 92.3%
Identification Positive
40°±2°C, 75% RH ±5% RH
Positive Positive Positive
Assy of Dexlansprazole
90.0-110.0%
40°±2°C, 75% RH ±5% RH
105.34% 106.88% 101.02%
Analyst signature (after completion of every time line)
Conclusion by QA (after completion of the study)
Minutes for 253rd
Registration Board Meeting 272
Stability Study Data Sheet
1.0 Product Detail:
Product Name /Generic
Name / Dosage Form D-LANZ 60mg (Dexlansoprazole) Batch No B#T-019
Description of Pack
(Container closure
System)
Almost White Spherical DDR Pellets 17% filled “EHG Capsule”
size
„1‟ with Cap Green & body Yellow, Blister In Alu-Alu Aluminum
Foil, 7‟s Packed in Printed Unit Carton along with leaflet.
Batch Size 10000 Caps
Parameter and tests
Mentioned As Per in house specification Mfg.Date Aug-2013
Recommended storage
Condition
Accelerated conditions (Accelerated Stability)
40°±2°C, and 75% ±5% RH (Accelerated Stability) Exp Date July 2015
Date of Completion
& implementation 10/05/2015 API Lot No DLP0113
Stability No 15/R & D /135
Approval by:
QC Manager…………………………………………………..
QA Manager…………………………………………………..
Production Manager………………………………………
R & D Manager………………………………………………
Sample taken for physical test = 100 Capsules
Sample taken for Chemical test = 100 Capsules
Sample taken for Microbiological Test = N/A
Extra Sample (if Needed) = N/A
Total Sample Size 200x3 = 600 Capsules
Minutes for 253rd
Registration Board Meeting 273
Assessment Frequency (Month) Initial (0) 1 2 3 4 6 9 11 20
Date of Testing 10/08/2013 10/11/2013 10/02/2014 10/05/2014
Mode of Testing (F = Full, P= Partial testing) F P F P F F
Tests (Physical, Chemical Microbiological)
Acceptance Criteria
Storage Condition
(Acce)
Appearance
White Spherical Pellets filled in EHG Capsule Size 4
40°±2°C, 75% RH ±5% RH
Complies Complies Complies
Dissolution
0.1 N HCL After 2 hours NMT 10% 4.39% 2.43% 3.50%
Buffer pH7.0
After 1 hours NMT 10% After 3 hours NMT 10%
40°±2°C, 75% RH ±5% RH
48.7% 91.4%
52.2% 94.7%
48.0%
90.20%
Identification Positive
40°±2°C, 75% RH ±5% RH
Positive Positive Positive
Assay of Dexlansprazole
90.0-110.0%
40°±2°C, 75% RH ±5% RH
105.59% 104.84% 102.04%
Analyst signature (after completion of every time line)
Conclusion by QA (after completion of the study)
Minutes for 253rd
Registration Board Meeting 274
Stability Study Data Sheet
1.0 Product Detail:
Product Name /Generic
Name / Dosage Form D-LANZ 30mg (Dexlansoprazole) Batch No B#T-0771
Description of Pack
(Container closure
System)
Almost White Spherical DDR Pellets 17% filled “EHG Capsule”
size
„4‟ with Cap Green & body Yellow, Blister In Alu-Alu Aluminum
Foil, 7‟s Packed in Printed Unit Carton along with leaflet.
Batch Size 10000 Caps
Parameter and tests
Mentioned As Per in house specification Mfg.Date Aug-2013
Recommended storage
Condition
Long Term conditions (Long Term Stability)
30°±2°C, and 65% ±5% RH (Long Term Stability) Exp Date July 2015
Date of Completion
& implementation 15/02/2015 API Lot No DLP0113
Stability No 15/R & D /135
Approval by:
QC Manager…………………………………………………..
QA Manager…………………………………………………..
Production Manager………………………………………
R & D Manager………………………………………………
Sample taken for physical test = 100 Capsules
Sample taken for Chemical test = 100 Capsules
Sample taken for Microbiological Test = N/A
Extra Sample (if Needed) = N/A
Total Sample Size 200x6 = 1200 Capsules
Minutes for 253rd
Registration Board Meeting 275
Assessment Frequency (Month) Initial (0) 1 2 3 4 6 9 12 24
Date of Testing 10/08/2013 10/11/2013
10/02/2014 10/05/2014 10/08/2014 10/08/2015
Mode of Testing (F = Full, P= Partial testing) F P F P
F F F F
Tests (Physical, Chemical Microbiological)
Acceptance Criteria
Storage Condition
(Long)
Appearance
White Spherical Pellets filled in EHG Capsule Size 4
30°±2°C, 65% RH ±5% RH
Complies Complies Complies Complies Complies Complies
Dissolution
0.1 N HCL After 2 hours NMT 10%
2.9% 2.3% 3.1% 3.5% 2.9% 2.9%
Buffer pH7.0
After 1 hours NMT 10% After 3 hours NMT 10%
30°±2°C, 65% RH ±5% RH
51.6% 96.6%
49.4% 92.1%
50.3% 90.6%
50.8% 90.9%
46.4% 93.9%
47.6% 91.5%
Identification Positive
30°±2°C, 65% RH ±5% RH
Positive Positive Positive Positive Positive Positive
Assay of Dexlansprazole
90.0-110.0%
30°±2°C, 65% RH ±5% RH
104.38% 105.86% 105.14% 105.14% 105.14% 105.14%
Analyst signature (after completion of every time line)
Conclusion by QA (after completion of the study)
Minutes for 253rd
Registration Board Meeting 276
Stability Study Data Sheet
1.0 Product Detail:
Product Name /Generic
Name / Dosage Form D-LANZ 30mg (Dexlansoprazole) Batch No B#T-023
Description of Pack
(Container closure
System)
Almost White Spherical DDR Pellets 17% filled “EHG Capsule”
size
„4‟ with Cap Green & body Yellow, Blister In Alu-Alu Aluminum
Foil, 7‟s Packed in Printed Unit Carton along with leaflet.
Batch Size 10000 Caps
Parameter and tests
Mentioned As Per in house specification Mfg.Date Aug-2013
Recommended storage
Condition
Long Term conditions (Long Term Stability)
30°±2°C, and 65% ±5% RH (Long Term Stability) Exp Date July 2015
Date of Completion
& implementation 12/02/2015 API Lot No DLP0113
Stability No 15/R & D /135
Approval by:
QC Manager…………………………………………………..
QA Manager…………………………………………………..
Production Manager………………………………………
R & D Manager………………………………………………
Sample taken for physical test = 100 Capsules
Sample taken for Chemical test = 100 Capsules
Sample taken for Microbiological Test = N/A
Extra Sample (if Needed) = N/A
Total Sample Size 200x6 = 1200 Capsules
Minutes for 253rd
Registration Board Meeting 277
Assessment Frequency (Month) Initial (0) 1 2 3 4 6 9 12 24
Date of Testing 10/08/2013 10/11/2013
10/02/2014 10/05/2014 10/08/2014 10/08/2015
Mode of Testing (F = Full, P= Partial testing) F P F P
F F F F
Tests (Physical, Chemical Microbiological)
Acceptance Criteria
Storage Condition
(Long)
Appearance
White Spherical Pellets filled in EHG Capsule Size 4
30°±2°C, 65% RH ±5% RH
Complies Complies Complies Complies Complies Complies
Dissolution
0.1 N HCL After 2 hours NMT 10%
3.59% 3.01% 2.85% 4.5% 2.9% 2.9%
Buffer pH7.0
After 1 hours NMT 10% After 3 hours NMT 10%
30°±2°C, 65% RH ±5% RH
49.3% 96.7%
51.2% 92.6%
46.9% 92.1%
52.5% 91.2%
51.5% 91.4%
47.6% 91.5%
Identification Positive
30°±2°C, 65% RH ±5% RH
Positive Positive Positive Positive Positive Positive
Assay of Dexlansprazole
90.0-110.0%
30°±2°C, 65% RH ±5% RH
106.77% 106.88% 105.14% 104.88% 102.59% 100.77%
Analyst signature (after completion of every time line)
Conclusion by QA (after completion of the study)
Minutes for 253rd
Registration Board Meeting 278
Stability Study Data Sheet
1.0 Product Detail:
Product Name /Generic
Name / Dosage Form D-LANZ 30mg (Dexlansoprazole) Batch No B#T-024
Description of Pack
(Container closure
System)
Almost White Spherical DDR Pellets 17% filled “EHG Capsule”
size
„4‟ with Cap Green & body Yellow, Blister In Alu-Alu Aluminum
Foil, 7‟s Packed in Printed Unit Carton along with leaflet.
Batch Size 10000 Caps
Parameter and tests
Mentioned As Per in house specification Mfg.Date Aug-2013
Recommended storage
Condition
Long Term conditions (Long Term Stability)
30°±2°C, and 65% ±5% RH (Long Term Stability) Exp Date July 2015
Date of Completion
& implementation 15/02/2015 API Lot No DLP0113
Stability No 15/R & D /135
Approval by:
QC Manager…………………………………………………..
QA Manager…………………………………………………..
Production Manager………………………………………
R & D Manager………………………………………………
Sample taken for physical test = 100 Capsules
Sample taken for Chemical test = 100 Capsules
Sample taken for Microbiological Test = N/A
Extra Sample (if Needed) = N/A
Total Sample Size 200x6 = 1200 Capsules
Minutes for 253rd
Registration Board Meeting 279
Assessment Frequency (Month) Initial (0) 1 2 3 4 6 9 12 24
Date of Testing 10/08/2013 10/11/2013
10/02/2014 10/05/2014 10/08/2014 10/08/2015
Mode of Testing (F = Full, P= Partial testing) F P F P
F F F F
Tests (Physical, Chemical Microbiological)
Acceptance Criteria
Storage Condition
(Long)
Appearance
White Spherical Pellets filled in EHG Capsule Size 4
30°±2°C, 65% RH ±5% RH
Complies Complies Complies Complies Complies Complies
Dissolution
0.1 N HCL After 2 hours NMT 10%
4.41% 2.33% 3.80% 3.4% 3.4% 2.0%
Buffer pH7.0
After 1 hours NMT 10% After 3 hours NMT 10%
30°±2°C, 65% RH ±5% RH
48.5% 91.36%
51.18% 94.5%
48.3%
90.37% 52.8% 91.8%
51.1% 94.31.%
49.9% 93.8%
Identification Positive
30°±2°C, 65% RH ±5% RH
Positive Positive Positive Positive Positive Positive
Assay of Dexlansprazole
90.0-110.0%
30°±2°C, 65% RH ±5% RH
106.70% 106.123% 104.63% 105.45% 104.65% 103.86%
Analyst signature (after completion of every time line)
Conclusion by QA (after completion of the study)
Minutes for 253rd
Registration Board Meeting 280
Stability Study Data Sheet
1.0 Product Detail:
Product Name /Generic
Name / Dosage Form D-LANZ 60mg (Dexlansoprazole) Batch No B#T-017
Description of Pack
(Container closure
System)
Almost White Spherical DDR Pellets 17% filled “EHG Capsule”
size
„1‟ with Cap Green & body Yellow, Blister In Alu-Alu Aluminum
Foil, 7‟s Packed in Printed Unit Carton along with leaflet.
Batch Size 10000 Caps
Parameter and tests
Mentioned As Per in house specification Mfg.Date Aug-2013
Recommended storage
Condition
Long Term conditions (Long Term Stability)
30°±2°C, and 65% ±5% RH (Long Term Stability) Exp Date July 2015
Date of Completion
& implementation 10/08/2015 API Lot No DLP0113
Stability No 15/R & D /135
Approval by:
QC Manager…………………………………………………..
QA Manager…………………………………………………..
Production Manager………………………………………
R & D Manager………………………………………………
Sample taken for physical test = 100 Capsules
Sample taken for Chemical test = 100 Capsules
Sample taken for Microbiological Test = N/A
Extra Sample (if Needed) = N/A
Total Sample Size 200x6 = 1200 Capsules
Minutes for 253rd
Registration Board Meeting 281
Assessment Frequency (Month) Initial (0) 1 2 3 4 6 9 12 24
Date of Testing 10/08/2013 10/11/2013
10/02/2014 10/05/2014 10/08/2014 10/08/2015
Mode of Testing (F = Full, P= Partial testing) F P F P
F F F F
Tests (Physical, Chemical Microbiological)
Acceptance Criteria
Storage Condition
(Long)
Appearance
White Spherical Pellets filled in EHG Capsule Size 4
30°±2°C, 65% RH ±5% RH
Complies Complies Complies Complies Complies Complies
Dissolution
0.1 N HCL After 2 hours NMT 10%
2.9% 2.3% 3.1% 3.5% 2.9% 2.9%
Buffer pH7.0
After 1 hours NMT 10% After 3 hours NMT 10%
30°±2°C, 65% RH ±5% RH
51.6% 96.6%
49.4% 92.1%
50.3% 90.6%
50.8% 90.9%
46.4% 93.9%
47.6% 91.5%
Identification Positive
30°±2°C, 65% RH ±5% RH
Positive Positive Positive Positive Positive Positive
Assay of Dexlansprazole
90.0-110.0%
30°±2°C, 65% RH ±5% RH
106.12% 102.82% 102.82% 102.04% 101.28% 98.20%
Analyst signature (after completion of every time line)
Conclusion by QA (after completion of the study)
Minutes for 253rd
Registration Board Meeting 282
Stability Study Data Sheet
1.0 Product Detail:
Product Name /Generic
Name / Dosage Form D-LANZ 60mg (Dexlansoprazole) Batch No B#T-018
Description of Pack
(Container closure
System)
Almost White Spherical DDR Pellets 17% filled “EHG Capsule”
size
„1‟ with Cap Green & body Yellow, Blister In Alu-Alu Aluminum
Foil, 7‟s Packed in Printed Unit Carton along with leaflet.
Batch Size 10000 Caps
Parameter and tests
Mentioned As Per in house specification Mfg.Date Aug-2013
Recommended storage
Condition
Long Term conditions (Long Term Stability)
30°±2°C, and 65% ±5% RH (Long Term Stability) Exp Date July 2015
Date of Completion
& implementation 10/08/2015 API Lot No DLP0113
Stability No 15/R & D /135
Approval by:
QC Manager…………………………………………………..
QA Manager…………………………………………………..
Production Manager………………………………………
R & D Manager………………………………………………
Sample taken for physical test = 100 Capsules
Sample taken for Chemical test = 100 Capsules
Sample taken for Microbiological Test = N/A
Extra Sample (if Needed) = N/A
Total Sample Size 200x6 = 1200 Capsules
Minutes for 253rd
Registration Board Meeting 283
Assessment Frequency (Month) Initial (0) 1 2 3 4 6 9 12 24
Date of Testing 10/08/2013 10/11/2013
10/02/2014 10/05/2014 10/08/2014 10/08/2015
Mode of Testing (F = Full, P= Partial testing) F P F P
F F F F
Tests (Physical, Chemical Microbiological)
Acceptance Criteria
Storage Condition
(Long)
Appearance
White Spherical Pellets filled in EHG Capsule Size 4
30°±2°C, 65% RH ±5% RH
Complies Complies Complies Complies Complies Complies
Dissolution
0.1 N HCL After 2 hours NMT 10%
3.59% 3.01% 2.85% 4.5% 2.9% 2.9%
Buffer pH7.0
After 1 hours NMT 10% After 3 hours NMT 10%
30°±2°C, 65% RH ±5% RH
49.3% 96.7%
51.2% 92.6%
46.9% 92.1%
52.5% 91.2%
51.5% 91.4%
47.6% 91.5%
Identification Positive
30°±2°C, 65% RH ±5% RH
Positive Positive Positive Positive Positive Positive
Assay of Dexlansprazole
90.0-110.0%
30°±2°C, 65% RH ±5% RH
105.86% 102.82% 101.79% 101.53% 102.05% 97.94%
Analyst signature (after completion of every time line)
Conclusion by QA (after completion of the study)
Minutes for 253rd
Registration Board Meeting 284
Stability Study Data Sheet
1.0 Product Detail:
Product Name /Generic
Name / Dosage Form D-LANZ 60mg (Dexlansoprazole) Batch No B#T-019
Description of Pack
(Container closure
System)
Almost White Spherical DDR Pellets 17% filled “EHG Capsule”
size
„1‟ with Cap Green & body Yellow, Blister In Alu-Alu Aluminum
Foil, 7‟s Packed in Printed Unit Carton along with leaflet.
Batch Size 10000 Caps
Parameter and tests
Mentioned As Per in house specification Mfg.Date Aug-2013
Recommended storage
Condition
Long Term conditions (Long Term Stability)
30°±2°C, and 65% ±5% RH (Long Term Stability) Exp Date July 2015
Date of Completion
& implementation 10/08/2015 API Lot No DLP0113
Stability No 15/R & D /135
Approval by:
QC Manager…………………………………………………..
QA Manager…………………………………………………..
Production Manager………………………………………
R & D Manager………………………………………………
Sample taken for physical test = 100 Capsules
Sample taken for Chemical test = 100 Capsules
Sample taken for Microbiological Test = N/A
Extra Sample (if Needed) = N/A
Total Sample Size 200x6 = 1200 Capsules
Minutes for 253rd
Registration Board Meeting 285
Assessment Frequency (Month) Initial (0) 1 2 3 4 6 9 12 24
Date of Testing 10/08/2013 10/11/2013
10/02/2014 10/05/2014 10/08/2014 10/08/2015
Mode of Testing (F = Full, P= Partial testing) F P F P
F F F F
Tests (Physical, Chemical Microbiological)
Acceptance Criteria
Storage Condition
(Long)
Appearance
White Spherical Pellets filled in EHG Capsule Size 4
30°±2°C, 65% RH ±5% RH
Complies Complies Complies Complies Complies Complies
Dissolution
0.1 N HCL After 2 hours NMT 10%
4.41% 2.33% 3.80% 3.4% 3.4% 2.03%
Buffer pH7.0
After 1 hours NMT 10% After 3 hours NMT 10%
30°±2°C, 65% RH ±5% RH
48.5% 91.36%
51.18% 94.5%
48.3%
90.37% 52.8% 91.8%
51.1% 94.31%
49.9% 93.8%
Identification Positive
30°±2°C, 65% RH ±5% RH
Positive Positive Positive Positive Positive Positive
Assay of Dexlansprazole
90.0-110.0%
30°±2°C, 65% RH ±5% RH
105.61% 105.86% 102.30% 101.79% 101.79% 98.97%
Analyst signature (after completion of every time line)
Conclusion by QA (after completion of the study)
Minutes for 253rd
Registration Board Meeting 286
Documents / Data provided by the applicant
(M/s Global Pharma, Islamabad)
Sr. No. Documents to be provided Status
1. COA of API Yes
2. Approval of API by regulatory authority of country of origin or GMP
certificate of API manufacturer issued by regulatory authority of country of
origin.
Yes (Source Vision
Pharma, Islambad)
3. Protocols followed for conduction of stability study and details of tests. Yes
4. Data of 03 batches will be supported by attested respective documents like
chromatograms, laboratory reports, data sheets etc.
30 mg Cap: One batch
(Real Time)
30 mg cap: One batch
(Accelerated and real time)
60 mg Cap: One batch real
time
5. Documents confirming import of API etc. NA (Source Vision Pharma,
Islambad)
6. All provided documents will be attested (name, sign and stamp) for ensuring
authenticity of data / documents.
Yes
7. Commitment to continue real time stability study till assigned shelf life of the
product.
No
Decision: Mr.Zamir-ul-Hussan and Muhammad Anis presented the data. Registration Board observed that the stability data
provided by the firm is in accorndace with the guidelines approved by the Board in 251st meeting. Therefore, Board granted
approval of registration of Dexlansoprazole 30 mg and 60 mg capsules to the firm. However, manufacturer will inform concerned
Federal Inspector of Drugs for taking sample of Active Pharmaceutical Ingredient (used in manufacture of first commercial
batch) for test/ analysis from Central Drugs Laboratory, Karachi before sale of finished product.
Minutes for 253rd
Registration Board Meeting 287
Following applicants did not submitted stability studies data.
S/N Name and address of
manufacturer / Applicant
Brand Name
(Proprietary name + Dosage Form + Strength)
Composition, Pharmacological Group
Finished product Specification
Type of Form
Initial date, diary
Fee including differential fee
Demanded Price / Pack size
1. M/s Hiranis Pharmaceuticals (Pvt)
Ltd
Plot No. E-145E-149, North West
Industrial Zone, Port Qasim,
Karachi.
SAFLIV Tablet 400 mg
Each film coated tablet contains
Sofosbuvir……400 mg
(Nucleotide Analog NS5B Polymerase Inhibitor)
Manufacturer spec‟s
Form 5 D
16-07-2014
Rs 50,000/-
As per PRC
2. M/s Weatherfolds Pharmaceuticals
69/ 2, Phase II, industrial estate,
Hattar
WINOFOLD Tablet 400 mg
Each film coated tablet contains
Sofosbuvir……400 mg
(Nucleotide Analog NS5B Polymerase Inhibitor)
Manufacturer
Form 5 D
15-07-2014
Rs 50000/-
Rs 85,000/ tablet
Blister Pack alu alu 10‟s
3. M/s Winbrains Research
Laboratories Plot No. 69/1, Block B
Phase 1 & 2 Industrial Estate
Hattar, Pakistan.
WINOFOS 400mg Tablets
Each Film Coated Tablet contain:-
Sofosbuvir…400mg
(Anti viral)
(Manufacturer Spec‟s)
Form 5-D
15-07-2014 (330)
Rs. 50,000/-
Rs. 85000/Tablet
4. M/s Wel Wink Pharmaceuticals
G.T Road, Industrial Estate
Gujranwala, Cantt
SOFOWINK 400mg Tablets
Each Film Coated Tablet contain:-
Sofosbuvir…400mg
(Anti viral)
Manufacturer‟s specs
Form 5-D
15-07-2014 (1529)
Rs. 50,000/-
Rs. 85000/Tablet
Minutes for 253rd
Registration Board Meeting 288
5. M/s Helix Pharma (Pvt) Limited,
Hakimson‟s House, A/56, S.I.T.E.
Manghopir Road, Karachi
SOFOVIR Tablets 400mg
Each film coated tablet contains Sofosbuvir…..400mg
Direct Acting Anti-viral
Manufacturer specs
Form-5D
Dated:26/03/14
Dy No: 138-R-II
Rs: 50,000/-
As per PRC/ Pack of 10‟s, 20,s
and 30,s
a. Attested copy of DML/
renewal in case of more than five
years.
b. Evidence of approval of
section.
c. An undertaking to change the
brand name in case of
resemblance with the already
registered brands.
d. An undertaking to submit
Patient information leaflet (PIL),
Summary of poduct
characteristics (SmPC) and
rescribing information as per
approved by drug regulatory
agencies or authorities of FDA,
EMA, TGA, Health Canada and
MHLW
e
6. M/s Saffron Pharma Faisalabad SAFALDI Tablets
Each film coated tablet contains Sofosbuvir……400mg
Anti-viral (NS5B RNA Polymerase Inhibitor)
Manufacturer‟s Specs
Form-5 D
Dated:07-08-14
Dy No: 3122
Rs: 20,000/- dated 12-0914
30000/- dated 18-09-14
As per SRO/ Pack of 28‟s
7. M/s Rotexmedica Pakistan (Pvt)
Limited, Islamabad.
SOLGAR Tablets
Each film coated tablet contains Sofosbuvir……400mg
Anti-viral (NS5B RNA Polymerase Inhibitor)
Manufacturer‟s Specs
Form-5 D
Dated:12-09-14
Dy No: 170
Rs: 50000 dated 07-08-14
30000/- Pack of 10‟s
90000/- Pack of 30‟s
8. M/s OBS Pakistan , Karachi VIRATRON Tablets
Each film coated tablet contains Sofosbuvir……400mg
Form-5 D
Dated:08-09-14
Dy No: 05
Minutes for 253rd
Registration Board Meeting 289
Anti-viral (NS5B RNA Polymerase Inhibitor)
Manufacturer‟s Specs
Rs: 50000 dated 08-09-14
70000/- Pack of 7‟s
2,80000/- Pack of 28‟s
9. M/s Wnsfeild Pharmaceuticals
Plot No.122, Block A, Phase V,
Industrial Estate, Hattar
WINOVIR Tablet 400 mg
Each tablet contains
Sofosbuvir……400 mg
(Nucleotide Analog NS5B Polymerase Inhibitor)
Manufacturer‟s Specs
Form 5 D
15-07-2014
Rs 50,000/-
Rs 85,000/ tablet
Blister Pack alu alu 10‟s
10. M/s Titlis Pharma, Lahore FOSBOU 400mg
Tablets
Each Film Coated Tablet contains:-
Sofosbuvir ….400mg
(Antiviral agent)
Manufacturer Spec.s)
Form 5-D
Dy No: 570 dated 19-09-14
Rs.20000/ dated 03-09-14
30000/- 19-09-14
As per SRO
11. M/s Linear Pharma , Islamabad SOBUVIR Tablets 400 mg
Each film coated tablet contains
Sofosbuvir MS……..400 mg
(Nucleotide Analog NS5B Polymerase Inhibitor)
Manufacturer‟s Specs
Form 5 D
Dy No 1732 dated 21-07-14
Rs. 50000 dated 21-07-14
As per SRO
12. M/s Cirin Pharmacuticals Pvt. Ltd
32/2-A, Phase-III, Industrial Estate
Hattar District Haripur, Khyber
Pakhtunkhwa.
Sovir 400mg
Tablets
Each Film Coated Tablet contains:-
Sofosbuvir ….400mg
(Nucleotide analog inhibitor of HCV)
(Manufacturer‟s Spec.s)
Form 5-D
12-03-2014 (855) Rs.50,000/
20000 per tablet / 4×7‟s,
28‟s
13. M/s Martin Dow Limited, Plot No
37, Sector 19, Korangi Industrial
Area, Karachi.
Osvir Tablets 400mg
Each film coated tablet contains sofosbuvir…..400mg
Direct acting antiviral agents
Manufacturer‟s Specs
Form-5D
Dated:15/07/2014
Dy No: 1561
Rs: 50,000/-
As per PRC/ Pack of 7‟s,and10‟s
14. M/s Wenovo Pharmaceuticals
Taxila,
Sofovir 400 mg
Tablets
Each Film Coated Tablet contains:-
Sofosbuvir ….400mg
(Anti-Viral)
(Manufacturer‟s Spec.s)
Form – 5D
Dated 07-03-2014
Dy No. 932
Rs: 50,000/-
Rs.85,000/- per Tablet
Pack of 10‟s
Minutes for 253rd
Registration Board Meeting 290
15. M/s Saibins Pharma, Islamabad Sofvir 400 mg
Tablets
Each Film Coated Tablet contains:-
Sofosbuvir ….400mg
(Anti-Viral)
(Manufacturer‟s Spec.s)
Form – 5D
Dated 04-08-2014
Dy No. 2801
Rs: 20,000/- dt 04-08-14 and
30000 dated 28-8-2014 (Challan
not attested by STO)
Rs. As per SRO
16. M/s Akson Pharmaceuticals (Pvt)
Ltd.
Plot No. 9-B/1&2, Sector D-1, Old
Industrial Estate,
Mirpur, Azad Kashmir,
Heposbuvir 400mg
Tablets
Each Film Coated Tablet contains:-
Sofosbuvir (M.S)….400mg
(Anti-Viral)
(Manufacturer‟s Spec.s)
Form 5-D
18-07-2014 (518) Rs.50,000/
As per SRO
Pack size:
1 x10‟s,
17. M/s S J & G Fazal Elahi, Karachi Novus 400mg
Tablets
Each Film Coated Tablet contains:-
Sofosbuvir (M.S)….400mg
(Anti-Viral)
(Manufacturer‟s Spec.s)
Form – 5D
Dated 21-07-2014
Dy No. 1803
Rs: 150,000/- dt 21-07-14
Rs. As per SRO
Pack size:
10‟s, 20‟s
18. M/s Dyson Research Laboratories
(Pvt) Ltd., 28 Km, Ferozpur Road,
Lahore.
Sovir 400mg Tablets
Film coated tablets
Each film coated tablet contains:
Sofosbuvir …. 400mg
Direct acting antiviral
Manufacturers specifications
Form 5D
17/07/2014
1628 R&I
17/07/2014
(Rs. 50,000/-)
28‟s As per SRO
19. M/s McOlson Research
Laboratories (Pvt) Ltd., M-2
Pharma Zone, 26 Km, Sharikpur
Road, Sheikhupura.
Sofo 400mg Tablets
Film coated tablets
Each film coated tablet contains:
Sofosbuvir …. 400mg
Direct acting antiviral
Manufacturers specifications
Form 5D
17/07/2014
1629 R&I
17/07/2014
(Rs. 50,000/-)
28‟s As per SRO
Minutes for 253rd
Registration Board Meeting 291
20. M/s Highnoon, Lahore Sovax 400mg Tablets
Film coated tablets
Each film coated tablet contains:
Sofosbuvir …. 400mg
Direct acting antiviral
Manufacturers specifications
Form 5D
29/09/2014
1181 R&I
29/09/2014
(Rs. 50,000/-)
28‟s As per SRO
21. M/s Welward Pharmaceuticals
Plot No. 3, Block A, Phase I-II,
Industrial Estate, Hattar
Sofoward Tablet 400 mg
Each tablet contains
Sofosbuvir……400 mg
(Nucleotide Analog NS5B Polymerase Inhibitor)
Manufacturer‟s Specs
Form 5 D
15-07-2014
Rs 50,000/-
Rs 85,000/ tablet
Blister Pack alu alu 10‟s
22. M/s Shaigan Pharma, Rwp. Vebuvir 400mg
Tablets
Each Film Coated Tablet contains:-
Sofosbuvir ….400mg
(Anti-Hepatitis C)
(Manufacturer‟s Spec.s)
Form 5-D
27-08-2014 (3845) Rs.50,000/
Not mentioned
23. M/s Pearl Pharma, Islamabad Hepavir 400mg
Tablets
Each Film Coated Tablet contains:-
Sofosbuvir ….400mg
(Anti-Hepatitis C)
(Manufacturer‟s Spec.s)
Form 5
26-09-2014
(993)
Rs 20,000/-
As per SRO
24. M/s Akson Pharmaceuticals, Pvt
Limited, Mirpur.
LIVERSOF Tablets
Each film coated tablet contains:
Sofosbuvir…..400mg
Ledipasvir….90mg
Antiviral
Manufacturer
Form 5D
Dy No. 1720 dated 18-07-14
50000/-
As per SRO
25. M/s. Rasco Pharma Lahore HC-BUVIR Tablets
Each film coated tablet contains:-
Sofosbuvir…….400mg
Antiviral
Manufacturer
Form-5
Dy. No.118. Date.4-2-2015
Not mentioned/As per SRO
20000/-2-02-2015
Minutes for 253rd
Registration Board Meeting 292
26. M/s. The Schazoo Pharma,Lahore LAVIE Tablets
Each film coated tablet contains:-
Sofosbuvir…….400mg
Antiviral
Manufacturer
Form-5
Dy.No.1010 Reg-V /11-6-2015
Rs.1190/ per tab, Rs.33300/4x7‟s
20,000/-28-05-2015
27. M/s. Pharmedic Laboratories
Lahore
HEPAVIR Tablets
Each film coated tablet contains:-
Sofosbuvir…….400mg
Antiviral
Manufacturer
Form-5
Dy.No.238 Reg-V /10-6-2015
Rs.55000.00/28‟s
20,000/-29-05-2015
28. M/s. Friends Pharma Lahore SOFOVIR Tablets
Each film coated tablet contains:-
Sofosbuvir…….400mg
Antiviral
Manufacturer
Form-5D
Dy. No. 133 Date.3-3-2015
As Per SRO/10‟s
50000/-3-03-2015
29. M/s. Seatle (Pvt) Ltd, Lahore ISUVIR Tablets
Each film coated tablet contains:-
Sofosbuvir…….400mg
Antiviral
Manufacturer
Dy.No.164 Date.26-1-2015
As per brand leader/7‟s,14‟s,28‟s
20000/-23-01-2015
30. M/s. English Pharma Lahore ESOVIR Tablets
Each film coated tablet contains:-
Sofosbuvir…….400mg
Antiviral
Manufacturer
Form-5
Dy. No. 207 date 29-4-2015
As Per SRO/10‟s
20,000/- 28-4-2015
31. -do- LEDSOVIR Tablets
Each film tablet contains:-
Sofosbuvir…….400mg
Ledipasvir….90mg
Antiviral
Manufacturer
Form-5
Dy. No. 208 date 29-4-2015
As Per SRO/10‟s
20,000/- 28-4-2015
32. M/s Neutro Pharma Lahore NUVALDI Tablets
Each film coated tablet contains:-
Sofosbuvir…….400mg
Antiviral
Manufacturer
Form-5D
Dy. No. 531 date 08-09-2014
As Per SRO
50,000/-
Minutes for 253rd
Registration Board Meeting 293
Decision: Board decided to defer all the cases till provision of scientifically rationale lab scale stability data in accorndace with the
guidelines approved by the Board in 251st meeting.
33. M/s. Wilshire Labs; Lahore Ziqar Tablet
Each film coated tablet contains:-
Sofosbuvir ……………………….. 400mg
Form-5D
Dy. No. 469 date 25-08-2014
As Per SRO
50,000/-
34. M/s. Novamed Pharmaceutical
Lahore
Each film coated tablet contains:-
Sofosbuvir ……………………….. 400mg
Form-5
As Per SRO
35. M/s. Ferozsons Nowshera KPK Each film coated tablet contains:-
Sofosbuvir ……………………….. 400mg
Form-5
As Per SRO
Minutes for 253rd
Registration Board Meeting 294
Case No.02: Grant of registrations to New Molecules.
a. Locally manufactured.
Incharge PEC
S/
N
Name and
address of
manufacturer
/ Applicant
Brand Name
(Proprietary name +
Dosage Form + Strength)
Composition
Pharmacological Group
Finished product
Specification
Type of Form
Initial date,
diary
Fee including
differential fee
Demanded
Price / Pack
size
Remarks on
the
formulation
(if any)
including
Internationa
l status in
stringent
drug
regulatory
agencies /
authorities
Me-too
status
GMP status
as depicted
in latest
inspection
report (with
date) by the
Evaluator
Remarks by
Evaluator
1. M/s Hilton
Pharma (Pvt.)
Ltd. 13, Sector
15, Korangi
Industrial
Area, Karachi.
Esli 800mg Tablets
Each Tablet contains:
Eslicarbazepine
Acetate….800mg
(Anti-epileptic)
Form-5-D
Dy. No: 1639
dated 27-08-
2013
50,000/- dated
27-08-2013
Rs.825/Tab
Aptiom
800mg by
Sunovion
Pharms INC
(FDA)
Stability
Studies
conducted
under the Zone
IV-A
conditions as
per ICH /
WHO
guidelines.
2. M/s Hilton
Pharma (Pvt.)
Ltd. 13, Sector
15, Korangi
Industrial
Area, Karachi.
Esli 400mg Tablets
Each Tablet contains:
Eslicarbazepine
Acetate….400mg
(Anti-epileptic)
Form-5-D
Dy. No: 1637
dated 27-08-
2013
50,000/- dated
27-08-2013
10‟s,20‟s,30‟s
Rs.6,000/-
Rs.12,000/-
Rs.18,000/-
Aptiom
400mg by
Sunovion
Pharms INC
(FDA)
Stability
Studies
conducted
under the Zone
IV-A
conditions as
per ICH /
WHO
guidelines.
Minutes for 253rd
Registration Board Meeting 295
3. M/s Hilton
Pharma (Pvt.)
Ltd. 13, Sector
15, Korangi
Industrial
Area, Karachi.
Esli 200mg Tablets
Each Tablet contains:
Eslicarbazepine
Acetate….200mg
(Anti-epileptic)
Form-5-D
Dy. No: 1638
dated 27-08-
2013
50,000/- dated
27-08-2013
10‟s,20‟s,30‟s
Rs.4,000/-
Rs.8,000/-
Rs.12,000/-
Aptiom
200mg by
Sunovion
Pharms INC
(FDA)
Stability
Studies
conducted
under the Zone
IV-A
conditions as
per ICH /
WHO
guidelines.
4. M/s Hilton
Pharma (Pvt.)
Ltd. 13, Sector
15, Korangi
Industrial
Area, Karachi.
Rasidon 120mg
Each Tablet contains:
Lurasidone
HCl………..…120mg
(Antipsychotic)
Form-5-D
Dy. No: 139
dated 13-02-
2013
50,000/- dated
13-02-2013
10‟s,20‟s30‟s
Rs.16,000/-
Rs.32,000/-
Rs.48,000/-
Latuda
Sunovion
Pharm INC
Stability
Studies
conducted
under the Zone
IV-A
conditions as
per ICH /
WHO
guidelines.
5. M/s Hilton
Pharma (Pvt.)
Ltd. 13, Sector
15, Korangi
Industrial
Area, Karachi.
Rasidon 80mg
Each Tablet contains:
Lurasidone
HCl………..…80mg
(Antipsychotic)
Form-5-D
Dy. No: 141
dated 13-02-
2013
50,000/- dated
13-02-2013
10‟s,20‟s30‟s
Rs.15,000/-
Rs.30,000/-
Rs.45,000/-
Latuda
Sunovion
Pharm INC
Stability
Studies
conducted
under the Zone
IV-A
conditions as
per ICH /
WHO
guidelines.
6. M/s Hilton
Pharma (Pvt.)
Ltd. 13, Sector
15, Korangi
Industrial
Area, Karachi.
Rasidon 40mg
Each Tablet contains:
Lurasidone
HCl………..…40mg
(Antipsychotic)
Form-5-D
Dy. No: 180
dated 13-02-
2013
50,000/- dated
13-02-2013
10‟s,20‟s30‟s
Rs.14,000/-
Rs.28,000/-
Rs.42,000/-
Latuda
Sunovion
Pharm INC
Stability
Studies
conducted
under the Zone
IV-A
conditions as
per ICH /
WHO
guidelines.
7. M/s Hilton
Pharma (Pvt.)
Ltd. 13, Sector
15, Korangi
Industrial
Area, Karachi.
Rasidon 20mg
Each Tablet contains:
Lurasidone
HCl………..…20mg
(Antipsychotic)
Form-5-D
Dy. No: 183
dated 13-02-
2013
50,000/- dated
13-02-2013
Latuda
Sunovion
Pharm INC
Stability
Studies
conducted
under the Zone
IV-A
conditions as
per ICH /
Minutes for 253rd
Registration Board Meeting 296
10‟s,20‟s30‟s
Rs.13,000/-
Rs.26,000/-
Rs.39,000/-
WHO
guidelines.
8. M/s Hilton
Pharma (Pvt.)
Ltd. 13, Sector
15, Korangi
Industrial
Area, Karachi.
Canaglu 100mg Tablets
Each film coated Tablet
contains:
Canagliflozin……100mg
(Anti-Diabetic)
Form-5-D
Dy. No: 1585
dated 23-08-
2013
50,000/- dated
23-08-2013
10‟s/Rs.6,500/-
Invokana
FDA
Stability
Studies
conducted
under the Zone
IV-A
conditions as
per ICH /
WHO
guidelines.
9. M/s Hilton
Pharma (Pvt.)
Ltd. 13, Sector
15, Korangi
Industrial
Area, Karachi.
Canaglu 300mg Tablets
Each film coated Tablet
contains:
Canagliflozin……300mg
(Anti-Diabetic)
Form-5-D
Dy. No: 1582
dated 23-08-
2013
50,000/- dated
23-08-2013
10‟s/Rs.7,500/-
Invokana
FDA
Stability
Studies
conducted
under the Zone
IV-A
conditions as
per ICH /
WHO
guidelines.
10. M/s Hilton
Pharma (Pvt.)
Ltd. 13, Sector
15, Korangi
Industrial
Area, Karachi.
Dapa 10mg Tablets
Each film coated Tablet
contains:
Dapagliflozin………10mg
(Anti-Diabetic)
Form-5-D
Dy. No: 1584
dated 23-08-
2013
50,000/- dated
23-08-2013
10‟s/Rs.7,000/-
Farxiga
(Astrazeneca
ab) 50mg,
10mg FDA
Stability
Studies
conducted
under the Zone
IV-A
conditions as
per ICH /
WHO
guidelines.
11. M/s Hilton
Pharma (Pvt.)
Ltd. 13, Sector
15, Korangi
Industrial
Area, Karachi.
Dapa 5mg Tablets
Each film coated Tablet
contains:
Dapagliflozin………5mg
(Anti-Diabetic)
Form-5-D
Dy. No: 1583
dated 23-08-
2013
50,000/- dated
23-08-2013
10‟s/Rs.5,500/-
Farxiga
(Astrazeneca
ab) 50mg,
10mg FDA
Stability
Studies
conducted
under the Zone
IV-A
conditions as
per ICH /
WHO
guidelines.
12. M/s Hilton
Pharma (Pvt.)
Ltd. 13, Sector
15, Korangi
Industrial
Area, Karachi.
Apix 2.5mg Tablets
Tablet.
Each film coated Tablet
contains:
Apixaban…….2.5mg
(Anticoagulant)
Form-5-D
Dy. No: 400
dated 06-11-
2013
50,000/- dated
06-11-2013
Eliquis
2.5mg, 5mg
(BMS) FDA
Stability
Studies
conducted
under the Zone
IV-A
conditions as
per ICH /
Minutes for 253rd
Registration Board Meeting 297
10‟s,20‟s,60‟s
Rs.475/tablet-
WHO
guidelines.
13. M/s Hilton
Pharma (Pvt.)
Ltd. 13, Sector
15, Korangi
Industrial
Area, Karachi.
Apix 5mg Tablets
Tablet.
Each film coated Tablet
contains:
Apixaban…….5mg
(Anticoagulant)
Form-5-D
Dy. No: 102
dated 07-02-
2014
50,000/- dated
07-02-2014
10‟s,20‟s,60‟s
Rs.516.58/tablet
-
Eliquis
2.5mg, 5mg
(BMS) FDA
Stability
Studies
conducted
under the Zone
IV-A
conditions as
per ICH /
WHO
guidelines.
14. M/s Getz
Pharma,
(Private)
Limited 29-
30/27, Korangi
Industrial Area
Karachi.
Lansodex Capsule 60mg
Delayed Release Capsules
Each delayed release
contains:
Enteric coated pellets of
Dexlansoprazole…….60mg
PPI (Proton Pump
Inhibitor)
Form-5-D
Dy. No: Not
mentioned.
dated 19-10-
2011
Rs.15,000/-
dated 30-07-
2013
Rs. 5,000/-
06-08-2015
Rs.30,000/-
14‟s/Rs.1680/-
Dexlanxilant
30mg, 60mg
Takeda
Pharms FDA.
Stability
Studies
conducted
under the Zone
IV-A
conditions as
per ICH /
WHO
guidelines.
15. M/s Getz
Pharma,
(Private)
Limited 29-
30/27, Korangi
Industrial Area
Karachi.
Lansodex Capsule 30mg
Delayed Release Capsules
Each delayed release
contains:
Enteric coated pellets of
Dexlansoprazole…….30mg
PPI (Proton Pump
Inhibitor)
Form-5-D
Dy. No: Not
mentioned.
dated 19-10-
2011
Rs.15,000/-
dated 30-07-
2013
Rs. 5,000/-
06-08-2015
Rs.30,000/-
14‟s/Rs.840/-
Dexlanxilant
30mg, 60mg
Takeda
Pharms FDA.
Stability
Studies
conducted
under the Zone
IV-A
conditions as
per ICH /
WHO
guidelines.
16. M/s Getz
Pharma,
(Private)
Limited 29-
30/27, Korangi
Industrial Area
Karachi.
Previr
Film coated tablet.
Each film coated tablet
contains:
Telaprevir……750
Anti viral (HCV serine
protease inhibitors)
Form-5-D
Dy. No: Not
mentioned.
dated 31-08--
2013
15,000/-
Rs.35,000/-
dated 30-08-
2013
10‟s,30‟s
Rs.10,000/-
Inspection.
15-12-2010
International
status not
confirmed
Stability
Studies
conducted
under the Zone
IV-A
conditions as
per ICH /
WHO
guidelines.
Minutes for 253rd
Registration Board Meeting 298
Rs.30,000/-
17. M/s Getz
Pharma,
(Private)
Limited 29-
30/27, Korangi
Industrial Area
Karachi.
Previr
Film coated tablet.
Each film coated tablet
contains:
Telaprevir……375
Anti viral (HCV serine
protease inhibitors)
(Getz specs)
Form-5-D
Dy. No: Not
mentioned.
dated 31-08-
2013
15,000/-
Rs.35,000/-
dated 30-07-
2013
10‟s,30‟s
Rs.5,000/-
Rs.15,000/-
Incivek by
Vertex
pharms
FDA:375mg
Inspection.
15-12-2010
Stability
Studies
conducted
under the Zone
IV-A
conditions as
per ICH /
WHO
guidelines.
18. M/s Searl
Company
Limited. 1st
Floor N.I.C
Building
Abbasi
Shaheed Road
Off: Shahrah-
E-Faisal
Karachi.
Dexlans 60mg Capsule
Capsule.
Each Capsule contains:
Dexlansoprazole…..60mg
(Anti Ulcerant)
Form-5-D
Dy. No: Not
mentioned.
Dated. 08-10-
2013
Rs.50,000/-
14‟s,/Rs.15,000/
-
Dexlanxilant
30mg, 60mg
Takeda
Pharms FDA.
The innovator
product is
delayed
release capsule
while firm has
not applied it.
19. M/s Searl
Company
Limited. 1st
Floor N.I.C
Building
Abbasi
Shaheed Road
Off: Shahrah-
E-Faisal
Karachi.
Dexlans 30mg Capsule
Capsule.
Each Capsule contains:
Dexlansoprazole…..30mg
(Anti Ulcerant)
Form-5-D
Dy. No: Not
mentioned.
Dated. 08-10-
2013.Rs.50,000/
-
14‟s,
Rs.880/-
Dexlanxilant
30mg, 60mg
Takeda
Pharms FDA.
The innovator
product is
delayed
release capsule
while firm has
not applied it.
20. M/s
Remington
Pharmaceutica
l Industries
(Pvt.) Ltd.
18km Multan
Road, Lahore
Amgydex ST
Ophthalmic Suspension
Each ml contains:-
Tobramycin
U.S.P………3.0mg
Dexamethasone
U.S.P…..0.5mg
(Antibiotic &
Corticosteroid)
Form-5D
Dy. No: not
mentioned
Rs.15,000/-
Dated. 30-06-
2012.
35,000/- dated
30-07-2013
5ml, 10ml,15ml
Rs.300/-
M/s
Remington
Pharmaceutica
l Industries
(Pvt.) Ltd.
18km Multan
Road, Lahore
21. M/s
Remington
Pharmaceutica
l Industries
(Pvt.) Ltd.
Moxear-D
Ear Drops
Each ml contains:-
Moxifloxacin
Hydrochloride B.P
Form-5D
Dy. No: 3420
Rs.15,000/-
Dated. 02-05-
2012.
M/s
Remington
Pharmaceutica
l Industries
(Pvt.) Ltd.
Minutes for 253rd
Registration Board Meeting 299
18km Multan
Road, Lahore
equivalent to
Moxifloxacin..5.0mg
Dexamethasone Sodium
Phosphate U.S.P eq to
Dexamethasone
Phosphate….1.0mg
(Antibiotic &
Corticosteroid)
35,000/- dated
30-07-2013
5ml, 10ml,15ml
Rs.300/-
18km Multan
Road, Lahore
22. M/s
Remington
Pharmaceutica
l Industries
(Pvt.) Ltd.
18km Multan
Road, Lahore
Dorolol
Eye Drops
Each ml contains:-
Dorzolamide Hydrochloride
U.S.P eq to
Dorzolamide…………20m
g
Timolol Maleate U.S.P. eq.
to
Timolol……………..5mg
Brimonidine
Tartrate……2mg
(Carbonic Anhydrase
Inhibitor)
Form-5D
Dy. No: 3420
Rs.15,000/-
Dated. 02-05-
2012.
35,000/- dated
30-07-2013
5ml, 10ml,15ml
Rs.1100/-
M/s
Remington
Pharmaceutica
l Industries
(Pvt.) Ltd.
18km Multan
Road, Lahore
b. Finished Import.
Incharge PEC
S/
N
Name and
address of
manufacturer /
Applicant
Brand Name
(Proprietary name +
Dosage Form + Strength)
Composition
Pharmacological Group
Finished product
Specification
Type of
Form
Initial date,
diary
Fee
including
differential
fee
Demanded
Price / Pack
size
Remarks on
the
formulation
(if any)
including
Internationa
l status in
stringent
drug
regulatory
agencies /
authorities
Me-too
status
GMP status
as depicted
in latest
inspection
report (with
date) by the
Evaluator
Remarks by
Evaluator
Minutes for 253rd
Registration Board Meeting 300
23. M/s Novartis
Pharma
(Pakistan)
Limited, 15
West Wharf P.O
Box 100
Karachi.
Novartis Pharma
Stein AG, Stien,
Switzerland.
Ultibro Breezhaler
Each Capsule contains:
Indacaterol 110mcg and
Glycopyrronium 50mcg
(143 microgram
glycopyrrnium bromide
equivalent to 110
micrograms
glycopyrrnium)
(Bronchodilator)
Form-5 (A)
Dy. No: 84
dated 22-01-
2014
100,000/-
dated 22-01-
2014
30‟s
Rs.6,424/-
Ultibro
Breezhaler
Novartis
Europharm
Limited.
EMA
COPP was issued
on 23-01-2015
24. M/s AGP
(Private)
Limited. B-23
S.I.T.E Karachi.
LTS Lohmann
Therapie-
System AG,
Lohmannstr
2,D-56626
Andernach,
Germany
Neupro ® 2mg/24hr
Each patch of 10cm2
contains 4.5mg Rotigotine
(UCB Specs)
(Antiepileptic)
Form-5 (A)
Dy. No: 386
dated 19-05-
2014
100,000/-
dated 19-05-
2014
28‟s
Rs.7,115/-
Neupro UCB
INC
COPP is issued
on dated: 30-08-
2013
25. M/s AGP
(Private)
Limited. B-23
S.I.T.E Karachi.
LTS Lohmann
Therapie-
System AG,
Lohmannstr
2,D-56626
Andernach,
Germany
Neupro ® 4mg/24hr
Each patch of 20cm2
contains 9.0mg Rotigotine
(UCB Specs)
(Antiepileptic)
Form-5 (A)
Dy. No: 387
dated 19-05-
2014
100,000/-
dated 19-05-
2014
28‟s
Rs.14,225/-
Neupro UCB
INC
COPP is issued
on dated: 30-08-
2013
26. M/s AGP
(Private)
Limited. B-23
S.I.T.E Karachi.
LTS Lohmann
Therapie-
System AG,
Lohmannstr
2,D-56626
Andernach,
Germany
Neupro ® 6mg/24hr
Each patch of 30cm2
contains 13.5mg Rotigotine
(UCB Specs)
(Antiepileptic)
Form-5 (A)
Dy. No: 384
dated 19-05-
2014
100,000/-
dated 19-05-
2014
28‟s
Rs.21,340/-
Neupro UCB
INC
COPP is issued
on dated: 30-08-
2013
27. M/s AGP
(Private)
Limited. B-23
S.I.T.E Karachi.
Neupro ® 8mg/24hr
Each patch of 40cm2
contains 18.0mg Rotigotine
(UCB Specs)
(Antiepileptic)
Form-5 (A)
Dy. No: 380
dated 19-05-
2014
Neupro UCB
INC
COPP is issued
on dated: 30-08-
2013
Minutes for 253rd
Registration Board Meeting 301
LTS Lohmann
Therapie-
System AG,
Lohmannstr
2,D-56626
Andernach,
Germany
100,000/-
dated 19-05-
2014
28‟s
Rs.28,450/-
28. M/s AGP
(Private)
Limited. B-23
S.I.T.E Karachi.
M/s Aesica
Pharmaceutical
GmbH
Galileistrasse 6
08056
Zwickau
Germany.
Vimpat film coated tablet
150mg
Tablet
Each film coated tablet
contains:
Lacosamide….150mg
(UCB specs)
(Antiepileptic)
Form-5 (A)
Dy. No: 131
dated 20-09-
2013
100,000/-
dated 20-09-
2013
56‟s
Rs.40,230/-
Vimpat UCB
INC FDA
50mg,
100mg,
150mg,
200mg
Lacolep by
Hilton Pharma
Karachi.
The product
is locally
registered in
50mg,
100mg,
150mg and
200mg.
COPP was
issued on 22-
11-2012
GMP was
issued on 27-
11-2012
29. M/s AGP
(Private)
Limited. B-23
S.I.T.E Karachi.
M/s Aesica
Pharmaceutical
GmbH
Galileistrasse 6
08056
Zwickau
Germany.
Vimpat film coated tablet
50mg
Tablet
Each film coated tablet
contains:
Lacosamide….50mg (UCB
specs)
(Antiepileptic)
Form-5 (A)
Dy. No: 133
dated 20-09-
2013
100,000/-
dated 20-09-
2013
14‟s
Rs.3,352/-
Vimpat UCB
INC FDA
50mg,
100mg,
150mg,
200mg
Lacolep by
Hilton Pharma
Karachi.
The product
is locally
registered in
50mg,
100mg,
150mg and
200mg.
COPP was
issued on 22-
11-2012
GMP was
issued on 27-
11-2012
30. M/s AGP
(Private)
Limited. B-23
S.I.T.E Karachi.
M/s Aesica
Pharmaceutical
GmbH
Galileistrasse 6
08056
Zwickau
Vimpat film coated tablet
100mg
Tablet
Each film coated tablet
contains:
Lacosamide….100mg
(UCB specs)
(Antiepileptic)
Form-5 (A)
Dy. No: 128
dated 20-09-
2013
100,000/-
dated 20-09-
2013
56‟s
Rs.26,820/-
Vimpat UCB
INC FDA
50mg,
100mg,
150mg,
200mg
Lacolep by
Hilton Pharma
Karachi.
The product
is locally
registered in
50mg,
100mg,
150mg and
200mg.
Minutes for 253rd
Registration Board Meeting 302
Germany. COPP was
issued on 22-
11-2012
GMP was
issued on 27-
11-2012
31. M/s AGP
(Private)
Limited. B-23
S.I.T.E Karachi.
M/s Aesica
Pharmaceutical
GmbH
Galileistrasse 6
08056
Zwickau
Germany.
Vimpat film coated tablet
200mg
Tablet
Each film coated tablet
contains:
Lacosamide….200mg
(UCB specs)
(Antiepileptic)
Form-5 (A)
Dy. No: 132
dated 20-09-
2013
100,000/-
dated 20-09-
2013
56‟s
Rs.53,640/-
Vimpat UCB
INC FDA
50mg,
100mg,
150mg,
200mg
Lacolep by
Hilton Pharma
Karachi.
The product
is locally
registered in
50mg,
100mg,
150mg and
200mg.
COPP was
issued on 22-
11-2012
GMP was
issued on 27-
11-2012
32. M/s AGP
(Private)
Limited. B-23
S.I.T.E Karachi.
M/s UCB
Manufacturing
Inc. 331 Clay
Road (755
Jefferson Road)
Rochester, NY
14623 USA
Vimpat Syrup 10mg/ml
Syrup
Each ml contains:
Lacosamide….10mg (UCB
specs)
(Antiepileptic)
Form-5 (A)
Dy. No: 129
dated 20-09-
2013
100,000/-
dated 20-09-
2013
200ml
Rs.14,268/-
Vimpat UCB
INC
10mg/ml oral
solution
COPP was
issued on
dated. 22-11-
2011 by
Eupeon
Medicines
Agency
33. M/s AGP
(Private)
Limited. B-23
S.I.T.E Karachi.
M/s UCB
Pharma SA
Chemin du
foriest B 1420
Braine-Alleud
Belgium
Vimpat 10mg/ml solution
for infusion
Infusion
Each ml of solution
contains:
Lacosamide….10mg (UCB
specs)
(Antiepileptic)
Form-5 (A)
Dy. No: 130
dated 20-09-
2013
100,000/-
dated 20-09-
2013
20ml
Rs.10,818/-
Vimpat UCB
INC
10mg/ml IV
infusion
Photocopy of
COPP dated.
22-11-2012
34. M/s Pfizer
Pakistan
Limited, 12
Dockyard Road,
West Wharf,
Karachi.
Xeljanz
Tablet
Each tablet contains:
Tofacitinib…….5mg
(Factor Xa Inhibitor)
Form-5 (A)
Dy. No: 170
dated 27-09-
2013
Xeljanz by
PF Prism CB
Storage
conditions
are not as per
innovator.
COPP is
issued by
Minutes for 253rd
Registration Board Meeting 303
Pfizer
Manufacturing
Deutschland
GmbH
Betriebsstatte
Freiburg
Mooswaldallee
179090 Freiburg
Germany.
50,000/-
dated 27-09-
2013
Not
mentioned.
Swissmedic
and does not
provide
information
of
manufacturin
g / packaging
to be done at
USA.
Label shows
the product is
manufactured
in Ireland
while as per
application it
is
manufactured
at Germany
and USA.
Last
Inspection
Report
conducted by
the concerned
Regulatory
Authority for
manufacturin
g process at
USA.
35. M/s Pfizer
Pakistan
Limited, 12
Dockyard Road,
West Wharf,
Karachi.
Pfizer
Manufacturing
Deutschland
GmbH
Betriebsstatte
Freiburg
Mooswaldallee
179090 Freiburg
Germany.
Xeljanz
Tablet
Each tablet contains:
Tofacitinib…….10mg
(Factor Xa Inhibitor)
Form-5 (A)
Dy. No: 169
dated 27-09-
2013
50,000/-
dated 27-09-
2013
Not
mentioned.
Xeljanz
10mg is not
FDA
approved.
Storage
condition are
not as per
innovator.
COPP is
issued by
Swissmedic
and does not
provide
information
of
manufacturin
g / packaging
to be done at
USA.
Label shows
the product is
manufactured
in Ireland
while as per
application it
is
manufactured
Minutes for 253rd
Registration Board Meeting 304
at Germany
and USA.
Last
Inspection
Report
conducted by
the concerned
Regulatory
Authority for
manufacturin
g process at
USA.
36. M/s Bayer
Pakistan (Pvt.)
Limited.
M/s Bayer
Pharma AG
51368
Leverkusen
Germany.
Stivarga (Regorafenib)
40mg film coated tablets.
Film coated tablets.
Each film coated tablet
contains.
Regorafenib……40mg
(Regorafenib is a protein
kinase inhibitor with the
ATC code L01XE21.)
Form-5 (A)
Dy. No: 370
dated 03-12-
2013
50,000/-
dated 03-12-
2013
To be
submitted
latter.
GMP
inspection
conducted
December 14
to 16, 2010
by German
Authority.
Certificate of
medicinal
product dated 18-
09-2013 issued
by EMA is
provided.
37. M/s Abbott
Laboratories,
Karachi.
M/s Ferrer
Internacional.
S.A. Joan
Buscalla 1-9
08173-Sant
Cugat del Valles
(Barcelona)
Spain
Nucleo CMP Forte
Capsules.
Capsules.
Each Capsule contains.
Cytidine……5mg
Uridine…..1.33mg
(Musculoskeletal System)
Form-5 D
Dy. No: 314
dated 11-11-
2013
50,000/-
dated 11-11-
2013
To be
forwarded.
GMP issued
on February
09-2011, by
Spanish
Government
COPP issued on
07-19-2013.
Stability studies
conducted at
30ºC / 60%
38. M/s Sanofi-
eventis Pakistan
Limited. Plot
No.23, Sector
No.22, Korangi
Industrial Area s
Plot No.23,
Sector No.22,
Korangi
Industrial Area
Karachi.
M/s Sanofi-
Aventis
Deutschland
GmbH,
Industriepark
Lyxumia.
Solution of injection.
Each dose of 0.2 ml
contains.
Lixisenatide……20mg
(ATC code: A10BX10)
Form-5 A
Dy. No: 763
dated 28-06-
2013
100,000/-
dated 28-06-
2013
1‟s/
Rs.7506.8
Lyxumia
(Sanofi
Aventis
EMA
approved)
FDA approval is
delayed sighting
internal data from
cardiovascular
risks study.
Minutes for 253rd
Registration Board Meeting 305
Hoechst 65926
Frankfurt am
Main Germany
39. M/s Sanofi-
eventis Pakistan
Limited. Plot
No.23, Sector
No.22, Korangi
Industrial Area s
Plot No.23,
Sector No.22,
Korangi
Industrial Area
Karachi.
M/s Sanofi-
Aventis
Deutschland
GmbH,
Industriepark
Hoechst 65926
Frankfurt am
Main Germany
Lyxumia.
Solution of injection.
Each dose of 0.2 ml
contains.
Lixisenatide……10mg
(ATC code: A10BX10)
Form-5 A
Dy. No: 761
dated 28-06-
2013
100,000/-
dated 28-06-
2013
1‟s/
Rs.7506.8
Lyxumia
(Sanofi
Aventis
EMA
approved)
FDA approval is
delayed sighting
internal data from
cardiovascular
risks study.
40. M/s Sanofi-
eventis Pakistan
Limited. Plot
No.23, Sector
No.22, Korangi
Industrial Area s
Plot No.23,
Sector No.22,
Korangi
Industrial Area
Karachi.
M/s Sanofi-
Aventis
Deutschland
GmbH,
Industriepark
Hoechst 65926
Frankfurt am
Main Germany
Lyxumia.
Solution of injection.
Lyxumia® Pen-injector is
available in two different
dosage strengths: 10µg and
20µg per 0.2ml
administration volume.
Body and cap are provided
in two different colors:
green (10µg) and burgundy
(20µg)
(ATC code: A10BX10)
Form-5 A
Dy. No: 762
dated 28-06-
2013
100,000/-
dated 28-06-
2013
1+1=2‟s/
Rs.15,013.6/
-
Lyxumia
(Sanofi
Aventis
EMA
approved)
FDA approval is
delayed sighting
internal data from
cardiovascular
risks study.
41. M/s Novartis
Pharma
(Pakistan)
Limited
Veltezom 3.5mg/Vial
Powder for Solution for
Injection.
Vial Injectable.
Each Vial contains.
Form-5
Dy. No: 296
dated 31-03-
2014
50,000/-
Velcade
Millennium
Pharms
COPP issued on
dated. 05-01-
2013
Minutes for 253rd
Registration Board Meeting 306
M/s Sandoz
Onco Therapies
Limited Plot No.
284,
Bommasandra-
Jigani Link
Road , Industrial
Area,
AnekalTaluk,
Bangalore 560,
105 India.
Brotezomib……3.5mg
(Antineoplastic agent)
dated 25-07-
2013
1‟s/
Rs.20,317/-
42. M/s
GlaxoSmithKlin
e Pakistan
Limited 35-
Dockyard Road,
West Wharf,
Karachi.
M/s Glaxo
Operations UK
Limited, Ware
UK
Relvar Ellipta
Dry Powder Inhaler
Each pre-dispensed dose
contains.
Fluticasone
furoate…….100mcg
Vilanterol (as
trifenatate)…25mcg
(Potent Corticosteroid plus
long acting beta-2
adrenergic agonist for the
maintenance treatment of
asthma and COPD)
Form-5A
Dy. No: 275
dated 04-04-
2014
50,000/-
dated 04-04-
2014
Will be
submitted
later
COPP issued on
dated. 06-02-
2014
43. M/s
GlaxoSmithKlin
e Pakistan
Limited 35-
Dockyard Road,
West Wharf,
Karachi.
M/s Glaxo
Operations UK
Limited, Ware
UK
Relvar Ellipta
Dry Powder Inhaler
Each pre-dispensed dose
contains.
Fluticasone
furoate…….200mcg
Vilanterol (as
trifenatate)…25mcg
(Potent Corticosteroid plus
long acting beta-2
adrenergic agonist for the
maintenance treatment of
asthma and COPD)
Form-5A
Dy. No: 275
dated 04-04-
2014
50,000/-
dated 04-04-
2014
Will be
submitted
later
COPP issued on
dated. 06-02-
2014
44. M/s
GlaxoSmithKlin
e Pakistan
Limited 35-
Dockyard Road,
West Wharf,
Karachi.
M/s Glaxo
Operations UK
Limited, Ware
UK
Anoro Ellipta
Dry Powder Inhaler
Each pre-dispensed dose
contains.
Umeclidinium…….62.5mc
g
Vilanterol (as
trifenatate)…25mcg
(Long acting muscarinic
antagonist (LAMA), and a
long-acting beta-2 agonist
(LABA)
Form-5A
Dy. No: 693
dated 18-09-
2014
50,000/-
dated 18-09-
2014
Will be
submitted
later
COPP issued on
dated. 06-08-
2014
Minutes for 253rd
Registration Board Meeting 307
45. M/s
GlaxoSmithKlin
e Pakistan
Limited 35-
Dockyard Road,
West Wharf,
Karachi.
M/s Glaxo
Operations UK
Limited, Ware
UK
Incruse Ellipta
Dry Powder Inhaler
Each pre-dispensed dose
contains.
Umeclidinium (equivalent
to 74.2 mcg of
umecidinium
bromide)…….62.5mcg
(Long acting muscarinic
antagonist (LAMA)
Form-5A
Dy. No: 234
dated 15-12-
2014
50,000/-
dated 15-12-
2014
Will be
submitted
later
COPP issued on
dated. 28-10-
2014
46. M/s Mazaton
Pharmaceuticals
(Pvt) Ltd.
720-X, Phase
III, D.H.A,
Lahore
M/s
Laboratories
Galderma Z.I.
Montdesir
74540 Alby sur
Cheran-France
Epiduo Gel
Gel
Each Gel Contains.
Adapalene……………0.1
%
Benzoyl Peroxide……
2.5%
(Not Mentioned)
Form-5A
Dy. No: 132
dated 01-12-
2014
50,000/-
15gm/
Rs.1500/-
Decision: Registration Board deferred case due to paucity of time.
Minutes for 253rd
Registration Board Meeting 308
Case No. 03: Grant of registration to New Drug Manufacturing Licenses / Sections
S/N Name and address
of manufacturer /
Applicant
Brand Name
(Proprietary name +
Dosage Form +
Strength)
Composition
Pharmacological
Group
Finished product
Specification
Type of Form
Initial date,
diary
Fee including
differential fee
Demanded
Price / Pack
size
International
status in
reference drug
agencies /
authorities
Me-too status
GMP status as
depicted in
latest
inspection
report (with
date) by the
Evaluator
Remarks
EVALUATOR-I
Tablet (General)
47. M/s Iceberg
Pharmaceuticals
(Pvt) Ltd, Plot #
144, Nowshera
Industrial Estate,
Risalpur, KPK
Tablet (General)
approved in 241st
meeting of Central
Licensing Board
held on 15-05-
2015.
Pantberg Tablet
Each enteric coated
tablet contains
Pantoperazole Sodium
as sesquihydrate 40mg
Proton Pump Inhibitor
Manufacturer‟s
Specifications
Form-5
17-06-2015
diary No 224.
Rs20,000
As per SRO/
Blister of 10‟s
and 14‟s Pack
Pantoperazole
40 mg gastro
resistant tablet
by M/s
Wockhardt UK
Ltd
Abrazol tablet
by M/s Sapient
Approved.
48. -do- Bixin Tablet
Each tablet contains
Piroxicam beta
Cyclodextrin eq to
Piroxicam….. 20mg
NSAIDs
Manufacturer‟s
specifications
Form-5
17-06-2015
diary No 222.
Rs20,000
As per SRO/
Blister of 2x10
tablets Pack
Albocam by M/s
Albro
Approved with
the change of
name.
49. -do- Icepram Tablet
Each film coated tablet
contains Escitalopram
as Oxalate eq to
Escitalopram… 10mg
SSRIs
USP specifications
Form-5
17-06-2015
diary No 221.
Rs20,000
As per SRO/
1x10‟s & 1x14‟s
tablets Pack
BNF. Cipralex
f/c,
Escitalopram (as
oxalate) 10 mg
Ciproxin by M/s
Bayer
Approved with
the change of
name.
50. -do- Cipberg Tablet
Each film coated tablet
contains Ciprofloxacin
HCl eq to
Ciprofloxacin….
500mg
Form-5
05-06-2015
diary No 206.
Rs20,000
As per
SRO/1x10‟s
BNF.
Ciprofloxacin
(as
hydrochloride)
500 mg,
Ciproxin 500mg
Approved with
the change of
name.
Minutes for 253rd
Registration Board Meeting 309
Quinolone
USP Specifications
tablets blister
Pack
Bayer
51. -do- Icedol Tablet
Each tablet contains
Paracetamol ….500mg
Caffeine…65mg
Chlorpheniramine
Maleate….2mg
500mg
Analgesic
Manufacturer‟s
specifications
Form-5
05-06-2015
diary No 209.
Rs20,000
As per SRO/10x
10‟s & 10x20
tablets blister
Pack
Amidol by M/s
Bloom Pharma
Defered for the
confirmation of
approval by
reference
regulatory
authorities.
52. -do- Cipberg Tablet
Each film coated tablet
contains Ciprofloxacin
HCl eq to ciprofloxacin
250mg
Quinolone
USP Specifications
Form-5
05-06-2015
diary No 216.
Rs20,000
As per SRO/
10‟s tablets
Pack
BNF.
Ciprofloxacin
(as
hydrochloride)
250mg,
Ciproxin by M/s
Bayer
Approved with
the change of
name.
53. -do- Moxib Tablet
Each film coated tablet
contains Moxifloxacin
HCl eq to
Moxifloxacin 400mg
Floroquinolone
Manufacturer‟s
specifications
Form-5
05-06-2015
diary No 207.
Rs20,000
As per SRO/
1x5‟s tablets
blister Pack
BNF.Avelox
Tablets, f/c,
Moxifloxacin
(as
hydrochloride)
400 mg,
Moxiflox by
M/s Scottman
Approved.
54. -do- Levberg Tablet
Each film coated tablet
contains Levofloxacin
Hemihydrate eq to
Levofloxacin 250mg
Quinolone
Manufacturer‟s
specifications
Form-5
17-06-2015
diary No 231.
Rs20,000
As per SRO/
1x10‟s tablets
blister Pack
BNF.Tavanic
Tablets, f/c,
Levofloxacin
250 mg,
Leflox by M/s
Getz Pharma
Approved with
the change of
name.
55. -do- Desoberg Tablet
Each film coated tablet
contains Desloratadine
5mg
Antiallergic,
antihistamine
Manufacturer‟s
specifications
Form-5
17-06-2015
diary No 219.
Rs20,000
As per SRO/
10‟s tablets
blister Pack
Dailymed.
Clarinex Each
f/c tablet
contains
desloratidine
5mg
Alenor tablet by
M/s Macter
Approved with
the change of
name.
56. -do- Paxetin Tablet
Each film coated tablet
contains Paroxetine
Form-5
17-06-2015
diary No 232.
BNF.Paroxetine
Tablets,
paroxetine (as
Minutes for 253rd
Registration Board Meeting 310
HCl eq to Paroxetine
20mg
SSRIs
Manufacturer‟s
specifications
Rs20,000
As per SRO/
1x10‟s tablets
blister Pack
hydrochloride)
20 mg, Seroxat
Tablets, f/c,
paroxetine (as
hydrochloride)
20 mg,
Paraxyl tablet
by M/s CCL
Approved.
57. -do- Levberg Tablet
Each film coated
Tablet contains
Levofloxacin
Hemihydrate eq to
Levofloxacin…
500mg.
Quinolone
Manufacturer‟s
Specifications
Form-5
17-06-2015
diary No 229.
Rs20,000
As per SRO/
1x10 tablet
blister pack.
BNF.Tavanic
Tablets, f/c,
Levofloxacin
500 mg,
Leflox by M/s
Getz Pharma
Approved with
the change of
name.
58. -do- Fexoberg Tablet
Each film coated
Tablet contains
Fexofenadine HCl eq
to Fexofenadine
120mg.
Antiellergic
Manufacturer‟s
Specifications
Form-5
17-06-2015
diary No 223.
Rs20,000
As per SRO/
1x10 tablet
blister pack.
Fexofenadine
HCl 120mg by
M/s Dr Reddy‟s
Laboratories UK
Aloc tablet by
M/s Bosch
Defered as the
firm has applied
for more than 10
products per
section.
Capsule General Sections
59. M/s Iceberg
Pharmaceuticals
(Pvt) Ltd, Plot #
144, Nowshera
Industrial Estate,
Risalpur, KPK
Capsule (General)
approved in 241st
meeting of Central
Licensing Board
held on 15-05-
2015.
Dicloberg Capsule
Each capsule contains
Diclofenac Sodium
enteric coated pellets
eq to Diclofenac
Sodium… 100mg
NSAID
B.P specifications
Form-5
17-06-2015
diary No 239.
Rs20,000
As per SRO/
2x10‟s & 3x10
capsules blister
Pack
------------
Dicloyan-S
capsules by M/s
Roryan, Pharma
Defered for the
confirmation of
approval by
reference
regulatory
authorities.
60. -do- Zithberg Capsule
Each capsule contains
Azithromycin as
Dihydrate 250mg
Macrolide
USP specifications
Form-5
05-06-2015
diary No 212.
Rs20,000
As per SRO/
1x6‟s & 1x10
capsules blister
Pack
Zithromax
capsule 250mg
by M/s Pfizer
UK
Acim capsule
250mg by M/s
Fynk Pharma
Approved with
the change of
name.
Minutes for 253rd
Registration Board Meeting 311
61. -do- Riseberg Capsule
Each capsule contains
Omeprazole as enteric
coated pellets eq to
Omeprazole.. 20 mg
Proton pump inhibitor
USP specifications
Source of Pellets M/s
Vision Pharma
Islamabad
Form-5
05-06-2015
diary No 213.
Rs20,000
As per SRO/
1x10‟s & 1x14
capsules blister
Pack
Losec capsule
20mg by M/s
AstraZeneca UK
Omega 20mg
capsule by M/s
Ferozsons
Approved with
the change of
name.
62. -do- Essoberg Capsule
Each capsule contains
Esomeprazole
magnesium trihydrate
pellets eq to
Esomeprazole 20 mg
Proton pump inhibitor
Manufacturer‟s
specifications
Source of Pellets M/s
Vision Pharma
Islamabad
Form-5
05-06-2015
diary No 218.
Rs20,000
As per SRO/
1x10‟s & 1x14
capsules blister
Pack
Emozul capsule
20mg by M/s
Consilient
Health UK
Esso 20mg
(shaigan)
Approved with
the change of
name.
63. -do- Essoberg Capsule
Each capsule contains
Esomeprazole
magnesium trihydrate
pellets eq to
Esomeprazole 40 mg
Proton pump inhibitor
Manufacturer‟s
specifications
Source of Pellets M/s
Vision Pharma
Islamabad
Form-5
05-06-2015
diary No 214.
Rs20,000
As per SRO/
1x10‟s & 1x14
capsules blister
Pack
Emozul 40 mg
capsule by M/s
Consilient UK
Esso 40mg
(shaigan)
Approved with
the change of
name.
Capsule Cephalosporin Sections
64. M/s Iceberg
Pharmaceuticals
(Pvt) Ltd, Plot #
144, Nowshera
Industrial Estate,
Risalpur, KPK
Capsule
(Cephalosporin)
approved in 241st
meeting of Central
Licensing Board
held on 15-05-
2015.
Icesif Capsule
Each capsule contains
Cephradine 500 mg
Cephalosporin
USP specifications
Form-5
17-06-2015
diary No 226.
Rs20,000
As per SRO/
2x6 capsules
blister Pack
Cefradine
500mg capsule
by M/s Kent
Pharmaceuticals
UK
Aksosef capsule
500mg by M/s
Akson Pharma.
Approved with
the change of
name.
65. -do- Icexib Capsule
Each capsule contains
Form-5
17-06-2015
Celebrex
capsule 200mg
Approved with
the change of
Minutes for 253rd
Registration Board Meeting 312
Celecoxib 200 mg
NSAID
Manufacturer‟s
specifications
diary No 220.
Rs20,000
As per SRO/
1x10‟s & 2x10
capsules blister
Pack
by M/s Pfizer
UK
Cobix 200mg
capsule by M/s
EG Pharma
name.
66. -do- Cxime Capsule
Each capsule contains
Cefixime trihydrate
400 mg
NSAID
USP Specifications
Form-5
05-06-2015
diary No 205.
Rs20,000
As per SRO/
1x5 capsules
blister Pack
FDA.Suprax
capsule 400mg
Avecol capsule
400mg by M/s
Aventek
Approved with
the change of
name.
Oral Dry Powder Suspension (Cephalosporin)
67. M/s Iceberg Pharmaceuticals
(Pvt) Ltd, Risalpur, KPK
Oral Dry Powder Suspension
(Cephalosporin) approved in
241st meeting of Central
Licensing Board held on 15-
05-2015
Icesif Dry
Suspension
Each 5ml contains
Cephradine
125mg
Cephalosporin
USP
Specifications
Form-5
17-06-2015 diary
No 228.
Rs20,000
As per SRO/ 60ml
glass bottle.
FDA Velosef
125mg/5ml
Alosef
125mg/5ml by
M/s Aventek
Approved with
the change of
name.
68. -do- Icesif Dry
Suspension
Each 5ml contains
Cephradine
250mg
Cephalosporin
USP
Specifications
Form-5
17-06-2015 diary
No 228.
Rs20,000
As per SRO/ 60ml
glass bottle.
FDA Velosef
250mg/5ml
Alosef
250mg/5ml by
M/s Aventek
Approved with
the change of
name.
69. -do- Cxime Dry
Suspension
Each 5ml contains
Cefixime
Trihydrate
100mg
Cephalosporin
USP
Specifications
Form-5
05-06-2015 diary
No 216.
Rs20,000
As per SRO/ 30ml
glass bottle.
FDA Cefixime
100mg/5ml by
M/s Aurobindo
pharma
Avecol
100mg/5ml by
M/s Aventek
Approved with
the change of
name.
Oral Dry Powder Suspension (General)
70. Oral Dry Powder
Suspension (general)
approved in 241st meeting
of Central Licensing Board
Cipberg Dry
Suspension
Each 5ml contains
Ciprofloxacin
Form-5
05-06-2015 diary
No 217.
Rs20,000
FDA Cipro
250mg/5ml
Ciprin 250mg/5ml
by M/s Werrick
Approved with
the change of
name
(Master
Minutes for 253rd
Registration Board Meeting 313
held on 15-05-2015 HCl 250mg
Quinolone
USP
Specifications
As per SRO/ size
not provided glass
bottle.
formulation
should be as per
decision of Board
in its 250th
meeting).
71. -do- Cipberg Dry
Suspension
Each 5ml contains
Ciprofloxacin
HCl 125mg
Quinolone
USP
Specifications
Form-5
05-06-2015 diary
No 215.
Rs20,000
As per SRO/ 60ml
glass bottle.
Ciprin 125mg/5ml
by M/s Werrick
Rejected as per
decision of
Registration
Board in its 250th
meeting.
72. -do- Zithberg Dry
Suspension
Each 5ml contains
Azithromycin
Dihydrate eq to
azithromycin
200mg
Macrolide
USP
Specifications
Form-5
05-06-2015 diary
No 211.
Rs20,000
As per SRO/ 15ml
glass bottle.
FDA
Azithromycin
200mg/5ml by
M/s Pliva
Azure
200mg/5ml, by
M/s Fynk
Approved with
the change of
name.
Evaluator I
Tablet (General)
73. M/s Zeta
Pharmaceuticals, 494-A,
Sundar Industrial Estate,
Raiwind Road, Lahore.
Tablet (General)
approved in 241st meeting
of Central Licensing
Board held on 15-05-
2015.
Zetamol Tablet
Each tablet
contains
paracetamol….45
0mg
Orphenadrine
Citrate….35mg
Antirheumatic/ant
i-inflammatory
Form-5
28-07-2015 diary
No 4648.
Rs20,000
Rs. 426/10x10
tablets
Require to be
verified.
Finegesic Tablet
by M/s
Mediceena
New section
Deferred as the
formulation is
under review.
74. -do- Propazet Tablet
Each enteric
coated tablet
contains
Pantoperazole
Sodium
sesquihydrate eq
to
pantoperazole….4
0mg
Manufacturer‟s
specifications
Form-5
28-07-2015 diary
No 4641.
Rs20,000
Rs. 688.10/02x07
tablets
MHRA
Pantoperazole
40mg gastro
resistant tablet by
M/s Wockhardt
Losec Tablet by
M/s Barret
New section
Approved
75. -do- Levozet Tablet
250
Each film coated
Form-5
28-07-2015 diary
No 4638.
FDA Levaquin by
Janssen Pharma
Tavanic Tablet by
Minutes for 253rd
Registration Board Meeting 314
tablet contains
Levofloxacine
Hemihydrate eq
to
Levofloxacine.….
250mg
Fluroquinolone
Manufacturer‟s
specifications
Rs20,000
Rs. 545/10
tablets
M/s Sanofi
New section
Approved
76. -do- Levozet Tablet
500
Each film coated
tablet contains
Levofloxacine
Hehihydrate eq to
Levofloxacine.….
500mg
Fluroquinolone
Manufacturer‟s
specifications
Form-5
28-07-2015 diary
No 4637.
Rs20,000
Rs. 1095/10
tablets
FDA Levaquin by
Janssen Pharma
cravit Tablet by
M/s Hilton
New section
Approved
77. -do- Zeta-Relax Tablet
Each tablet
contains
Piroxicam beta
Cyclodextrin….2
0mg
Tizinidine
HCl…2mg
Antirheumatic/ant
i-inflammatory
Form-5
28-07-2015 diary
No 4639.
Rs20,000
Rs. 513/2x10
tablets
Require to be
verified.
Abxicam 20mg
Tablet by M/s
Innvotek
New section
Deferred for
confirmation of
approval by
reference
regulatory
authority and
finished product
specifications.
78. -do- Zetaluhast Tablet
Each tablet
contains
Montelukast
Sodium….5mg
Citrizine
2HCl..10mg
Antiasthmatic/anti
allergic
Form-5
28-07-2015 diary
No 4636.
Rs20,000
Rs. 1285.36/2x7
tablets
Require to be
verified.
Require to be
verified
New section
Deferred for
confirmation of
approval by
reference
regulatory
authority and
finished product
specifications.
79. -do- Zeta Fenac-K
Tablet
Each film coated
tablet contains
Diclofenac
Potassium….50m
g
Antirheumatic
USP
Specifications
Form-5
28-07-2015 diary
No 4635.
Rs20,000
Rs. 160.66/2x10
tablets
FDA. Cataflam by
M/s Novartis
Cataflam Tablet
by M/s Novartis
New section
Approved
80. -do- Ciprozet Tablet
250
Each film coated
tablet contains
Ciprofloxacine
Form-5
28-07-2015 diary
No 4634.
Rs20,000
Rs. 286/10
FDA. Cipro 250
by Bayer
Ciproxin Tablet
by M/s Bayer
New section
Approved
Minutes for 253rd
Registration Board Meeting 315
HCl eq to
ciprofloxacine.….
250mg
Fluroquinolone
USP
specifications
tablets
81. -do- Ciprozet Tablet
500
Each film coated
tablet contains
Ciprofloxacine
HCl eq to
ciprofloxacine….
500mg
Fluroquinolone
USP
Specifications
Form-5
28-07-2015 diary
No 4640.
Rs20,000
Rs. 504.60/10
tablets
FDA. Cipro 250
by Bayer
Ciproxin Tablet
by M/s Bayer
New section
Approved
82. -do- Zetamox Tablet
Each film coated
tablet contains
Moxifloxacin HCl
eq to
Moxifloxacine….
400mg
Fluroquinolone
Manufacturer‟s
specifications
Form-5
28-07-2015 diary
No 4632.
Rs20,000
Rs. 475/10
tablets
FDA. Avelox
400mg by M/s
Bayer
Avelox Tablet by
M/s Bayer
New section
Approved
Capsule (General)
83. M/s Zeta Pharmaceuticals,
494-A, Sundar Industrial
Estate, Raiwind Road,
Lahore.
Capsule (General)
approved in 241st meeting
of Central Licensing Board
held on 15-05-2015.
Zetaprazole
Capsule 40mg
Each capsule
contains
omeprazole as
enteric coated
pellets eq to
omeprazole…..40
mg
PPI
Manufacturer,s
Specifications.
Source of pellets
M/s Ravoos
Laboratories, Ltd
sy. Nos.542, 543
& 544 Chivemla
(V&M),
Nalgonda District,
Telangana State,
India.
Form-5
28-07-2015 diary
No 4630.
Rs20,000 &
80,000
Rs. 688.10/2x7
tablets
FDA Omeprazole
40mg by M/s
Impex Labs
Omega Capsule
by M/s Ferozsons
New section
Approved. Firm
will submit
stability data and
legalized GMP of
pellet‟s
manufacturer and
Chairman
Registration
Board will permit
issuance of
registration letter.
84. -do- Zetaprazole
Capsule 20mg
Each capsule
contains
omeprazole as
enteric coated
pellets eq to
Form-5
28-07-2015 diary
No 4630.
Rs20,000 &
80,000
Rs. 295/2x7
tablets
FDA Omeprazole
20mg by M/s
Impex Labs
Omega Capsule
by M/s Ferozsons
New section
Approved. Firm
will submit
stability data and
legalized GMP of
pellet‟s
manufacturer and
Chairman
Minutes for 253rd
Registration Board Meeting 316
omeprazole.20mg
PPI
Manufacturer,s
Specifications.
Source of pellets
M/s Ravoos
Laboratories, Ltd
sy. Nos.542, 543
& 544 Chivemla
(V&M),
Nalgonda District,
Telangana State,
India.
Registration
Board will permit
issuance of
registration letter.
85. -do- Esozet Capsule
20mg
Each capsule
contains
Esomeprazole
magnesium
trihydrate as
enteric coated
pellets eq to
Esomeprazole…..
20mg
Domperidone
…5mg
PPI/antiemetic
Manufacturer,s
Specifications.
Source of pellets
of esomeprazole
M/s Ravoos
Laboratories, Ltd
sy. Nos.542, 543
& 544 Chivemla
(V&M),
Nalgonda District,
Telangana State,
India.
Form-5
28-07-2015 diary
No 4633.
Rs20,000 &
80,000
As per SRO
FDA. Nexium
20mg by M/s
Astrazeneca
Esso 20mg by
M/s Shaigan
New section
Deffered for the
confirmation of
International
availability.
86. -do- Esozet Capsule
40mg
Each capsule
contains
Esomeprazole
magnesium
trihydrate as
enteric coated
pellets eq to
Esomeprazole…..
40mg
Domperidone
…5mg
PPI/antiemetic
Form-5
28-07-2015 diary
No 4629.
Rs20,000 &
80,000
As per SRO
FDA. Nexium
20mg by M/s
Astrazeneca
Esso 20mg by
M/s Shaigan
New section
Deferred for
confirmation of
approval by
reference
regulatory
authority.
Minutes for 253rd
Registration Board Meeting 317
Manufacturer,s
Specifications.
Source of pellets
of esomeprazole
M/s Ravoos
Laboratories, Ltd
sy. Nos.542, 543
& 544 Chivemla
(V&M),
Nalgonda District,
Telangana State,
India.
87. -do- Fluconazet
Capsule 150mg
Each capsule
contains
Fluconazole…..15
0mg
Antifungal
USP
specifications
Form-5
28-07-2015 diary
No 4642.
Rs20,000
Rs.442.06/1
capsule
Diflucan 150mg
by M/s Pfizer.
Diflucan by M/s
Pfizer.
New section
Approved
88. -do- Diclozet SR 100
Capsule
Each capsule
contains
Diclofenac
Sodium as enteric
coated pellets eq
to Diclofenac
sodium ..100mg
Antirhemautic
B.P
Specifications
Form-5
28-07-2015 diary
No 4647.
Rs20,000
Rs.340.26/3x10
capsule
Dicloyan-S
capsules by M/s
Roryan, Pharma
Deferred for
confirmation of
approval by
reference
regulatory
authority and
finished product
specifications.
89. -do- Zetadol Capsule
Each capsule
contains
Tramadol
HCl…..50mg
Opoid analgesic
synthetic
Manufacturer‟s
specifications
Form-5
28-07-2015 diary
No 4644.
Rs20,000
Rs.303.16/3x1
capsule
MHRA Tramadol
50mg capsule by
M/s Aurobindo
Tremomed by
M/s Medicraft.
New section
Approved
90. -do- Zetamycin
Capsule
Each capsule
contains
Azithromycin as
dehydrate eq to
azithromycin
…..250mg
Macrolide
Manufacturer‟s
Specifications
Form-5
28-07-2015 diary
No 4645.
Rs20,000
Rs.320/10 capsule
FDA Zithromax
250mg by Pfizer.
Azethocin by M/s
BexPharma.
New section
Approved
91. -do- Klarithrozet Form-5
Minutes for 253rd
Registration Board Meeting 318
Capsule
Each capsule
contains
Clarithromycin as
dihydrate eq to
Clarithromycin….
.250mg
Macrolide
Manufacturer
Specifications
28-07-2015 diary
No 4646.
Rs20,000
Rs.358.61/10
capsule
Klaricid by M/s
Abbott.
New section
Approved
96. -do- Lansozet Capsule
Each capsule
contains
Lansoperazole as
enteric coated
pellets eq to
Lansoperazole…
…30mg
PPI
Manufacturer‟s
specifications
Form-5
28-07-2015 diary
No 4643.
Rs20,000
Rs.378/2x7
capsule
MHRA
Lansoperazole 30
mg gastro
resistant capsules.
Lanzac by M/s
Don Valley.
New section
Approved
Evaluator IV
Deferred cases of 251st meeting
97. M/s Mafins Pharma, A-5,
S.I.T.E, Super Highway
Industrial Area, Karachi
Tablet (General)
approved in 241st meeting
of Central Licensing
Board held on 15-05-
2015.
Tablet Ciflox 250
mg
Each film coated
tablet contains
Ciprofloxacin (as
HCl.H2O) U.S.P
eq. to
Ciprofloxacin 250
mg
Quinolone Group
of Antibiotics
(USP
Specification)
Form 5
Rs. 20,000/-
(09-06-2015)
Dy. No. 305
Pack of
10‟s / Rs. 354
20‟s / Rs. 680
100‟s / Rs 2860
FDA approved
tablet Cipro 250
mg
Tablet Ciprin 250
mg (Werrick)
New License
Approved
98. -do- Ciflox Tablet 500
mg
Each film coated
tablet contains:
Ciprofloxacin [as
HCl.H2O] (USP
Spec) eq to
Ciprofloxacin 500
mg
Quinolone
Antibiotics
Form 5
Rs. 20,000/-
(09-06-2015)
Dy. No. 303
Pack of
10‟s/Rs.623
20‟s / Rs. 1246
100‟s / Rs. 6230
FDA approved
Tablet Cipro 500
mg manufactured
by BAYER
HEALTHCARE
Tablet Ciprin 500
mg by Werrick
Approved
99. -do- Tablet D-Fenac
50 mg
Each enteric
coated tablet
Form 5
Rs. 20,000/-
(09-06-2015)
Dy. No. 296
Pack of
FDA approved
Diclofenac
Sodium Tablet 50
mg manufactured
by ACTAVIS
Approved
Minutes for 253rd
Registration Board Meeting 319
contains
Diclofenac
Sodium 50 mg
(USP
specification)
Phenylacetic acid
10‟s / Rs. 45
20‟s / Rs 210
30‟s / Rs. 269
100‟s / Rs. 875
200‟s / Rs. 910
300‟s / Rs. 980
500‟s / Rs 1020
ELIZABETH
Tablet Mobikare
50 mg (Barrett
Hodgson)
100. -do- Mecob Tablet 500
mcg
Each Sugar
Coated Tablet
contains:
Mecobalamin J.P
500 mcg
Vitamin B12 co -
enzyme
(Manufacture
Spec.s)
Form 5
Rs. 20,000/-
(09-06-2015)
Dy. No. 293
Pack of
20‟s / Rs. 573
30‟s / Rs. 655
100‟s / Rs. 940
------
Elgin Tablet 500
mcg (Novartis)
Approved
101. -do- Tablet Levox 250
mg
Each film coated
tablet contain
Levofloxacin (as
hemihydrate) USP
eq to
Levofloxacin 250
mg
(USP
specification)
Quinolone group
of antibiotics
Form 5
Rs. 20,000/-
(09-06-2015)
Dy. No. 302
Pack of
10‟s / Rs. 545
14‟s / Rs. 680
100‟s / Rs 1656
FDA Pfiziflox
tablet 250 mg
Tablet Leflox
250 mg (Getz)
Approved
102. -do- Tablet Levox 500
mg
Each film coated
tablet contain
Levofloxacin (as
hemihydrate) USP
eq to
Levofloxacin 500
mg
(USP
Specification)
Quinolone group
of antibiotics
Form 5
Rs. 20,000/-
(09-06-2015)
Dy. No. 298
Pack of
10‟s / Rs. 1095
14‟s / Rs. 1320
100‟s / Rs 1820
FDA Pfiziflox
500 mg tablet
Tablet Leflox
500 mg (Getz)
Approved
103. -do- Tablet Meflam 75
mg
Each sugar coated
Form 5
Rs. 20,000/-
(09-06-2015)
Tablet Artimov-
K 75 mg (Hilton)
Deferred for
confirmation of
approval by
reference
Minutes for 253rd
Registration Board Meeting 320
tablet contains
Diclofenac
Potassium 75 mg
(USP
specification)
Phenylacetic acid
Dy. No. 278
Pack of
10‟s / Rs. 45
20‟s / Rs. 160
30‟s / Rs 195
100‟s / Rs. 800
200‟s / Rs. 1620
regulatory
authority and
finished product
specifications.
The Board further
decided to review
all the locally
registered
products in the
same strength and
dosage form
104. -do- Tablet Tenor 50
mg
Each film coated
tablet contain
Atenolol 50 mg
(USP
specification)
Beta Blocking
Agent,
Cardioselective
Form 5
Rs. 20,000/-
(09-06-2015)
Dy. No. 306
Pack of
10‟s / Rs. 37
14‟s / Rs. 85
20‟s / Rs. 100
30‟s / Rs 180
100‟s / Rs 485
FDA Tenormin
tablet 50 mg
Tablet Zafnol 50
mg (Zafa)
Approved
105. -do- Tablet Profen 100
mg
Each film coated
tablet contain
Flurbiprofen USP
100 mg
Propionic acid
(USP
specification)
Form 5
Rs. 20,000/-
(09-06-2015)
Dy. No. 295
Pack of
10‟s / Rs. 75
20‟s / Rs 140
30‟s / Rs. 210
100‟s / Rs. 785
FDA Ansaid 100
mg Tablet
Tablet Vobifen
100 mg (Novartis)
Approved
106. -do- Tablet Fammo 40
mg
Each film coated
tablet contains
Famotidine 40
mg
(USP
specification)
Anti ulcer
Form 5
Rs. 20,000/-
(09-06-2015)
Dy. No. 301
Pack of
10‟s / Rs. 325
20‟s / Rs 428
30‟s / Rs. 690
100‟s / Rs. 976
FDA Pepcid 40
mg Tablet
Tablet Ulfam 40
mg (High Noon)
Approved
107. M/s Mafins Pharma, A-5,
S.I.T.E, Super Highway
Industrial Area, Karachi
Capsule (General)
approved in 241st meeting
Indosone Capsule
25 mg
Each Capsule
contains:
Indomethcin 25
mg
Form 5
Rs. 20,000/-
(09-06-2015)
Dy. No. 282
Pack of
100‟s / Rs. 96
500‟s / Rs. 294
FDA Indocin
25mg
Capsule Epomet
25 mg (Epoch
International)
Approved
Minutes for 253rd
Registration Board Meeting 321
of Central Licensing
Board held on 15-05-
2015.
NSAID
(USP Spec.s)
1000‟s / Rs. 589 New License
108. -do- Azzi Capsule 250
mg
Each Capsule
contains:
Azithromycin [as
Dihydrate] USP
262 mg eq to
Azithromycin 250
mg
Macrolide
Antiobiotic
(USP Spec‟s)
Form 5
Rs. 20,000/-
(09-06-2015)
Dy. No. 288
Pack of
3‟s / Rs. 150
6‟s / Rs. 255
10‟s / Rs. 320
12‟s / Rs. 398
FDA Capsule
Zithromax 250
mg
Capsule Zetro 250
mg (Getz)
Approved
109. -do- Meso Capsule 40
mg
Each Capsule
contains:
Esomeprazole as
[magnesium
trihydrate] USP
enteric coated
pellets eq (22.5%)
to esomeprazole
40mg
Proton Pump
Inhibitor
(Manufacturer
Spec.s)
Source of pellets
M/s Qualitek
Pharma Plot #115,
Jeedimetla
Industrial Ara,
Phase V, Extn.
Doolapally
Village,
Quthbullapur
Mandal,
Hyderabad.
Form 5
Rs. 20,000/- +
80,000/-
(09-06-2015)
Dy. No. 290
Pack of
14‟s / Rs. 323
10‟s / Rs. 230
20‟s / Rs. 461
100‟s / Rs 2300
FDA Capsule
Nexium 40 mg
Esso 40 Capsule
(Shaigan)
Approved. Firm
will submit
stability data and
legalized GMP of
pellet‟s
manufacturer and
Chairman
Registration
Board will permit
issuance of
registration letter.
110. -do- Meso Capsule 20
mg
Each Capsule
contains:
Esomeprazole as
[magnesium
trihydrate] enteric
Form 5
Rs. 20,000/- +
80,000/-
(09-06-2015)
Dy. No. 289
Pack of
FDA Capsule
Nexium 20 mg
Esso 20 Capsule
(Shaigan)
Approved. Firm
will submit
stability data and
legalized GMP of
pellet‟s
manufacturer and
Chairman
Registration
Minutes for 253rd
Registration Board Meeting 322
coated pellets
(22.5%) eq to
esomeprazole 20
mg
Proton Pump
Inhibitor
(Manufacturer
Spec.s)
Source of pellets
M/s Qualitek
Pharma Plot #115,
Jeedimetla
Industrial Ara,
Phase V, Extn.
Doolapally
Village,
Quthbullapur
Mandal,
Hyderabad.
14‟s / Rs.170
10‟s / Rs. 121
20‟s / Rs. 437
100‟s / Rs 2185
Board will permit
issuance of
registration letter.
111. -do- Rissem Capsule
20 mg
Each Capsule
contains:
Omeprazole as
enteric coated
pellets 8.5% USP
eq to omeprazole
20mg
Proton Pump
Inhibitor
(Manufacturer
Spec.s)
Source of pellets
M/s Ravoos
Laboratories Ltd,
situated at Sy. No.
542,543 & 544,
Chivemla (V &
M), Nalgonda
District,
Telangana, India
Form 5
Rs. 20,000/- +
80,000/-
(09-06-2015)
Dy. No. 291
Pack of
10‟s / Rs.350
14‟s / Rs. 688
20‟s / Rs. 705
28‟s / Rs 765
30s‟s / Rs. 825
100‟s / Rs. 918
FDA Capsule
Lozal 20 mg
Risek 20 mg
Capsule (Getz)
Approved. Firm
will submit
stability data and
legalized GMP of
pellet‟s
manufacturer and
Chairman
Registration
Board will permit
issuance of
registration letter.
112. -do- Rissem Capsule
40 mg
Each Capsule
contains:
enteric coated
pellets of
Omeprazole eq to
omeprazole 40mg
(Manufacturer
Spec.s)
Form 5
Rs. 20,000/- +
80,000/-
(09-06-2015)
Dy. No. 292
Pack of
10‟s / Rs.900
14‟s / Rs. 1643
20‟s / Rs. 1875
100‟s / Rs. 2500
FDA Capsule
Lozal 40 mg
Risek 40 mg
Capsule (Getz)
Approved. Firm
will submit
stability data and
legalized GMP of
pellet‟s
manufacturer and
Chairman
Registration
Board will permit
issuance of
registration letter.
Minutes for 253rd
Registration Board Meeting 323
Proton Pump
Inhibitor
Source of pellets
Qualtek Pharma,
Plot # 115,
Jeedimetla
Industrial Area,
Phase V, Extn.
Doolapally
Village,
Quthbullapur
Mandal,
Hyderabad. India
113. -do- Doxyclin Capsule
100 mg
Each Capsule
contains:
Doxycyclin
Hyclate USP 115
mg eq to
Doxycycline 100
mg
Antibiotic
Tetracyclin
(USP Spec‟s)
Form 5
Rs. 20,000/-
(09-06-2015)
Dy. No. 304
Pack of
10‟s / Rs. 60/-
14‟s / Rs. 77/-
20‟s / Rs. 60/-
30‟s / Rs, 190
50‟s / Rs. 250
60‟s / Rs 381
80‟s / Rs 389
100‟s / Rs. 636
120‟s / Rs. 763
200‟s /Rs. 1270
1000‟s / Rs. 1820
FDA Capsule
Wellcodox (GSK)
Capsule Megadox
(Hilton)
Approved
114. -do- Transa Capsule
500 mg
Each Capsule
contains:
Tranexamic Acid
500 mg
Haemostatic /
Fibrinolytic
(JP Spec.s)
Form 5
Rs. 20,000/-
(09-06-2015)
Dy. No. 300
Pack of
10‟s / Rs. 125/-
20‟s / Rs. 330/-
30‟s / Rs, 431
50‟s / Rs. 780
100‟s / Rs. 960
Capsule
Maxma(AGP)
Approved with
the change of
name
115. -do- Linnco Capsule
500 mg
Each Capsule
contains:
Lincomycin (as
HCl) USP 544mg
eq to Lincomycin
500mg
Form 5
Rs. 20,000/-
(09-06-2015)
Dy. No. 294
Pack of
10‟s / Rs. 94/-
12‟s / Rs. 132
FDA Capsule
Lincocin
Capsule Linerg
(Helix)
Approved
Minutes for 253rd
Registration Board Meeting 324
Antibiotics
(USP Spec.s)
20‟s / Rs. 220/-
100‟s / Rs. 890
116. -do- Pirox Capsule 20
mg
Each Capsule
contains:
Piroxicam (U.S.P)
20 mg
NSAID/Antigout/
Antipyretic
(USP Spec‟s)
Form 5
Rs. 20,000/-
(09-06-2015)
Dy. No. 283
Pack of
10‟s / Rs. 189/-
14‟s / Rs. 205.
20‟s / Rs. 294/-
30‟s / Rs, 360
40‟s / Rs 410
100‟s / Rs. 771
500s Rs. 3680/
FDA Capsule
Felene
Capsule
Fycam(Fynk)
Approved
117. M/s Mafins Pharma, A-5,
S.I.T.E, Super Highway
Industrial Area, Karachi
Cream/Ointment/Gel
(General) approved in
241st meeting of Central
Licensing Board held on
15-05-2015.
Moltral Gel 1%
Each gm contains
Diclofenac
Diethylamine
11.6 mg eq. to
Diclofenac
Sodium 10 mg
Phenyl Acetic
Acid
(B.P
Specification)
Form 5
Rs. 20,000/-
(09-06-2015)
Dy. No. 287
Pack of
10 gm / Rs. 49
15 gm / Rs. 78
20 gm / Rs 112
25 gm / Rs. 129
50 gm / Rs. 257
FDA
Voltarol® 1.16%
Emulgel®, gel
Mobikare Gel
(Asian
Continental)
Approved
118. -do- Clotrim Cream
1%
Each gm contains
Clotrimazole 10
mg
Imidazole / Anti
fungal
(USP Spec‟s)
Form 5
Rs. 20,000/-
(09-06-2015)
Dy. No. 279
Pack of
5 gm / Rs. 30
10 gm / Rs. 57
15 gm / Rs. 46
20 gm / Rs 98
35 gm / Rs. 105
FDA Canesten
Topical
Stimazole (GSK)
Approved
119. -do- Pirox Gel 0.5%
Each gm contains
Piroxicam 5 mg
(BP)
BP Specifications
NSAID ,Oxicam
Form 5
Rs. 20,000/-
(09-06-2015)
Dy. No. 280
Pack of
10 gm / Rs. 47
20 gm / Rs 87
25 gm / Rs. 165
MHRA approved
Feldene Gel 0.5
%
Diodex 0.5%
(Pearl)
Approved
Minutes for 253rd
Registration Board Meeting 325
120. -do- Neomyskin
Ointment 0.5%
Each gram
contains
Neomycin 5mg
equivalent to
Neomycin 3.5mg.
Aminoglycolide
Antibiotics
(USP
Specification)
Form 5
Rs. 20,000/-
(09-06-2015)
Dy. No. 284
Pack of
5 gm / Rs. 13
13 gm / Rs. 32
15 gm / Rs. 36
20 gm / Rs 48
Approved as OTC
in USFDA
Tsomycin (Tas
Pharmaceuticals)
Approved
121. -do- Menadex – N
Cream
Each gram
contains
Dexamethasone
Phosphate 10 mg
(Dexamethasone
Sodium
Phosphate)
Neomycin 3.5 mg
(as Sulfate)
(USP
Specification)
Form 5
Rs. 20,000/-
(09-06-2015)
Dy. No. 297
Pack of
5 gm / Rs. 19
13 gm / Rs. 40
15 gm / Rs. 35
20 gm / Rs 68
Dexamin – N
Cream
(Geoffman)
Deferred for
confirmation of
approval by
reference
regulatory
authority.
122. -do- Lignocaine
Compound
Ointment
Each Ointment
contains
Lignocaine HCl
0.5%
Ephedrine HCl
0.25%
Allantoin 0.50%
(BP Specification)
Form 5
Rs. 20,000/-
(09-06-2015)
Dy. No. 286
Pack of
15 gm / Rs. 16
30 gm / Rs 49.88
Logel (Elite
Pharma)
New License
Deferred for
confirmation of
approval by
reference
regulatory
authority.
123. -do- Derma Cream 1%
Each Ointment
contains Silver
Sulphadiazine 1%
(USP
Specification)
Form 5
Rs. 20,000/-
(09-06-2015)
Dy. No. 285
Pack of
10 gm / Rs. 18
15 gm / Rs. 45
20 gm / Rs 88
25gm / Rs 83
30gm / Rs 97
FDA approved
Dermazin
manufactured by
Novartis
Sulphazin (Swiss
Pharma )
Approved
Minutes for 253rd
Registration Board Meeting 326
50 gm / Rs 220
250 gm / Rs. 617
500 gm / Rs. 900
124. -do- Beta – N Cream
Each 1 g contains
1 mg of
betamethasone
(0.1% w/w) as
valerate and 5 mg
of neomycin
sulphate (0.5%
w/w).
(USP
Specification)
Corticosteroid +
Antibiotics
Form 5
Rs. 20,000/-
(09-06-2015)
Dy. No. 274
Pack of
5 gm / Rs. 17
10 gm / Rs 34
15gm / Rs 38
MHRA approved
Betnovate-N
Cream (GSK)
Betaderm-N
Cream (ATCO)
Approved
125. -do- Xylo Gel 2% w/v
Each mL contains
20 mg of
lignocaine HCl
(USP
Specification)
local anesthetic
agent
Form 5
Rs. 20,000/-
(09-06-2015)
Dy. No. 274
Pack of
5 gm / Rs. 25
10 gm / Rs 34.5
15gm / Rs 45
30 gm / Rs. 80
TGA approved
Lignocaine Gel
2% Sterile
Lignocaine HCl
(Orion
Laboratories)
Xylocaine Gel
(Barrett Hodgson)
Registration
Board deferred
the case for
determining status
of PARAS.
126. -do- Gentacin Cream
(0.1%)
Each gram
contains
Gentamicin
Sulfate USP
equivalent to 1
mg gentamicin
base
(USP
Specification)
Aminoglycoside
Antibiotics
Form 5
Rs. 20,000/-
(09-06-2015)
Dy. No. 299
Pack of
4 gm / Rs. 9.06
10 gm / Rs 27
15gm / Rs 54
20 gm / Rs. 85
FDA approved
Gentamicin
Sulphate Cream
USP 0.1%
Xylocaine Gel
(Barrett Hodgson)
Approved
Minutes for 253rd
Registration Board Meeting 327
DDC (PEC)
(Sachet Section) approved in 240th
meeting of Central Licensing Board held on 06th
March 2015.
127. M/s Linta
pharmaceuticals
(Pvt) Limited Plot
No. 03, Street no.
S-5, National
Industiral Zone
Rawat Islamabad.
(Sachet Section)
Stron 2g Sachet.
Sachet
Each Sachet contains:
Strontium Ranelate…..2.0g
(Granules for oral suspension)
Antiosteoporotic
(Manufacturer’s Specs)
Form-5
Dy. No:
1002 dated
16-04-2015
20000/-
dated 15-04-
2015
As per SRO
MHRA, UK
available in the form
of granules for oral
suspension
Onita by Pharmevo
Karachi.
.
Approved
128. M/s Linta
pharmaceuticals
(Pvt) Limited Plot
No. 03, Street no.
S-5, National
Industiral Zone
Rawat Islamabad.
Linte Sachet.
Sachet
Each Sachet contains:
Sodium chloride………3.5g
Sodium citrate………..2.9g
Potassium chloride……1.5g
Glucose, anhydrous….13.5g
Electrolyte replenisher,
Antidiarrhoeals
(Manufacturer’s Specs)
Form-5
Dy. No:
1003
dated 16-04-
2015
20000/-
dated 15-04-
2015
As per SRO
WHO Approved Approved
129. M/s Linta
pharmaceuticals
(Pvt) Limited Plot
No. 03, Street no.
S-5, National
Industiral Zone
Rawat Islamabad.
Strong Sachet.
Sachet
Each Sachet contains:
Calcium lactate
gluconate..1000mg
Vit c (ascorbic acid)….500mg
Calcium
carbonate…….327mg
Calcium supplement
(Manufacturer’s Specs)
Form-5
Dy. No: 997
dated 16-04-
2015
20000/-
dated 15-04-
2015
As per SRO
International
availability is not
confirmed
Calcium pearl sachet
by Pearl
Pharmaceuticals
Deferred for
confirmation of
approval by
reference
regulatory
authority.
130. M/s Linta
pharmaceuticals
(Pvt) Limited Plot
No. 03, Street no.
S-5, National
Industiral Zone
Rawat Islamabad.
PNK Sachet.
Sachet
Each Sachet contains:
Macrogol 3350…….13.125g
Sodium Chloride…..0.3507g
Sodium
Bicarbonate……0.1785g
Potassium
Chloride……0.0466g
(Powder for oral solution)
(Manufacturer’s Specs)
Form-5
Dy. No:
1005
dated 16-04-
2015
20000/-
dated 15-04-
2015
As per SRO
Available in MHRA,
UK. Movicol sachet
by Norgine Limited.
NabiQasim, Hilton,
Genix
Approved
131. M/s Linta
pharmaceuticals
(Pvt) Limited Plot
No. 03, Streett no.
S-5, National
Industiral Zone
Rawat Islamabad.
Airmax Sachet.
Sachet
Each Sachet of granules
contains:
Montelukast sodium
equivalent to
montelukast……4mg
Leukotriene receptor
Form-5
Dy. No: 998
dated 16-04-
2015
20000/-
dated 15-04-
2015
As per SRO
Available in MHRA,
SINGULAIR®
Paediatric sachet by
Merck Sharp &
Dohme Limited
Aerokast by Barret
Hodgson
Deferred for:
Complete
description of the
product /
pharmaceutical
form.
Correction of
manufacturing
Minutes for 253rd
Registration Board Meeting 328
antagonist (LTRA)
(Manufacturer’s Specs)
method as FPP in
the form of
granules whereas
the manufacturing
process lacks
granulation as a
part of
manufacturing
process.
132. M/s Linta
pharmaceuticals
(Pvt) Limited Plot
No. 03, Streett no.
S-5, National
Industiral Zone
Rawat Islamabad.
Ospra Sachet.
Sachet
Each Sachet contains:
Omeprazole……40mg
Sodium
bicarbonate……1680mg
Anti-ulcerants (Proton Pump
Inhibitors)
(Powder for oral suspension)
(Manufacturer’s Specs)
Form-5
Dy. No:
1000
dated 16-04-
2015
20000/-
dated 15-04-
2015
As per SRO
Available in FDA,
Zegerid sachet by
Santarus INC
Risek by Getz
Pharma.
Deferred as
product is under
review.
133. M/s Linta
pharmaceuticals
(Pvt) Limited Plot
No. 03, Street no.
S-5, National
Industiral Zone
Rawat Islamabad.
RSNK Sachet.
Sachet
Each Sachet contains:
Pre-cooked Rice
Powder……6.0g
Sodium Citrate……..0.580g
Sodium Chloride…….0.350g
Potassium
Chloride……0.300g
Antidiarrhoeals (Rehydration
Fluids)
(Sachet containing powder for
mixing with water prior to
administration).
(Manufacturer’s Specs)
Form-5
Dy. No:
1004
dated 16-04-
2015
20000/-
dated 15-04-
2015
As per SRO
Available in MHRA,
Dioralyte
Relief sachet by M/s
Sanofi, UK.
Dioralyte Rice of
M/s Sanofi, Karachi.
Approved
134. M/s Linta
pharmaceuticals
(Pvt) Limited Plot
No. 03, Street no.
S-5, National
Industiral Zone
Rawat Islamabad.
ISMEB Sachet.
Sachet
Each Sachet of granules
contains:
Mebeverine hydrochloride B.P
….135mg
Ispaghula husk B.P……3.5g
(Granules for oral suspension)
Irritable bowel syndrome
(Laxative)
(Manufacturer’s Specs)
Form-5
Dy. No:
1002
dated 16-04-
2015
20000/-
dated 15-04-
2015
As per SRO
Available in MHRA,
Fybogel Mebeverine
of Forum Health
Products Limited
Husk-M of Genix
Karachi.
Deferred for:
Complete
description of the
product /
pharmaceutical
form.
Correction of
manufacturing
method as FPP in
the form of
granules whereas
the manufacturing
process lacks
granulation as a
part of
manufacturing
process.
Minutes for 253rd
Registration Board Meeting 329
135. M/s Linta
pharmaceuticals
(Pvt) Limited Plot
No. 03, Street no.
S-5, National
Industiral Zone
Rawat Islamabad.
Zakam Sachet.
Sachet
Each Sachet contains:
Paracetamol……..500mg
Pseudoephedrine
Hcl……30mg
Mepyramine
Maleate……13mg
Pheniramine
maleate……13mg
Cold Preparations without
Anti-Infective.
(Manufacturer’s Specs)
Form-5
Dy. No: 999
dated 16-04-
2015
20000/-
dated 15-04-
2015
As per SRO
International
availability in
reference authorities
not confirmed.
Me too not
confirmed
Deferred for
confirmation of
International
availability in
reference
authorities and
me-too status.
Change of brand
name required.
136. M/s Linta
pharmaceuticals
(Pvt) Limited Plot
No. 03, Street no.
S-5, National
Industiral Zone
Rawat Islamabad.
Trof Sachet.
Sachet
Each Sachet contains:
Fosfomycin tromethamine
equivalent to
fosfomycin….3.0g
Antibiotec
(Manufacturer’s Specs)
Form-5
Dy. No:
1001
dated 16-04-
2015
20000/-
dated 15-04-
2015
As per SRO
Munorol, USFDA.
Monurol by Scharper
Pharmaceutical Pvt
Ltd.
Approved
Cream/Ointment/Gel (General) approved in 240th
meeting of CLB dated 06-03-2015
137. M/s Linta
pharmaceuticals
(Pvt) Limited Plot
No. 03, Street no.
S-5, National
Industiral Zone
Rawat Islamabad.
(Ointment section)
Fude Ointment 2.0%
Ointment
Each gram contains:
Sodium fusidate……20mg
(2%)
Antibiotec (Topical
antibacterials)
(B.P Specs)
Form-5
Dy. No:
1009
dated 16-04-
2015
20000/-
dated 15-04-
2015
As per SRO
Available in MHRA,
UK. Fusidin of Leo
labs UK.
Fusac by Sante Pvt
Ltd
Approved
138. M/s Linta
pharmaceuticals
(Pvt) Limited Plot
No. 03, Street no.
S-5, National
Industiral Zone
Rawat Islamabad.
Voltag Gel 1.0%
Gel
Each gram of gel contains:
Diclofenac Diethylamine
equivalent to diclofenac Na
B.P ….10mg (1.0%)
Non-Steroidal Anti-
Inflammatory Drug
(B.P Specs)
Form-5
Dy. No:
1011
dated 16-04-
2015
20000/-
dated 15-04-
2015
As per SRO
Available in MHRA,
UK. Voltral emugel
of M/s Novartis UK.
Klic by Tabros
pharma
Approved with
change of brand
name.
139. M/s Linta
pharmaceuticals
(Pvt) Limited Plot
No. 03, Street no.
La‟Pain Gel 0.5%
Gel
Each gram of gel contains:
Piroxicam……5mg (0.5%)
Form-5
Dy. No:
1012
dated 16-04-
Available in MHRA,
UK. Feldene of M/s
Pfizer UK.
Felden of M/s Pfizer
Approved with
change of brand
name.
Minutes for 253rd
Registration Board Meeting 330
S-5, National
Industiral Zone
Rawat Islamabad.
Non-Steroidal Anti-
Inflammatory Drug
(B.P Specs)
2015
20000/-
dated 15-04-
2015
As per SRO
Karachi.
140. M/s Linta
pharmaceuticals
(Pvt) Limited Plot
No. 03, Street no.
S-5, National
Industiral Zone
Rawat Islamabad.
Fude Cream 2.0%
Cream
Each gram of cream contains:
Fusidic acid….20mg (2.0%)
Antibiotic (Topical
antibacterials)
(B.P Specs)
Form-5
Dy. No:
1013
dated 16-04-
2015
20000/-
dated 15-04-
2015
As per SRO
Available in MHRA,
UK. Fusidin of Leo
labs UK.
Sidic of Epoch
Karachi.
Approved
141. M/s Linta
pharmaceuticals
(Pvt) Limited Plot
No. 03, Street no.
S-5, National
Industiral Zone
Rawat Islamabad.
Nobac Cream 2.0%
Cream
Each gram of cream contains:
Mupirocin Calcium 2H2O
equivalent to
Mupirocin…20mg/g
Antibiotic (Topical
antibacterials)
(U.S.P Specs)
Form-5
Dy. No:
1007
dated 16-04-
2015
20000/-
dated 15-04-
2015
As per SRO
Available in MHRA,
UK. Bactroban
cream of M/s GSK,
UK
Bactroban of GSK,
Karachi
Approved with
change of brand
name.
142. M/s Linta
pharmaceuticals
(Pvt) Limited Plot
No. 03, Street no.
S-5, National
Industiral Zone
Rawat Islamabad.
Keston Cream 0.005%
Cream
Each gram of cream contains:
Calcipotriol as
Monohydrate…. 0.05mg/g
(0.005%)
Vitamin D analogue
(Manufacturer’s Specs)
Form-5
Dy. No:
1010
dated 16-04-
2015
20000/-
dated 15-04-
2015
As per SRO
Discontinued by Leo
Pharma Uk.
Calcipot of Valor
Pharmaceutical
Deferred for
confirmation of
International
availability in
reference
authorities.
143. M/s Linta
pharmaceuticals
(Pvt) Limited Plot
No. 03, Street no.
S-5, National
Industiral Zone
Rawat Islamabad.
Ketpro Gel 2.5%
Gel
Each gram of gel contains:
Ketoprofen……25mg(2.5%)
Non-Steroidal Anti-
Inflammatory Drug
(B.P Specs)
Form-5
Dy. No:
1015
dated 16-04-
2015
20000/-
dated 15-04-
2015
As per SRO
Available in MHRA,
UK. Orovail 2.5%
Gel of M/s Sanofi
UK
Profenid of M.s
Sanofi Karachi.
Approved
144. M/s Linta
pharmaceuticals
(Pvt) Limited Plot
No. 03, Street no.
S-5, National
Industiral Zone
Rawat Islamabad.
Acpro Gel 0.1%
Gel
Each gram of gel contains:
Adapalene……0.1%(1mg)
Anti-acne
(B.P Specs)
Form-5
Dy. No:
1008
dated 16-04-
2015
20000/-
dated 15-04-
2015
As per SRO
Available in MHRA,
UK. Differin Gel of
M/s Galdermas UK
Mingle of Valor
Pharma
Approved
Minutes for 253rd
Registration Board Meeting 331
145. M/s Linta
pharmaceuticals
(Pvt) Limited Plot
No. 03, Street no.
S-5, National
Industiral Zone
Rawat Islamabad.
Bina Cream 1.0%
Cream
Each gram of cream contains:
Terbinafine as HCl …..10mg
(1.0%)
Antifungal
(Manufacturer’s Specs)
Form-5
Dy. No:
1014
dated 16-04-
2015
20000/-
dated 15-04-
2015
As per SRO
Available in MHRA,
UK. Lamisil Cream
of M/s Novartis UK.
Antifun by M/s
Chas.A Mendoza
Approved
146. M/s Linta
pharmaceuticals
(Pvt) Limited Plot
No. 03, Street no.
S-5, National
Industiral Zone
Rawat Islamabad.
Clin Gel 20g
Gel
Each gram of gel contains:
Clindamycin
Phosphate…1.2%
Tretinoin…….0.025%
Antibiotic and Retinoid
(USP Specs)
Form-5
Dy. No:
1006
dated 16-04-
2015
20000/-
dated 15-04-
2015
As per SRO
International
availability is not
confirmed.
Cleret by M/s Tabros
Pharma
Deferred for
confirmation of
approval by
reference
regulatory
authority.
DDC (PEC)
M/s Gallop Water Sciences 404, Sunder Industrial Estate Lahore.
New License (IV solution, LVP) Section
147. M/s Gallop Water
Sciences 404, Sunder
Industrial Estate
Lahore.
New License
(IV solution, LVP)
Section approved in
241st meeting of CLB
held on 15-05-2015.
G-SOL RL
IV Infusion
Each 100ml contains:
sodium
chloride……..0.60gm
Potassium
Chloride…0.04gm
Calicum Chloride2H2o
…0.27gm
Sodium lactate……0.32gm Electrolytic solution.
(B.P Specs)
Form-5
Dy. No: 3469.
dated 18-05-2015
20,000/-
Rs.77/-
Rs.56/-
Rs.50/-
1000ml, / 500ml
/200ml
Available in
MHRA, UK.
Compound
Sodium Lactate
Intravenous
Infusion of M/S
Baxter Health
ca3333333re
UK, Ltd.
.Me-too:
Hartmann‟s Sol
M/s LCPW,
Lahore
Approved.
Firm will select one
pack size as per
procedure and
Registration Board
authorized its
Chairman for
subsequent approval
for issuance of
registration letter
148. M/s Gallop Water
Sciences 404, Sundar
Industrial Estate
Lahore.
G-SOL DS
IV Infusion
Each 100ml contains:
Dextrose
anhydrous…..5gm
Sodium
chloride…….0.9gm
Caloric & Electrolyte
Sodium
(B.P Specs)
Form-5
Dy. No: 3463.
dated 18-05-2015
20,000/-
Rs.65/-
Rs.55/-
Rs.500
1000ml,500ml
200ml
• Available in US
FDA. dextrose 5%
and sodium
chloride 0.9% in
plastic container of
M/s Hospira, US.
(nda # 017585)
Me-too: M/s
Elko , Karachi
Approved.
Firm will select one
pack size as per
procedure and
Registration Board
authorized its
Chairman for
subsequent approval
for issuance of
registration letter
Minutes for 253rd
Registration Board Meeting 332
149. M/s Gallop Water
Sciences 404, Sundar
Industrial Estate
Lahore.
G-SOL 5%
IV Infusion
Each 100ml contains:
Dextrose
anhydrous….5gm
Caloric solution
(B.P Specs)
Form-5
Dy. No: 3465.
dated 18-05-2015
20,000/-
Rs.57/- RS.55/-
Rs.50/- 1000ml,
500ml, 200ml
• Available in US
FDA. dextrose 5%
and in plastic
container of M/s
Hospira, US.
Me-too: M/s
FDL, Hattar.
Approved.
Firm will select one
pack size as per
procedure and
Registration Board
authorized its
Chairman for
subsequent approval
for issuance of
registration letter
150. M/s Gallop Water
Sciences 404, Sundar
Industrial Estate
Lahore.
G-SOL (1/2) IV Infusion
IV Infusion
Each 100ml contains:
Dextrose
anhydrous……5gm
Sodium
Chloride……0.45gm Caloric & Electrolytic
solution
Form-5
Dy. No: 3467
dated 18-05-2015
20,000/-
Rs.55/500ml
Bottle
Rs.50/200ml
Bottle
• Available in US
FDA. dextrose 5%
and NaCl 0.45% in
plastic container of
M/s Hospira, US.
Me-too: M/s
Atlantic Pharma,
Ltd.
Approved.
Firm will select one
pack size as per
procedure and
Registration Board
authorized its
Chairman for
subsequent approval
for issuance of
registration letter
151. M/s Gallop Water
Sciences 404, Sundar
Industrial Estate
Lahore.
G-SOL PAEDS
IV Infusion
Each 100ml contains:
Dextrose anhydrous….4.3g
Sodium
Chloride……..0.18g
Caloric & Electrolytic
solution
Form-5
Dy. No: 3472
dated 18-05-2015
20,000/-
Rs.50/- Rs.40/-
500ml, 200ml
• Int availability
not confirmed.
Me-too: Macsol
Paeds of M/s Mac
& Rains Lahore.
Deferred for
confirmation of
approval by
reference
regulatory
authority.
152. M/s Gallop Water
Sciences 404, Sundar
Industrial Estate
Lahore.
G-SOL RLD
IV Infusion
Each 100ml contains:
Sodium
chloride…….0.60gm
Potassium
chloride…0.03gm
Calcium
chloride2H2o..0.2gm
Sodium
lactate…….0.31gm
Dextrose …………….5gm
Electrolytic & caloric
sodium
(B.P Specs)
Form-5
Dy. No: 3455
dated 18-05-2015
20,000/-
Rs.84/- Rs.59/-
Rs.50/-
1000ml,500ml
200ml
• Available in US
FDA. M/s B Braun
, US.
Me-too:
Ringolact-D of
M/s Otsuka,
Karachi.
Approved.
Firm will select one
pack size as per
procedure and
Registration Board
authorized its
Chairman for
subsequent approval
for issuance of
registration letter
153. M/s Gallop Water
Sciences 404, Sundar
Industrial Estate
Lahore.
G-SOL (NS)
IV Infusion
Each 100ml contains:
Sodium
chloride……….0.9gm
Electrolyte
(USP Specs)
Form-5
Dy. No: 3471
dated 18-05-2015
20,000/-
Rs.60/-, Rs.55/-
Rs.50/-, 1000ml,
500ml, 200ml,
• Available in US
FDA. M/s Hospira
, US.
Me-too: Lifesol
of M/s Geofman,
Karchi
Approved.
Firm will select one
pack size as per
procedure and
Registration Board
authorized its
Chairman for
Minutes for 253rd
Registration Board Meeting 333
subsequent approval
for issuance of
registration letter
154. M/s Gallop Water
Sciences 404, Sundar
Industrial Estate
Lahore.
G-SOL 10%
IV Infusion
Each 100ml contains:
Dextrose
Anhydrous…..10gm
Caloric solution
(BP Specs)
Form-5
Dy. No: 3473
dated 18-05-2015
20,000/-
Rs.70/- Rs.56/-
1000ml, 500ml,
• Available in US
FDA. M/s Baxter
Healthcare, US.
Me-too: M/s
LCPW, Lahore.
Approved.
Firm will select one
pack size as per
procedure and
Registration Board
authorized its
Chairman for
subsequent approval
for issuance of
registration letter
155. M/s Gallop Water
Sciences 404, Sundar
Industrial Estate
Lahore.
G-Lyte M
IV Infusion
Each 100ml contains:
Sodium
Chloride……..0.216gm
Potassium
Chloride…..1.5gm
Calcium Chloride 2 H2O
…..…0.022
Sodium Acetate 3 H2O
…0.313gm
Dextrose………..5.0gm
Electrolytic & Caloric
solution
Form-5
Dy. No: 3473
dated 18-05-2015
20,000/-
Rs.100/- Rs.70/-
1000ml, 500ml,
Internationally,
not available in
this strength.
Me-too:
Plabolyte-M of
M/s Otsuka,
Karachi
Deferred for
confirmation of
approval by
reference
regulatory
authority.
156. M/s Gallop Water
Sciences 404, Sundar
Industrial Estate
Lahore.
Mannitol
IV Infusion
Each 100ml contains:
Mannitol…….17.5gm
Sorbitol…….2.5gm
Osmotic diuretic
Form-5
Dy. No: 3458
dated 18-05-2015
20,000/-
Rs.200/- 500ml
Internationally
Not available in
this strength
Me-too: Mactol
of M/s Mac &
Rains, Lahore
Deferred for
confirmation of
approval by
reference
regulatory
authority.
Evaluator II
159. M/s Hi-Medic
pharmaceuticals
private limited
19- km link
multan road
Lahore
Capsule
Ceftrim Capsule 200mg
Each Capsule contains.
Cefixime Trihydrate eq to
Cefixime USP……. 200mg
Capsule
(Cephalosporin)
In-House Specs.
Form 5
Dy No.4846
Dated.
04-08-2015
Rs.20,000/-
Rs.313/-
10‟s
Maxophine
Capsule of M/s
Global
Pharmaceutical
Islamabad.
International
Availability not
provided.
As per Decision of RB.
In 250th meeting is:-
1. Applicants shall
either revise their
formulation to tablet
dosage form, if not
registered previously
and if manufacturing
facility is approved by
Minutes for 253rd
Registration Board Meeting 334
Cephalosporin
Section approved
in 242nd
meeting
of CLB held on
08-07-2015.
CLB (new registration
application with
complete fee) or,
2. Shall submit
Pharmaceutical
development data
including stability,
bioavailability/
bioequivalence studies
within six months
period.
3. For already registered
drugs, same procedure
as mentioned above (at
Sr. No. i & ii) shall be
adopted. Otherwise
show cause notice shall
be issued for
deregistration of drug in
this formulation.
4.All such application
shall be processed on
priority basis.
160. -Do-
Ceftrim Capsule 400mg
Each Capsule contains.
Cefixime Trihydrate eq to
Cefixime USP……. 400mg
Capsule
(Cephalosporin)
In-House Specs.
Form 5
Dy No.4847
Date.04-08-2015
Rs.20,000/-
Rs.512.51/-
5‟s
Cefspan Capsule
400mg by M/s
Barrett Hodgson
Pharmaceuticals.
(US-FDA)
Approved
161. -Do-
Cefrad Capsule 500 mg
Each Capsule contains
Cephradine Monohydrate eq
to Cephradine USP…
…500mg
(Cephalosporin)
Usp specs
Form 5
04-08-2015
Rs.20,000/-
12‟s /Rs.244.67/-
Velosef 250mg by
Glaxosmithkline
Pakistan.
(US-FDA)
Approved
162. -Do-
Cefrad Capsule 250 mg
Each Capsule contains.
Cephradine Monohydrate eq
to Cephradine USP…..
250mg
(Cephalosporin)
Usp specs
Form 5
04-08-2015
Rs.20,000/-
12‟s/Rs.124.55/-
Velosef 250mg per
Capsule by
Glaxosmithkline
Pakistan.
(US-FDA)
Approved
163. -Do-
Roxil Capsule 500 mg
Each Capsule contains.
Cefadroxil Monohydrate eq
to Cefadroxil USP…. 500
mg
(Cephalosporin)
USP specs.
Form 5
04-08-2015
Rs.20,000/-
12‟s / Rs.359.23/-
Duricef Capsule
500mg by
Glaxosmithkline
Pakistan.
MHRA
Approved
Minutes for 253rd
Registration Board Meeting 335
164. -Do-
Farox Capsule 100 mg
Each capsule contains.
Cefpodoxime Proxetil eq to
Cefpodoxime …… 100 mg
(Cephalosporin)
Inhouse specs
Form 5
04-08-2015
Rs.20,000/-
10‟s/ Rs. 300/-
Nefdoxime Capsule
100mg by
Neomedix
Islamabad.
International
availability not
provided.
As per Decision of RB
in 250th meeting is as
follow.
1.New applicants shall
either revise their
formulation to tablet
dosage form, if not
registered previously
and if manufacturing
facility is approved by
CLB (new registration
application with
complete fee) or,
2.Shall submit
Pharmaceutical
development data
including stability,
bioavailability/
bioequivalence studies
within six months
period.
3.For already registered
drugs, same procedure
as mentioned above (at
Sr. No. i & ii) shall be
adopted. Otherwise
showcause notice shall
be issued for
deregistration of drug in
this formulation.
All such application
shall be processed on
priority basis.
165. -Do-
Clocef Capsule 500 mg
Each Capsule contains.
Cefaclor Monohydrate eq to
Cefaclor USP…………
500mg
(Cephalosporin)
USP specs.
Form 5
04-08-2015
Rs.20,000/-
12‟s/-
Rs. 557.82/-
Ceclor Capsule
500mg by AGP
Karachi.
(US-FDA)
Approved
166. -Do-
Clocef Capsule 250 mg
Each Capsule contains.
Cefaclor Monohydrate eq to
Cefaclor USP…… 250mg
(Cephalosporin)
USP specs.
Form 5
04-08-2015
Rs.20,000/-
12‟s /
Rs. 304.78/-
Ceclor Capsule
250mg by AGP
Karachi.
US-FDA
Approved
Minutes for 253rd
Registration Board Meeting 336
167. -Do-
Lecef Capsule 500 mg
Each Capsule contains.
Cephalexin Monohydrate eq
to Cephalexin USP 500 mg
Capsule
(Cephalosporin)
USP specs.
Form 5
04-08-2015
Rs.20,000/-
12‟s/ Rs. 244.67/-
Ceporex Capsule
200mg by
Glaxosmithkline
Karachi.
(MHRA)
Approved
168. -Do-
Lecef Capsule 250 mg
Each Capsule contains.
Cephalexin Monohydrate eq
to Cephalexin USP………
250mg
(Cephalosporin)
USP specs.
Form 5
04-08-2015
Rs.20,000/-
12‟s / Rs. 102/-
Ceporex Capsule
250mg by
Glaxosmithkline
Karachi.
(MHRA)
Approved
Dry Powder Injection (Cephalosporin)
169. M/s Hi-Medic
pharmaceuticals
private limited
19- km link
multan road
Lahore
Dry Powder
injection Vials
Cephalosporin
approved in 242nd
meeting of CLB
dated 08-07-2015.
Hyphin Injection 1 gm
Each vial contains:-
Ceftriaxone Sodium USP eq
to Ceftriaxone 1.0 gm
Injection (IV)
(Cephalosporin)
USP specs.
Form 5
04-08-2015
Rs.20,000/-
597/- per
pack(1‟s)
Rocephin
Injection 1gm by
Martin Dow
Pharmaceuticals-
Karachi
USFDA
Deferred for
clarification of API
(Ceftriaxone DiSodium
Pentahydrate) as
claimed by the firm
170.
-do-
Hyphin Injection 500 mg
Each vial contains:-
Ceftriaxone Sodium USP eq
to Ceftriaxone 500 mg
Injection (IV)
(Cephalosporin)
USP specs.
Form 5
04-08-2015
Rs.20,000/-
299/- per pack
Rocephin
Injection 500 mg
By M/s Martin
Dow
Pharmaceuticals-
Karachi.
USFDA
Deferred for
clarification of API
(Ceftriaxone DiSodium
Pentahydrate) as
claimed by the firm
171.
-do-
Hyphin Injection 250 mg
Each vial contains:-
Ceftriaxone Sodium USP eq
to Ceftriaxone 250 mg
Injection (IV)
(Cephalosporin)
USP specs.
Form 5
04-08-2015
Rs.20,000/-
141.4/- per pack
Rocephin
Injection 250 mg
By m/s Martin
Dow
Pharmaceuticals-
Karachi.
USFDA
Deferred for
clarification of API
(Ceftriaxone DiSodium
Pentahydrate) as
claimed by the firm
172.
-do-
Ceftam Injection 2 gm
Each vial contains:-
Cefoperazone Sodium USP
eq to Cefoperazone 1.0 gm
Sulbactam Sodium USP eq
to Sulbactam 1.0 gm Injection
Form 5
04-08-2015
Rs.20,000/-
680/pack
Sulzone Injection
2.0 gm by m/s
Biocare
Laboratories.
Not available in
SRA„s However
the Registration
Approved with one
route of administration
as per innovator (IM or
IV)
Minutes for 253rd
Registration Board Meeting 337
(Cephalosporin)
USP specs.
Board approved the
applied product in
previous meetings
due to its clinical
importance.
Ref:245th meeting
173.
-do-
Ceftam Injection 1.0 gm
Each vial contains:-
Cefoperazone Sodium USP
eq to Cefoperazone 500mg
Sulbactam Sodium USP eq
to Sulbactam 500 mg
Injection
(Cephalosporin)
USP specs.
Form 5
04-08-2015
Rs.20,000/-
400/-
Sulzone Injection
2.0 gm by m/s
Biocare
Laboratories.
Not available in
SRA„s However
the Registration
Board approved the
applied product in
previous meetings
due to its clinical
importance.
Ref:245th meeting
Approved with one
route of administration
as per innovator (IM or
IV)
174.
-do-
Hifime Injection 500 mg
Each vial contains:-
Cefepime Hydrochloride USP
eq to Cefepime 500 mg
Injection
(Cephalosporin)
USP specs.
Form 5
04-08-2015
Rs.20,000/-
445.63/-
Maxipime of
Hospira Inc
Maxipime of GSK,
Karachi.
Approved in 245th
meeting.
Approved with one
route of administration
as per innovator (IM or
IV)
175.
-do-
Hifime Injection 1.0 gm
Each vial contains:-
Cefepime Hydrochloride USP
eq to Cefepime 1.0 gm
Injection
(Cephalosporin)
USP specs.
Form 5
04-08-2015
Rs.20,000/-
839.59/-
Maxipime of
Hospira Inc
Maxipime of GSK,
Karachi.
Approved in 245th
meeting.
Approved with one
route of administration
as per innovator (IM or
IV)
176.
-do-
Cefzid Injection 1.0 gm
Each vial contains:-
Ceftazidime Pentahydrate
USP eq to 1.0 gm
Ceftazidime
(Cephalosporin)
USP specs.
Form 5
04-08-2015
Rs.20,000/
Rs.477.00/-
Fortum Injection
1.0 gm by m/s
Glaxosmithkline
Pakistan Ltd
Karachi.
Ceftazidime for
injection, USP is a
sterile, dry-
powdered mixture
of ceftazidime
pentahydrate and
sodium carbonate.
The amount of
sodium carbonate
in the powder for
injection/infusion is
about 118 mg per 1
g of ceftazidime.
Approved with one
route of administration
as per innovator (IM or
IV)
Minutes for 253rd
Registration Board Meeting 338
USFDA, MHRA
177.
-do-
Cefzid Injection 500 mg
Each vial contains:-
Ceftazidime Pentahydrate
USP eq to 500 mg
Ceftazidime
(Cephalosporin)
USP specs.
Form 5
04-08-2015
Rs.20,000/-
254.00/-
Fortum Injection
1.0 gm by m/s
Glaxosmithkline
Pakistan Ltd
Karachi.
Ceftazidime for
injection, USP is a
sterile, dry-
powdered mixture
of ceftazidime
pentahydrate and
sodium carbonate.
The amount of
sodium carbonate
in the powder for
injection/infusion is
about 118 mg per 1
g of ceftazidime.
USFDA, MHRA
Approved with one
route of administration
as per innovator (IM or
IV)
178.
-do-
Cefzid Injection 250 mg
Each vial contains:-
Ceftazidime Pentahydrate
USP eq to 250 mg
Ceftazidime
(Cephalosporin)
USP specs.
Form 5
04-08-2015
Rs.20,000/-
167.00/-
Fortum Injection
250 mg by m/s
Glaxosmithkline
Pakistan Ltd
Karachi.
MHRA
Approved with one
route of administration
as per innovator (IM or
IV)
Oral Dry Powder Suspension (Cephalosporin)
179. M/s Hi-Medic
pharmaceuticals
private limited
19- km link
multan road
Lahore
Oral Dry Powder
Suspension
Cephalosporin
approved in 242nd
meeting of CLB
held on 08-07-
2015.
Ceftrim Oral Suspension
100mg/5ml
Each 5 ml contains:-
Cefixime USP 100mg/5ml
Suspension
(Cephalosporin)
USP specs.
Form 5
04-08-2015
Rs.20,000/-
Rs.286/30 ml
Cefspan Oral
Suspension
100mg/5ml by m/s
Barrett Hodgson
Phramaceuticals
(pvt) Ltd Karachi.
(US-FDA)
Approved.
180. -do- Ceftrim DS Oral Suspension
200mg/5ml
Each 5 ml contains:-
Cefixime USP 200mg/5 ml
Suspension
(Cephalosporin)
USP specs.
Form 5
04-08-2015
Rs.20,000/-
Rs.350/30 ml –
Cefspan DS Oral
Suspension
200mg/5ml by m/s
Barrett Hodgson
Phramaceuticals
(pvt) Ltd Karachi.
(US-FDA)
Approved
Minutes for 253rd
Registration Board Meeting 339
181. -do- Cefrad Oral Suspension
250mg/5ml
Each 5 ml contains:-
Cephradine Monohydrate eq
to Cephradine USP 250mg/5
ml Suspension
(Cephalosporin)
USP specs.
Form 5
04-08-2015
Rs.20,000/-
90 ml –
Rs.211.60/-
Velosef Oral
Suspension
250mg/5ml by m/s
Glaxosmithkline
Pakistan Ltd
Karachi, Pakistan
(US-FDA)
Approved
182. -do- Cefrad Oral Suspension
125mg/5ml
Each 5 ml contains:-
Cephradine Monohydrate eq
to Cephradine USP 125mg/5
ml Suspension
(Cephalosporin)
USP specs.
Form 5
04-08-2015
Rs.20,000/-
90 ml – 124.2/-
Velosef Oral
Suspension
125mg/5ml by m/s
Glaxosmithkline
Pakistan Ltd
Karachi, Pakistan
(US-FDA)
Approved
183. -do- Roxil Oral Suspension
125mg/5ml
Each 5 ml contains:-
Cefadroxil Monohydrate eq
to Cefadroxil USP 125mg/5
ml Suspension
(Cephalosporin)
USP specs.
Form 5
04-08-2015
Rs.20,000/-
60 ml – 161.63/-
Duricef Oral
Suspension
125mg/5ml by m/s
Glaxosmithkline
Pakistan Ltd
Karachi, Pakistan
(USFDA)
Deferred for
clarification that firm
has demanded pack size
90 ml but fill weight is
30gm/60ml.
184. -do- Clocef Oral Suspension 250
mg/5ml
Each 5 ml contains:-
Cefaclor Monohydrate eq to
Cefaclor USP 250 mg/5 ml
Suspension
(Cephalosporin)
USP specs.
Form 5
04-08-2015
Rs.20,000/-
60 ml – 328.53/-
Ceclor Oral
Suspension
250mg/5ml by m/s
AGP Karachi,
Pakistan
(US-FDA)
Deferred for the
clarification of Essence
powder flavor.
185. -do- Clocef Oral Suspension 125
mg/5ml
Each 5 ml contains:-
Cefaclor Monohydrate eq to
Cefaclor USP 125mg/5 ml
Suspension
(Cephalosporin)
USP specs.
Form 5
04-08-2015
Rs.20,000/-
60 ml – 187.94/-
Ceclor Oral
Suspension
125mg/5ml by m/s
AGP Karachi,
Pakistan
(US-FDA)
Deferred for the
clarification of Essence
powder flavor.
186. -do- Farox Oral Suspension
40mg/5ml
Each 5 ml contains:-
Cefpodoxime Proxetil eq to
Cefpodoxime USP 40mg/5
ml Suspension
(Cephalosporin)
USP specs.
Form 5
04-08-2015
Rs.20,000/-
50 ml – 338.89/-
Orelox Oral
Suspension
40mg/5ml by m/s
Sanofi Aventis
Karachi, Pakistan
(MHRA)
Approved
Minutes for 253rd
Registration Board Meeting 340
187. -do- Lecef Oral Suspension 250
mg/5ml
Each 5 ml contains:-
Cephalexin Monohydrate eq
to Cephalexin USP 250 mg/5
ml Suspension
(Cephalosporin)
USP specs.
Form 5
04-08-2015
Rs.20,000/-
60 ml – 102/-
Ceporex Oral
Suspension
250mg/5ml by m/s
Glaxosmithkline
Pakistan Ltd
Karachi, Pakistan
(USFDA, MHRA)
Approved with change
of brand name
188. -do- Lecef Oral Suspension
125mg/5ml
Each 5 ml contains:-
Cephalexin Monohydrate eq
to Cephalexin USP 125mg/5
ml Suspension
(Cephalosporin)
USP specs.
Form 5
04-08-2015
Rs.20,000/-
60 ml – 61.95/-
Ceporex Oral
Suspension
125mg/5ml by m/s
Glaxosmithkline
Pakistan Ltd
Karachi, Pakistan
(USFDA, MHRA)
Approved
Capsule (General) Section (New License approved in 242nd
Meeting of CLB)
189. Jenner
Pharmaceuticals
(Pvt.) Ltd.
Plot # 3, M2-
Pharma Zone,
26KM, Lahore-
Sharikpur Road,
Shaikhupura –
Pakistan
Sulsin Capsules 0.4mg
Each Capsule Contains:
Tamsulosin Hydrochloride
0.4mg (Pellets)
(Alfa 1-a blocker)
USP Specs.
Pellets source: Vision
Pharmaceuticals,
Islamabad
Dairy Date
28.08.15
Rs: 20000.00
dated 18.08.15
Form 5
As per SRO
10‟s
Flomax Capsules
USA and Japan
Astellas Pharma
MHRA, FDA
Maxflow Cap
(CCL)
Deferred for
confirmation regarding
permission for
Tamsulosin pellets
manufacturing by M/s
vision pharma
Islamabad.
190. -do- Ezol Capsul
es 40mg
Each Capsule Contains:
Esomeprazole Magnesium
enteric coated pellets
equivalent to Esomeprazole:
40mg
(proton pump inhibitor)
Pellets source: Ocean
Pharmacoat (Pvt) Ltd. Plot
no.44 C.I.E. Ghandi Nagar,
Bolanagar, Hyderabad,
India.
Form 5
Dairy Date
28.08.15
Rs: 20000.00
dated 18.08.15
Rs: 80000.00
Dated 28.08.15
As per SRO
14‟s
Nexium Capsules
By AstraZeneca
UK
1- Nexum (Getz)
2- Purpal (DRL)
Newly Licensed
Unit
Approved. Firm will
submit stability data and
legalized GMP of
pellet‟s manufacturer
and
Chairman Registration
Board will permit
issuance of registration
letter.
191. -do- Eespa SR 200mg Capsules
Each Capsule Contains:
Mebeverine Hydrochloride as
enteric coated pellets: 200mg
(Smooth muscles relaxant,
anti spasmods)
Pellets source: M/S RA
chem. Pharm, R.S. No.50/1.
Mukteswarapuram,
Jaggaiahpet Manadal,
Form 5
Dairy Date
28.08.15
Rs: 20000.00
dated 18.08.15
As per SRO
Colofac MR
Capsules By
Abbott Health Care
UK
MHRA
Mebever MR
Capsules (Getz)
Deferred for
clarification of
following points.
Registered as modified
release pallets.
Firm has provided only
COA (copy) of pellets
from manufacturer.
COA don‟t shows it as
modified release pellets.
Minutes for 253rd
Registration Board Meeting 341
Krishna (Dist). A.P.,521175,
India.
192. -do- Meraz Capsules 20mg
Each Capsule Contains:
Omeprazole as enteric coated
pellets: 20mg
(proton pump Inhibitor)
Pellets source: M/s
Spansules Formulations,
plot No.154, A4, I.D.A.
Bollaram, Hyderabad,
India.
Form 5
Dairy Date
28.08.15
Rs: 20000.00
dated 18.08.15
Rs: 80000.00
Dated 19.08.15
As per SRO
10‟s
Prilosec Capsules
By
AstraZeneca, USA
Risec Capsules
(Getz)
Newly Licensed
Unit
Last inspection as
on 19.05.15
Approved. Firm will
submit stability data and
legalized GMP of pellet‟s
manufacturer and
Chairman Registration
Board will permit issuance
of registration letter.
Dry Powder Suspension (General) Section (New License approved in 242nd
Meeting of CLB)
193. -do- Linolid Dry Suspension
100mg
Each 5ml after reconstitution
contains :
Linezolid : 100mg
(Anti bacterial)
USP Specs.
Form 5
Dairy Date
24.08.15
Rs: 20000.00
dated 18.08.15
As per SRO
60ml
Zyvox Suspension
By
Pharmacia &
Upjohn, UK
MHRA
Zevoxid (Genome)
Approved
194. -do- Azitro Dry Suspension
200mg
Each 5ml after reconstitution
contains :
Azithromycin as Dihydrate :
200mg
(Macrolide)
Form 5
Dairy Date
24.08.15
Rs: 20000.00
dated 18.08.15
As per SRO
15ml
Zithromax Powder
for Suspension By
Pfizer Limited, UK
MHRA
Azithrocin Susp by
m/s Bexpharma
Approved
195. -do- Claritro Dry Suspension
125mg
Each 5ml after reconstitution
contains :
Clarithromycin : 125mg
(Macrolide)
Form 5
Dairy Date
24.08.15
Rs: 20000.00
dated 18.08.15
As per SRO
60ml
Klaricid
Suspension By
BGP Products
Limited, UK
MHRA
Claritek Susp. By
m/s (Getz)
Deferred for
clarification of
manufacturing method.
Minutes for 253rd
Registration Board Meeting 342
196. -do- Zisel Dry Suspension 10mg
Each 5ml after reconstitution
contains :
Zinc sulphate eq to elemental
Zinc: 10mg
(Mineral supplement,
Antidirrial)
(In House)
Form 5
Dairy Date
24.08.15
Rs: 20000.00
dated 18.08.15
As per SRO
60ml
WHO/ UNICEF
recommendation is
for zinc sulphate
10mg/5 ml.
solution.
Yes 2 Zinc (Zafa)
Deferred for
confirmation of
approval by reference
regulatory authority and
commemts/ opinion of
WHO Pakistan.
Dosage
recommendation
(UNICEF/ WHO):
Tablets may contain
either 10 or 20 mg of
zinc and the
concentration of zinc in
oral solutions may be
10mg/5mL. Decisions
about the best strength
to be used should
depend on better
adherence to treatment
by patient, taking into
consideration other
issues as well, such as
price, medicine
delivery, and duration
of treatment (10- or 14-
day treatment).
Preferably, in any
given country, only one
strength of tablets or
oral solution should be
available to avoid
dosing errors. If 10-mg
zinc tablets are chosen,
it will mean that older
children will have to
take two tablets each
day; if 20-mg zinc
tablets are chosen, it
will mean that for
younger infants only
half a tablet will be
given each day and
therefore tablets will
have to be scored to
facilitate this.
With oral solutions,
because it is difficult to
accurately measure
half a teaspoon of
solution, it is
recommended that oral
solution of zinc contain
Minutes for 253rd
Registration Board Meeting 343
10mg of elemental zinc
per 5 mL, that is to say
per one teaspoon. It
means that infants
below 6 months of age
will receive one
teaspoon, while older
children will need 2
teaspoons of oral
solution per day.
(Ref: UNICEF/ WHO)
197. -do- I-Malt Dry Suspension 50mg
Each 5ml after reconstitution
contains : Iron III Hydroxide
Polymaltose complex eq. to
Elemental Iron…..50mg
(Iron deficiency & Iron
associated anemia)
IN House Specs.
Form 5
Dairy Date
28.08.15
Rs: 20000.00
dated 18.08.15
As per SRO
60ml
Ferry Suspension
(Tabros)
International
availability not
confirmed.
Deferred for
confirmation of
approval of regulatory
authority
198. -do- Nazole Dry Suspension 50mg
Each 5ml after reconstitution
contains :
Fluconazole : 50mg
(anti fungal)
Form 5
Dairy Date
24.08.15
Rs: 20000.00
dated 18.08.15
As per SRO
35ml
Fluconazole
Powedr for
Suspension By
Genus
Pharmaceuticals,
UK
MHRA
Fcozole Susp
(Medicraft)
Approved
Sachet (General) Section (New License approved in 242nd
Meeting of CLB)
199. -do- Montel Satchet 4mg
Each Sachet Contains:
Montelukast as Sodium : 4mg
(Anti-Asthametic)
(in house)
Form 5
Dairy Date
24.08.15
Rs: 20000.00
dated 18.08.15
As per SRO
14‟s
Singulair Granule
By Merck Sharp
and Dohme, UK
MHRA, USFDA
Singulair (OBS
Pharma)
Approved
200. -do- Ronat Sachet 2 gm
Each Sachet Contains:
Strontium Ranelate : 2 gm
(Osteoprosis, bone diseases)
(granules for oral sachet)
(In House Specs.)
Form 5
Dairy Date
28.08.15
Rs: 20000.00
dated 18.08.15
As per SRO
7‟s
Protelos Sachet By
LES Laboratories
Servier, France
This medicinal
product is subject
to additional
monitoring. This
will allow quick
Approved
Minutes for 253rd
Registration Board Meeting 344
identification of
new safety
information.
Healthcare
professionals are
asked to report any
suspected adverse
reactions.
MHRA
Onita Sachet
(Pharmevo)
201. -do- RC Powder Sachet
Each Sachet Contains:
Rice Powder (pre-cooked):
6.00 gm
Sodium Citrate: 0.58 gm
Sodium Chloride : 0.35 gm
Potassium Chloride: 0.30gm
(granules for oral sachet)
(Treatment of electrolytes)
In House Specs.
Form 5
Dairy Date
24.08.15
Rs: 20000.00
dated 18.08.15
As per SRO
10‟s
Dioralyte Sachet
By
Aventis Pharma
Limited, UK
MHRA
Gastrolyte Sachet
(sanofi Aventis)
Approved
202. -do- Smect Sachet 3 gm
Each Sachet Contains:
Dioctahedral Smectite: 3gm
(Antidiarrhoeal)
(granules for oral sachet)
In House
Form 5
Dairy Date
28.08.15
Rs: 20000.00
dated 18.08.15
As per SRO
30‟s
Smecta Sachet
(Atco)
Available in france.
Approved in 250th
meeting.
Approved
203. -do- Mebeplus Sachet
135mg/3.5mg
Each Sachet Contains:
Mebeverine HCl: 135mg
Ispaghula Husk: 3.5gm
(Antispasmodic)
(granules for oral sachet)
Form 5
Dairy Date
24.08.15
Rs: 20000.00
dated 18.08.15
As per SRO
10‟s
Fybogel
Mebeverine By
Reckitt Benckiser
Healthcare (UK)
MHRA
Mevulak Sachet
(sami)
Approved
New Molecules
204. -do- Lansodex Capsules 30mg
Each Capsule contains:
Dexlansoprazole as enteric
coated pellets 30mg
(Proton Pump Inhibtor)
Form 5D
Dairy Date
28.08.15
Rs: 50000.00
dated 19.08.15
Dexilant Capsules
By
Takeda
Pharmaceuticals
Deferred for documents
regarding pellets source
and stability studies as
per 249th meeting of RB
Minutes for 253rd
Registration Board Meeting 345
Pellets source: M/s
Spansules Formulations,
plot No.154, A4, I.D.A.
Bollaram, Hyderabad,
India.
Rs 50000.00
28.08.15
As per SRO
10‟s
USA
USFDA
205. -do- Lansodex Capsules 60mg
Each Capsule contains:
Dexlansoprazole as enteric
coated pellets 60mg
(Proton Pump Inhibtor)
Pellets source: M/s
Spansules Formulations,
plot No.154, A4, I.D.A.
Bollaram, Hyderabad,
India.
Form 5D
Dairy Date
28.08.15
Rs: 50000.00
dated 19.08.15
Rs 50000.00
28.08.15
As per SRO
10‟s
Dexilant Capsules
By
Takeda
Pharmaceuticals
USA
USFDA
Deferred for documents
regarding pellets source
and stability studies as
per 249th meeting of RB
206. -do- Linaclo Capsules 145mcg
Each Capsule Contaiss:
Linaclotide Capsules :
145mcg
(Guanylate cyclase-C recptor
agnoist)
Form 5D
Dairy Date
28.08.15
Rs: 50000.00
dated 19.08.15
As per SRO
10‟s
Linzess Capsules
By
Forest
Laboratories, USA
Deferred for Stability
Data as per giudlines
approved by the board
in 249th meeting not
provided.
207. -do- Linaclo Capsules 290mcg
Each Capsule Contaiss:
Linaclotide Capsules :
290mcg
(Guanylate cyclase-C recptor
agnoist)
Form 5D
Dairy Date
28.08.15
Rs: 50000.00
dated 19.08.15
As per SR
10‟s
Linzess Capsules
By
Forest
Laboratories, USA
Deferred for Stability
Data as per giudlines
approved by the board
in 249th meeting not
provided.
208. -do- Silosin Capsule 4mg
Each Capsule Contains:
Silodosin 4mg
(Alfa 1-a blocker)
Form 5D
Dairy Date
28.08.15
Rs: 50000.00
dated 19.08.15
As per SRO
10‟s
Rapaflo Capsules
By
Watson Laboratory
USA
Deferred for Stability
Data as per giudlines
approved by the board
in 249th meeting not
provided.
209. -do- Silosin Capsule 8mg
Each Capsule Contains:
Silodosin 8mg
(Alfa 1-a blocker)
Form 5D
Dairy Date
28.08.15
Rs: 50000.00
dated 19.08.15
As per SRO
10‟s
Rapaflo Capsules
By
Watson Laboratory
USA
Deferred for Stability
Data as per giudlines
approved by the board
in 249th meeting not
provided.
EVALUATOR III M/s PCP Laboratories, Okara
Oral Dry Powder Suspension (Cephalosporin)
Minutes for 253rd
Registration Board Meeting 346
210. M/s PCP
Laboratories,
98-Km
Multan Road
Akhtarabad,
Okara.
Cephalospori
n dry powder
oral
suspension
approved in
240th meeting
of CLB
PEXIME Suspension 100mg
Each 5ml contains:
Cefixime as
trihydrate…..100mg
Cephalosporin
USP
Form-5
Dy. No 4530
dated 15-07-15
20000/-
As per SRO/
30ml Amber
glass bottle
Suprax 100mg/5ml
(USFDA)
Cefspan of Barrett
Hodgson Karachi
Approved with change
in brand name.
211. -do- PEXIME Suspension 200mg
Each 5ml contains:
Cefixime as
trihydrate…..200mg
Cephalosporin
USP
Form-5
Dy. No 4543
dated 15-07-15
20000/-
As per SRO/
30ml Amber
glass bottle
Suprax 100mg/5ml
(USFDA)
Cefspan of Barrett
Hodgson Karachi
Approved with change
in brand name.
212. -do- PECEDIN Suspension 250mg
Each 5ml contains:
Cefradine……..250mg
Cephalosporin
USP
Form-5
Dy. No 4528
dated 15-07-15
20000/-
As per SRO/
60ml Amber
glass bottle
Valosef of
Apothecon
(USFDA)
Valosef of GSK
Karachi
Approved
213. -do- PECEDIN Suspension 125mg
Each 5ml contains:
Cefradine…………..125mg
Cephalosporin
USP
Form-5
Dy. No
4535dated 15-07-
15
20000/-
As per SRO/
60ml Amber
glass bottle
Valosef of
Apothecon
(USFDA)
Valosef of GSK
Karachi
Approved
214. -do- PEDROX Suspension 250mg
Each 5ml contains:
Cefadroxil as monohydrate
Cephalosporin
USP
Form-5
Dy. No 4526
dated 15-07-15
20000/-
As per SRO/
60ml Amber
glass bottle
Cefadroxil
Suspension
(USFDA)
Duracef of GSK
Karachi
Approved
215. -do- PECHLOR Suspension 125mg
Each 5ml contains:
Cefaclor….125mg
Cephalosporin
BP
Form-5
Dy. No 4542
dated 15-07-15
20000/-
As per SRO/
60ml Amber
glass bottle
Cefaclor
Suspension
(USFDA)
Duracef of GSK
Karachi
Approved
Minutes for 253rd
Registration Board Meeting 347
216. -do- PECHLOR Suspension 250mg
Each 5ml contains:
Cefaclor….250mg
Cephalosporin
BP
Form-5
Dy. No 4542
dated 15-07-15
20000/-
As per SRO/
60ml Amber
glass bottle
Cefaclor
Suspension
(USFDA)
Duracef of GSK
Karachi
Approved
217. -do- PROXIME Suspension 125mg
Each 5ml contains:
Cefuroxime as axetil….125mg
Cephalosporin
Manufacturer
Form-5
Dy. No 4533
dated 15-07-15
20000/-
As per SRO/
60ml Amber
glass bottle
Cefuroxime
Suspension
(USFDA)
Daycef of Shrooq
Pharma
Approved
218. -do- PEFALEX Suspension 125mg
Each 5ml contains:
Cefalexin as
monohydrate…..125mg
Cephalosporin
USP
Form-5
Dy. No 4536
dated 15-07-15
20000/-
As per SRO/
60ml Amber
glass bottle
Keflex of Shiongi
(USFDA)
Keflex of AGP
Karachi
Approved
219. -do- PEFALEX Suspension 250mg
Each 5ml contains:
Cefalexin as
monohydrate…..250mg
Cephalosporin
USP
Form-5
Dy. No 4537
dated 15-07-15
20000/-
As per SRO/
60ml Amber
glass bottle
Keflex of Shiongi
(USFDA)
Keflex of AGP
Karachi
Approved
Capsule (Cephalosporin)
220. M/s PCP
Laboratories,
98-Km
Multan Road
Akhtarabad,
Okara.
(Cephalospori
n dry powder
oral
suspension) in
241st meeting
of CLB
PEFALEX Capsules 500mg
Each capsule contains:
Cefalexin as
monohydrate…..500mg
Cephalosporin
USP
Form-5
Dy. No 4529
dated 15-07-15
20000/-
As per SRO/
Pack of 1x12‟s
Keflex of Shiongi
(USFDA)
Keflex of AGP
Karachi
Approved
Minutes for 253rd
Registration Board Meeting 348
221. -do- PEFALEX Capsules 250mg
Each capsule contains:
Cefalexin as
monohydrate…..250mg
Cephalosporin
USP
Form-5
Dy. No 4540
dated 15-07-15
20000/-
As per SRO/
Pack of 1x12‟s
Keflex of Shiongi
(USFDA)
Keflex of AGP
Karachi
Approved
222. -do- PROXIME Capsules 250mg
Each capsule contains:
Cefuroxime as axetil….250mg
Cephalosporin
Manufacturer
Form-5
Dy. No 4524
dated 15-07-15
20000/-
As per SRO/
Pack of 1x12‟s
Not found in
stringent SRA‟s
Daycef of Sharooq
Pharma Lahore
Deferred for
confirmation of
approval of reference
regulatory authorities.
223. -do- PROXIME Capsules 500mg
Each capsule contains:
Cefuroxime as axetil….500mg
Cephalosporin
Manufacturer
Form-5
Dy. No 4527
dated 15-07-15
20000/-
As per SRO/
Pack of 1x12‟s
Not found in
stringent SRA‟s
Trucef of Synchro
Pharma
Deferred for
confirmation of
approval of reference
regulatory authorities.
224. -do- PECEDIN Capsules250mg
Each capsule contains:
Cefradine……..250mg
Cephalosporin
BP
Form-5
Dy. No 4525
dated 15-07-15
20000/-
As per SRO/
Pack of 1x12‟s
Valosef of
Apothecon
(USFDA)
Valosef of GSK
Karachi
Approved
225. -do- PECEDIN Capsules500mg
Each capsule contains:
Cefradine……..500mg
Cephalosporin
BP
Form-5
Dy. No 4534
dated 15-07-15
20000/-
As per SRO/
Pack of 1x12‟s
Valosef of
Apothecon
(USFDA)
Valosef of GSK
Karachi
Approved
226. -do- PEDROX capsules 500mg
Each capsule contains:
Cefadroxil as
Form-5
Dy. No 4532
dated 15-07-15
Cefadroxil capsules
(USFDA)
Duracef of GSK
Approved
Minutes for 253rd
Registration Board Meeting 349
monohydrate….500mg
Cephalosporin
USP
20000/-
As per SRO/
Pack of 1x12‟s
Karachi
227. -do- PECHLOR capsules 500mg
Each capsule contains:
Cefaclor….500mg
Cephalosporin
BP
Form-5
Dy. No 4538
dated 15-07-15
20000/-
As per SRO/
Pack of 1x12‟s
Cefaclor capsules
(USFDA)
Duracef of GSK
Karachi
Approved
228. -do- PECHLOR capsules 250mg
Each capsule contains:
Cefaclor….250mg
Cephalosporin
BP
Form-5
Dy. No 4538
dated 15-07-15
20000/-
As per SRO/
Pack of 1x12‟s
Cefaclor capsules
(USFDA)
Duracef of GSK
Karachi
Approved
229. -do- PEXIME Capsules 400mg
Each capsule contains:
Cefixime as
trihydrate…..400mg
Cephalosporin
USP
Form-5
Dy. No 4531
dated 15-07-15
20000/-
As per SRO/
Pack of 1x5‟s
Suprax (USFDA)
Cefspan of Barrett
Hodgson Karachi
Approved
Minutes for 253rd
Registration Board Meeting 350
Case no 4 :- ADDITIONAL SECTIONS CASES
EVALUATOR I
M/s Wilshire Laboratories, Lahore
Injection (Psychotropic/Narcotics)
230. M/s Wilshire
Laboratories (Pvt)
Ltd, 124/1, Quaid-e-
Azam Industrial
Estate, Kot
Lakhpat, Lahore.
Liquid Injection
(Psychotropic/Narc
otics) Ampoule
approved in 241st
meeting of CLB
dated 15-05-2015.
Reqnyl Injection
Each ml contains
Fentanyl Citrate eq to
fentanyl....50mcg
Narcotic Analgesic
USP Specifications
Form-5
07-07-2015 diary
No 7300.
Rs20,000
As per SRO
471(I)93
Fentanyl Citrate, USA,
Abbott
Fentra by M/s Brookes
Pharma
Approved
231. -do- Efed Injection
Each ml contains
Ephedrine
hydrochloride....30mg
Sympathomimetic
B.P Specifications
Form-5
07-07-2015 diary
No 7302.
Rs20,000
As per SRO
471(I)93
Ephedrine HCL, UK,
by M/sAuden
Vepressor by M/s
Venus Pharma
.
Approved
232. – -do- Zultra Injection
Each 2ml contains
Tramadol
Hydrochloride..100mg
Opiod Analgesic
Manufacturer‟s
Specifications
Form-5
07-07-2015 diary
No 7305.
Rs20,000
As per SRO
471(I)93
Tramadol HCL
injection, UK, by M/s
Brown & Burk.
Tamadol by M/s
Highnoon Pharma
Approved
233. -do- Zultra Injection
Each ml ampoule
contains Tramadol
Hydrochloride..50mg
Opiod Analgesic
Manufacturer‟s
Specifications
Form-5
07-07-2015 diary
No 7296.
Rs20,000
As per SRO
471(I)93
Tramadol HCL
injection, UK, by M/s
Brown & Burk.
Tamadol by M/s
Highnoon Pharma
Approved
Minutes for 253rd
Registration Board Meeting 351
234. -do- Qonza Injection
Each ml contains
Morphine
Sulphate..15mg
Narcotic Analgesic
B.P Specifications
Form-5
07-07-2015 diary
No 7301.
Rs20,000
As per SRO
471(I)93
Morphine Sulphate
injection, USA, by
M/s Meridian.
Morphine Sulphate
injection by M/s PDH
Approved
235. -do- Opronex Injection
Each ml contains
Buprenorphine
Hydrochloride eq. to
Buprenorphine..0.3mg
Narcotic Analgesic
B.P Specifications
Form-5
07-07-2015 diary
No 7304.
Rs20,000
As per SRO
471(I)93
Buprenex injection,
USA, by M/s Reckit.
Temgesic injection by
M/s Reckit
Approved
236. -do- Pentalop Injection
Each ml contains
Pentazocine Lactate eq
to Pentazocine...30mg
Narcotic Analgesic
B.P Specifications
Form-5
07-07-2015 diary
No 7303.
Rs20,000
As per SRO
471(I)93
Talwin injection,
USA, by M/s Hospira.
Sosegon injection by
M/s Sanofi
Approved
237. -do- Phenoject Injection
Each ml ampoule
contains phenobarbitone
Sodium...200mg
Long acting Barbiturates
B.P Specifications
Form-5
07-07-2015 diary
No 7297.
Rs20,000
As per SRO
471(I)93
Phenobarbitone
sodium injection, UK,
by M/s Macarthys.
Phenobarb injection
by M/s Acto
Approved
238. -do- Relax Injection
Each 2ml contains
Diazepam...10mg
Benzodiazepine
B.P Specifications
Form-5
07-07-2015 diary
No 7299.
Rs20,000
As per SRO
471(I)93
Valium injection,
USA, by M/s Roche.
Valium injection by
M/s Martin Dow
Approved
Minutes for 253rd
Registration Board Meeting 352
239. -do- Qotum Injection
Each ml contains
Nalbuphine HCl...20mg
Narcotic Analgesic
Manufacturer
Specifications
Form-5
07-07-2015 diary
No 7298.
Rs20,000
As per SRO
471(I)93
Nubain injection,
USA, by M/s Endo
Pharms.
Kinzs injection by M/s
Sami
Approved
M/s Aventek Pharmaceuticals, Lahore
Tablet (General)
240. M/s Aventek
Pharmaceuticals
(Pvt) Ltd., 44-C,
Sunder Industrial
Estate, Lahore.
Tablet (General)
section approved by
Central Licensing
Board in its 239th
meeting held on 22-
01-2015.
POXETINE 60mg
Tablet
Each
tabletcontains:
Dapoxetine (as
HCl) ….60mg
Antidepressant
Manufacturers
specifications
Form 5
Rs. 8,000/-
Dated 26-06-
2012
Rs. 12,000/-
Dated 09-03-
2015
Dy. No. 1494
R&I
Price: Rs. 830/-
10‟s
Deferred for
submission of
following:
1) Antidepressant
has been
mentioned as
pharmacological
group, whereas,
premature
ejaculation has
been mentioned
under proposed
indications.
Clarification
required.
2) Undertaking
that label claim
and prescribing
information shall
be same as
approved by
reference drug
agencies e.g.,
FDA, TGA,
MHLW, EMA
and Health
Canada.
3) Evidence of
approval of same
formulation by
reference drug
agencies e.g.,
FDA, TGA,
MHLW, EMA
and Health
Canada.
4) Evidence of
me too status
required.
5) Source of
Deferred for confirmation of me too
status
Minutes for 253rd
Registration Board Meeting 353
active and in-
actives along
with their role
and justification
for quantity used.
6) Details of
reference
standard
required.
7) Evidence of
approval of
technical staff by
licensing
required.
8) Verification of
Rs. 12,000/- and
Rs. 8,000/- fee
challan required.
241. -do-
AVEMOX400mg
Tablet
Each tablet
contains:
Moxifloxacin (as
Hcl) ….400mg
Quinolones
Manufacturers
specifications
Form 5
Rs. 8,000/-
Dated 26-06-
2012
Rs. 12,000/-
Dated 09-03-
2015
Dy. No. 1503
R&I
Price: Rs. 475/-
5‟s
AVELOX
400mg f/c tablet
US FDA
AVELOX
400mg f/c tablet
M/s Bayer
Approved
242. -do-
AVEFLOX250mg
Tablet
Each
tabletcontains:
Levofloxacin (as
Hemihydrate)
…………...
250mg
Quinolones
USP specifications
Form 5
Rs. 8,000/-
Dated 26-06-
2012
Rs. 12,000/-
Dated 09-03-
2015
Dy. No. 1501
R&I
Price: Rs. 250/-
10‟s
LEVAQUIN
250mg f/c tablet
US FDA
TAVANIC
250mg tablet
M/s Sanofi
Approved with the change of name.
243. -do-
AVEFLOX
500mg Tablet
Each
tabletcontains:
Form 5
Rs. 8,000/-
Dated 26-06-
2012
LEVAQUIN
500mg f/c tablet
US FDA
TAVANIC
Approved with the change of name.
Minutes for 253rd
Registration Board Meeting 354
Levofloxacin (as
Hemihydrate)
…………...
500mg
Quinolones
USP specifications
Rs. 12,000/-
Dated 09-03-
2015
Dy. No. 1495
R&I
Price: Rs. 415/-
10‟s
500mg tablet
M/s Sanofi
244. -do-
AVEROXIN
250mg Tablet
Each
tabletcontains:
Ciprofloxacin (as
Hcl) ……...
250mg
Quinolones
BP specifications
Form 5
Rs. 8,000/-
Dated 26-06-
2012
Rs. 12,000/-
Dated 09-03-
2015
Dy. No. 1499
R&I
Price: Rs. 180/-
10‟s
CIPRO
250mg f/c tablet
US FDA
CIPROXIN
250mg tablet
M/s Bayer
Approved with the change of name.
245. -do-
AVEROXIN
500mg Tablet
Each
tabletcontains:
Ciprofloxacin (as
Hcl) ……...
500mg
Quinolones
BP specifications
Form 5
Rs. 8,000/-
Dated 26-06-
2012
Rs. 12,000/-
Dated 16-03-
2015
Dy. No. 1708
R&I
Price: Rs. 180/-
10‟s
CIPRO
500mg f/c tablet
US FDA
CIPROXIN
500mg tablet
M/s Bayer
Approved with the change of name.
246. -do-
GLIPTIN 50mg
Tablet
Each
tabletcontains:
Vildagliptin…
50mg
Anti diabetic
Manufacturers
specifications
Form 5
Rs. 8,000/-
Dated 26-06-
2012
Rs. 12,000/-
Dated 16-03-
2015
Dy. No. 1706
R&I
Price: Rs. 2112/-
28‟s
GALVUS
50mg tablet
TGA
GALVUS
50mg tablet
M/s Novartis
Approved with the change of name.
Minutes for 253rd
Registration Board Meeting 355
247. -do-
AVETOSE-F
Tablets
Each tablet
contains:
Iron Polymaltose
complex…..100m
g
Folic
acid….0.35mg
Haematinic
Manufacturers
specifications
Form 5
Rs. 8,000/-
Dated 26-06-
2012
Rs. 12,000/-
Dated 16-03-
2015
Dy. No. 1705
R&I
Price: Rs. 200/-
2x10‟s
FEROSOFT FA
100/0.35mg
M/s Hilton
Approved.
248. -do-
AVEGREL
Tablets
Each
tabletcontains:
Clopidogrel…….
75mg
Aspirin…75mg
Antiplaletst,
analgesic
antipyretic
Manufacturers
specifications
Form 5
Rs. 8,000/-
Dated 26-06-
2012
Rs. 12,000/-
Dated 09-03-
2015
Dy. No. 1504
R&I
Price: Rs.110/-
2x10‟s
Deferred for
submission of
following:
1) Undertaking
that label claim
and prescribing
information shall
be same as
approved by
reference drug
agencies e.g.,
FDA, TGA,
MHLW, EMA
and Health
Canada.
Moreover,
indications to be
revised
accordingly.
2) Master
formulation and
manufacturing
method for plain
tablet have been
submitted.
However,
internationally
Rejected as the firm does not have
the facility for the formulation of
this drug.
Minutes for 253rd
Registration Board Meeting 356
the product is
available as a
bilayer tablet.
Rectification
required.
Moreover,
evidence of
availability of
manufacturing
facility for
bilayer tablet
required.
3) Label claim to
be revised in
accordance to
internationally
approved
formulations.
4) Batch size,
quantities to be
used per batch,
source of active
and in-actives
along with their
role and
justification for
quantity used
required.
5) Finished
product
specifications to
be revised as per
internationally
available
formulation.
6) Details of
reference
standard
required.
7) Evidence of
approval of
technical staff by
licensing
required.
Firm has
requested to
change the
formulation as
single ingredient
formulation
Minutes for 253rd
Registration Board Meeting 357
249. -do- AVELUME
Each tablet
contains:
Artemether...80mg
Lumefantrine…
480mg
Synthetic
antimalarial
derived from
artemisinin/Synthe
tic recemic
fluorine mixture.
(USP Salmous
Spec.s)
Form 5
Rs. 8,000/-
Dated 26-06-
2012
Rs. 12,000/-
Dated 16-03-
2015
Dy. No. 1704
R&I
Price: 264/- per
pack.
8‟s
ARCEVA
M/s Sami
Approved
Capsule (General)
250. Capsule (General)
section approved by
Central Licensing
Board in its 239th
meeting held on 22-
01-2015.
AVEOME 20mg
Capsule
Each capsule
contains:
Omeprazole…….
20mg (BP)
Proton pump
inhibitor
Manufacturer
Source of pellets:
M/s Smilax
Laboratories
Limited.,
Plot No. 12/A,
Phase-III, I.D.A.,
Jeedimetla,
Hyderabad – 500
055, Telangana
State
Form 5
Rs. 8,000/-
Dated 26-06-
2012
Rs. 12,000/-
Dated 09-03-
2015
Dy. No. 1502
R&I
+ Rs. 80,000/-
dated 15.03.15
Price: Rs.200/-
per pack
FDA Losec 20mg
RISEK
M/s Getz
Approved. and the Chairman
Registration Board is authorized to
issue the letter after obtaining the
stability data and Legalized GMP.
251. -do- AVEOME 40mg
Each Capsule
contains:
Omeprazole
……...40mg (BP)
Proton pump
inhibitor
Manufacturer
Form 5
Rs. 8,000/-
Dated 26-06-
2012
Rs. 12,000/-
Dated 16-03-
2015
Dy. No. 1707
R&I
FDA Losec 40mg
RISEK
M/s Getz
Approved. Firm will submit
stability data and legalized GMP of
pellet‟s manufacturer and
Chairman Registration Board will
permit issuance of registration letter.
Minutes for 253rd
Registration Board Meeting 358
Source of pellets:
M/s Smilax
Laboratories
Limited.,
Plot No. 12/A,
Phase-III, I.D.A.,
Jeedimetla,
Hyderabad – 500
055, Telangana
State
+ Rs. 80,000/-
dated 15.03.15
Price: As per
DRAP Policy
252. -do- DIATEK Capsule
Each Capsule
contains:
Diacerein…….
50mg
Anti Osteoarthritis
Manufacturers
specifications
Form 5
Rs. 8,000/-
Dated 26-06-
2012
Rs. 12,000/-
Dated 09-03-
2015
Dy. No. 1505
R&I
Price: Rs.810/-
Per pack
DIORA
50mg Capsules
M/s Getz
Defered as the Formulation is under
review
253. -do- TRANSOBIQ
Each Capsule
contains:
Tranexamic acid
…….500mg
Hemostatic
Manufacturers
specifications
Form 5
Rs. 8,000/-
Dated 26-06-
2012
Rs. 12,000/-
Dated 16-03-
2015
Dy. No. 1711
R&I
Price: 325/-
2x10‟s
MAXNA
500mg Capsules
M/s AGP
Approved
254. -do- AOXTINE
Each Capsule
contains:
FluxetineHcleq to
Fluoxetine 20mg
5-HT reuptake
inhibitor
B.P specifications
Form 5
Rs. 8,000/-
Dated 26-06-
2012
Rs. 12,000/-
Dated 16-03-
2015
Dy. No. 1710
R&I
Price: 75/- per
pack.
FLUOXETINE
HYDROCHLOR
IDE
20mg Capsules
US FDA
DEPEX
M/s Merck
Approved
Minutes for 253rd
Registration Board Meeting 359
255. -do- AZTRO 250mg
Capsule.
Each Capsule
contains:
Azithromycin
Dihydrate eq. to
Azithromycin
…..250mg
Macrolides
Manufacturers
specifications
Form 5
Rs. 8,000/-
Dated 26-06-
2012
Rs. 12,000/-
Dated 09-03-
2015
Dy. No. 1498
R&I
Price: 320/- per
pack.
10‟s
ZITHROMAX
250mg capsule
TGA
AZOMAX
250mg Capsules
M/s Novartis
Approved
256. -do- ALENSO 30mg
Capsule.
Each Capsule
contains:
Lansoprazole
……… 30mg
Proton pump
inhibitor
Manufacturers
specifications
Source of pellets:
M/s Smilax
Laboratories
Limited.,
Plot No. 12/A,
Phase-III, I.D.A.,
Jeedimetla,
Hyderabad – 500
055, Telangana
State
Form 5
Rs. 8,000/-
Dated 26-06-
2012
Rs. 12,000/-
Dated 09-03-
2015
Dy. No. 1496
R&I
+ Rs. 80,000/-
dated 15.03.15
Price: 206/- per
pack.
14‟s
PREVACID
30mg capsule
US FDA
LANZOL
30mg Capsules
M/s Pharmatec
Approved. Firm will submit
stability data and legalized GMP of
pellet‟s manufacturer and
Chairman Registration Board will
permit issuance of registration letter.
257. -do- AESMOL
Each Capsule
contains:
Esomeprazole
Magnesium eq. to
Esomeprazole
……….. 40mg
Proton pump
inhibitor
Source of pellets:
M/s Smilax
Laboratories
Limited.,
Form 5
Rs. 8,000/-
Dated 26-06-
2012
Rs. 12,000/-
Dated 09-03-
2015
Dy. No. 1497
R&I
+ Rs. 80,000/-
dated 15.03.15
Price: 323/- per
pack.
NEXIUM
40mg capsules
US FDA
NEXUM
M/s Getz
Approved. Firm will submit
stability data and legalized GMP of
pellet‟s manufacturer and
Chairman Registration Board will
permit issuance of registration letter.
Minutes for 253rd
Registration Board Meeting 360
Plot No. 12/A,
Phase-III, I.D.A.,
Jeedimetla,
Hyderabad – 500
055, Telangana
State
258. -do- AESMOL
Each Capsule
contains:
Esomeprazole
Magnesium eq. to
Esomeprazole
……….. 20mg
Proton pump
inhibitor
Manufacturers
specifications
Source of pellets:
M/s Smilax
Laboratories
Limited.,
Plot No. 12/A,
Phase-III, I.D.A.,
Jeedimetla,
Hyderabad – 500
055, Telangana
State
Form 5
Rs. 8,000/-
Dated 26-06-
2012
Rs. 12,000/-
Dated 09-03-
2015
Dy. No. 1500
R&I
+ Rs. 80,000/-
dated 15.03.15
Price: 198/-
14‟s
NEXIUM
20mg capsules
US FDA
NEXUM
M/s Getz
Approved. Firm will submit
stability data and legalized GMP of
pellet‟s manufacturer and
Chairman Registration Board will
permit issuance of registration letter.
259. -do- Avegab 100mg
Capsules
Each Capsule
contains:
Pregabalin
……….… 100mg
Antiepileptic
Manufacturers
specifications
Form 5
Rs. 8,000/-
Dated 26-06-
2012
Rs. 12,000/-
Dated 16-03-
2015
Dy. No. 1709
R&I
Price: 259/- per
pack 14‟s
LYRICA
100mg Capsule
US FDA
GABICA
100mg Capsules
M/s Getz
Approved
Minutes for 253rd
Registration Board Meeting 361
Evaluator – I
M/s Fynk Pharmaceuticals, Lahore
Cream/Ointment/Gel (Steroid)
260. M/s Fynk
Pharmaceuticals
19-Km G.T Road,
Kalashah Kaku,
Lahore.
Cream
/Ointment/Gel
(Steroid) approved
in 239th meeting of
Central Licensing
Board held on 22-01-
2015.
Dermit Cream
Clobetasol
propionate B.P.
0.05%
(Corticosterides)
(B.P
Specifications)
Form 5
(03.07.2014)
Dy. No. 1112
Rs.20,000
As per DRAP
policy/5gm &
15gm
BNF:
Dermovate®
(GSK) Cream
(clobetasol
propionate
0.05%),
Biovate
(Wisdom)
Approved
261. -do- Kandax N Cream
15gm
Dexamethasone
Phosphate (as
Disodium USP)
0.1%, Neomycin
(as Sulphate USP)
0.5%
(Corticosterides &
antibacterial)
Manufacturer‟s
specifications
Form 5
30.-07-2014,
vide Dy No.
1121
As per SRO/15
gm
Dexa-N Cream ,
Swiss Pharma
Defered for confirmation of
approval by regulatory authority of
reference countries.
262. -do- Fusirum B Cream
Fusidic Acid 2%
and
betamethasone
0.1%
Corticosteroid &
antibacterial
Manufacturer‟s
specifications
Form 5
03.-07-2014,
vide Dy No.
1127
As per
SRO/5gm &15
gm
Fucibet cream
UK
Fusimin B by M/s
Sharooq
Approved
263. -do- Fusirum-H Cream
Fusidic Acid 2%
and
Hydrocortisone
acetate 1%
Corticosteroid &
antibacterial
Manufacturer‟s
specifications
Form 5
03.-07-2014,
vide Dy No.
1119
As per SRO/15
gm
Fucidin H cream
UK
Fucidin H cream
by M/s Zam zam
Approved
Minutes for 253rd
Registration Board Meeting 362
264. -do- Fengen HC Cream
Gentamicin(as
sulphate)B.P…
0.3%
Hydrocortisone
AcetateB.P….1.0
%
Corticosteroid &
antibacterial
Manufacturer‟s
specification
Form 5
03.-07-2014,
vide Dy No.
1109
As per SRO/
10 gm
Defered for confirmation of
approval by regulatory authority of
reference countries.
265. -do- Benovit N Cream
Each gram
contains
Betamethasone (as
Valerate B.P)0.1%
and Neomycin (as
Sulphate B.P)
0.5%
Corticosteroid &
antibacterial
Manufacturer‟s
specifications
Form 5
03.-07-2014,
vide Dy No.
1127
As per
SRO/5gm &15
gm
BNF Betnovate N
Betnovate N
cream GSK
Approved with the change of name
266. -do- Benovit Cream
Each gram
contains
Betamethasone (as
Valerate B.P)0.1%
Corticosteroid
B.P specifications
Form 5
03-07-2014,
vide Dy No.
1126
As per
SRO/5gm &15
gm
Betnovate cream
GSK UK
Betnovate cream
by M/s GSK
Approved with the change of name
267. -do- B-Nate Cream
Betamethasone (as
Dipropionate
B.P)0.05% and
Gentamicin (as
Sulfate B.P) 0.1%
Corticosteroid &
antibacterial
Manufacturer‟s
Specifications
Form 5
03-07-2014,
vide Dy No.
1115
As per SRO/15
gm
DIPROGEN
Cream of Merck
(Health Canada)
Diprogenta
(Atco)
Approved
Minutes for 253rd
Registration Board Meeting 363
268. -do- Fermicon H
Cream
Hydrocortisone
B.P 1% and
Miconazole
Nitrate B.P 2%
Corticosteroid &
antifungal
B.P specification
Form 5
03-07-2014,
vide Dy No.
1380
As per SRO/10
gm
Daktacort
Hydrocortisone
Cream UK
Mycon (Valor)
Approved
269. -do- Orimazole-HC
Cream
Clotrimazole B.P
1% and
HydrocortisoneB.
P 1%
Corticosteroid &
antifungal
Manufacturer‟s
Specifications
Form 5
03-07-2014,
vide Dy No.
1110
As per SRO/
10 gm
Canesten HC
Cream UK
Clozox H
(Shaigan)
Approved
270. -do- Fosmin Cream
Contains:-
Isotretinoin
B.P…0.05% w/w
Vitamin A
analogue
(retinoid);
Treatment of Acne
Manufacturer‟s
Specifications
Form 5
R&I 1381, 04-
03-2015
Rs.20,000
As per
SRO/10gm
Acutane of Roche
USA as approved
in 243rd
meeting
Isotrol Cream
Valor Pharma
Defered for confirmation of
approval by regulatory authority of
reference countries.
271. -do- Locin Gel
Contains:-
Lignocaine HCl
Anhydrous B.P.
2% w/w
(Local
Anesthetics)
(B.P.
Specifications)
Form 5
R&I 203
14-01-2015,
Rs. 20,000/-
As Per SRO/15
Gm
Australia:
Xylocaine 2%
Jelly
(AstraZeneca Pty
Ltd)
XYLOCAINE
(BARRET
HUODGSON)
Grant of
additional section
Cream/Ointment
(General and
Steroidal)
Approved
Minutes for 253rd
Registration Board Meeting 364
M/s Ipram International, Islamabad.
Capsule (Cephalosporin)
272. M/s Ipram
International, Plot
# 26, S-S-3,
National Industrial
Zone, Rawat,
Islamabad.
Capsule
(Cephalosporin)secti
on approved
by Central
Licensing Board in
its 239th meeting
held on 22-01-
2015 (vide letter
No. F. 1-13/98-Lic
[Vol-I] dated
25/02/2015)
Ipraceph 500mg
Capsule.
Each Capsule
Contains:-
Cephradine
U.S.P.……500mg
Anti-Biotic,
1stGeneration
Cephalosporin
Form 5
Rs.20000/-
Dy. No. 9787
R&I
Dated 19-11-
2012
Price: As fixed
by
Govt. 2x6‟s
NICEF 500mg
Capsules
Cefradine
MHRA
VELOSEF
500mg Capsules
GSK
Approved
273. -do- Mecef 500mg
Capsule.
Each Capsule
Contains:-
Cefadroxil
BP…………500m
g
Anti-Biotic, 1st
Generation
Cephalosporin
Form 5
Rs.20,000/-
Dy. No. 9788
R&I
Dated 19-11-
2012
Price: As fixed
by
Govt.
2x6‟s
CEFADROXIL
(as monohrdrate)
500mg
US FDA
DURICEF
500mg
GSK
Approved
274. -do- Cilicef 200mg
Capsule.
Each Capsule
Contains:-
Cefixime as
trihydrate
……200mg
Anti-Biotic,
Cephalosporin
Form 5
Rs.20000/-
Dy. No. 9786
R&I
Dated 19-11-
2012
Price: As fixed
by
Govt.
Firm has
mentioned
SUPRAX 200mg
of M/s Lupin
USA. However,
the FDA
approved strength
of SUPRAX is
400mg capsule.
CEFIM
200mg Capsules
M/s Hilton
Rejected as the formulation is not
internationally available in same
strength and dosage form.
275. -do- Ipraclor 500mg
Capsule.
Each Capsule
Contains:
Cefaclor
U.S.P….500mg
Anti-Biotic, 2nd
Generation
Cephalosporin
Form 5
Rs.20000/-
21-01-2015
Dy. No. 405
R&I
Price: As fixed
by
Govt.
2x6‟s
BNF.cefaclor
500mg capsule
CECLOR
M/s AGP
Approved
Minutes for 253rd
Registration Board Meeting 365
276. -do- Cilicef 400mg
Capsule.
Each Capsule
Contains:
Cefixime as
trihydrate….400m
g
Antibiotic
(Cephalosporin)
Form 5
Rs.20000/-
Dy. No. 9785
R&I
Dated 19-11-
2012
Price: As fixed
by
Govt.
SUPRAX 400mg
Capsule
US FDA
CEBOSCH
400mg capsule
M/s Bosch
Approved
EVALUATOR IV
M/s Mallard Pharmaceuticals, Multan
Veterinary Injectable Vials (General / General Antibiotics)
277. M/s Mallard
Pharmaceuticals
(Pvt.) Ltd, 23-km
Lahore Road,
Multan.
ADDITIONAL
SECTION:
Veterinary
Injectable Vials
(General / General
Antibiotics) approved in 241
st
meeting of CLB
Gentamall Liquid
Injection
Each ml contains
Gentamycin
Sulphate Eq to
100 mg
Gentamycin Base
Antibiotics
(BP
Specification)
Form 5
Rs. 20,000/-
vide Dy. No.
303 dated 29-
08-2015
Pack of
10 ml, 50 ml,
100 ml
Garasol Injection
100mg / ml
(Merck Animal
Health,USA)
Genex (My Lab
Pvt. Ltd)
Approved with condition of one
pack size only.
278. -do- Ivermall 1%
Injection
Each ml contains
Ivermectin 10 mg
Anthelmintic
(BP
Specification)
Form 5
Rs. 20,000/-
vide Dy. No.
301 dated 29-
08-2015
Pack of
10 ml, 50 ml,
100 ml
Qualimec Vet
(ECO Animal
Health Ltd,UK)
Wormec
Injection
(Nawan)
Approved with condition of one
pack size only.
Minutes for 253rd
Registration Board Meeting 366
279. -do- Novamall
Injection
Each 100 ml
contains
Etilefrin (as HCl)
BP 0.2 mg
Caffein BP 10 mg
Sodium Salicylate
BP 7 mg
Novaminsulfon
BP 40 mg
Nicotinamide BP
0.3 mg
Calcium
Gluconate USP
100 mg
Magnesium
Gluconate USP 10
mg
Boric Acid BP 10
mg
Sorbitol 200 mg
Sodium Oxy
benzylphosphoric
acid 5 mg
Methyl
Parahydroxy
Benzoate 0.7 mg
Analgesic &
Antipyretic
(Manufacture
Specification)
Form 5
Rs. 20,000/-
vide Dy. No.
299 dated 28-
05-2015
Pack of
100 ml, 250 ml,
500 ml
Not provided
Novastar
Injection (Star
Laboratories)
Deferred for confirmation of
validity of the testing method and
for provision of one pack size
only.
280. -do- Fluxin Injection
50mg/ml
Each 100 ml
contains
Flunixin
Meglumine eq to
Flunixine Base 5
gm
Analgesic/Antipyr
etic
(USP
Specification)
Form 5
Rs. 20,000/-
vide Dy. No.
298 dated 29-
05-2015
Pack of
10 ml, 50 ml,
100 ml
Benamine
Injection
Approved by
FDA vide
NADA #101-
479.
FLUZAK
(ZAKFAS)
Approved with condition of one
pack size only.
Minutes for 253rd
Registration Board Meeting 367
281. -do- Meloxmall
Injection
Each ml contains
Meloxicam 10 mg
NSAID
(BP
Specification)
Form 5
Rs. 20,000/-
vide Dy. No.
296 dated 29-
05-2015
Pack of
50 ml, 100 ml,
200 ml
Metacam
5mg/ml, FDA
approved
Meloxi-10
(SELMORE)
Deferred for clarification of
proposed dosage form because
international the product is
available in strength 5mg/ml.
282. -do- Hepamall
Injection
Each 100 ml
contains Phenoxy-
2methyl-2-
propionic acid 10
gm
Liver Tonic
(Manufcature
Specification)
Form 5
Rs. 20,000/-
vide Dy. No.
296 dated 29-
05-2015
Pack of
50 ml, 100 ml
HEPAGEN 100
mg/ml (Fatro,
Italy)
Hepaguard (Star
Lab)
Deferred for clarification
regarding indication and usage.
283. -do- Synogent Injection
Each ml contains
Gentamycin
Sulphate BP 50
mg
Tylosin Tartrate
BP 100 mg
Antibiotics
(Manufacture
Specification)
Form 5
Rs. 20,000/-
vide Dy. No.
296 dated 29-
05-2015
Pack of
20ml, 50 ml,
100 ml
Taylogen
Injection IM
(Vilsan, turkey)
Genta T Coli
Injection (Alina)
Approved with condition of one
pack size only.
284. -do- Bursamall
Injection
Each ml contains
Trimethoprim 80
mg
Sulphdiazine 400
mg
Antibiotics
(Manufacture
Specification)
Form 5
Rs. 20,000/-
vide Dy. No.
296 dated 29-
05-2015
Pack of
10ml, 50 ml,
100 ml
Tribressin 48%
(Schering plough
animal health,
New Zealand)
Altrim Plus
Injection (Alina)
Approved
285. -do- Bursamall
Injection
Each ml contains
Oxytetracycline
Form 5
Rs. 20,000/-
vide Dy. No.
304 dated 29-
05-2015
FDA approved
oxytetracycline
injection
Oxyla 5%
Approved with condition of one
pack size only.
Minutes for 253rd
Registration Board Meeting 368
HCl eq to
Oxytetracycline
base 50 mg
Antibiotics
(Manufacture
Specification)
Pack of
10ml, 50 ml,
100 ml
Injection (Alina)
286. -do- DIMALL 33.33%
Injection
Each 100 ml
contains
Sulphadimidine
Sodium 33.33 gm
Sulphonamide
Antibiotics
(Manufacture
Specification)
Form 5
Rs. 20,000/-
vide Dy. No.
308 dated 29-
05-2015
Pack of
100 ml, 500 ml
Sulphadimidine
Sodium 33.3 %
injection IM
(UCCMA,
Egypt)
Sulfavet (Zakfas)
Deferred for the clarification of
pack size 500 ml which is LVP.
EVALUATOR IV
M/s Hamaz Pharmaceuticals, Multan
Liquid Injectable (Ampoule/Vial) (General and General Antibiotics)
287. M/s Hamaz
Pharmaceuticals
(Pvt.) Ltd, 13-km,
Lutafabad, Bosan
Road, Multan
ADDITIONAL
SECTION -
Liquid Injectable
(Ampoule/Vial)
(General and
General
Antibiotics) approved in 242
nd
meeting of CLB
Vialox IV
Infusion
Each 100 ml
contains Ofloxacin
HCl 220 mg eq to
Ofloxacin 200 mg
Quinolone
Antibiotics
(USP
Specification)
Form 5
Rs. 20,000/-
vide Dy. No.
4808 dated 04-
08-2015
Pack of
1 x 100 ml/
price 768.
MHRA approved
Tarivid
Adios (Wilshire)
Deferred for clarification from
Central Licensing Board
regarding separate section for
ampoule and vials.
288. -do- Spizole IV
Infusion
Each 100 ml bottle
contains
Metronidazole 500
mg
Quinolone
Antibiotics
(USP
Specification)
Form 5
Rs. 20,000/-
vide Dy. No.
4810 dated 04-
08-2015
Pack of
1 x 100 ml/
price 78.
FDA approved
Flagyl
ANAROB
(Global)
Deferred for clarification from
Central Licensing Board
regarding separate section for
ampoule and vials.
Minutes for 253rd
Registration Board Meeting 369
289. -do- Nixin IV Infusion
Each 100 ml bottle
contains
Ciprofloxacin (as
Lactate) 200 mg
Quinolone
Antibiotics
(USP
Specification)
Form 5
Rs. 20,000/-
vide Dy. No.
4844 dated 04-
08-2015
Pack of
1 x 100 ml/
price 971.
FDA approved
Ciproxin (Bayer)
Caralox
(Caraway)
Deferred for clarification from
Central Licensing Board
regarding separate section for
ampoule and vials.
290. -do- Flikz IV Infusion
Each 50 ml bottle
contains
Fluconazole 100
mg
Antifungal Trizole
(USP
Specification)
Form 5
Rs. 20,000/-
vide Dy. No.
4840 dated 04-
08-2015
Pack of
1 x 50 ml/ price
560.
FDA Fluconazole
Injection (Hikma
farmaceutica)
Lunim (Nimrall)
Deferred for clarification from
Central Licensing Board
regarding separate section for
ampoule and vials.
291. -do- Flacin IV Injection
600 mg
Each Vial 02 ml
contains
Lincomycin as
HCl 600mg
Lincosamide
(USP
Specification)
Form 5
Rs. 20,000/-
vide Dy. No.
4837 dated 04-
08-2015
Pack of
1 x 02 ml vials /
price 55.
Deferred for
clarification
from Central
Licensing Board
regarding
separate section
for ampoule and
vials.
05 ampoules /
price 255
FDA approved
Lincocin (Pfizer)
Viocin (Venus)
Deferred for clarification from
Central Licensing Board
regarding separate section for
ampoule and vials.
Minutes for 253rd
Registration Board Meeting 370
292. -do- Linor IV Injection
200 mg
Each 100 ml
contains Linezolid
200mg
Oxazolidinone,
Antibiotic
(Manufacture
Specification)
Form 5
Rs. 20,000/-
vide Dy. No.
4831 dated 04-
08-2015
Pack of
1 x 100 ml vial /
price 346.
1 x 200 ml vial/
price 400
1 x 300 ml vial /
Price 600
FDA approved
Linezolid
(Sandoz)
Zolrest (Bosch)
Deferred for clarification from
Central Licensing Board
regarding separate section for
ampoule and vials.
293. -do- Lupin IV Infusion
500 mg
Each 100 ml
contains
Levofloxacin
500mg
Quinolone
Antibiotic
(USP
Specification)
Form 5
Rs. 20,000/-
vide Dy. No.
4830 dated 04-
08-2015
Pack of
1 x 100 ml vial /
price 300.
FDA approved
Livaquin
(Johnson)
Leflox (Getz)
Deferred for clarification from
Central Licensing Board
regarding separate section for
ampoule and vials.
294. -do- I-MOX IV
Infusion 400 mg
Each 250 ml
contains
Moxifloxacin as
HCl 400 mg
Quinolone
Antibiotic
(USP
Specification)
Form 5
Rs. 20,000/-
vide Dy. No.
4830 dated 04-
08-2015
Pack of
1 x 250 ml vial /
price 1250.
FDA approved
Avelox(Bayer)
Goldspec
(Nimrall)
Deferred for clarification from
Central Licensing Board
regarding separate section for
ampoule and vials.
295. -do- ESTADOL IV
Infusion 1g
Each 100 ml
contains
Paracetamol
USP… 1 gm
Antipyretic /
analgesic
(USP
Specification)
Form 5
Rs. 20,000/-
vide Dy. No.
4816 dated 04-
08-2015
Pack of
1 x 100 ml vial /
price 80.
TGA approved
paracetamol
(Bristol)
Provas (Sami)
Deferred for clarification from
Central Licensing Board
regarding separate section for
ampoule and vials.
Minutes for 253rd
Registration Board Meeting 371
296. -do- Ocian (WFI)
Each ampoule
contains
Water for
Injection
… 10ml
WFI
(USP
Specification)
Form 5
Rs. 20,000/-
vide Dy. No.
4812 dated 04-
08-2015
MRP. Rs 5.00
for 1‟s per 10ml
MRP. Rs 250.00
for 25‟s per
10ml
MRP. Rs. 500
for 50‟s per 10
ml
MRP. Rs. 4.00
for 1‟s per 5ml
MRP. Rs.
100.00 for 25‟s
per 05 ml
MRP Rs. 200
for 50‟s per 05
ml
MRP Rs. 400
for 100‟s per 05
ml
MRP Rs. 150
for 50‟s per 03
ml
MRP Rs 300 for
100‟s per 03ml.
MHRA approved
WFI (TARO)
WFI (Epoch)
Deferred for clarification from
Central Licensing Board
regarding separate section for
ampoule and vials.
297. -do- Gastid Injection
Each ampoule (2
ml) contains
Ranitidine HCl
… 50 mg
H2 Blocker
(USP
Specification)
Form 5
Rs. 20,000/-
vide Dy. No.
4811 dated 04-
08-2015
MRP. Rs 110.56
for 05 Ampoule
MHRA approved
Ranitidine
(mercury
Pharma)
Zantac (GSK)
Deferred for clarification from
Central Licensing Board
regarding separate section for
ampoule and vials.
298. -do- 3-D Injection
Each ampoule (1
ml) contains
Cholecalciferol
(Vit D3) ….
250,000 IU equal
to 5 mg
Vitamin
(USP
Specification)
Form 5
Rs. 20,000/-
vide Dy. No.
4821 dated 04-
08-2015
MRP. Rs 165
for 01 Ampoule
Indrop D
(Neutro)
Deferred for clarification from
Central Licensing Board
regarding separate section for
ampoule and vials.
Minutes for 253rd
Registration Board Meeting 372
299. -do- Nitid Injection
Each ampoule (2
ml) contains
Phenaramine
Maleate 50 mg
equivalent to
Pheniramine
Salicylate 45.4 mg
Arylakylamine
(USP
Specification)
Form 5
Rs. 20,000/-
vide Dy. No.
4823 dated 04-
08-2015
MRP. Rs 500
for 50 x 02 ml
Ampoule
MRP Rs 1211
per 100 x 02 ml
International
availability not
confirmed
javil (Irza)
Deferred for clarification from
Central Licensing Board
regarding separate section for
ampoule and vials.
300. -do- Phonac Injection
75 mg
Each ampoule (2
ml) contains
Diclofenac
Sodium USP 75
mg
Lignocaine HCl
20 mg
Phenylacetic acid/
anesthetic
(Manufacture
Specification)
Form 5
Rs. 20,000/-
vide Dy. No.
4828 dated 04-
08-2015
MRP Rs 140 per
05 Ampoule
International
availability not
confirmed
Afenac – plus
(ACMA
Laboratories
Pakistan Ltd)
Deferred for clarification from
Central Licensing Board
regarding separate section for
ampoule and vials.
301. -do- Cloprel Injection
10 mg
Each ampoule (2
ml) contains
Metoclopramide
HCl … 10mg
Antidopaminergic
(USP
Specification)
Form 5
Rs. 20,000/-
vide Dy. No.
4841 dated 04-
08-2015
MRP Rs 230 per
10 Ampoule
MRP Rs. 410
per 20 ampoules
MHRA approved
metoclopramide
(Ennogen)
Maxolon (GSK)
Deferred for clarification from
Central Licensing Board
regarding separate section for
ampoule and vials.
302. -do- Dinate Injection
50 mg
Each ampoule (1
ml) contains
Dimenhydrinate
… 50mg
Form 5
Rs. 20,000/-
vide Dy. No.
4845 dated 04-
08-2015
MRP Rs 250 per
FDA approved
Dimenhydrinate
(APP Pharma)
Gravinate
(Searle)
Deferred for clarification from
Central Licensing Board
regarding separate section for
ampoule and vials.
Minutes for 253rd
Registration Board Meeting 373
Antihistamine
(USP
Specification)
25 Ampoule
MRP Rs. 410
per 20 ampoules
303. -do- Lignox Injection
20 mg
Each ampoule (2
ml) contains
Lignocaine HCl
anhydrous … 20
mg
Local anesthetic
(BP
Specification)
Form 5
Rs. 20,000/-
vide Dy. No.
4845 dated 04-
08-2015
MRP Rs 187 per
100 Ampoules
MHRA approved
Lidocaine
Injection BP (B-
Braun germany)
Xylocaine
(Barrett)
Deferred for clarification from
Central Licensing Board
regarding separate section for
ampoule and vials.
304. -do- Ferin Injection
100 mg
Each ampoule (5
ml) contains
Iron Sucrose
Complex … 100
mg
Haematinic
(USP
Specification)
Form 5
Rs. 20,000/-
vide Dy. No.
4834 dated 04-
08-2015
MRP Rs 1831
per 05
Ampoules x 5ml
MHRA approved
Ferrologic 20
mg/ml (Fresenius
germany)
Bisleri (Sami)
Deferred for clarification from
Central Licensing Board
regarding separate section for
ampoule and vials.
305. -do- M.B Vit Injection
500 mcg
Each ampoule (1
ml) contains
Mecobalamin…
500 mcg
Coenzyme Type
Vitamin B12
(Manufacture
Specification)
Form 5
Rs. 20,000/-
vide Dy. No.
4836 dated 04-
08-2015
MRP Rs 814 per
10 Ampoules
Methycobal
(Eisai, Japan)
Methycobal
(Hilton)
Deferred for clarification from
Central Licensing Board
regarding separate section for
ampoule and vials.
EVALUATOR IV
Dry Powder Injection (Cephalosporin)
306. M/s Hamaz
Pharmaceuticals
(Pvt.) Ltd, 13-km,
Lutafabad, Bosan
Road, Multan
ADDITIONAL
SECTION: Dry
OPEROX
injection 1 g
Each Vials
contains
Cefoperazone as
Sodium (USP) eq
Form 5
Rs. 20,000/-
vide Dy. No.
4839 dated 04-
08-2015
FDA approved
Cefobid (Pfizer)
Aricef (Aries)
Approved
Minutes for 253rd
Registration Board Meeting 374
Powder Injection
(Cephalosporin) approved in 242
nd
meeting of CLB
to Cefoperazone
… 1 gm
Antibiotics
(Cephalosporin)
(USP
Specification)
MRP Rs 329.46
per 01 Vial
307. -do- OPEROX
injection 500 mg
Each Vial contains
Cefoperazone as
Sodium (USP) eq
to Cefoperazone
… 500 mg
Antibiotics
(Cephalosporin)
(USP
Specification)
Form 5
Rs. 20,000/-
vide Dy. No.
4828 dated 04-
08-2015
MRP Rs 211.16
per 01 Vial
FDA approved
Cefobid (Pfizer)
Aricef (Aries)
Approved
308. -do- OPEROX
injection 250 mg
Each Vial contains
Cefoperazone as
Sodium (USP) eq
to Cefoperazone
… 250 mg
Antibiotics
(Cephalosporin)
(USP
Specification)
Form 5
Rs. 20,000/-
vide Dy. No.
4818 dated 04-
08-2015
MRP Rs 114.40
per 01 Vial
FDA approved
Cefobid (Pfizer)
Aricef (Aries)
Approved
309. -do- Pyrocef injection 1
gm
Each Vial contains
Cefoperazone as
Sodium (USP) eq
to Cefoperazone
… 500 mg
Salbactum (USP)
as sodium … 500
mg
Antibiotics
(Cephalosporin)(B
eta Lactamase
Inhibitor)
(USP
Specification)
Form 5
Rs. 20,000/-
vide Dy. No.
48268 dated 04-
08-2015
MRP Rs 250 per
01 Vial
Magnex (Pfizer,
India)
Biped (Shawan)
Approved.
Minutes for 253rd
Registration Board Meeting 375
310. -do- Pyrocef injection 2
gm
Each Vial contains
Cefoperazone as
Sodium (USP) eq
to Cefoperazone
… 1 gm
Salbactum (USP)
as sodium … 1 gm
Antibiotics
(Cephalosporin)(B
eta Lactamase
Inhibitor)
(USP
Specification)
Form 5
Rs. 20,000/-
vide Dy. No.
4807 dated 04-
08-2015
MRP Rs 350 per
01 Vial
Magnex (Pfizer,
India)
Biped (Shawan)
Approved as product is also
available in Japan.
311. -do- ON-CEF injection
500 mg
Each Vial contains
Cefipime as HCl
(USP) … 500 mg
Antibiotics
(Cephalosporin)
(USP
Specification)
Form 5
Rs. 20,000/-
vide Dy. No.
4833 dated 04-
08-2015
MRP Rs 387.50
per 01 Vial
FDA approved
Maxipime
(Bristol ,USA)
Cefstar (Barrett)
Approved
312. -do- ON-CEF Injection
1 gm
Each Vial contains
Cefipime as HCl
(USP) … 1 gm
Antibiotics
(Cephalosporin)
(USP
Specification)
Form 5
Rs. 20,000/-
vide Dy. No.
4814 dated 04-
08-2015
MRP Rs 730.08
per 01 Vial
FDA approved
Maxipime
(Bristol ,USA)
Cefstar (Barrett)
Approved
313. -do- Teraxone
Injection 250 mg
Each Vial contains
Ceftriaxone
Sodium equivalent
to Ceftriaxone
(USP) … 250 mg
Antibiotics
(Cephalosporin)
(USP
Specification)
Form 5
Rs. 20,000/-
vide Dy. No.
4819 dated 04-
08-2015
MRP Rs 123.00
per 01 Vial
MHRA approved
Ceftriaxone
(Bowmed, ,UK)
Novosef
(Himont)
Approved
Minutes for 253rd
Registration Board Meeting 376
314. -do- Teraxone
Injection 500 mg
Each Vial contains
Ceftriaxone
Sodium equivalent
to Ceftriaxone
(USP) … 500 mg
Antibiotics
(Cephalosporin)
(USP
Specification)
Form 5
Rs. 20,000/-
vide Dy. No.
4817 dated 04-
08-2015
MRP Rs 242.00
per 01 Vial
MHRA approved
Ceftriaxone
(Bowmed, ,UK)
Novosef
(Himont)
Approved
EVALUATOR IV
Cream/Ointment/Gel (General
315. M/s Hamaz
Pharmaceuticals
(Pvt.) Ltd, 13-km,
Lutafabad, Bosan
Road, Multan
ADDITIONAL
SECTION :
Cream/Ointment/
Gel (General) approved in 242
nd
meeting of CLB
Labicin Ointment
Each 1gm contains
i. Bacitracin Zinc
500 units
ii. Neomycin
Sulphate … 3.5
mg
iii. Polymyxin B
Sulphate 5000
units
iv. Lidocaine …
40 mg
Antibiotics / local
anesthetic
(Manufacture
Specification)
Form 5
Rs. 20,000/-
vide Dy. No.
4832 dated 04-
08-2015
Pack size
10 gm /Rs. 55
25 gm / Rs. 69
BACIMIX
(EPLA)
Defered for confirmation of
approval by regulatory authority of
reference countries.
316. -do- Laphenor Cream
Each 20gm
contains
Diphenhydramine
… 1 % (0.2 gm)
Antihistamine
(USP
Specification)
Form 5
Rs. 20,000/-
vide Dy. No.
4825 dated 04-
08-2015
Pack size
20 gm / Rs. 60
Benadryl Cream
(Canada)
Nil
(New dosage
form in Pakistan)
Deferred with direction to firm to
apply on prescribed Form 5D as it
is a new molecule.
317. -do- Laphenor
Ointment
Each 20gm
contains
Hydrocortisone…
1 % (0.2 gm)
Form 5
Rs. 20,000/-
vide Dy. No.
4829 dated 04-
08-2015
Pack size
FDA approved
Hydrocortisone
Ointment (Dow
pharma)
EKSALB (AGP)
Approved
Minutes for 253rd
Registration Board Meeting 377
Corticosteroid
(USP
Specification)
20 gm / Rs. 60
318. -do- Levacin Ointment
Each 1 gm
contains
Bacitracin Zinc
500 units
Neomycin
Sulphate … 3.5
mg
Polymyxin B
Sulphate 10000
units
Pramoxin HCl…
10 mg
Antibiotic Pain
reliever
(Manufacture
Specification)
Form 5
Rs. 20,000/-
vide Dy. No.
4820 dated 04-
08-2015
Pack size
15 gm / Rs. 80
FDA approved
Triple Antibiotic
Ointment
Not available
Deferred with direction to firm to
apply on prescribed Form 5D as it
is a new formulation to be
manufactured in Pakistan.
319. -do- Verocin Ointment
Each 10gm
contains
Mupirocin 2%
w/w
Broad Spectrum
Antibiotics
(USP
Specification)
Form 5
Rs. 20,000/-
vide Dy. No.
4822 dated 04-
08-2015
Pack size
10 gm / Rs 100
15 gm / Rs. 160
5 gm / Rs. 75
FDA Approved
Bactroban (GSK,
Newzealand
Bactoderm
(Steifel)
Approved
320. -do- Lavisone Cream
Each 5 gm
contains
Fluticasone
Propionate ….
0.05%
Corticosteroid
(USP
Specification)
Form 5
Rs. 20,000/-
vide Dy. No.
4809 dated 04-
08-2015
Pack size
10 gm / Rs 120
5 gm / Rs. 75
FDA approved
Fluticasone
Propionate
(Perrigo
newyork)
Cutivate (GSK)
Approved
Minutes for 253rd
Registration Board Meeting 378
321. -do- Lavotren Cream
Each 10 gm
contains
i. Erythromycin ..
2 % w/w
ii. Isotretinoin
0.5% w/w
Antibiotic &
retinoid
(USP
Specification)
Form 5
Rs. 20,000/-
vide Dy. No.
4815 dated 04-
08-2015
Pack size
10 gm / Rs 264
MHRA approved
Isotrexin Gel
(Steifel,UK)
Isotrexin (GSK)
Deferred for clarification of
following points
i. The international
availability of the Isotrexin
is in gel form whereas firm
has proposed cream dosage
firm.
ii. The quantity of Isotretinoin
in Isotrexin Gel is 0.05%
w/w whereas firm has
proposed Isotretinoin 0.5%
w/w.
322. -do- Laviquin Cream
Each 20 gm
contains
Hydroquinone 4%
Skin Bleaches
(USP
Specification)
Form 5
Rs. 20,000/-
vide Dy. No.
4813 dated 04-
08-2015
Pack size
20 gm / Rs 120
FDA approved
Clariderm DS
(USA)
Dermolite (Elite)
Approved
323. -do- Lavizole Topical
Cream
Each 10 gm
contains
Clotrimazole 1%
Anti Fungal
(USP
Specification)
Form 5
Rs. 20,000/-
vide Dy. No.
4835 dated 04-
08-2015
Pack size
10 gm / Rs 54
FDA approved
Canesten (Bayer)
Clotrim (Zafa)
Approved
324. -do- Vizole Cream
Each 10 gm
contains
i. Clotrimazole
1%
ii. Hydrocortisone
1%
Anti Fungal
(USP
Specification)
Form 5
Rs. 20,000/-
vide Dy. No.
48385 dated 04-
08-2015
Pack size
10 gm / Rs 80
TGA approved
Hydrozole (GSK)
Clozox H
(Shaigan)
Approved
Minutes for 253rd
Registration Board Meeting 379
EVALUATOR IV
M/s Decent Pharma, Islamabad
Oral Powder (General) Veterinary
325. M/s Decent
Pharma, Plot # 30,
Street No. SS-3,
National Industrial
Zone, Rawat,
Islamabad.
Additional section:
Oral Powder
(General)
Veterinary approved in 242
nd
meeting of Central
Licensing Board
Scada Water
Soluble Powder
Each 100 gm
contains
Ammonium
Chloride 30 gm
Aspirin 10 gm
Vitamin C 10 g
Di-Methionine 10
g
Vitamin A
150,000 IU
Sorbitol 5 gm
Analgesic &
Antipyretic
NSAID
Supplement
(Manufacture
Specification)
Form 5
Rs. 20,000/-
vide Dy. No.
152 dated 07-
08-2015
Pack size of
100g, 500 g, 1
kg, 2.5kg, 5kg,
10kg & 25 kg
Decontrolled
Gumbosol Water
Soluble Powder
(Westmont
Pharma)
Approved
326. -do- Decoc Water
Soluble Powder
Each 1 kg contains
Sulphadimidin
Sodium 225 gm
Diveridine HCl
62.5 gm
Vitamin K3.. 20.5
mg
Anticoccidial
(Manufacture
Specification)
Form 5
Rs. 20,000/-
vide Dy. No.
119 dated 06-
08-2015
Pack size of
100g, 500 g, 1
kg, 2.5kg, 5kg,
10kg & 25 kg
Decontrolled
Coxicide W/S
Powder. (Sana
Lab)
Approved
327. -do- Acelyte Water
Soluble Powder
Each 100 gm
contains
Aspirin 67 gm
Vitamin C 200 g
Sodium Citrate 0.7
gm
Calcium
Carbonate 50 g
Sodium Chloride
Form 5
Rs. 20,000/-
vide Dy. No.
115 dated 06-
08-2015
Pack size of
100g, 500 g, 1
kg, 2.5kg, 5kg,
10kg & 25 kg
S-PRO-C W/S
POWDER
(NAWAL)
Approved
Minutes for 253rd
Registration Board Meeting 380
40 gm
Magnesium
Sulphate 40 gm
Analgesic &
Antipyretic
NSAID
Supplement
Veterinary
Preparation
(Manufacture
Specification)
Decontrolled
328. -do- Fresh All Water
Soluble Powder
Each kg contains
Furosemide 20 gm
Potassium
Chloride 4 gm
Calcium
Carbonate 45 g
Magnesium
Sulphate 35 gm
Maganese
Sulphate 1gm
Sodium Chloride
35 gm
Antiinfectives
minerals
(Manufacture
Specification)
Form 5
Rs. 20,000/-
vide Dy. No.
116 dated 06-
08-2015
Pack size of
100g, 500 g, 1
kg, 2.5kg, 5kg,
10kg & 25 kg
Decontrolled
Flush DM
Powder (D-
Maarson)
Approved
329. -do- Frusatop Water
Soluble Powder
Each kg contains
Furosemide B.P
20 gm
Calcium
Carbonate B.P 45
g
Sorbitol B.P 50
gm
Magnesium
Sulphate B.P
35gm
Form 5
Rs. 20,000/-
vide Dy. No.
143 dated 06-
08-2015
Pack size of
100g, 500 g, 1
kg, 2.5kg, 5kg,
10kg & 25 kg
Decontrolled
Frusatol Powder
(Inshal)
Approved
Minutes for 253rd
Registration Board Meeting 381
Antiinfectives
minerals
(Manufacture
Specification)
330. -do- Segan Water
Soluble Powder
Each kg powder
contains
Trichlorphon 98%
Antiparasitic
(BP Specification)
Form 5
Rs. 20,000/-
vide Dy. No.
121 dated 06-
08-2015
Pack size of
100g, 500 g, 1
kg, 2.5kg, 5kg,
10kg & 25 kg
Decontrolled
Seguvan Powder
(Symans)
Approved
331. -do- Amporo-60 Water
Soluble Powder
Each kg contains
Amprolium HCl
600 gm
Anticoccidial
(BP Specification)
Form 5
Rs. 20,000/-
vide Dy. No.
117 dated 06-
08-2015
Pack size of
100g, 500 g, 1
kg, 2.5kg, 5kg,
10kg & 25 kg
Decontrolled
Amproshell-60%
powder (Inshal)
Approved
332. -do- Paracet Water
Soluble Powder
Each 100 gm
contains
Paracetamol 20
gm
Vitamin C 5 gm
Potassium
Carbonate 12.5
gm
Sodium
Bicarbonate 12.5
gm
Vitamin E 12.5
gm
Anticoccidial
(Manufacture
Specification)
Form 5
Rs. 20,000/-
vide Dy. No.
1144 dated 07-
08-2015
Pack size of
100g, 500 g, 1
kg, 2.5kg, 5kg,
10kg & 25 kg
Decontrolled
Para c powder
(Biogen)
Approved
Minutes for 253rd
Registration Board Meeting 382
333. -do- Wormidec Water
Soluble Powder
Each kg contains
Levamisole HCl
500 gm
Antielmintic
(BP Specification)
Form 5
Rs. 20,000/-
vide Dy. No.
118 dated 07-
08-2015
Pack size of
100g, 500 g, 1
kg, 2.5kg, 5kg,
10kg & 25 kg
Decontrolled
Anthiy Powder
(Marketed by
Seza Pharma)
Approved
334. -do- Aspidot Water
Soluble Powder
Each kg contains
Aspirin 67 gm
Vitamin C 200 gm
Analgesic and
antipyretic
NSAIDs
(Manufacture
Specification)
Form 5
Rs. 20,000/-
vide Dy. No.
118 dated 07-
08-2015
Pack size of
100g, 500 g, 1
kg, 2.5kg, 5kg,
10kg & 25 kg
Decontrolled
SPC W/S Powder
(Cherished)
Approved
EVALUATOR IV
Oral Liquid (General) Veterinary
335. M/s Decent Pharma,
Plot # 30, Street No.
SS-3, National
Industrial Zone,
Rawat, Islamabad
Additional section:
Oral Liquid
(General)
Veterinary approved in 242
nd
meeting of Central
Licensing Board.
Fendex Oral
Suspension
Each ml contains
Febendazole 100
mg
Antielmintic
(USP
Specification)
Form 5
Rs. 20,000/-
vide Dy. No.
146 dated 07-
08-2015
Pack size of
100ml, 150ml,
500 ml, 1 Liter,
2.5 lit, 5 lit, 10
lit
Decontrolled
UK authorized
veterinary
medicine
(PAnacur)
Fenbak 10%
(Attabak)
Approved
336. -do- Endex Oral
Suspension
Each ml contains
Triclabendazol
5%
Levamisole HCl
Form 5
Rs. 20,000/-
vide Dy. No.
148 dated 07-
08-2015
Triclapar oral
liquid (Grand
Pharma)
Approved with change of brand
name.
Minutes for 253rd
Registration Board Meeting 383
3.75%
Antielmintic
(Manufacture
Specification)
Pack size of
100ml, 150ml,
250ml, 500 ml,
1 Liter,
2.5 lit, 5 lit,
Decontrolled
337. -do- Endex DS Oral
Suspension
Each ml contains
Triclabendazol
12%
Levamisole HCl
7.5%
Antielmintic
(Manufacture
Specification)
Form 5
Rs. 20,000/-
vide Dy. No.
148 dated 07-
08-2015
Pack size of
100ml, 200ml,
450 ml,500ml, 1
Liter,
2.5 lit, 5 lit, 10
L, 20 L
Decontrolled
Endonid 19.5%%
(Grand Pharma)
.
Approved with change of brand
name.
338. -do- Zonide Oral
Suspension
Each ml contains
Oxfendazole 22.65
mg
Oxyclozanide 62.5
mg
Cobalt as Sulphate
1.67 mg
Selenium as
Sodium Selenite
0.5 mg
Antielmintic
(Manufacture
Specification)
Form 5
Rs. 20,000/-
vide Dy. No.
142 dated 07-
08-2015
Pack size of
100ml, 150ml,
500 ml, 1 Liter,
2.5 lit, 5 lit,
Decontrolled
Clozafen
(attabak)
Approved
339. -do- Levanide Oral
Suspension
Each ml contains
Levamisole HCl
B.P 1.5 gm
Oxyclozanide B.P
3.0 gm
Antielmintic
Form 5
Rs. 20,000/-
vide Dy. No.
149 dated 07-
08-2015
Pack size of
100ml, 150ml,
500 ml, 1 Liter,
2 lit, 5 lit,
Floxy-L (Leo
biocare)
Approved
Minutes for 253rd
Registration Board Meeting 384
(Manufacture
Specification)
Decontrolled
340. -do- Oxadec Oral
Suspension
Each ml contains
Oxfendazole
B.P2.265%
Antielmintic
(BP Specification)
Form 5
Rs. 20,000/-
vide Dy. No.
150 dated 07-
08-2015
Pack size of
100ml, 150ml,
250 ml, 500 ml,
1 Liter,
2.5 lit, 5 lit,
Decontrolled
Oxzole (Nawal)
Approved
341. -do- Cyper 10 Pour On
Oral Suspension
Each ml contains
Cypermethrin 100
mg
Antiparasitic
(manufacture
Specification)
Form 5
Rs. 20,000/-
vide Dy. No.
150 dated 07-
08-2015
Pack size of
100ml, 150ml,
250 ml, 500 ml,
1 Liter,
2.5 lit, 5 lit,
Decontrolled
Ecofleece (Prix)
Approved
342. -do- Trimec Oral
Suspension
Each 100ml
contains
Triclabendazol 5
gm
Ivermectin 100 mg
Antielmintic
(manufacture
Specification)
Form 5
Rs. 20,000/-
vide Dy. No.
154 dated 07-
08-2015
Pack size of
100ml, 150ml,
250 ml, 500 ml,
1 Liter,
2.5 lit, 5 lit,
Decontrolled
Endoplus 5.1%
(Biolabs)
Approved
Minutes for 253rd
Registration Board Meeting 385
343. -do- Trimec DS Oral
Suspension
Each 100ml
contains
Triclabendazol 12
gm
Ivermectin 200 mg
Antielmintic
(manufacture
Specification)
Form 5
Rs. 20,000/-
vide Dy. No.
141 dated 07-
08-2015
Pack size of
100ml, 150ml,
250 ml, 500 ml,
1 Liter,
2.5 lit, 5 lit,
Decontrolled
Endoplus
12.2%(Biolabs)
Approved
344. -do- Albadec Super
Oral Suspension
Each Liter
contains
Albendazole B.P
12.50%
Antielmintic
(manufacture
Specification)
Form 5
Rs. 20,000/-
vide Dy. No.
147 dated 07-
08-2015
Pack size of
100ml, 150ml,
250 ml, 500 ml,
1 Liter,
2.5 lit, 5 lit,
Decontrolled
ALBAZOLE
(Nawan)
Approved
EVALUATOR IV
-
Oral Powder (Penicillin) Veterinary
345. M/s Decent Pharma,
Plot # 30, Street No.
SS-3, National
Industrial Zone,
Rawat, Islamabad
Additional section,
Oral Powder
(Penicillin)
Veterinary approved in 242
nd
meeting of Central
Licensing Board.
Augmencil Water
Soluble Powder
Each 1000gm
contains
Amoxycillin
Trihydrate 160 gm
Colistin Sulphate
40 gm
Clavulanic acid 40
gm
Dextrose
anhydrous
Penicillin/antibioti
cs
(manufacture
Specification)
Form 5
Rs. 20,000/-
vide Dy. No.
145 dated 07-
08-2015
Pack size of
100gm, 500
gm, 1kg,
5kg, 10kg &
20kg
Decontrolled
Caltin W/S
Powder (D-
maarson)
Approved
Minutes for 253rd
Registration Board Meeting 386
346. -do- Colab Water
Soluble Powder
Each 1000 gm
contains
Colistin Sulphate
500 MIU
Lincomycin HCl
50gm
moxycillin
Trihydrate 100 gm
Bromhexin HCl 5
gm
Penicillin/antibioti
cs
(manufacture
Specification)
Form 5
Rs. 20,000/-
vide Dy. No.
124 dated 07-
08-2015
Pack size of
100gm, 500
gm, 1kg,
5kg, 10kg &
20kg
Decontrolled
Moxin-L WSP
(Attabak)
Approved
347. -do- ASLE Water
Soluble Powder
Each gram
contains
Amoxycillin as
Trihydrate B.P
200 mg
Spectinomycin
2HCl B.P 80mg
Lincomycin B.P
80 mg
Vitamin E Acetate
B.P 30 mg
Penicillin/antibioti
cs
(manufacture
Specification)
Form 5
Rs. 20,000/-
vide Dy. No.
127 dated 07-
08-2015
Pack size of
50gm, 100gm,
500 gm, 1kg,
5kg, 10kg &
20kg
Decontrolled
Lincamox –s
(Breeze)
Approved
348. -do- Linkomox Water
Soluble Powder
Each 100 gram
contains
Amoxycillin as
Trihydrate B.P
100 g
Lincomycin as
HCl B.P 50 g
Streptomycin
2HCl B.P 50gm
Penicillin/antibioti
cs
(manufacture
Specification)
Form 5
Rs. 20,000/-
vide Dy. No.
128 dated 07-
08-2015
Pack size of
100gm, 250gm,
500 gm, 1kg, 2.5
kg,
5kg, 10kg &
25kg
Decontrolled
Moxapect
(Biogen)
Approved
Minutes for 253rd
Registration Board Meeting 387
349. -do- Euromox-50
Water Soluble
Powder
Each 100 gram
contains
Amoxycillin
Trihydrate 50 g
Colistin Sulphate
50 MIU
Dextrose
anhydrous QS 100
gm
Penicillin/antibioti
cs
(manufacture
Specification)
Form 5
Rs. 20,000/-
vide Dy. No.
125 dated 07-
08-2015
Pack size of
50gm , 100gm,
500 gm, 1kg,
5kg, 10kg &
25kg
Decontrolled
Amox C (D-
maarson )
Approved
350. -do- Ascot Water
Soluble Powder
Each kg contains
Amoxycillin
Trihydrate 200 g
Colistin Sulphate
800 MIU
Dextrose
anhydrous QS
1000 gm
Penicillin/antibioti
cs
(manufacture
Specification)
Form 5
Rs. 20,000/-
vide Dy. No.
122 dated 07-
08-2015
Pack size of
50gm , 100gm,
500 gm, 1kg,
5kg, 10kg &
25kg
Decontrolled
Polimox W/S
Powder (Biogen)
Approved
351. -do- Lyzomox Water
Soluble Powder
Each kg contains
Amoxycillin (as
Trihydrate) B.P
50gm
Lyzosyme HCl 10
gm
Guaifenesin 35
gm
Penicillin
(manufacture
Specification)
Form 5
Rs. 20,000/-
vide Dy. No.
129 dated 07-
08-2015
Pack size of
50gm , 100gm,
500 gm, 1kg,
5kg, 10kg &
25kg
Decontrolled
Amoxy Add
(Hassan
Brothers)
Approved
Minutes for 253rd
Registration Board Meeting 388
352. -do- Potencil Water
Soluble Powder
Each kg contains
i. Amoxycillin
Trihydrate 150
g
ii. Colistin
Sulphate 500
MIU
iii. Dextrose
anhydrous QS
1000 gm
Penicillin/antibioti
cs
(manufacture
Specification)
Form 5
Rs. 20,000/-
vide Dy. No.
123 dated 07-
08-2015
Pack size of
50gm , 100gm,
500 gm, 1kg,
5kg, 10kg &
25kg
Decontrolled
Amoxybar-c
(Baariq)
Approved
353. -do- Neo AC Water
Soluble Powder
Each kg contains
Amoxycillin as
Trihydrate B.P
100 g
Colistin Sulphate
B.P 50 gm
Neomycin
Sulphate USP 200
gm
Penicillin/antibioti
cs
(manufacture
Specification)
Form 5
Rs. 20,000/-
vide Dy. No.
126 dated 07-
08-2015
Pack size of
100gm, 500
gm, 1kg,
5kg, 10kg &
20kg
Decontrolled
Amoxy-N W/S
Powder (Hira)
Approved
354. -do- Betamox Water
Soluble Powder
Each kg contains
Amoxycillin as
Trihydrate B.P
230 g
Colistin Sulphate
B.P 1000 MIU
Dextrose
anhydrous QS
1000 gm
Penicillin/antibioti
cs
(manufacture
Specification)
Form 5
Rs. 20,000/-
vide Dy. No.
130 dated 07-
08-2015
Pack size of
50gm , 100gm,
500 gm, 1kg,
5kg, 10kg &
25kg
Decontrolled
Pentamox
(biogen)
Approved
Minutes for 253rd
Registration Board Meeting 389
EVALUATOR IV
M/s Alza Pharmaceuticals (Formerly M/s Alshife Trust Eye Hospital), Rawalpindi
Cream/Ointment/Gel (General)
355. M/s Alza
Pharmaceuticals
(Formerly M/s
Alshife Trust Eye
Hospital), Jhelum
Road, Rawalpindi.
Additional section:
Cream/Ointment/
Gel (General) approved in 241
st
meeting of Central
Licensing Board.
Benasil Cream 1%
Each gram
contains
Terbinafine USP
… 10 mg
Antifungal
(USP
Specification)
Form 5
Rs. 20,000/-
vide Dy. No.
5241 dated 07-
08-2015
Pack size of
10gm as per
SRO
MHRA approved
Terbinafine HCl
1% (Niche, UK)
Lamisil
(Novartis)
Approved
356. -do- Methyroid Cream
0.1%
Each gram
contains
Methylprednisolo
ne Aceponate 1mg
Glucocorticoids
(Manufacture
Specification)
Form 5
Rs. 20,000/-
vide Dy. No.
5233 dated 07-
08-2015
Pack size of
10gm as per
SRO
TGA approved
Advantan Cream
0.1% (CSL,
Australia)
Advantan
(Bayer)
Approved
357. -do- Silza Cream
Each gram
contains Silver
Sulfadiazine 10
mg
Sulfonamide
Antibiotics
(USP
Specification)
Form 5
Rs. 20,000/-
vide Dy. No.
5251 dated 07-
08-2015
Pack size of
15gm as per
SRO
FDA approved
SSD (Dr. Reddys
LA, USA)
Quench
(Ferozsons)
Approved
358. -do- Hyclozole Cream
Each gram
contains
Hydrocortisone 10
mg
Clotrimazole 10
mg
Antifungal/
Corticosteroid
(Manufacture
Specification)
Form 5
Rs. 20,000/-
vide Dy. No.
5229 dated 07-
08-2015
Pack size of
10gm as per
SRO
MHRA approved
Canesten HC
cream (Bayer)
Hydrozole (GSK)
Approved
Minutes for 253rd
Registration Board Meeting 390
359. -do- Hirsunil Cream
11.5%
Each gram
contains
Eflornithine (as
HCl) 115mg
Antiprotozoal
(Manufacture
Specification)
Form 5
Rs. 20,000/-
vide Dy. No.
5231 dated 07-
08-2015
Pack size of
15gm as per
SRO
MHRA approved
Vaniqa (Almirall,
Barcelona)
Depilus (Atco)
Approved
360. -do- Erytrexin Gel
Each gram
contains
Erythromycin
(USP) 20 mg
Isotretenoin (BP)
0.5 mg
Antibacterial/Anti
acne
(Manufacture
Specification)
Form 5
Rs. 20,000/-
vide Dy. No.
5226 dated 07-
08-2015
Pack size of
10gm as per
SRO
MHRA approved
Isotrexin Gel
(GSK)
Tretocin (Derma
Techno)
Approved
361. -do- Taclimus
Ointment
Each gram
contains
Tacrolimus
Immunomodulator
(Manufacture
Specification)
Form 5
Rs. 20,000/-
vide Dy. No.
5223 dated 07-
08-2015
Pack size of
10gm as per
SRO
MHRA approved
Protopic 0.03%
Ointment
(Astellas,
Netherland)
Crolimus (Valor)
Deferred as product is under
review and refered to the
Licensing Division for
requirement of manufacturing
area for immunomodulatory
products.
362. -do- Mucin F Ointment
Each gram
contains
Fluticasone
Propionate 0.5 mg
Mupirocin 20 mg
Corticosteroid/anti
bacterial
(Manufacture
Specification)
Form 5
Rs. 20,000/-
vide Dy. No.
5224 dated 07-
08-2015
Pack size of
5gm as per SRO
Cutivate M
(GSK) not
available in
Pakistan but india
Deferred for confirmation of
approval by reference regulatory
authorities
Minutes for 253rd
Registration Board Meeting 391
363. -do- Calbetol Ointment
Each gram
contains
Calcipotriol
anhydrous 0.05
mg
Betamethasone (as
Dipropionate) 0.5
mg
Corticosteroid/Vit
D analogue
(Manufacture
Specification)
Form 5
Rs. 20,000/-
vide Dy. No.
5250 dated 07-
08-2015
Pack size of
10gm as per
SRO
MHRA approved
(Dalbecal by
Teva,UK)
Calcibet (Valor)
Approved
364. -do- Mucin Ointment
Each gram
contains
Mupirocin 20 mg
USP
Antibacterial
(USP
Specification)
Form 5
Rs. 20,000/-
vide Dy. No.
5234 dated 07-
08-2015
Pack size of
15gm as per
SRO
MHRA approved
Mupirocin
ointment
Bactroban (GSK)
Approved
EVALUATOR I M/s Ardin Pharmaceuticals, Karachi
Cream/Ointment/Gel (General)
365. M/s Ardin
Pharmaceuticals,
plot No. 56 Sector
27, Korangi
Industrial area,
Karachi.
Cream/Ointment/G
el (General)
approved in 240th
meeting of CLB
Gentarin Cream
0.3%
Each gram
contains
Gentamicin
Sulphate 0.3%
Antibiotic
USP
Specifications
Form-5
23-06-2015
diary No 302.
Rs20,000
As per SRO/10
Gm Pack
Not confirmed
Not confirmed
Deferred for clarification as
firm has changed the
formulation from 0.3% to
0.1%.
366. -do- Ardic Cream 2%
Each gram
contains Fusidic
acid….. 20mg
Antibiotic
B.P
Specifications
Form-5
23-06-2015
diary No 309.
Rs20,000
As per SRO/15
Gm Pack
Fucidin 2% By M/s Leo
MHRA
Fucirog 2% by M/s
Wisdom
Approved
Minutes for 253rd
Registration Board Meeting 392
367. -do- Ardefenac Gel 1%
Each gram
contains
Diclofenac
diethylamine eq to
Diclofenac
Sodium….. 10mg
Analgesic
B.P Specifications
Form-5
23-06-2015
diary No 309.
Rs20,000
As per SRO/15
Gm Pack
FDA approved Voltral
Gel
Voltral (Novartis)
Approved
368. -do- Sulfadin Cream
1%
Each gram
contains:- Silver
Sulfadiazine….10
mg
Antibacterial
Manufacturer‟s
Specifications
Form-5
23-06-2015
diary No 311.
Rs20,000
As per SRO/25
Gm Pack
FDA Silvadene Cream
1%
Burnasil Cream 1% by
M/s Bloom
Approved
369. -do- Neocin Cream
Each gram
contains
betamethasone as
valerate….1mg
Neomycin
sulphate …. 5mg
Corticosteride/Ant
ibacterial
Manufacturer‟s
Specifications
Form-5
23-06-2015
diary No 304.
Rs20,000
As per SRO/10
Gm Pack
Not confirmed
Betnovate-N by M/s
GSK
Deferred for confirmation
of approval by reference
regulatory authorities
370. -do- Dermazin Gel
Each gram
contains
Lignocaine HCl
…. 20mg
Local Anesthetic
B.P Specifications
Form-5
23-06-2015
diary No 303.
Rs20,000
As per SRO/15
Gm Pack
FDA Lidocaine 2%
Xylocaine gel 2% by
M/s Barret Hodgson
Approved with the change of
name.
371. -do- Clomidin 1%
Cream
Each gram
contains
Clotrimazole….10
mg
Antifungal
B.P Specifications
Form-5
23-06-2015
diary No 310.
Rs20,000
As per SRO/10
Gm Pack
FDA Clotrimazole 1%
Clotrim 1% by M/s
Zafa.
Approved
Minutes for 253rd
Registration Board Meeting 393
372. -do- Polydin Ointment
Each gram
contains
Polymyxin B
Sulphate….10,000
Units Bacitracin
Zinc …500Units
Antifungal
USP
Specifications
Form-5
23-06-2015
diary No 307.
Rs20,000
As per SRO/20
Gm Pack
FDA Bacitracin &
Polymyxin by M/s
Akorn
Polyfax by M/s GSK
Approved
373. -do- Pain-Go Balm
Each 100 gram
contains
Methyl
Salicylate….15gm
Menthol ….10gm
Analgesic
B.P Specifications
Form-5
23-06-2015
diary No 306.
Rs20,000
As per SRO/50
Gm Pack
Not confirmed
Not confirmed
Deferred for clarification as
firm has changed the
formulation from 0.3% to
0.1%.
374. -do- Burnil Cream
Each gram
contains
Euflavine(Acriflav
in) …1mg
Antiseptic
Manufacturer‟s
Specifications
Form-5
23-06-2015
diary No 305.
Rs20,000
As per SRO/30
Gm Pack
MHRA approved
Burnol by M/s Abbott.
Approved with the change of
name.
Capsule (General)
375. M/s Ardin
Pharmaceuticals,
plot No. 56 Sector
27, Korangi
Industrial area,
Karachi.
Capsule (General)
approved in 240th
meeting of CLB
Esoprazole
Capsule 40mg
Each capsule
contains enteric
coated
Esomeprazole
Magnesium pellets
eq.to
Esomeprazole
40mg
Proton Pump
Inhibitor
Manufacturer
Specifications
Form-5
23-06-2015
diary No 315.
Rs20,000
As per SRO
Source M/s
Vision Pharma,
Islamabad.
FDA, Nexium by M/s
Astrazeneca
Esso 40mg by Shaigan
Approved
376. -do- Ardefenac
Capsule 100mg
Each capsule
contains
Diclofenac
Sodium SR
pellets eq.to
Diclofenac
Form-5
23-06-2015
diary No 318.
Rs20,000
As per SRO
Source M/s
Vision Pharma,
Islamabad.
Diclomax Retard
100mg capsule by M/s
Galen Ltd
Dicloyan-S capsules by
M/s Roryan, Pharma
Deferred for confirmation
of approval by reference
regulatory authorities
Minutes for 253rd
Registration Board Meeting 394
Sodium 100mg
NSAIDs
BP Spec
377. -do- Azin Capsule
250mg
Each capsule
contains
Azithromycin
Dihydrate eq. to
Azithromycin
250mg
Macrolide
USP
Specifications
Form-5
23-06-2015
diary No 321.
Rs20,000
As per SRO
Zithromax capsule
250mg by M/s Pfizer
UK
Acim capsule 250mg by
M/s Fynk Pharma
Approved
378. -do- Lincodin Capsule
500mg
Each capsule
contains
Lincomycin HCl
eq. to Lincomycin
500mg
Antibiotic
USP
Specifications
Form-5
23-06-2015
diary No 317.
Rs20,000
As per SRO
FDA Lincomycin
500mg capsule by M/s
Pharmacia
Lincocin 500mg by M/s
Pfizer
Approved
379. -do- Celedin Capsule
200mg
Each capsule
contains
Celecoxib 200mg
NSAID
USP
Specifications
Form-5
23-06-2015
diary No 319.
Rs20,000
As per SRO
Celebrex capsule 200mg
by M/s Pfizer UK
Cobix 200mg capsule by
M/s EG Pharma
Approved
380. -do- Ardicam Capsule
20mg
Each capsule
contains
Piroxicam 20mg
NSAID
B.P Specifications
Form-5
23-06-2015
diary No 318.
Rs20,000
As per SRO
FDA Feldene 20mg by
M/s Pfizer
Feldene 20mg Cap by
M/s Pfizer
Approved
381. -do- Ardium Capsule
2mg
Each capsule
contains
Loperamide 2mg
USP
Specifications
Form-5
23-06-2015
diary No 318.
Rs20,000
As per SRO
FDA,Imodium 2mg by
M/s J & J
Imodium 2mg by M/s
Janssen
Approved
Minutes for 253rd
Registration Board Meeting 395
M/s Soma Laboratories, has been shifted from residential area of Saman Abad Lahore to their new site located at Plot # 43-D,
Sundar Industrial Estate Raiwind Road Lahore, in compliance of the SRO 470/98 dated 15-05-1998 of the Drugs Act 1976.
Central Licesning Board in its 241st meeting held on 15-05-2015 approved the grant/shifting of their DML No. 000225
(Formulation).
The already licensed sections of the firm in the previous site in residential area i.e. Sachet (General) and Tablet (General) of
the firm have been shifted / re-granted to new location and in addition, firm also developed new facility for Capsule General
section.
Status of the firm for previous registered products of the firm is not clear. However, firm has reported to apply for transfer of
eight (8) previous products in R-V section. In addition to these, firm has also applied for registration of following new products
in Sachet general and tablets general sections. It is submitted for consideration of RB for registration of new products in shifted
/ re-granted section.
382. M/s Soma
Laboratories, Plot
# 43-D, Sundar
Industrial Estate
Raiwind Road
Lahore.
(Sachet General)
shifted.
Someta
Sachet
Each Sachet contains:
Dioctahedralsmectite……3gm
Antidiarrheal, Gastro-intestinal
protectant
Form-5
Dy. No: 4391
dated09-07-15
Rs.20000/- (As
per PRC)
1x30‟s
Smecta by Atco
Available in
France.
Approved in
250th
meeting.
Deferred for
confirmation of
registration status in
shifted sections as firm
has already applied for
transfer of registrations
to new site and for
clarification of
followings:
Firm using no
excepient in
formulation.
Finished product specs
not provided.
Sign of QC manger and
production manger
seems different on
submitted commitment.
383. M/s Soma
Laboratories, Plot
# 43-D, Sundar
Industrial Estate
Raiwind Road
Lahore.
(Sachet General)
Calcinate
Sachet
Each Sachet contains:
Calcium
Gluconate………578mg
Calcium Lactate…………422mg
Calcium carbonate………327mg
Vit C …………………….500mg
Calcium salt
Form-5
Dy. No: 4392
dated 09-07-15
Rs.20000/- (As
per SRO)
1x10‟s
Lachida by M/s
Zephyr
Pharmatec.
International
availability not
provided.
Deferred for
confirmation of
registration status in
shifted sections as firm
has already applied for
transfer of registrations
to new site and for
clarification of
followings:
Me too not correct as it
also contain calcium
pentothenate 1000mg.
International
availability not
confirm.
Finished product specs
not provided.
Sign of QC manger and
production manger
Evaluator II
Minutes for 253rd
Registration Board Meeting 396
seems different on
submitted commitment
384. M/s Soma
Laboratories, Plot
# 43-D, Sundar
Industrial Estate
Raiwind Road
Lahore.
(Sachet General)
Sodalime
Sachet
Each Sachet contains:
Sodium
Bicarbonate……1.716gm
Sodium
Citrate…………0.613gm
Citric Acid……………. 0.702gm
Tartaric Acid…………. 0.858gm
Antacid & Anti-flatulent
Form-5
Dy. No: 4393
dated.
09-07-15
Rs.20000/- (As
per PRC)
1x10‟s, 1x100‟s
Sodazaf by m/s
zafa
pharmaceuticals.
International
availability not
confirmed.
Deferred for
confirmation of
registration status in
shifted sections as firm
has already applied for
transfer of registrations
to new site and for
clarification of
followings:
Sign of QC manger and
production manger
seems different on
submitted commitment.
International
availability needs to be
confirmed.
Testing method given
for “sodium citrate and
citric acid oral
solution”.
Tablet (General) shifted
385. M/s Soma
Laboratories, Plot
# 43-D, Sundar
Industrial Estate
Raiwind Road
Lahore.
(Tablet General)
Dicophen 75
Tablet
Each tablet contains:
Diclifenac Potassium
NSAID
Form-5
Dy. No: 4372
dated.
09-07-15
Rs.20000/- (As
per SRO)
2x10‟s,
100‟s Jar
ACHEX 75mg by
m/s Wise
Pharmaceuticals.
International
availability not
confirmed.
Deferred for
confirmation of
registration status in
shifted sections as firm
has already applied for
transfer of registrations
to new site and for
clarification of
following:
International
availability not
confirmed.
Label claim not correct.
Formulation contains
sweetening agents and
flavours but method
outline shows it is film
coated tablets.
Master formulation
contains diclofenac
sodium instead of
diclofenac potassium.
Finished products specs
not provided.
Minutes for 253rd
Registration Board Meeting 397
386. M/s Soma
Laboratories, Plot
# 43-D, Sundar
Industrial Estate
Raiwind Road
Lahore.
(Tablet General)
Sofloxin 500
Tablet
Each tablet contains:
Ciprofloxacin
(HCl)……599.99mg
Fluoroquinolones (Antibiotics)
Form-5
Dy. No: 4373
dated.
09-07-15
Rs.20000/- (As
per SRO) 10‟s
AMPROX 500
mg by m/s
ROGEN
Pharmaceuticals.
USFDA, MHRA
Deferred for
confirmation of
registration status in
shifted sections as firm
has already applied for
transfer of registrations
to new site and for
clarification of
following:
Coating material
contains methylene
chloride.
Sign of QC manger and
production manger
seems different on
submitted commitment.
Firm has copied and
pasted the formulation
in products at serial no.
5, 6, 7.
387. M/s Soma
Laboratories, Plot
# 43-D, Sundar
Industrial Estate
Raiwind Road
Lahore.
(Tablet General)
Sefenic Forte
Tablet
Each tablet contains:
Mefenamic Acid……599.99mg
NSAID
Form-5
Dy. No: 4380
dated.
09-07-15
Rs.20000/- (As
per SRO) 100‟s
Ponstan forte by
m/s Pfizer
laboratories.
MHRA
Deferred for
confirmation of
registration status in
shifted sections as firm
has already applied for
transfer of registrations
to new site and for
clarification of
following:
Quantity of active not
as per Me too.
Manufacturing out line
shows it as film coated
tablets.
Sign of QC manger and
production manger
seems different on
submitted commitment.
Firm has copied and
pasted the formulation
in products at serial no.
5, 6, 7.
388. M/s Soma
Laboratories, Plot
# 43-D, Sundar
Industrial Estate
Raiwind Road
Lahore.
(Tablet General)
Gastracil
Tablet
Each tablet contains:
Magnesium
Trisilicate….599.99mg
Antacid
Form-5
Dy. No: 4379
dated.
09-07-15
Rs.20000/- (As
per SRO)
1000‟s
AMTRI 500mg by
m/s Mian
Brothers.
International
availability not
confirmed. In
MHRA and
USFDA it exist in
combination with
Deferred for
confirmation of
registration status in
shifted sections as firm
has already applied for
transfer of registrations
to new site and for
clarification of
following:
Minutes for 253rd
Registration Board Meeting 398
Aluminium
Hydroxide.
Quantity of active not
as per Me too.
Manufacturing out line
shows it as film coated
tablets.
Sign of QC manger and
production manger
seems different on
submitted commitment.
Firm has copied and
pasted the formulation
in products at serial no.
5, 6, 7.
389. M/s Soma
Laboratories, Plot
# 43-D, Sundar
Industrial Estate
Raiwind Road
Lahore.
(Tablet General)
Levofac
Tablet
Each tablet contains:
Levofloxacin…….500mg
Antacid
Form-5
Dy. No: 4374
dated.
09-07-15
Rs.20000/- (As
per SRO) 10‟s
Aksolox 500mg
by m/s Akson
Pharmaceuticals.
USFDA, MHRA
Deferred for
confirmation of
registration status in
shifted sections as firm
has already applied for
transfer of registrations
to new site and for
clarification of
following:
Quantity of active is
256.15 mg instead of
500 mg eq to Base.
No binder, lubricant or
gliding agent etc given.
Finished products specs
required.
Coating material
contains methylene
chloride.
Firm has copied and
pasted the formulation
in products at serial no.
8, 12.
390. M/s Soma
Laboratories, Plot
# 43-D, Sundar
Industrial Estate
Raiwind Road
Lahore.
(Tablet General)
Dicolin 50
Tablet
Each tablet contains:
Diclofenac Sodium…….50mg
NSAID
Form-5
Dy. No: 4375
dated.
09-07-15
Rs.20000/- (As
per SRO)
2x10‟s Blister
Jar 100 Tablet
Accred 50mg
Tablets by m/s
Albro Pharma.
MHRA, USFDA
Deferred for
confirmation of
registration status in
shifted sections as firm
has already applied for
transfer of registrations
to new site and for
clarification of
following:
It exist as extended/
delayed release or
gastro-resistant but firm
has provided flavouring
and sweetening agents
that are used chewable
tablets. It needs
Minutes for 253rd
Registration Board Meeting 399
confirmation.
Label claim not clear.
Finished products specs
required.
Sign of QC manger
and production manger
seems different on
submitted commitment.
391. M/s Soma
Laboratories, Plot
# 43-D, Sundar
Industrial Estate
Raiwind Road
Lahore.
(Tablet General)
Sofloxin
Tablet
Each tablet contains:
Ciprofloxacin HCl
Monohydrate…. 750mg
Fluoroquinolones (Antibiotics)
Form-5
Dy. No: 4376
dated.
09-07-15
Rs.20000/- (As
per SRO) 10‟s
Amesure 750mg
by m/s Medisure
Laboratories.
MHRA
Deferred for
confirmation of
registration status in
shifted sections as firm
has already applied for
transfer of registrations
to new site and for
clarification of
following:
Quantity of active not
justified.
Firm is using
methylene chloride for
coating.
Finished products specs
required.
Sign of QC manger and
production manger
seems different on
submitted commitment.
392. M/s Soma
Laboratories, Plot
# 43-D, Sundar
Industrial Estate
Raiwind Road
Lahore.
(Tablet General)
Clith 500
Tablet
Each tablet contains:
Clarithromycin…….599.99mg
Macrolide Antibiotic
(USP Specs.)
Form-5
Dy. No: 4381
dated.
09-07-15
Rs.20000/- (As
per SRO)
1x10‟s
Claritek by m/s
Getz Pharma.
MHRA, USFDA
Deferred for
confirmation of
registration status in
shifted sections as firm
has already applied for
transfer of registrations
to new site and for
clarification of
following:
Label claim not clear.
Firm has copied and
pasted the formulation
in products at serial no.
5, 6, 7.
No coating material
given.
Sign of QC manger and
production manger
seems different on
submitted commitment.
393. M/s Soma
Laboratories, Plot
# 43-D, Sundar
Industrial Estate
Levofac 250
Tablet
Each tablet contains:
Levofloxacin…….250mg
Form-5
Dy. No: 4382
dated.
09-07-15
Aksolox 500mg
by m/s Akson
Pharmaceuticals.
USFDA, MHRA
Deferred for
confirmation of
registration status in
shifted sections as firm
Minutes for 253rd
Registration Board Meeting 400
Raiwind Road
Lahore.
(Tablet General)
Fluoroquinolones (Antibiotics)
Rs.20000/- (As
per SRO) 10‟s
has already applied for
transfer of registrations
to new site and for
clarification of
following:
No binder, lubricant or
gliding agent etc given.
Finished products specs
required.
Coating material
contains methylene
chloride.
Sign of QC manger and
production manger
seems different on
submitted commitment.
Firm has copied and
pasted the formulation
in products at serial no.
8, 12.
394. M/s Soma
Laboratories, Plot
# 43-D, Sundar
Industrial Estate
Raiwind Road
Lahore.
(Tablet General)
Ib-Fen
Tablet
Each tablet contains:
Ibuprofen…..400mg
NSAID
Form-5
Dy. No: 4384
dated.
09-07-15
Rs.20000/- (As
per PRC) 100‟s
Actifen by m/s
Glaxosmithkline.
MHRA
Deferred for
confirmation of
registration status in
shifted sections as firm
has already applied for
transfer of registrations
to new site and for
clarification of
following:
Label claim not clear.
Firm has mentioned
sodium Ibupofen
Dihydrate as active.
Sign of QC manger and
production manger
seems different on
submitted commitment.
Capsule (General)-New Section
395. M/s Soma
Laboratories, Plot
# 43-D, Sundar
Industrial Estate
Raiwind Road
Lahore.
(Capsule
General)
Azitho
Capsule
Each Capsule contains:
Azithromycin…… 500mg
Macrolide Antibiotic
Form-5
Dy. No: 4377
dated.
09-07-15
Rs.20000/- (As
per SRO) 6‟s
Azomax of M/s
Novartis Pharma
Deferred for
clarification of
following Azomax
500mg exist in tablets
form.
Firm using no
excepient in
formulation and has
mentioned that no
excepient required.
Quantity of active not
justified.
Outline method of
manufacturing shows it
Minutes for 253rd
Registration Board Meeting 401
soft gelatin capsule
Sign of QC manger and
production manger
seems different on
submitted commitment
Strength active and in
active material is not
provided.
Capsule shell size not
provided.
International
availability need to be
confirmed.
396. M/s Soma
Laboratories, Plot
# 43-D, Sundar
Industrial Estate
Raiwind Road
Lahore.
(Capsule
General)
Azitho
Capsule
Each Capsule contains:
Azithromycin…… 250mg
Macrolide Antibiotic
(Specs USP 32)
Form-5
Dy. No: 4371
dated.
09-07-15
Rs.20000/- (As
per SRO) 12‟s
Azomax of M/s
Novartis Pharma
MHRA
Firm using no
excepient in
formulation and has
mentioned that no
excepient required.
Quantity of active not
justified.
Outline method of
manufacturing shows it
soft gelatin capsule
Sign of QC manger and
production manger
seems different on
submitted commitment
Strength active and in
active material is not
provided.
Capsule shell size not
provided.
397. M/s Soma
Laboratories, Plot
# 43-D, Sundar
Industrial Estate
Raiwind Road
Lahore.
(Capsule
General)
Sotran 500
Capsule
Each Capsule contains:
Tranexamic Acid……527.44
Anti-Fibrinolytic Agent
Form-5
Dy. No: 4385
dated.
09-07-15
Rs.20000/- (As
per SRO) 20‟s
Hixamic of M/s
Himont
Chemicals.
It exist as 650mg
tablets in USFDA
and 500mg tablets
in MHRA. It exist
as capsule in
japanes
Pharmacopiea but
strength not clear.
Deferred for
clarification of
following
Quantity of active need
justification.
Outline method of
manufacturing shows it
soft gelatin capsule
Sign of QC manger and
production manger
seems different on
submitted commitment
Strength active and in
active material is not
provided.
Capsule shell size not
provided.
Product specification is
not provided.
Minutes for 253rd
Registration Board Meeting 402
398. M/s Soma
Laboratories, Plot
# 43-D, Sundar
Industrial Estate
Raiwind Road
Lahore.
(Capsule
General)
Sodox
Capsule
Each Capsule contains:
Doxycycline (hyclate)
…..100.44mg
Tetracycline Antibiotic
(USP Specs.)
Form-5
Dy. No: 4378
dated.
09-07-15
Rs.20000/- (As
per SRO)
10x10‟s
D-Clin of M/s
Caylex
Pharmaceuticals
(Pvt) Ltd.
MHRA
Deferred for
clarification of
following
Outline method of
manufacturing shows it
soft gelatin capsule
Sign of QC manger and
production manger
seems different on
submitted commitment
Quantity of active
needs justification
399. M/s Soma
Laboratories, Plot
# 43-D, Sundar
Industrial Estate
Raiwind Road
Lahore.
(Capsule
General)
Ezole-40
Capsule
Each Capsule contains:
Esomeprazole……40mg
Anti-Ulcer
USP-32 Specs
Form-5
Dy. No: 4383
dated.
09-07-15
Rs.20000/- (As
per SRO) 2x7‟s
Omega of M/s
Ferozsons
Laboratoies Ltd.
USFDA
Deferred for
clarification of
following
Outline method of
manufacturing shows it
soft gelatin capsule
Sign of QC manger and
production manger
seems different on
submitted commitment
Strength active and in
active material is not
provided.
Capsule shell size not
provided.
Quantity of active
needs justification
Source of pellets not
provided.
From master
formulation its not
clear that active
material is in powder
form or pellet form.
400. M/s Soma
Laboratories, Plot
# 43-D, Sundar
Industrial Estate
Raiwind Road
Lahore.
(Capsule
General)
Ezole-20
Capsule
Each Capsule contains:
Esomeprazole……20mg
Anti-Ulcer
USP-32 Specs
Form-5
Dy. No: 4386
dated.
09-07-15
Rs.20000/- (As
per SRO) 14‟s
Omega of M/s
Ferozsons
Laboratoies Ltd.
(omega contains
omeprazole but
me too exists.)
USFDA
Deferred for
clarification of
following
Composition and
specification of each
ingredient per unit not
provided.
Proposed shelf life
three years.
Outline method of
manufacturing shows it
soft gelatin capsule
Sign of QC manger and
production manger
seems different on
submitted commitment
Minutes for 253rd
Registration Board Meeting 403
Strength active and in
active material is not
provided.
Details of water
processing facility are
required.
Capsule shell size not
provided.
Quantity of active
needs justification
Source of pellets not
provided.
Master formulation
contains active as pellet
and excipients as
powder that is not
justified.
Although Me too
available in Pakistan
but Omega contain
Omeprazole instead of
esomeprazole.
401. M/s Soma
Laboratories, Plot
# 43-D, Sundar
Industrial Estate
Raiwind Road
Lahore.
(Capsule
General)
Eprazole-20
Capsule
Each Capsule contains:
Omperazole……20mg
Anti-Ulcer
USP-32 Specs
Form-5
Dy. No: 4387
dated.
09-07-15
Rs.20000/- (As
per SRO) 14‟s
Acezole
Of M/s T.G.
Pharma
Deferred for
clarification of
following
Outline method of
manufacturing shows it
soft gelatin capsule
Sign of QC manger and
production manger
seems different on
submitted commitment
Strength active and in
active material is not
provided.
Details of water
processing facility are
required.
Capsule shell size not
provided.
Quantity of active
needs justification
Source of pellets not
provided.
From master
formulation its not
clear that active
material is in powder
form or pellet form
Minutes for 253rd
Registration Board Meeting 404
402. M/s Soma
Laboratories, Plot
# 43-D, Sundar
Industrial Estate
Raiwind Road
Lahore.
(Capsule
General)
Eprazole-40
Capsule
Each Capsule contains:
Omperazole……40mg
Anti-Ulcer
USP-32 Specs
Form-5
Dy. No: 4388
dated.
09-07-15
Rs.20000/- (As
per SRO) 14‟s
Acezole
Of M/s T.G.
Pharma
Deferred for
clarification of
following
Composition and
specification of each
ingredient per unit not
provided.
Proposed shelf life
three years.
Outline method of
manufacturing shows it
soft gelatin capsule
Sign of QC manger and
production manger
seems different on
submitted commitment
Strength active and in
active material is not
provided.
Details of water
processing facility are
required.
Capsule shell size not
provided.
Quantity of active
needs justification
Source of pellets not
provided.
From master
formulation its not
clear that active
material is in powder
form or pellet form
403. M/s Soma
Laboratories, Plot
# 43-D, Sundar
Industrial Estate
Raiwind Road
Lahore.
(Capsule
General)
Andol
Capsule
Each Capsule contains:
Indomethacin…….27.44
NSAID
USP-32 Specs
Form-5
Dy. No: 4389
dated.
09-07-15
Rs.20000/- (As
per SRO)
10x50‟s
Jar (500‟s)
Methacid
Of M/s Unexo
Labs International
availability not
provided.
Deferred for
clarification of
following
Quantity of active need
justification.
Outline method of
manufacturing shows it
soft gelatin capsule
Sign of QC manger and
production manger
seems different on
submitted commitment
Strength active and in
active material is not
provided.
Capsule shell size not
provided.
Minutes for 253rd
Registration Board Meeting 405
Product specification is
not provided.
404. M/s Soma
Laboratories, Plot
# 43-D, Sundar
Industrial Estate
Raiwind Road
Lahore.
(Capsule
General)
Vetinol
Capsule
Each Capsule contains:
Vitamin A ……100mg=50000
I.U
NSAID
Form-5
Dy. No: 4390
dated.
09-07-15
Rs.20000/- (As
per SRO)
2x10‟s
Jar 100
ACE-BEX by M/s
Schazoo
Laboratories
International
availability not
provided
Mee too not
correct
Deferred for
clarification of
following
Me too not correct
International
availability needs to be
confirmed.
Firm using 100% active
without any excepient.
Sign of QC manger and
production manger
seems different on
submitted commitment
Capsule shell size not
provided.
Product specification is
not provided.
Evaluator II
Deferred cases of Additional sections of 251st meeting
M/s Bio-Labs (Pvt) Ltd. Islamabad
405. M/s Bio-Labs
(Pvt) Ltd. Plot
No.145 Industrial
Triangle, Kahuta
Road, Islamabad.
Oral Powder
Penicillin approved in 241
st
meeting of CLB
dated 15-05-2015.
BIO Lincoxyspectin ws powder.
Water soluble Powder.
Each 100gm contains:
Amoxicillin Trihydrate…..10gm
Lincomycin (HCl)…………5gm
Spectinomycin dihydrochloride
pentahydrate eq to
spectionmycin……5.0gm
(Antibacterial)
Manufacturer Specs.
Form-5
Dy. No: 290
Dated. 28-05-
2015
Rs.20,000/-
100gm, 500gm,
1000gm, 2kg,
3kg, 5kg/ As
per SRO
Salinobak wsp
Of M/s
Attabak
Pharmaceutical
Approved
406. -do- BIO-Amoxyllin 20% ws powder.
Water soluble Powder.
Each 100gm contains:
Amoxcilline Trihydrate
equivalent to
amoxicilline….20gm
(Antibiotec)
BP Specs.
Form-5
Dy. No: 292
Dated. 28-05-
2015
Rs.20,000/-
100gm, 500gm,
1000gm, 2kg,
3kg, 5kg/ As
per SRO
S.B Ormaox-
20wsp of M/s S.B
pharma
Islamabad.
Approved
407. -do- BIO-Amoxyllin 70% powder.
Water soluble Powder.
Each 100gm contains.
Amoxicillin trihydrate…..80gm
Equivalent 70gm of Amoxicillin
Form-5
Dy. No: 289
Dated. 28-05-
2015
Rs.20,000/-
Primox 70% of
M/s Prix Pharma Approved
Minutes for 253rd
Registration Board Meeting 406
base
(Anti bacterial amoxicillin
trihydrate is moderate spectrum,
bacteriolytic)
B.P Specs.
100gm, 500gm,
1000gm, 2kg,
3kg, 5kg/ As
per SRO
408. -do- BIO Lincocilline ws powder.
Water soluble Powder.
Each 1gm contains.
Amoxycillin
Trihydrate…..200mg
Lincomycin (HCl)……..88mg
Spectinomycin Dihydrochloride
Pentahydrate equivalent to
Spectinomycin……88mg
Vitamin-E………..30mg
(All the active one‟s are
Antibacterial)
Bio-Labs Specs.
Form-5
Dy. No: 232
Dated. 06-05-
2015
Rs.20,000/-
100gm, 500gm,
1000gm, 2kg,
3kg, 5kg/ As
per SRO
Lincamox-S of
M/s Breeze
pharma
Approved
409. M/s Vetz
Pharmaceuticals,
private Limited,
S.I.T.E Kotri
Sindh
Oral Powder
(Vet) approved in
241st meeting of
CLB held on 15-
05-2015.
Sulprolium
Each Kg contains.
Amprolium B.P…200gm
Sulfaquinoxaline (B.P)…200gm
Vit k (B.P)…..2gm
Antibactrial
(Manufacturer specs)
Form-5
Dy. No: 365
dated. 19-06-
2015
20000/- dated
30-06-2015
Decontrolled
Pack of 100gm,
250gm,500gm,
1 kg, 5Kg,
25Kg
Vety Flush by
Leads
Pharmaceutical
Approved
410. M/s GMP
Pharmaceuticals
Lahore.
Oral dry powder
Suspension
(Cephalosporin)
in 241st meeting
of CLB
Gedoxim 40mg suspension
Each 5ml contain:
Cefpodoxime (as
proxitil)…..40mg
Cephalosporin Antibiotics
(USP specs)
Form-5
Dy. No: 2372
dated. 09-12-14
20000/- dated
08-12-2014
Rs. (As Per
SRO) Pack of 1
x 50ml
Quink Susp by
Wilshire Lab
Lahore.
Approved
Minutes for 253rd
Registration Board Meeting 407
Evaluator I
M/s Kohinoor Industries Sahiwal
Cream/Ointment/Gel (General)
411. M/s Kohinoor
Industries
Sahiwal, Plot #
159-160/B Small
Industrial Estate,
Sahiwal.
Cream
/Ointment/ Gel
(General) approved in 241
st
meeting of CLB.
Cloocin Cream 2%
Each gram contains:-
Clindamycin Phosphate eq. to
Clindamycin….20mg
Antibiotic
USP Specifications
Form-5
29-07-2015
diary No 4697.
Rs20,000
As per SRO/ 40
gm tube
Dalacin Cream
UK, by M/s Pfizer
Clind-V by M/s
Highnoon
Approved
412. –
-
-do- Traxin-E Gel
Each gram contains:-
Isotretenoin….0.5mg (0.05%)
Erythromycin….20mg (2%)
Retnoid & Macrolide
Manufacturer‟s Specifications
Form-5
29-07-2015
diary No 4696.
Rs20,000
As per SRO/ 10
gm tube
Isotrexin Gel UK,
by M/s Stockley
Tretocin by M/s
Derma Techno
Approved
413. -do- Gynaeclov-V Cream 2%
Each gram contains:-
Clotrimazole B.P….20mg (2%)
Antifungal
B.P Specifications
Form-5
29-07-2015
diary No 4689.
Rs20,000
As per SRO/ 35
gm tube
Canasten Cream
UK, by M/s Bayer
Fresno Cream by
M/s Biogen
Approved
414. -do- Fusi-Topical Cream 2%
Each gram contains:-
Fusidic Acid….20mg (2%)
Antibacterial
B.P Specifications
Form-5
29-07-2015
diary No 4694.
Rs20,000
As per SRO/ 15
gm tube
Fucidin Cream
UK, by M/s Leo
Fusimin Cream by
M/s Sharooq
Approved
415. -do- Regain Ointment 0.005%
Each gram contains:-
Calcipotriol….50mcg (0.005%)
Antipsoriatics
Manufacturer‟s Specifications
Form-5
29-07-2015
diary No 4691.
Rs20,000
As per SRO/ 30
gm tube
Calcipotriol
Ointment UK, by
M/s Sandoz
Dervit by M/s
Nabiqasim
.
Approved with the
change of name
416. -do- Hydrozone Cream 2.5%
Each gram contains:-
Hydrocortisone Acetate eq. to
Hydrocortisone ….25mg (2.5%)
Corticosteride
B.P Specifications
Form-5
29-07-2015
diary No 4698.
Rs20,000
As per SRO/ 15
gm tube
Emo Cort Cream
Canada, by M/s
GSK
Hydrocort Cream
by M/s Atco
Approved
Minutes for 253rd
Registration Board Meeting 408
417. -do- Derma Care Cream 0.05%
Each gram contains:- Clobetasol
Propionate ….0.5mg (0.05%)
Corticosteride
B.P Specifications
Form-5
29-07-2015
diary No 4701.
Rs20,000
As per SRO/ 10
gm tube
Dermovate Cream
UK, by M/s GSK
Clobevate Cream
by M/s Stiefel
Approved
418. -do- Safe Burn Cream 1%
Each gram contains:- Silver
Sulfadiazine USP ….10mg (1%)
Anti-microbial
USP Specifications
Form-5
29-07-2015
diary No 4695.
Rs20,000
As per SRO/ 20
gm tube
Thermazine
Cream USA, by
M/s The
pharmanetwork
Quench Cream by
M/s Ferozsons
Approved with the
change of name
419. -do- Betnocare Cream 0.1%
Each gram contains:-
Betamethasone as Valerate eq. to
betamethasone….1mg (0.1%)
Corticosteride
B.P Specifications
Form-5
29-07-2015
diary No 4702.
Rs20,000
As per SRO/ 10
gm tube
Betnovate Cream
UK, by M/s The
GSK
Betnovate Cream
by M/s GSK
Approved
420. -do- Flex-E Gel 1.16%
Each gram contains:- Diclofenac
diethylammonium….11.6mg
(1.16%) eq to Diclofenac Sodium
10 mg
NSAID
B.P Specifications
Form-5
29-07-2015
diary No 4690.
Rs20,000
As per SRO/ 20
gm tube
Voltral Emul Gel
UK, by M/s The
Novartis
Voltral Emul Gel
Cream by M/s
Novartis
Approved
Sachet (General)
421. M/s Kohinoor
Industries
Sahiwal, Plot
# 159-160/B
Small
Industrial
Estate,
Sahiwal.
Sachet
(General) approved in
241st meeting
of CLB.
Komizol Sachet
Each sachet contains:-
Omeprazole...40mg Sodium
bicarbonate............1680mg
PPI & Antacid
Manufacturer‟s Specifications
Form-5
29-07-2015
diary No 4692.
Rs20,000
As per SRO/
Box of 10
sachet
Zegerid Powder
for oral
suspension,
USA, by M/s
Santarus
Risek Insta by M/s
Getz
Panel vide
inspection vide
dated 08-09-2014,
new section
recommended.
Deferred as the
formulation is under
review.
Minutes for 253rd
Registration Board Meeting 409
422. -do- Mobegel Sachet
Each sachet contains:-
Mebeverine HCl….135mg
Ispaghula Husk…3.5g
Bulk forming laxative &
antispasmodic agent
Manufacturer‟s Specifications
Form-5
04-08-2015
diary No 4878.
Rs20,000
As per SRO/
Box of 10
sachet
Fybogel
Mebverine, UK,
by M/s Reckit
Benckiser
Colonil Fibro by
M/s Nabiqasim
Approved
423. -do- ORK Sachet
Each sachet contains:- Glucose
Anhydrous….13.5g Sodium
Chloride…2.6g Potassium
Chloride….1.5g Trisodium citrate
dehydrate…2.9gm
Oral Rehydration Therapy
B.P Specifications
Form-5
29-07-2015
diary No 4703.
Rs20,000
As per SRO/
Box of 07
sachet
WHO
recommended
formulation
OEM Sachet by
M/s Indus
recommended.
Approved
424. -do- Komizol Sachet 20
Each sachet contains:-
Omeprazole...20mg Sodium
bicarbonate............1680mg
PPI & Antacid
Manufacturer‟s Specifications
Form-5
29-07-2015
diary No 4693.
Rs20,000
As per SRO/
Box of 10
sachet
Zegerid Powder
for oral
suspension,
USA, by M/s
Santarus
Risek Insta by M/s
Getz
Panel vide
inspection vide
dated 08-09-2014,
new section
recommended.
Deferred as the
formulation is under
review
425. -do- Bonita Sachet
Each sachet contains:-
Strontium Ranelate...2g
Treatment of osteoporosis
Manufacturer‟s Specifications
Form-5
29-07-2015
diary No 4699.
Rs20,000
As per SRO/
Box of 07
sachet
The firm has
provided the
reference of france
which require to
be confirmed
Onita by M/s
Pharmevo
Approved
426. -do- Grafort Sachet
Each sachet contains:-
Dioctahedral Smectite...3g
Mucoprotective Agent
Manufacturer‟s Specifications
Form-5
04-08-2015
diary No 4879.
Rs20,000
As per SRO/
Box of 01
sachet
The product is
approved in 250th
meeting of RB.
Smecta by M/s
Acto
Approved
Minutes for 253rd
Registration Board Meeting 410
427. -do- Acecol Sachet 200mg
Each sachet contains:-
Acetylcysteine...2g
Mucolytics
Manufacturer‟s Specifications
Form-5
04-08-2015
diary No 4882.
Rs20,000
As per SRO/
Box of 30
sachet
The firm has
provided the
reference of south
Africa and
Switzerland which
require to be
confirmed
mucolator by M/s
Abbott
Deferred as the
formulation is under
review
428. -do- Fomy-C Sachet
Each sachet contains:-
Fosfomycin as trometamol...3g
Antibacterial
Manufacturer‟s Specifications
Form-5
04-08-2015
diary No 4881.
Rs20,000
As per SRO/
Box of 1 sachet
Munorol
(USFDA)
Monurol by M/s
Angelini
Approved
429. -
-
-do- MKS Pediatric Sachet
Each sachet contains:-
Montelukast as Sodium...4mg
Leukotriene Receptor Antagonist
Manufacturer‟s Specifications
Form-5
04-08-2015
diary No 4880.
Rs20,000
As per SRO/
Box of 1 sachet
Singulair
Paediatric Sachet,
USA
Singulair
Paediatric Sachet
by M/s OBS
Approved
430. -do- Movease Sachet
Each sachet contains:-
Polyethylene glycol
3350.....13.125g Sodium
Chloride…0.3507g Sodium
Bicarbonate….0.1785g
Potassium Chloride….0.0466g
Laxative and electrolyte
Manufacturer‟s Specifications
Form-5
29-07-2015
diary No 4700.
Rs20,000
As per SRO/
Box of 10
sachet
Movicol Sachet,
UK
Movcol by M/s
Genix Pharma
Approved with the
change of name.
Minutes for 253rd
Registration Board Meeting 411
EVALUATOR III M/s Ras Pharmaceuticals, Multan
Additional section – Veterinary
(Oral powder general & Vitamin premix-Veterinary)
431. M/s Ras
Pharmaceuticals,
Lahore Road,
Multan.
(Oral powder
general & Vitamin
premix-
Veterinary)
approved in 241st
meeting of CLB
BURSARENAL Oral
Powder
Each 100 gm contains
Potassium citrate…..3.60g
Sodium citrtate….2.50g
Nicotinamide….0.70g
Menadione….0.025g
Vitamin B1……0.007g
Vitamin B2….0.004g
Vitamin C…0.300g
Vitamin & Minerals
Manufacturer
Form-5
Dy. No 5120
dated 12-08-15
20000/-
Decontrolled/
100gm, 500gm,
1kg, 2.5kg, 5kg
& 25 kg
Selectromin Oral
Powder of Sanna
Labs
Approved
432. -do- CA SUPER Oral Powder
Each 100gm contains:
Acetylsalicylic
acid…..22.2g
Ascorbic acid….666gm
Analgesic & Vitamin
Manufacturer
Form-5
Dy. No 5119
dated 12-08-15
20000/-
Decontrolled/
100gm, 500gm,
1kg, 2.5kg, 5kg
& 25 kg
Acevit-C Oral
Powder of A &K
Pharma
Approved
433. -do- ICE-VIT Oral Powder
Each 100gm contains:
Potassium chloride…4gm
Sodium chloride….3gm
Biotin…0.1g
Calcium D
pantothenate….10.2gm
Folic acid….0.850gm
Vitamin A….2025000IU
Vitamin
D3…..1850000IU
Vitamin E…5500IU
Vitamin K3…5000IU
Vitamin B1….4.150gm
Vitamin B2….1.110gm
Vitamin B12…20mcg
Form-5
Dy. No 5135
dated 12-08-15
20000/-
Decontrolled/
100gm, 500gm,
1kg, 2.5kg, 5kg
& 25 kg
Selectromin
powder of sanna
labs
Deferred for
confirmation of Me too
status.
Minutes for 253rd
Registration Board Meeting 412
Vitamin C….1.750gm
Vitamin & Mineral
Manufacturer
434. -do- ONEVIT Oral Powder
Each 100gm contains:
Oxytetraycline
HCL….10gm
Neomycin
Sulphate…10gm
Vitamin A….75000IU
Vitamin D3….50000IU
Vitamin E….0.25gm
Vitamin B 1….0.1gm
Vitamin B2….0.12gm
Vitamin…B6….0.12gm
Vitamin B12…0.75g
Vitamin C….50gm
Calcium
Pantopatheante…10gm
Folic acid….0.030gm
Nicotinic acid…0.15gm
dL-Methionine….3gm
L-Lysine….5gm
Antibiotic & Multivitamin
Manufacturer
Form-5
Dy. No 5140
dated 12-08-15
20000/-
Decontrolled/
100gm, 500gm,
1kg, 2.5kg, 5kg
& 25 kg
NO-BAC Oral
powder of sanna
Labs
Approved
435. -do-
(Oral powder
general Antibiotic-
Veterinary)
COCCI Super Oral
Powder
Each 100gm contains:
Sulphadimidine
Sodium…..80gm
Diaveridine….8gm
Vitamin K3….0.8gm
Antibacterial
Manufacturer
Form-5
Dy. No 5144
dated 12-08-15
20000/-
Decontrolled/
100gm, 500gm,
1kg, 2.5kg, 5kg
& 25 kg
Super-Coxin
Powder of
Intervac Lahore
Approved
Minutes for 253rd
Registration Board Meeting 413
436. AMOXY-150 Oral
Powder
Each 100gm contains:
Amoxycilline
trihydrate…..15gm
Colistin
Sulphate…50MIU
Antibacterial
Manufacturer
Form-5
Dy. No
5143dated 12-
08-15
20000/-
Decontrolled/
100gm, 500gm,
1kg, 2.5kg, 5kg
& 25 kg
ATC-Water
soluble powder of
Sasna Labs
Rejected as firm does
not have dedicated
penicillin section, as
required for
manufacturing of
penicillin product.
437. -do- LC-100 Oral Powder
Each 100gm contains:
Lincomycin as
HCL….10gm
Colistin
sulphate…80,000,000IU
Antibacterial
Manufacturer
Form-5
Dy. No 5136
dated 12-08-15
20000/-
Decontrolled/
100gm, 500gm,
1kg, 2.5kg, 5kg
& 25 kg
LINCOL Powder
of Intervac
Approved
438. -do- LICOGROW-44 Oral
Powder
Each 100gm contains:
Lincomycin HCL….44
Antibacterial
Manufacturer
Form-5
Dy. No 5134
dated 12-08-15
20000/-
Decontrolled/
100gm, 500gm,
1kg, 2.5kg, 5kg
& 25 kg
Licofas-44 of
Intervac
Approved
439. -do- NEOCIN-S Oral Powder
Each 100gm contains:
Neomycin
Sulphate…..72gm
Antibacterial
Manufacturer
Form-5
Dy. No 5122
dated 12-08-15
20000/-
Decontrolled/
100gm, 500gm,
1kg, 2.5kg, 5kg
& 25 kg
Neomar 72
Powder of Zumar
Pharma
Approved
440. -do- SUPER GROW Oral
Powder
Each 100gm contains:
Procaine penicillin….1.2g
Streptomycin
sulphate….3.6gm
Form-5
Dy. No 5132
dated 12-08-15
20000/-
Ultragrow of
Intervac
Rejected as firm does
not have dedicated
penicillin section, as
required for
manufacturing of
penicillin product.
Minutes for 253rd
Registration Board Meeting 414
Zinc bacitracin….5.2gm
Colistin sulphate….6MIU
Antibacterial
Manufacturer
Decontrolled/
100gm, 500gm,
1kg, 2.5kg, 5kg
& 25 kg
441. -do- AMCOLINC-S Oral
Powder
Each 100gm contains:
Amoxicilline
trihydrate….20gm
Lincomycin
base….8.8gm
Spectinomycin
base…8.8gm
Vitamin E acetate…..3gm
Antibacterial and Vitamin
Manufacturer
Form-5
Dy. No 5140
dated 12-08-15
20000/-
Decontrolled/
100gm, 500gm,
1kg, 2.5kg, 5kg
& 25 kg
LINCAMOX-S of
ICI
Rejected as firm does
not have dedicated
penicillin section, as
required for
manufacturing of
penicillin product.
442. -do- SUPER CNC-Oral
Powder
Each 100gm contains:
Chlortetracycline
HCL…..8gm
Neomycin
Sulphate…7gm
Colistin sulphate….0.4gm
Antibiotic
Manufacturer
Form-5
Dy. No 5141
dated 12-08-15
20000/-
Decontrolled/
100gm, 500gm,
1kg, 2.5kg, 5kg
& 25 kg
CNC-200 Powder
of Epla Labs
Approved
443. -do- AF-200 Oral Powder
Each 100gm contains:
Amprolium…..20gm
Furltadon……20gm
Antibacterial
Manufacturer
Form-5
Dy. No 5143
dated 12-08-15
20000/-
Decontrolled/
100gm, 500gm,
1kg, 2.5kg, 5kg
& 25 kg
Sancox of Sana
Labs
Approved
444. -do- T-FON 100 Oral Powder
Each 100gm contains:
Trichlorfon….98gm
Silicon dioxide…..2g
Antibacterial
Manufacturer
Form-5
Dy. No 5142
dated 12-08-15
20000/-
Decontrolled/
100gm, 500gm,
1kg, 2.5kg, 5kg
& 25 kg
Santrifon 100 W/S
powder of Sanna
Labs.
Approved
Minutes for 253rd
Registration Board Meeting 415
445. -do- RESPICARE Oral
Powder
Each 100gm contains:
Tylosin tartrate….5g
Erythromycin
thioicynate….6g
Furaltadon HCL….14g
Antibacterial
Manufacturer
Form-5
Dy. No 5126
dated 12-08-15
20000/-
Decontrolled/
100gm, 500gm,
1kg, 2.5kg, 5kg
& 25 kg
Respinil Powder
of Sanna Labs
Approved with change
of brand name.
446. -do- SPIROX-10 Oral Powder
Each 100gm contains:
Spiramycin….10gm
Doxycycline
HCL…10gm
Bromhexine HCL….2gm
Antibiotic
Manufacturer
Form-5
Dy. No 5138
dated 12-08-15
20000/-
Decontrolled/
100gm, 500gm,
1kg, 2.5kg, 5kg
& 25 kg
Me too status
needs
confirmation
Deferred for
confirmation of me too
status.
(Oral liquid general Antibiotic- Veterinary)
447. M/s Ras
Pharmaceuticals,
Lahore Road,
Multan.
(Oral liquid
general Antibiotic-
Veterinary)
approved in 241st
meeting of CLB
NAFLOXIN-23 Oral
Liquid
Each 100ml contains:
Florfenicol……23g
Antibacterial
Manufacturer
Form-5
Dy. No 5123
dated 12-08-15
20000/-
Decontrolled/
100ml, 500ml,
1L, 2.5 L , 5 L
& 25 L
Neflox solution of
Selmore
Approved
448. -do- FD-20 Oral liquid
Each 100ml contains:
Florfenical CPV…..20g
Doxycycline HCL….20g
Antibacterial
Manufacturer
Form-5
Dy. No 5124
dated 12-08-15
20000/-
Decontrolled/
100ml, 500ml,
1L, 2.5 L , 5 L
& 25 L
Not provided Deferred for
confirmation of me too
status.
Minutes for 253rd
Registration Board Meeting 416
449. -do- FLORDOX Oral Liquid
Each 100ml contains:
Florfenicol CPV…..10g
Doxycycline HCL…..10g
Antibacterial
Manufacturer
Form-5
Dy. No 5127
dated 12-08-15
20000/-
Decontrolled/
100ml, 500ml,
1L, 2.5 L , 5 L
& 25 L
Deferred for
confirmation of me too
status.
450. -do-
ENICIN-20 Oral Liquid
Each 100ml contains:
Enrofloxacin….20gm
Antibacterial
Manufacturer
Form-5
Dy. No 5137
dated 12-08-15
20000/-
Decontrolled/
100ml, 500ml,
1L, 2.5 L , 5 L
& 25 L
Senrox-20 oral
Liquid of Sanna
Labs
Approved
451. -do- WARM-NIL Plus Oral
Liquid
Each 100ml contains:
Levamisole HCl….1.5gm
Oxyclozanide…3.0g
Cobalt
sulphate….0.382gm
Antibacterial/ Dewormer
Form-5
Dy. No 5125
dated 12-08-15
20000/-
Decontrolled/
100ml, 500ml,
1L, 2.5 L , 5 L
& 25 L
Deferred for
confirmation of me too
status.
452. -do- TETZOLE Oral Liquid
Each 100ml contains:
Toltrazuril….2.5gm
Vitamin K3…..0.3gm
Antibacterial
Manufacturer
Form-5
Dy. No 5128
dated 12-08-15
20000/-
Decontrolled/
100ml, 500ml,
1L, 2.5 L , 5 L
& 25 L
Toltra Liquid of
Intervac
Deferred for
clarification of
Pharmacological group
submitted.
Minutes for 253rd
Registration Board Meeting 417
453. -do- OXFEN Oral Liquid
Each 100ml contains:
Oxfendazole….2.265gm
Anthelmintic
Manufacturer
Form-5
Dy. No 5130
dated 12-08-15
20000/-
Decontrolled/
100ml, 500ml,
1L, 2.5 L , 5 L
& 25 L
Oxanazole
suspension of
Sana Labs
Approved
454. -do- IVAGIN Oral Liquid
Each 100ml contains:
Milk Thistle (tandrazied
extract)…..210mg
Choline
chloride….200mg
Sorbitol….1000mg
Inositol….1500mg
Lysine….3000mg
Biotin ….150mg
Vitamin E….2000mg
Vitamin & Minerals
Manufacturer
Form-5
Dy. No 5133
dated 12-08-15
20000/-
Decontrolled/
100ml, 500ml,
1L, 2.5 L , 5 L
& 25 L
Deferred for
confirmation of me too
status.
455. -do- MYCOSTOP Oral Liquid
Each 100ml contains:
Tylosin tartrate….10gm
Doxycycline
HCL…20gm
Colistin
sulphate…500MIU
Bromhexine HCL…5gm
Antibacterial
Manufacturer
Form-5
Dy. No 5131
dated 12-08-15
20000/-
Decontrolled/
100ml, 500ml,
1L, 2.5 L , 5 L
& 25 L
Tylo-biotec liquid
of Grand Pharma
Approved
456. -do- CINARAS Oral Liquid
Each 100ml contains:
Cinoxin…..0.75g
Sulphamethoxy
pyridazine…..0.75g
Sulphamethazine…….5g
Trimethoprim…..2.50gm
Antibacterial
Manufacturer
Form-5
Dy. No 5117
dated 12-08-15
20000/-
Decontrolled/
100ml, 500ml,
1L, 2.5 L , 5 L
& 25 L
JFCINA of Jfrine
Karachi
Approved
Minutes for 253rd
Registration Board Meeting 418
457. -do- NEF-10 Oral Liquid
Each 100ml contains:
Florfenicol……10g
Antibacterial
Manufacturer
Form-5
Dy. No 5118
dated 12-08-15
20000/-
Decontrolled/
100ml, 500ml,
1L, 2.5 L , 5 L
& 25 L
Florobak oral
liquid of Attabak
Approved
458. -do- NOR-TS Oral Liquid
Each 100ml contains:
Norfloxacin…..5g
Sulphamethoxypyridazine
…..5g
Trimethoprim….1g
Phenylbutazone…1.2g
Bomhexine…..0.5g
Antibacterial
Manufacturer
Form-5
Dy. No 5129
dated 12-08-15
20000/-
Decontrolled/
100ml, 500ml,
1L, 2.5 L , 5 L
& 25 L
Me too status
submitted needs
confirmation.
Deferred for
confirmation of me too
status.
459. -do- NOVAFORT Oral
Solution
Each ml contains:
Novaminsulfon…..40mg
Etileferin……0.2mg
Calcium
gluconate….100mg
Magnesium
gluconate…..10mg
Sodium
Salicylate……7mg
Nicotinamide….0.3mg
Caffiene ….10mg
Boric acid…..10mg
Antibacterial
Manufacturer
Form-5
Dy. No
27-08-15
20000/-
Decontrolled/
100ml, 500ml,
1L, 2.5 L , 5 L
& 25 L
NOVAFAS of
Intervac
Approved
460. -do- CARDISOL Oral
Solution
L-Carnitine….500mg
Vitamin B6
(PyrodoxineHCL)….50m
g
Vitanmin B12 ….1.5mg
Nicotinamide….100mg
Calpan….100mg
Sorbitol….10g
dl-Methionine…1000mg
Form-5
Dy. No
27-08-15
20000/-
Decontrolled/
100ml, 500ml,
1L, 2.5 L , 5 L
& 25 L
Deferred for
confirmation of me too
status.
Minutes for 253rd
Registration Board Meeting 419
L-Arginine…..300mg
L-Citruline….200mg
L-Glycine….200mg
L-Aspartic Acid…150mg
L-Lysine…..100mg
L-Glutamic acid…150mg
L-Ornithine….200mg
(Multi Vitamin)
Manufacturer
Case No. 05: Grant of Registration for Routine Cases (Local)
S/N Name and
address of
manufacturer /
Applicant
Brand Name
(Proprietary name +
Dosage Form +
Strength)
Composition
Pharmacological Group
Finished product
Specification
Type of Form
Initial date,
diary
Fee including
differential fee
Demanded
Price / Pack
size
International
status in
reference drug
agencies /
authorities
Me-too status
GMP status as
depicted in latest
inspection report
(with date) by the
Evaluator
Remarks
461. M/s Safe
Pharmaceuticals, (
Pvt) Limited, Plot
No. 20, Sector 6-
B, North Karachi
Industrial area,
Karachi
VOLIDO Injection
Each 2ml contains:
Diclofenac
Sodium…..75mg
Lidocaine HCL….20mg
NSAID/ Local Anesthetic
Manufacture
Form-5
20000/-
As per SRO/
5‟sx2ml & 10‟s
x 2ml
Not found/ not
provided
Dinopen Injection
of Centaury
Pharmaceuticals
Inspection of the
firm was carried
out on 28-08-14
by the area FID
and GMP is rated
as GOOD
Deferred for
confirmation of
approval of reference
regulatory authorities
462. -do- MECOLIN Capsules
Each capsule contains:
Mecobalamin…..500mcg
Co-enzyme type vitamin
B12
Form-5
8000 dated 10-
05-10
12000 dated
04-07-13
As per SRO/
2x10‟s
Not found/ Not
provided
Mecomars of Max
Pharma
Deferred for
confirmation of
approval of reference
regulatory authorities
Minutes for 253rd
Registration Board Meeting 420
463. -do- I-TOSE Capsules
Each capsule contains:
Iron-III Hydroxide
polymaltose….100mg
Anti-anemic
Manufacturer
Form-5
8000 dated 10-
05-10
12000 dated
04-07-13
As per SRO/
1x10‟s
Ferry capsules of
Tabros Pharma
Approved
464. -do- DIC-POT Capsules
100mg SR
Each capsule contains:
Diclofenac
potassium…100mg
NSAID
Manufacturer
Form-5
8000 dated 10-
05-10
12000 dated
04-07-13
As per SRO/
2x10‟s
Not found/ Not
provided
Ariflam SR
capsules of Aeries
Pharma
Deferred for
confirmation of
approval by reference
regulatory authorities
465. -do- ZEROX Capsules 250mg
Each capsule contains:
Azithromycin as
dihydrate…..250mg
Antibiotic
Manufacturer
Form-5
8000 dated 17-
02-10
12000 dated
22-05-13
As per SRO/
2x10‟s
Azithromycin
Capsules 250mg
(BNF)
AZZA Capsules
of Genome
Approved
466. -do- ZEROX Capsules 500mg
Each capsule contains:
Azithromycin as
dihydrate…..500mg
Antibiotic
Manufacturer
Form-5
Dy. No
8000 dated 17-
02-10
12000 dated
22-05-13
As per SRO/
6‟s
Not found/ Not
provided
Azogen capsules
of Rogen Pharma
Deferred for
clarification by firm in
light of 250th
Registration Board
meeting decision
467. -do- FAYNEEC Capsules
50mg
Each capsule contains:
Diclofenac
sodium….50mg
NSAID
Manufacturer
Form-5
Dy. No
8000 dated 17-
02-10
12000 dated
22-05-13
As per SRO/
10‟s
Not found/ Not
provided
Dicloras of Rasco
Pharma
Deferred for
confirmation of
approval by reference
regulatory authorities
Minutes for 253rd
Registration Board Meeting 421
468. -do- SAFOXICAM Capsules
10mg
Each capsule contains:
Piroxicam…..10mg
NSAID
Manufacturer
Form-5
Dy. No
8000 dated 17-
02-10
12000 dated
22-05-13
As per SRO/
2x10‟s
Feldene Capsules
of Pfizer (MHRA)
Exican capsules of
Novamed pharma
Approved
469. -do- LEVO Capsules 250mg
Each capsule contains:
Levofloxacin…..250mg
Fluoroquinolone
Manufacturer
Form-5
Dy. No
8000 dated 17-
02-10
12000 dated
22-05-13
As per SRO/
1x10‟s
Not found/ Not
provided
E-Lev capsules of
English Pharma
Deferred for
confirmation of
approval by reference
regulatory authorities
470. -do- LEVO Capsules 500mg
Each capsule contains:
Levofloxacin…..500mg
Fluoroquinolone
Manufacturer
Form-5
Dy. No
8000 dated 17-
02-10
12000 dated
22-05-13
As per SRO/
1x10‟s
Not found/ Not
provided
E-Lev capsules of
English Pharma
Deferred for
confirmation of
approval by reference
regulatory authorities
471. -do- CIPRO Capsules 500mg
Each capsule contains:
Ciprofloxacin…..500mg
Fluoroquinolone
Manufacturer
Form-5
Dy. No
8000 dated 17-
02-10
12000 dated
22-05-13
As per SRO/
1x10‟s
Not found/ Not
provided
CIPFAS of
Genome
Deferred for
confirmation of
approval by reference
regulatory authorities
Minutes for 253rd
Registration Board Meeting 422
472. -do- CIPRO Capsules 250 mg
Each capsule contains:
Ciprofloxacin…..250mg
Fluoroquinolone
Manufacturer
Form-5
Dy. No
8000 dated 17-
02-10
12000 dated
22-05-13
As per SRO/
1x10‟s
Not found/ Not
provided
CIPFAS of
Genome
Deferred for
confirmation of
approval by reference
regulatory authorities
473. -do- SITAPRAM Tablets
Each film coated tablet
contains:
Escitalopram as
oxalate….10mg
Antidepressant
Manufacturer
Form-5
Dy. No
8000 dated 17-
02-10
12000 dated
22-05-13
As per SRO/
1x14‟s
Cipralex tabltes of
Lundbeck
Citalem tablets of
Lundbeck
Approved
474. -do- SITAPRAM Tablets
Each film coated tablet
contains:
Escitalopram as
oxalate….20mg
Antidepressant
Manufacturer
Form-5
Dy. No
8000 dated 17-
02-10
12000 dated
22-05-13
As per SRO/
1x14‟s
Cipralex tabltes of
Lundbeck
Citalem tablets of
Lundbeck
Approved
475. -do- HYRSET Tablets 15mg
Each tablet contains:
Midazolam
meleate…..15mg
Sedative & Hypnotic
Manufacturer
Form-5
Dy. No
8000 dated 17-
02-10
12000 dated
22-05-13
As per SRO/
5‟s
Not found/ Not
provided
Not found/ Not
provided
Deferred for
confirmation of
approval by reference
regulatory authorities
and me too status
Minutes for 253rd
Registration Board Meeting 423
476. -do- TORINDA-O Tablet
Each film coated tablet
contains:
Tinidazole….600mg
Ofloxacin……200mg
Quinolone, Amoebicide
Manufacturer
Form 5
Dy. No: 1522
R-II dated 03-
08-2010
8,000/- dated
10-05-10
12,000/- dated
04-07-13
As Per
SRO/10‟s
Not found/ Not
provided
Not found/ Not
provided
Deferred for
confirmation of
approval by reference
regulatory authorities
and me too status
477. -do- TORINDA-N Tablet
Each film coated tablet
contains:
Tinidazole….600mg
Norfloxacin……400mg
Quinolone, Amoebicide
Manufacturer
Form 5
Dy. No: 1519
R-II dated 03-
08-2010
8,000/- dated
10-05-10
12,000/- dated
04-07-13
As Per
SRO/10‟s
Not found/ Not
provided
Not found/ Not
provided
Deferred for
confirmation of
approval by reference
regulatory authorities
and me too status
478. -do- TORINDA-C Tablet
Each film coated tablet
contains:
Tinidazole….600mg
Ciprofloxacin………500
mg
Quinolone, Amoebicide
Manufacturer
Form 5
Dy. No: 1519
R-II dated 03-
08-2010
8,000/- dated
10-05-10
12,000/- dated
04-07-13
As Per
SRO/10‟s
Not found/ Not
provided
Not found/ Not
provided
Deferred for
confirmation of
approval by reference
regulatory authorities
and me too status
479. M/s Berlex Lab
International
Multan.
MOXIL Tablets 400mg
Each film coated tablet
contains:
Moxifloxacin as
HCL….400mg
Fluoroquinolone
Manufacturer
Form-5
Dy. No 4794
dated 03-06-10
8000 dated 01-
06-10
12000 dated
03-09-13
Rs 250/- Pack
of 1x10‟s
Avelox of Bayer
(MHRA)
Avelox of Bayer
Deferred as firm has
stopped production for
renovation and area
FID has identified
number of
shortcoimngs in
inspection conducted
on 28.05.2015, which
need rectification.
Minutes for 253rd
Registration Board Meeting 424
480. -do- SOLEX Tablets 10mg
Each film coated tablet
conatins:
Montelukast as
sodium……10mg
Leukotriene receptor
antagonist
Manufacturer
Form-5
Dy. No 4794
dated 03-06-10
8000 dated 01-
06-10
12000 dated
03-09-13
Rs 375/- Pack
of 1x10‟s
Montelukast
Sodium Tablets of
Roxane Labs Inc
Aerokast of
Barrett Hodgsen
Karachi
Deferred as firm has
stopped production for
renovation and area
FID has identified
number of
shortcoimngs in
inspection conducted
on 28.05.2015, which
need rectification.
481. -do- Acne Capsules 100mg
Each capsule contains
Minocycline as
Hydrochloride…………
100mg
Tetracycline
Manufacturer
Form-5
03/06/2010, Dy
No: 4800
8000+12000/-
Rs 70/- Pack of
1x10‟s
Minocin Capsules
of Onset
Dermatologics Inc
Minocin of Valor
Pharma
Rawalpindi
Deferred as firm has
stopped production for
renovation and area
FID has identified
number of
shortcoimngs in
inspection conducted
on 28.05.2015, which
need rectification.
482. -do- Solex Chewable Tablet
5mg
Each chewable tablet
contains Montelukast as
sodium …….5mg
Antiasthmatic
Manufacturer
Form-5
03/06/2010, Dy
No: 4795
8000+12000/-
Rs 275/- Pack
of 1x10‟s
Montelukast
Sodium Chewable
Tablets of Roxane
Labs Inc
Aerokast of
Barrett Hodgsen
Karachi
Deferred as firm has
stopped production for
renovation and area
FID has identified
number of
shortcoimngs in
inspection conducted
on 28.05.2015, which
need rectification.
483. -do- Clarix Tablets 500mg
Each film coated tablet
contains
Clarithromycin……
500mg
Antibiotic
BP
Form-5
03/06/2010, Dy
No: 4798
8000+12000/-
Rs 500/- Pack
of 1x10‟s
Biaxin of Abbvie
Klaricid of Abbott
Karachi
Deferred as firm has
stopped production for
renovation and area
FID has identified
number of
shortcoimngs in
inspection conducted
on 28.05.2015, which
need rectification.
484. -do- Clarix Tablets 250mg
Each film coated tablet
contains
Clarithromycin……
250mg
Form-5
03/06/2010, Dy
No: 4801
8000+12000/-
Biaxin of Abbvie
Klaricid of Abbott
Karachi
Deferred as firm has
stopped production for
renovation and area
FID has identified
number of
shortcoimngs in
inspection conducted
Minutes for 253rd
Registration Board Meeting 425
Antibiotic
BP
Rs 300/- Pack
of 1x10‟s
on 28.05.2015, which
need rectification.
485. -do- Synlex Tablet 550mg
Each film coated tablet
contains Naproxen
Sodium……550mg
Propionic acid
BP
Form-5
03/06/2010, Dy
No: 4793
8000+12000/-
Rs 200/- Pack
of 2x10‟s
Anaprox DS of
Genetech USA.
Dephlog of
StandPharm
Lahore.
Deferred as firm has
stopped production for
renovation and area
FID has identified
number of
shortcoimngs in
inspection conducted
on 28.05.2015, which
need rectification.
486. M/s OBS Pakistan
(Pvt) Limited
Karachi
I-BON Tablets
Each film coated
contains:
Ibandronate
Sodium…2.5mg
Postmenopausal
osteoporosis
Manufacturer
Form-5
22-12-2010,
Dy No: 165
8000+12000/-
Rs 100/- per
tablet/ Pack of
30‟s
Roche
Iband of Caraway
Pharma
Inspection of the
firm was carried
out on 08-04-15
by the panel of
inspectors and
recommended the
renewal of DML
Approved
487. -do- I-BON Tablets
Each film coated
contains:
Ibandronate as
Sodium…150mg
Postmenopausal
osteoporosis
Manufacturer
Form-5
22-12-2010,
Dy No: 166
8000+12000/-
Rs 3000/- per
tablet/ Pack of
1‟s
BONIVA
(USFDA)
Iband of Caraway
Pharma
Approved
488. -do- POLY-OBS Capsules
Each soft gelatin capsule
contains:
Zinc as
sulphate….22.5mg
Vitamin E…..30mg
Vitamin C….500mg
Folic acid….150mcg
Vitamin B1…15mg
Vitamin B2….15mg
Nicotinamide….100mg
Vitamin B6….20mg
Vitamin B12….12mcg
Pantothenic acid….20mg
Form-5
22-12-2010,
Dy No: 164
8000+12000/-
Rs 20/- per
capsule/ Pack
of 10‟s
Not found/ not
provided
Me too status
needs
confirmation
Deferred for
confirmation of me too
status.
Minutes for 253rd
Registration Board Meeting 426
Vitamin B complex
Manufacturer
489. M/s Innvotek
Pharmaceuticals,
35 Industrial
Estate Triangle,
Kahuta Road
Islamabad
MALGO Tablets
Each tablet contains:
Artemether….20mg
Lumefantrine….120mg
Anti-malarial
Manufacturer
Form-5
Dy. No 2055
dated 09-06-11
8000 dated 14-
06-11
12000 dated
23-07-13
Rs. 320/- Pack
of 16‟s
WHO
recommended
formulation
A-mether of Rasco
Pharma Lahore
GMP report dated
15.07.2015
satisfactory
Approved
490. -do- IMOX Tablets
Each film coated tablet
contains:
Moxifloxacin HCL eq. to
Moxifloxacin…..400mg
Antibacterial
Manufacturer
Form-5
Dy. No 2054
dated 09-06-11
8000 dated 14-
06-11
12000 dated
23-07-13
Rs. 680/- Pack
of 5‟s
Avelox of Bayer
Avelox of Bayer
Karachi
GMP report dated
15.07.2015
satisfactory
Approved
491. -do- D-PAL Tablets
Each film coated tablet
contains:
Diclofenac
Potassium….75mg
NSAID
Manufacturer
Form-5
Dy. No 2053
dated 09-06-11
8000 dated 14-
06-11
12000 dated
23-07-13
Rs. 160/- Pack
of 10x2‟s
Not found in
reference drug
agencies
Antiflam Tablets
of Wilshire
GMP report dated
15.07.2015
satisfactory
Deferred for
confirmation of
approval by reference
regulatory authorities
Minutes for 253rd
Registration Board Meeting 427
492. -do- D-PAL Tablets
Each film coated tablet
contains:
Diclofenac
Potassium...….50mg
NSAID
Manufacturer
Form-5
Dy. No 2052
dated 09-06-11
8000 dated 14-
06-11
12000 dated
23-07-13
Rs. 130/- Pack
of 10x2‟s
Diclofenac
Potassium tablets
of Actavis
Antiflam of
Wilshire
GMP report dated
15.07.2015
satisfactory
Approved
493. M/s Getz Pharma
(Pvt) Limited, 29-
30-Sector 27,
Korangi,
Industrial Area,
Karachi
TREVIAMET XR Tablets
Each extended release
tablet contains:
Sitagliptin as Phosphate
monohydrate….50mg
Metformin HCL…500mg
DPP-4 & Biguanide
Manufacturer
Form-5D
Dy. No : 1804
dated 14-12-12
50000 dated
12-12-12
Rs. 101/- per
tablet/ Pack of
14‟s & 30‟s
Janumet XR
(USFDA)
Laboratory scale
scientifically rational
stability data as per
requirements decided
in the 251st meeting of
Registration Board is
required
494. -do- TREVIAMET XR Tablets
Each extended release
tablet contains:
Sitagliptin as Phosphate
monohydrate….100mg
Metformin
HCL…1000mg
DPP-4 & Biguanide
Manufacturer
Form-5D
Dy. No 1803
dated 14-12-12
50000 dated
12-12-12
Rs. 169 /- per
tablet/ Pack of
14‟s & 30‟s
Janumet XR
(USFDA)
Laboratory scale
scientifically rational
stability data as per
requirements decided
in the 251st meeting of
Registration Board is
required
495. -do- TREVIAMET XR Tablets
Each extended release
tablet contains:
Sitagliptin as Phosphate
monohydrate….50mg
Metformin
HCL…1000mg
DPP-4 & Biguanide
Manufacturer
Form-5D
Dy. No :1805
dated 14-12-12
50000 dated
12-12-12
Rs. 102 /- per
tablet/ Pack of
14‟s & 30‟s
Janumet XR
(USFDA)
Laboratory scale
scientifically rational
stability data as per
requirements decided
in the 251st meeting of
Registration Board is
required
Minutes for 253rd
Registration Board Meeting 428
496. -do- TREVIAMET Tablets
Each film coated tablet
contains:
Sitagliptin as Phosphate
monohydrate….50mg
Metformin HCL…850mg
DPP-4 & Biguanide
Manufacturer
Form-5D
Dy. No :67
dated 06-08-11
15000 dated
04-08-11
35000 dated
30-07-13
Rs. 102 /- per
tablet/ Pack of
14‟s & 30‟s
Janumet (EMA)
Laboratory scale
scientifically rational
stability data as per
requirements decided
in the 251st meeting of
Registration Board is
required
497. -do- GLIX Tablet
Each film coated tablet
contains:
Saxagliptin as
HCL…..2.5mg
DPP-4 Inhibitor
Manufacturer
Form-5D
Dy. No :
15000 dated
21-02-11
5000 dated 30-
07-13
Rs. 90 /- per
tablet/ Pack of
14‟s & 20‟s
Onglyza (USFDA) Deferred for
clarification as firm has
submitted application
of Form-5D, however
the submitted fee is
20000/-
498. -do- GLIX Tablet
Each film coated tablet
contains:
Saxagliptin as
HCL…..5mg
DPP-4 Inhibitor
Manufacturer
Form-5D
Dy. No :
15000 dated
21-02-11
5000 dated 30-
07-13
Rs. 150 /- per
tablet/ Pack of
14‟s & 20‟s
Onglyza (USFDA) Firm has submitted
application of Form-
5D, however the
submitted fee is
20000/-
499. -do- GLIX-M Tablet
Each film coated tablet
contains:
Saxagliptin as
HCL…..5mg
Metformin HCL
(Extended
release)…..500mg
DPP-4 Inhibitor
Manufacturer
Form-5D
Dy. No : 620
dated 07-03-11
15000 dated
21-02-11
35000 dated
30-07-13
Rs. 151.50 /-
per tablet/ Pack
of 14‟s & 20‟s
KOMBIGLYZE
XR (USFDA)
Laboratory scale
scientifically rational
stability data as per
requirements decided
in the 251st meeting of
Registration Board is
required
Minutes for 253rd
Registration Board Meeting 429
500. -do- GLIX-M Tablet
Each film coated tablet
contains:
Saxagliptin as
HCL…..2.5mg
Metformin HCL
(Extended
release)…..1000mg
DPP-4 Inhibitor
Manufacturer
Form-5D
Dy. No : 619
dated 07-03-11
15000 dated
21-02-11
35000 dated
30-07-13
Rs. 93 /- per
tablet/ Pack of
14‟s & 20‟s
Kombiglyze XR
(USFDA)
Laboratory scale
scientifically rational
stability data as per
requirements decided
in the 251st meeting of
Registration Board is
required
501. -do- GLIX-M Tablet
Each film coated tablet
contains:
Saxagliptin as
HCL…..5mg
Metformin HCL
(Extended
release)…..1000mg
DPP-4 Inhibitor
Manufacturer
Form-5D
Dy. No : 623
dated 07-03-11
15000 dated
21-02-11
35000 dated
30-07-13
Rs. 153.50 /-
per tablet/ Pack
of 14‟s & 20‟s
Kombiglyze XR
(USFD A)
Laboratory scale
scientifically rational
stability data as per
requirements decided
in the 251st meeting of
Registration Board is
required
502. M/s Otsuka
Pakistan, F/4-9,
Hub Industrial
Tratding Estate
Distt Lasbella.
ACERING Injection
(Ringer acetate injection)
Each 1000ml contains:
Sodium acetate
Trihydrate….3.8gm
Potassium
chloride…..0.3gm
Calcium chloride
2H20….0.2gm
Sodium
chloride…..6.0gm
Water for injection
…..Q.s
Electrolyte solution
Manufacturer
Form-5
Dy. No : 43
dated 07-01-12
8000 dated 17-
01-12 replaced
by wfi 5ml
dated 11-02-
2011
Rs. 192.02/
Pack of 500ml
Acetated Ringer
Solution (USFDA)
Sterofundine
injection B.Braun
is closer mee too
of proposed
formulation
Deferred for
confirmation of me too
status and differential
fee.
Minutes for 253rd
Registration Board Meeting 430
ROUTINE (LOCAL-VET)
Evaluator III
503. -do- STERILE Water for
Injection
Each LDPE ampoule
contains:
Sterile water for
injection….20ml
Dilution of IV/IM
Injectables
USP
Form-5
Dy. No :
8000 dated 08-
02-11
12000 dated
12-08-13
Rs. 16/- LDPE
20ml ampoule
Approved
S/N Name and
address of
manufacturer /
Applicant
Brand Name
(Proprietary name +
Dosage Form +
Strength)
Composition
Pharmacological
Group
Finished product
Specification
Type of Form
Initial date, diary
Fee including
differential fee
Demanded Price /
Pack size
International
status in
reference drug
agencies /
authorities
Me-too status
GMP status as
depicted in latest
inspection report
(with date) by the
Evaluator
Decision
504. M/s Baariq
Pharmaceuticals,
Lahore
RESCUE-100 W/S
Powder
Each 1000gm contains:
Amantadine
HCL….10gm
Antiviral
Manufacturer
ForM-5
Dy. No 188 dated
28-04-11
8000 dated 28-04-11
12000 dated 29-06-
13
Decontrolled/ Pack
of 100, 250, 500
gm, 1,2.5, 10, 25kg
Acedine Powder
of Leads Pharma
Approved
505. -do- ENROBAR-20 Oral
Liquid
Each 1000ml contains:
Enrofloxacin….100gm
Antibiotic
Manufacturer
ForM-5
Dy. No 193 dated
28-04-11
8000 dated 28-04-11
12000 dated 29-06-
13
Decontrolled/ Pack
of 100, 250, 500 &
1000ml
FLOXIVET Oral
Liquid of Medivet
Lahore
Approved
Minutes for 253rd
Registration Board Meeting 431
506. -do- COXIRIQ Oral Powder
Each 100gm contains:
Sulfachlopyridazine…..
30gm
Antibiotic
Manufacturer
Form-5
Dy. No 188 dated
28-04-11
8000 dated 28-04-11
12000 dated 29-06-
13
Decontrolled/ Pack
of 100, 250, 500
gm, 1,2.5, 10, 25kg
SULZIN Powder
of Genome
Pharma (China)
Approved
507. -do- DOXI-TYLO C W/S
Oral Powder
Each 1000gm contains:
Colistin
Sulphate…..500MIU
Tylosin
Tartrate…100gm
Doxycycline
HCL….200gm
Antibiotic
Manufacturer
Form-5
Dy. No 188 dated
28-04-11
8000 dated 28-04-11
12000 dated 29-06-
13
Decontrolled/ Pack
of 100, 250, 500
gm, 1,2.5, 10, 25kg
TRIPLEX Powder
of Mylab
Approved
508. -do- TRICHLOFON Powder
Each gm powder
contains:
Trichlorfon…..985mg
Anthelmintic
Manufacturer
Form-5
Dy. No 185 dated
28-04-11
8000 dated 28-04-11
12000 dated 29-06-
13
Decontrolled/ Pack
of 100, 250, 500
gm, 1,2.5, 10, 25kg
Triclofon Powder
of Breeze Pharma
Approved
509. -do- TIMOBAR Suspension
Each 100ml contains:
Sulphadiazine….40gm
Trimethoprim…..8gm
Antibiotic
Manufacturer
ForM-5
Dy. No 570 dated
21-09-11
8000 dated 28-04-11
12000 dated 29-07-
13
Decontrolled/ Pack
of 100, 250, 500 &
1000ml
Sulphabitic Oral
liquid of Grand
Pharma
Approved
Minutes for 253rd
Registration Board Meeting 432
510. -do- OXYBAR W/s Powder
Each 100gm contains:
Oxytetracycline
HCL…95gm
Antibiotic
Manufacturer
ForM-5
Dy. No 569 dated
21-09-11
8000 dated 21-09-11
12000 dated 29-07-
13
Decontrolled/ Pack
of 100, 250, 500
gm, 1,2.5, 10, 25kg
OXY-950 Powder
of Attabak Pharma
Approved
511. -do- TUTRAZURIQ Oral
Liquid
Each 100ml contains:
Triclabendazole….5gm
Levamisole….3.75
Antalmintic
Manufacturer
ForM-5
Dy. No 569 dated
21-09-11
8000 dated 21-09-11
12000 dated 29-07-
13
Decontrolled/ Pack
of 100, 250, 500 &
1000ml
Tridex Drench of
Guyton
Approved
Minutes for 253rd
Registration Board Meeting 433
A. Miscelleneous Cases.
Case No.01: Contract Manufacturing Policy.
Rule 20A of Drugs (L R & A) Rules, 1976 pertains to contract manufacturing of drugs.
These rules have been amended vide SRO 152(I)/2014 dated 04.03.2014. Sub-rule 2(b) is as
follows:
2(b) Contract manufacturing shall be allowed only on basis of similar category of drugs
including human to human, veterinary to veterinary, cotton to cotton, medical device to medical
device or as the case may be, etc.
M/s Chisti Pharma, Okara is a licensed pharmaceutical unit for cotton. The firm has
submitted in 250th
meeting of Registration Board that contract permission of our products Scifix
(Cefixime) capsule(057380) and dry powder for suspension 100 mg (057382) and 200 mg
(057381) has been denied. In this regard we want to present our submission as follows:
That our products were approved by registration board in 215th
meeting and subsequently
renewed in 238th
meeting of registration board. Our products are manufactured by a GMP
compliant facility McOlson Research Laboratories, Sheikhupura.
It is a settled principle of law that a subordinate authority cannot make rules or issue
notification under a statute so as to give them retrospective effect unless the statute itself
grants such powers. (PLD 1967 Kar. 184 (DB), PLD 1972 SC 686, PLD 1974 SC 291 at
page 309).
Drug Act, 1976 empowers the federal government to make rules under section 43 of
drugs Act, 1976 but it nowhere empowers to make rules with retrospective effect. Denial
of renewal of our product based upon new contract policy is retrospective in its effect.
Our products were granted by registration board in 215th
meeting in 2009 and
subsequently renewed in 238th
meeting in 2014. It is unjust to deny renewal on the
grounds that it doesn‟t fall under new contract policy. When our products were granted
approval, it was in accordance with the contract policy of registration board.
According to Drugs Act, 1976 there is no categorization of DML for bandages
manufacture. We were granted “Formulation” license by central licensing board and
under this license other drugs like tablets, capsules, injectables can be manufactured.
Therefore our DML has same legal value as it has for other dosage form manufacturers.
Drugs Act, 1976 has also provided a procedure for cancellation of registration of a drug.
No drug can be deregistered/cancelled unless opportunity of personal hearing is provided
to the applicant. In our case this principle of law has also been denied.
Based upon above grounds, it is requested to review decision of the board and grant us
extension of contract permission for our products. Sir, we have promoted our product through
ethical means and years of efforts are involved in this process. Decision of Registration Board
Minutes for 253rd
Registration Board Meeting 434
shall results in huge losses for our company and shall also deprive the patients from access to a
quality drug.
Decision: Registration Board deferred the case due to paucity of time.
Case No.02: Registration of Linagliptin & Linagliptin containing products.
Linagliptin and Linagliptin containing products were considered by Registration Board in
its 237th
, 242nd
and 245th
meeting of the Board for registration. M/s. AGP Pharma, Karachi has
been granted approval of drug, however, Linagliptin of M/s. CCL Pharma, Lahore and other
companies have been deferred by Registration Board for opinion of Law & Justice Division due
to the reason that M/s. AGP, Karachi had filed a writ petition in the Sindh High Court, Karachi
to bar other applicants to obtain registration of this drug. Registration Board in its 245th
meeting
has decided to refer the case for comments of Law Division.
The case was referred to Law, Justice & Human Rights Division for direction / view in the
following Decision of Sindh High Court, Karachi:-
“till the validity of plaintiff’s’ patent No. 141311, 141044 and 141068, defendants is
restrained from selling ‘Linagliptin’ containing products or manufacturing or making
formulating, supplying, stocking, importing, exporting, offering for sale, passing off,
advertising or otherwise enabling others to infringe or pass off, offer for sale or use in
any form in any manner which is in infringement of the claims of the petitioners patent.
Resultantly, pending application (s) is also disposed of.”
Law Division has furnished legal opinion as under:-
“In the case in hand the court categorically said that the drug has a patent registered in
Pakistan since 21.08.2002 and it has restrained the defendant from selling “linagliptin”. This
restriction is to the extent of defendants only and is prohibiting manufacturing or making
formulating, supplying, stocking, importing, exporting offering for sale, advertising or
otherwise enabling others to infringe or pass off, offer of sale or use in any form or in any
manger, which is in infringement of the claims of plaintiffs paten till the validity of patens.
Therefore, this makes it a right in personam. As regards consideration of the cases for
registration no such direction or injunction can be inferred from the offer placed in the
reference. Thus the injunction is regarding making, sale and selling etc., and no such
injection is directed towards the Registration Board”.
Decision: Registration Board deliberated the case and referred for views of IPO,
Pakistan.
Minutes for 253rd
Registration Board Meeting 435
Case No.03: Registration of generic Nilotinib
Advocate Mr. Kazim Hasan, Barrister-at-Law of M/s Novartis Pharma Limited has
informed that they have been instructed by Novartis to advise the Drug Registration Board of the
DRAP that the intellectual property rights to Nilotinib vests in Novartis globally. Nilotinib is a
breakthrough treatment of Lukemia and it has been developed by Novartis. M/s Novartis has
come to know that M/s Genix Pharma has applied for generic registration of Nilotinib under the
trade name Lukopenil. Being intellectual property rights to Nilotinib vests in Novartis globally a
generic Nilotinib would be a violation intellectual property rights.
Advocate Mr. Kazim Hasan has further submitted that such registration would also
constitute a sovereign breach, as Pakistan is a signatory to international treaties which guarantee
protection of intellectual property rights. He requested that application filed by Genix Pharma for
generic registration of a Novartis product may be rejected and Drug Registration Board should
not even entertain any application for generic registration Nilotinib under any trade name.
Registration Board in 246th
meeting forwarded above reference to IPO, Pakistan for
comments, which are as follows.
“Intellectual Property Organization (IPO) has stated that the main function of the Patient
Office is to receive and examine applications for patents and grant patents to qualifying
applicants. Concept of the patent is the grant of property right to the inventor over his invention,
by the state to exclude others from making, using, selling or offering for sale and importing the
invention into the country where his patent rights exists. An inventor or applicant seeking patent
has to apply with patent specification in the Patent Office. The Patent specification needs to
fulfill three patentability criteria: Novelty (newness), Inventive step (innovative) and Industrial
application. Once patent is granted, the patent owner has the power to sue those who infringe his
patent in a court of law to stop the infringement and receive monetary compensation (damages).
On the other hand, the manufacturer needs to obtain marketing approval from Drug
Regulatory Authority of Pakistan (DRAP) by submitting data as required under Drugs Act, 1976.
The data demonstrating the safety and efficacy of the drug for which marketing approval is being
sought has to be furnished. The marketing approval is then granted by the Drug Regulatory
Authority of Pakistan (DRAP) if the bioequivalence protocol (safety, efficacy, quality) is
satisfactory.
It is pertinent to note there are no administrative, legislative and regulatory provisions in
Pakistan permitting the system of Patent linkages with marketing approval of the drug. The
TRIPs provisions, to which the country is a party leaves is to national legislation to establish
patent linkage of the kind sought. The question of Patent – registration linkage is in reality a
TRIPS plus policy.
Decision: Registration Board deliberated in detail and decided to get detail of patent
granted for Nilotinib by IPO, Pakistan.
Minutes for 253rd
Registration Board Meeting 436
Case No.04. Import of veterinary drugs by M/s. Zoic International, Lahore.
Dr. Muhammad Aslam Niazi of Lahore vide a complaint alleged that M/s. Zoic
International, Lahore has got registration of number of veterinary/poultry medicines of M/s.
Tithebarn Limited UK illegally by submitting fake and forged documents. The complainant
further alleged that M/s. Tithebarn Limited UK is not a manufacturer of medicines.
As per record, following drugs of M/s. Tithebarn Limited UK were registered for import
by M/s. Zoic International, Lahore:-
S. No. Reg. No. Name of Drug (s).
1. 021297 Cocostop 20% Water Soluble Powder.
2. 021298 Quincure 20% Liquid.
3. 021299 Quintril 20% Liquid.
4. 021300 Quintril 10% Liquid.
5. 021301 Grow More Water Soluble Powder.
6. 023422 Premix PL300 Powder.
7. 049580 Tithedox Water Soluble Powder.
8. 049581 Tithemox Injection.
9. 049582 Tithemox Water Soluble Powder.
10. 049583 Enrobarn Water Soluble Liquid.
11. 057176 Tithemycin Water Soluble Powder.
12. 057177 Tithechlore 20% Water Soluble
Powder.
M/s. Zoic International, Lahore was given a show cause notice to clarify their position
with regard to the complaint. The firm, in response, denied the allegations stating that their
principle M/s. Tithebarn Limited UK abroad is a manufacturer. M/s. Zoic International, Lahore
was again directed to submit fresh original latest approval letter for the products (CoPP) / Defra
I&II issued by Regulatory Authority of United Kingdom, within 7days, failing which it will be
presumed that they have nothing to offer in their defence and an ex-party decision will be took
against them.
In response M/s. Zoic International, Lahore vide letter dated 15-06-2015 informed that in
order to submit fresh documents from concern / issuing department i.e VMD UK (Veterinary
Medicine Directorate) they may require 42 to 56 days. The firm has further given undertaking
that they will immediately stop any further import of these products until the matter is resolved.
In accordance with decision taken by the Board in its 252nd
meeting, representative of
M/s. Zoic International, Lahore was called for personal hearing. Mr. S.M Wasim Khan, Chief
Minutes for 253rd
Registration Board Meeting 437
Executive, M/s. Zoic International, Lahore and Mr. Salman Tauqeer, Advocate, appeared on
behalf of firm and claimed that the name and address of the complainant is fake, therefore, the
complaint is not valid .They were of the view that no action can be initiated on the complaint due
to aforementioned reasons. The representatives further informed that they have not imported any
of the above drugs since the issue has been raised and requested for another 45 days time for
submission of legalized and attested CoPP from abroad.
Decision:- The Board decided to allow 45 days time for submission of the properly
legalized CoPP for the products in question. In the meantime the firm will not import any
of the above products until the matter is resolved/ clarified.
Minutes for 253rd
Registration Board Meeting 438
Additional agenda:
A. Biological drugs:
Case No.01 Court case of Recombinant Bovine Growth Hormone (rBST OR
rBGH)
The decision of the honourable court dated 15/09/2015 is reproduced as follows:
1. Learned Deputy Attorney General has submitted a report with respect to the meeting
held by the Chairman Drug Registration Board (“Board”) on 31.8.2015. Learned Law Officer
states that in the meeting of the Board it was ultimately decided after hearing all the parties to
cancel the registration. He further states that detailed minutes of the meeting will be made
available in three weeks time. It is noted that an explanation has been tendered by the Chairman
of the Board with respect to non-compliance of the order of this Court, which is placed on the
file.
2. Learned law Officer submits that as per the decision of the Board, the Respondents will
commence enforcement proceedings. Learned counsel for the Respondents also stated that they
will pursue that remedy under the law.
3. Board was apprise the latest position of the title case and proceedings of the Lahore
High Court, Lahore it was explained that rBST containing product related to the large animal
(Bovine) has already been approved for cancellation of registration whereas the product namely
Fish Powder imported by Ghazi Brothers which also contains rBST and is approved as fish
growth promoter only is required to be re-examine by the Board in today‟s proceeding.
4. After detail discussion Board has decided the case as under:
Decision: The information regarding the latest status of the case under examination by
the Honorable Lahore High Court, was noted by the Registration Board. It
was further decided that the matter of fish powder be referred to following
Veterinary Experts for evaluation regarding formulation and its intended
use / abuse.
i. Dr. Muhammad Akram, Assistant Animal Husbandry Commission, Ministry of Food
Security, Islamabad.
ii. Dr. Qurban Ali, National Veterinary Laboratory, Islamabad.
iii. Dr. Muhammad Arshad, Member Registration Board, DRAP, Islamabad.
Minutes for 253rd
Registration Board Meeting 439
Case No. 02 APPEAL UNDER SECTION 3 OF THE LAW REFORMS
ORDINANCE, 1973, R/W SECTION 15 OF CPC (AMENDMENT),
ORDINANCE, 1980 R/W SECTION 96 CPC 1908
M/s Ghazi Brothers Karachi versus IZO SPA Italy
M/s Ghazi Brother Karachi is in business dispute with its principle IZO SPA Italy on
issue of cancellation of distribution agreement for their registered products in Pakistan.
Currently 40 IZO Poultry Vaccines have been granted registration for marketing into Pakistan
whereas 8 vaccines are in the process of evaluation. All the above 40 products are being
marketed by M/s Ghazi Brothers Karachi.
IZO SPA Italy on 20.03.2014 has terminated agency agreement in the name of M/s Ghazi
Brothers Karachi and notifies new incorporation office in the name of IZO SPA Pvt Ltd, Johar
Town, Lahore. This has also submitted fresh applications on 13.06.2015 which are pending for
the sake of evaluation and owing to the suit filed by M/s Ghazi Brothers Karachi (Ex distributor
in the High Court Sindh at Karachi.
Earlier through CMA No. 7175 the Plaintiff has prayed for:-
“....suspend the operation of termination letter dated 20.03.2014 and restrained
the defendants, its officers, employees, agents or any other person claiming through,
under or in trust for the defendants from applying and / or cancelling the registration
of the poultry vaccine products existing in the name of the plaintiff (mentioned in
Annex-B with momo of plaint), till.....”.
According to the agency agreements available on record between the parties dated 1st
June, 1996 and 31st October, 2002. The jurisdiction to settle the dispute is in Italy. Whereas it
was asserted that since the business is being executed in Pakistan hence the fruits of the
agreement and the cause of irreparable loss occurred due to the termination of agreement should
be given to the applicant.
Honourable Sindh High Court Sindh after detailed examination of the case in Suit No.
871/2014 dated 21.9.2015 maintained that:
‘11......Civil Procedure Cod does explain the ‘jurisdiction’, ‘try all suits unless barred’.
Rejection of the plaint or return thereof for presentation before proper form but nowhere
permits’ the Courts to stay the proceedings of the suit. Once a lis is brought to a file of the Court,
the law provides mechanism for disposal thereof which in no way could include an order of
staying proceedings for an indefinite period. However, at the same time, i am conscious that
procedure in Court at Brescia Italy may be different from the one, provided n the Civil
Procedure Code, therefore, returning of the plaint (Order VII r 10 CPC) for presentation before
proper forum would not meet the requirement of law rather may result in causing prejudice to
plaintiff while resorting to proper forum.
Minutes for 253rd
Registration Board Meeting 440
‘12...... In view of what has been discussed above, I am clear in my view that suit before this
Court is not maintainable and is dismissed accordingly. The dismissal however shall not
prejudice the rights of the plaintiff to institute proper proceedings for adjudication of its
grievances/claims, as per the applicable limitation of laws, if any.
M/s Ghazi Brothers Karachi has now field an inter court appeal considering that
Hon’ble single bench has not taken up the facts stated in the petition. Since the above matter is
under adjudication, hence being placed before the Registration Board meeting seeking directions
for and maintaining the status co to the matter till pendency of the appeal before Honourable
High Court Sindh at Karachi.
Decision: Registration Board noted the information.
Case No. 03 Cases of local manufacturing of veterinary biological drugs.
The following cases of locally manufactured biological drugs are placed before the
Registration Board.
Sr.No Name of the
Manufacturer
Name of Drug and
Composition
Demanded Priced Date of Application
1.
Bio-Labs ,
Islamabad
Plot No 145,
Industrial triagle
Kahota Road ,
Islamabad
BIO-NDFLU
ND VIRUSES
(MUKTESWAR) 10
AND H9N2 VIRUS
DE-CONTROLLED 29.05.2013
2.
Grand Pharma
(pvt), Islamabad
GPVAC ND+IB+IBD
COMBINED
NEWCASTLE
DISEASE,
INFECTIOUS
BRONCHITIS &
INFECTIOUS
BURSAL DISEASE
VACCINE
DE-CONTROLLED 30.09.2014
3.
Grand Pharma
(pvt), Islamabad
GPVAC CORYZA INJ
30ML, 300ML, 600ML
KILLED
INFECTIOUS
CORYZA VACCINE
DE-CONTROLLED 30.09.2014
4.
Grand Pharma
(pvt), Islamabad
GPVAC IB PLUS
BIVALENT IBV
VARIANT VACCINE
DE-CONTROLLED 30.09.2014
5.
Grand Pharma
(pvt), Islamabad
GPVAC ORT
KILLED ORT
VACCINE
DE-CONTROLLED 30.09.2014
Minutes for 253rd
Registration Board Meeting 441
6.
Grand Pharma
(pvt), Islamabad
GPVAC CONJUFLU -
ND LIVE
AIVH9+NDV
VACCINE
DE-CONTROLLED 30.09.2014
7.
Grand Pharma
(pvt), Islamabad
GPVAC SALMONEL
KILLED FOWL
TYPHOID VACCINE
DE-CONTROLLED 30.09.2014
The above cases needs to be evaluated for the purpose of evaluation of manufacturing
techniques, vaccines safety, efficacy and quality parameters. It is proposed that the products may
be referred to experts for comprehensive evaluation and product specific inspection.
Matter is placed before the Board for a decision.
Decision: Registration Board deliberated and deferred the case for technical opinion
Dr.Muhammad Arshad (Member, Registration Board- veterinary expert) as he was not
present in the meeting.
Case No. 04 Cases of Imported Products of Veterinary Biological Drugs
S.#. Name of
Indenter/
Manufactu
rer
Manufacturer Name of Drug (s)/
Composition &
Therapeutic
Group
Date of
application
/ Fee status
Documentary
Details
Remarks
1. Ghazi
Brothers
Karachi.
IZO S.P.A
Via A. Binachi
Italy
IZOVAC ND-FLU
EMULSIFIED
INACTIVATED
VACCINE
AGAINST
NEWCASTLE
DISEASE AND
AVIAN
INFLUENZA A
15-Jul-08
Deposited
fee
50000
Balance Fee
Nil
CoPP No.
DML No.
Free Sale
Certificate
Indications
COURT
CASE +
NEW
MOLECU
LE+
Referred
from
Appellate
Board
2. Marush
(Pvt)
Limited, K-
123, Model
Town,
Lahore.
Laboratorios
Hipra S.A.
Avda. La
Selva Amer
(Girona)
Spain.
Avisan Multi
Each dose
contains:
- Avian Infectious
Bronchitis virus,
inactivated, strain
H52 HAI1 : 2
6 - 2
8
- Newcastle Disease
Virus
inactivated, La
Sota strain
…………………..
03.08.2010
Deposited
fee
100000
Balance Fee
Nil
CoPP No.
N 1765ESP
DML No.
Free Sale
Certificate.
YES
Me too
i.GALLIM
UNE 302
Reg
No.049592
ii.LIVONO
BILIS
(IB+ND+E
DS)
Minutes for 253rd
Registration Board Meeting 442
HAI2 : 2
4 – 2
6
- Egg Drop
Syndrome virus
inactivated,
Adenovirus-127
strain ………...
HAI1 : 2
7 – 2
9
1 Mean titre of the
haemagglutionation
inhibition after
inoculation of a
dose of vaccine to
SPF chicks 2 Mean titre of the
haemagglutionation
inhibition after
inoculation of a
dose of 1/50
vaccine to SPF
chicks
(Biologicals)
(Veterinary use
only)
Indications. New Castle
Disease (ND),
Infectious
Bronchitis (IB),
Egg Drop
Syndrome
(EDS)
iii. ND
EDS IB
by IZO
iv. AV
PRO 303
by
LOHMIN
v. CEVAC
ND IB
EDS Reg
No.022799
3. Ghazi
Brothers
Karachi.
Brilliant Bio
Pharma limited
Hyderabad,Ind
ia
19-Feb-10
Deposited
fee
50000
Balance Fee
Nil
CoPP No.
DML No.
Free Sale
Certificate
Indications
New
Molecule
The case
may be
deferred as
the dossiers
is not
traceable
and the firm
has shown
its non
concern
from the
exporter.
Minutes for 253rd
Registration Board Meeting 443
4. Mustafa
Brothers
Faisalabad.
Veyx-Pharma
B.V.,
Forellenwegm
SJ
Raamsodonksv
eer, The
Netherlands,
Vexy Pharma
Germany
Hypophysin® LA
injectable Solution
Each 1ml
contains:-
Carbetocin……0.7
mg
Chlorobutanolum
hemihydrate…2.00
mg Sodium Acetate
trihydrate….0.5mg
Acetic Acid,
glacial…..3.0mg
WFI….1,4004.43m
g (Minux 'X', see
below) Sod.
Hydroxide....0.8mg
(X=20% solution to
adjust the pH-
value)
For Vetrinary use
only.
26-Mar-10
Deposited
fee
100000
Balance Fee
Nil
CoPP No.
DML No.
Free Sale
Certificate
Indications
Me too
5. ICI
Pakistan
Limited,
Karachi.
Intervet
International
GmbH,
Unterschleissh
eim, Germany.
Receptal Injectable
Solution Each ml of
solution for
injection contains:-
Buserelin acetate
4.2 micrograms
(corresponding to
0.4 micrograms
buserelin)
(Gonadotropin-
releasing hormone).
(For Veterinary
Use).
11-Apr-10
Deposited
fee
100000
Balance Fee
Nil
CoPP No.
DML No.
Free Sale
Certificate
Indications
New
Molecule
6. Vet Line
Internationa
l, Lahore.
CEVA-
PHYLAXIA
Veterinary
Biologicals
Co. Ltd.,
Budapest,
Hungary.
Licence
Holder:-
Laprovet
Hungary
Veterinary
Pharmaceutica
l LTd.
Budapest,
Hungary.
AVI ND Lasota +
IB Vaccine
Each one dose
contains:-
Newcastle disease
virus (NDV),
LaSota strain…min.
105.5
EID50
Infectious
bronchitis virus
(IBV), B-48
strain…min.
102.6
EID50
(Biological-Avian
Live Vaccine).
(For Veterinary
Use).
24-Jun-10
Deposited
fee
100000
Balance Fee
Nil
CoPP No.
DML No.
Free Sale
Certificate
Indications
Me too
Minutes for 253rd
Registration Board Meeting 444
7. Vet Line
Internationa
l, Lahore.
CEVA-
PHYLAXIA
Veterinary
Biologicals
Co. Ltd.,
Budapest,
Hungary.
Licence
Holder:-
Laprovet
Hungary
Veterinary
Pharmaceutica
l LTd.
Budapest,
Hungary
AVI POX Vaccine
Each one dose
contains:- Fowl Pox
virus, Cutter strain
min…….102.7
EID50 (Biological-
Avian Live
Vaccine).
(For Veterinary
Use).
24-Jun-10
Deposited
fee
100000
Balance Fee
Nil
CoPP No.
DML No.
Free Sale
Certificate
Indications
Me too
8. Vet Line
Internationa
l, Lahore.
CEVA-
PHYLAXIA
Veterinary
Biologicals
Co. Ltd.,
Budapest,
Hungary.
Licence
Holder:-
Laprovet
Hungary
Veterinary
Pharmaceutica
l LTd.
Budapest,
Hungary.
ITA NEW (ND)
Vaccine Each dose
(0.5ml) contains:-
Inactivated
Newcastle disease
virus min(NDV-
SZ)…50 PD50 “SZ”
LaSota Strain
(Biological-Avian
inactivated
Vaccine).
(For Veterinary
Use).
24-Jun-10
Deposited
fee
100000
Balance Fee
Nil
CoPP No.
DML No.
Free Sale
Certificate
Indications
Me too
9. Hospital
Services &
Sales,
Karachi.
BIOLOGICAL
CO. LTD.,
Beijing,
P.R. China.
QYH-ND EDS
VAC
Each one dose
contains:- White
mineral oil for
injection, span,
Tween-80,
aluminium stearate,
and Allantoic fluids
from both NDV
infected chicken
embryonic eggs and
EDSV infected
duck embryo. The
titer of ND Virus in
> 108.0
EID50/0.1ml before
inactivation, those
of Egg drop
syrdrome virus is
25-Jun-10
Deposited
fee
100000
Balance Fee
Nil
CoPP No.
Production
Licese No.
1008 (2009)
GMP
Certificate No.
029 (2008)
DML No.
Free Sale
Certificate No.
10082043
Indications.
Me too
status not
confirmed
The
documents
are not
verified by
the
Embassy of
Pakistan
Minutes for 253rd
Registration Board Meeting 445
> 107.0
EID50/0.1ml before
inactivation.
(For Veterinary
Use) 10. Vet Line
Internationa
l, Lahore.
CEVA-
PHYLAXIA
Veterinary
Biologicals
Co. Ltd.,
Budapest,
Hungary.
Licence
Holder:-
Laprovet
Hungary
Veterinary
Pharmaceutica
l LTd.
Budapest,
Hungary
AVI IBD PLUS
Vaccine Each dose
contains:-
Infectious Bursal
Disease virus
Winterfiled 2512,
G61 strain…….at
least 2.0log10
EID50
(Biological-Avian
Live Vaccine).
(For Veterinary
Use).
29-Jun-10
Deposited
fee
100000
Balance Fee
Nil
CoPP No.
DML No.
Free Sale
Certificate
Indications
Me too
11. Mustafa
Brothers
Faisalabad.
Vexy Pharma
GmbH,
Germany
PGF Veyx ® Solution
for Injection Each
1ml contains:-
Cloprostenol
Sodium…..0.092mg(e
quivalent to
0.0875mg
Cloprostenol)(Prostag
landin F2a-agonists)
15-Sep-10
Deposited
fee
100000
Balance Fee
Nil
CoPP No.
DML No.
Free Sale
Certificate
Indications
Me too
12. Hospital
Services &
Sales,
Karachi.
QYH (QIAN
YUAN HAO)
BIOLOGICAL
CO. LTD.,
Beijing,
P.R. China.
QYH-ND Live
Vaccine Each one
dose contains:-
Newcastle Disease
Virus Sota
Strain).HA titer of
allanttoic fluids
> 106.5
EID50/0.1ml before
freeze drying.
(Veterinary
Vaccine).
(For Veterinary
Use).
22-Dec-10
Deposited
fee
100000
Balance Fee
Nil
CoPP No.
DML No.
(2010) 01008
Free Sale
Certificate No.
010082074
Indications
The
documents
are not
verified by
the
Embassy of
Pakistan
13. Golden
Harvest,
Karachi.
Lohmann
Animal
HealthInternati
onal, Winslow,
Maine, United
AviPro ® 108 FC 3
PlatinumVaccine
Each per dose
(0.25ml) contains:-
Pasteurella
22-Mar-11
Deposited
fee
CoPP No.
DML No.
Free Sale
May be
deferred as
no
response
from the
Minutes for 253rd
Registration Board Meeting 446
State of
America.
multocida, X-73
strain (Type
1)……….108.5
CFU Pasteurella
multocida, P-1662
strain (Type
4)….108.5 CFU
Pasteurella
multocida, 86-1913
strain (Type
3x4)…108.5 CFU
(Inactivated poultry
vaccine).
15000
Balance Fee
85000
Certificate
Indications
experts.
Deferred
for strain
for
Pakistani
Market By
following
experts
Prof Dr
Khushi
Muhamma
d
Prof Dr
Masood
Rabani
Dr Arshad
Dr
Manzoor
(M-240)
Deffered
for
clarificatio
n of
information
sought ny
committee
and review
by already
constituted
committee
and
veterinary
expert of
ECBD (M-
241) 14. Marush
(Pvt)
Limited, K-
123, Model
Town,
Lahore.
Boreingher
Ingelheim,
USA
Calvenza-03
EIV/EHV
Each dose contains:
Equine Herpesvirus
Type 1, strain KyA
(active ingredient)...
RP ≥ 1.0*
Equine Influenza,
strain
Newmarket/2/93,
subtype A2 (active
ingredient) ... ≥
128 HUH**
Equine Influenza,
strain Kentucky/95,
26-Mar-11
Deposited
fee
50000
Balance Fee
Nil
CoPP No. No
need
DML No. 124
Free Sale
Certificate No.
1500865
Indications:
Equine
Influenza in
Horses (EI)
Deffered
for strain
for
pakistani
Market By
following
experts
Prof Dr
Khushi
Muhamma
d
Prof Dr
Masood
Rabani
Dr Arshad
Minutes for 253rd
Registration Board Meeting 447
subtype A2 (active
ingredient)... ≥ 128
HUH**
Equine Influenza,
strain A/Equi-
2/Ohio/03 (active
ingredient)... ≥ 128
HUH**
Carbopol (adjuvant
0.5%)…… 20 ± 5%
Ethylenediaminetetr
aacetic acid
(chelating agent
14%)…..
0.134%***
Thimerosal
(preservative 2.…
0.1 – 0.2%
Gentamicin
(preservative,
residual amount
from medium)…. ≤
30µg/mL
Sodium chloride
solution (adjust
antigen
concentration
0.85%) …qs to
2mL .......
*RP= Relative
Potency when
compared to a
standard reference
vaccine by in vitro
test
**HAU=
Hemagglutination
units
***Quantity of
chelating agent is
by calculation
(Biologicals)
Dr
Manzoor
(M-240)
Minutes for 253rd
Registration Board Meeting 448
15. Marush
(Pvt)
Limited, K-
123, Model
Town,
Lahore.
Boreingher
Ingelheim,
USA
Elite 9 HS
Each dose contains:
Active Ingredients
Bovine
Rhinotracheitis
Virus (IBR)…
….min 1.58 x 10 8
or 10 8.2 virus
particles
Bovine Virus
Diarrhea Virus
(BVD) ……min
1.27 x 10 7 or 10
7.1 virus particles
Myxovirus
parainfluenza3
(PI3)…… min 1.00
x 10 8 or 10 8.0
virus particles
Bovine respiratory
syncytial virus
(BRSV)... .min 1.58
x 10 6 or 106.2
virus particles
Haemophilus
somnus P51… .min
3.1 x 10 8
organisms
Haempphilus
somnus,
Oklahoma…… min
3.1 x 10 8
organisms
Leptospira
canicola…… min
1.0 x 109 organisms
Leptospira
grippotyphosa…mi
n 7.0 x 10 8
organisms
Leptospira
hardjo……min 7.0
x 10 8 organisms
Leptospira
icterohaemorrhagia
e..min 1.0 x 10 9
organisms
Leptospira
pomona… min 7.0
x 10 8 organisms
Non-active
Ingredients
26-Mar-11
Deposited
fee
50000
Balance Fee
Nil
CoPP No. No
need
DML No. 124
Free Sale
Certificate No.
1402128
Indications:
For Cattles
Bovine Rhino
Tracheitis
(IBR), Bovine
Diarrhea Virus
(BVD),
Parainfluenza 3
(PL3), Bovine
Respiratory
Syncytial Virus
(BRSV).
New
Molecule
Minutes for 253rd
Registration Board Meeting 449
Potassium
aluminium (10%)…
.max. 125 µl
Thiomersal
(merthiolate)…ax.
84 µl
Neomycin … .max.
42 µl
Physiological
saline… .Qsf - as
necessary
(Biologicals)
16. Marush
(Pvt)
Limited, K-
123, Model
Town,
Lahore.
Laboratorios
Hipra S.A.
Avda. La
Selva Amer
(Girona)
Spain.
Avisan Secure
Each dose contains:
- Inactivated
Salmonella
Enteritidis
PT4……….….
MAT ≥ 1/13*
- Inactivated
Salmonella
Typhimurium
DT104..…. MAT ≥
1/40* ………..
* Title obtained by
Microagglutination
technique on plates
after
inoculation of the
vaccine in SPF
chicks.
(Biologicals)
31-Mar-11
Deposited
fee
100000
Balance Fee
Nil
DML No.
N 1720 ESP
dated 25-1-
2007
Indications:
For Poultry
Salmonella
Enteritidis (SE),
Salmonella
Typhimurium
(ST).
Mee too
confirmed
i.
LAYERM
UNE SE
Reg
No.020126
by
BIOMUNE
.
17. Vet.
Pharma
Trading
Company,
New Steel
Market,
Near
Regent
Cinema,
G.T. Road,
Gujranwala
- Pakistan./
KBNP, Inc.
Dugok-ri,
Sinam, Yesan,
Chungnam.
Korea.
Himmvac Fowl Pox
Vaccine Each dose
contains:-
Fowl Pox virus
2775 strain…30%
(at least 102.0
EID50)
(Biological Product
Vaccine).
(For Veterinary
Use).
16-Apr-11
Deposited
fee
15000
Balance Fee
85000
CoPP No.
DML No.
Free Sale
Certificate
Indications
Me too
Minutes for 253rd
Registration Board Meeting 450
18. Mustafa
Brothers
Faisalabad.
Federal State
Unitary
Enterprise
“Stavropol
Biofactory”
Russia.
Formol Vaccine
Against
Pasteurellosis of
Cattle And Buffalos
Semi-Liquid,
Aluminium
Hydroxise
Composition in
complete
-active constituent
of Pasteurella
multocida (serotype
B), The
concentration of
microbiological
cells in the vaccine
must be not less
than 6
Milliard/cm3;
-phosphate- buffer
suspension is
aluminum
hydroxide as
sorbent 7.5%;
-inzc tivant
formalin-practically
is not revealed.
(Immunity
Biological
preparation
vaccines).
28-May-11
Deposited
fee
15000
Balance Fee
85000
CoPP No.
DML No.
Free Sale
Certificate
Indications
Check for
fee and
Mee too
status
19. Mustafa
Brothers
Faisalabad.
Federal State
Unitary
Enterprise
“Stavropol
Biofactory”
Russia.
Vaccine Against
Birds Influenza
Inactivated
Emulsified Flu
Protekt H5
Composition in
complete
(Immunity
Biological
preparations.
Homogeneous
water emulsion of
ethe white or white-
pink color).
28-May-11
Deposited
fee
15000
Balance Fee
85000
CoPP No.
08/2010/BG
Dated 15-2-
2010.
GMP No.
DE/15/001/200
8
Dated 13-2-
2008
Check for
fee and
Mee too
status
20. Vety-Care
(Pvt) Ltd.,
Rawalpindi.
Cahic Lanzhou
Bio-
Pharmaceutica
l, China.
FMD Bivalent
Vaccine (FMDV
Virus type O &
Asia I) Each 0.2ml
contains:-
Not less than 107.0
LD50 in 0.2ml
23-Jul-11
Deposited
fee
15000+
50000
CoPP No.
DML No.
Free Sale
Certificate
Me too
Minutes for 253rd
Registration Board Meeting 451
solution
(Vaccine)
(For Veterinary
Use).
Balance Fee
35000
Indications
21. Hilton
Pharma
(Pvt) Ltd.,
Karachi.
PT. MEDION
JI. Raya
Batujajar
Cimareme,
Kabupaten
Bangdung,
Indonesia.
Medivac Pox
Vaccine
Each dose of
vaccine contains:-
Live attenuated
fowl pox virus of
M-92 strain at least
103 EID50
(Freeze dried live
vaccine against
infectious
Laryngotracheitis
(ILT) in poultry
(broilers, roosters,
layers and
breeders).
(For Veterinary
Use).
8-Feb-11
Deposited
fee
15000+
35000+
50000
Balance Fee
Nil
CoPP No.
DML No.
Free Sale
Certificate
Indications
Me too
status
confirmed
i.HIPRA
POX
By Marush
from
HIPRA
Germany.
22. Hilton
Pharma
(Pvt) Ltd.,
Karachi.
PT. MEDION
JI. Raya
Batujajar
Cimareme,
Kabupaten
Bangdung,
Indonesia.
Medivac ILT
Vaccine
Each dose of
vaccine contains:-
Live attenuated
Infectious
Laryngotracheitis
virus of A 96 strain
at least 102.5
EID50 (Freeze
dried live vaccine
against infectious
Laryngotracheitis
(ILT) in poultry
(broilers, roosters,
layers and
breeders).
(For Veterinary
Use).
8-Feb-11
Deposited
fee
15000+
35000+
50000
Balance Fee
Nil
CoPP No.
DML No.
Free Sale
Certificate
Indications
Me too
status
confirmed
i. LT 1
VAX
By ICI
Pakistan
23. Vety-Care
(Pvt) Ltd.,
Rawalpindi.
Intervet
International
B.V. Wim de
Korverstraat,
AN Boxmeer,
Netherland.
Nobilis SG 9R
Vacccine Each dose
0.2ml contains:-
Salmonella
Gallinarum strain
9R in
stabilizer………at
least 2x107 CFU
(Live vaccine).
18-Oct-11
Deposited
fee
15000+
85000
Balance Fee
Nil
CoPP No.
DML No.
Free Sale
Certificate
Indications
ECBD
Recommen
ded (M-
240)
Deferred
for
clarificatio
n about
justificatio
n of live
Minutes for 253rd
Registration Board Meeting 452
virus strain
(241)
24. Vety-Care
(Pvt) Ltd.,
Rawalpindi.
Intervet
International,
USA.
Innovax-Nd
Vaccine Each dose
contains:-
Live Turkey Herpes
Virus strain
HVT/NDV-
F>……at least
1810 PFU per bird
dose.
(Live virus
vaccine)
18-Oct-11
Deposited
fee
15000+
85000
Balance Fee
Nil
CoPP No.
DML No.
Free Sale
Certificate
Indications
ECBD
Reccomme
nded (M-
240)
Deferred
for
clarificatio
n about
serotype of
strain
NDV-F
and and
review by
already
constituted
committee
and
veterinary
expert of
ECBD. (M-
241) 25. Snam
Pharma,
Lahore. /
Bioveta a.s.
Ivanovice na
Hane, Czech
Republic.
Ornibur
Intermediate Plus,
Lyophilizate for the
preparation of
suspension for
domestic fowl Each
one dose contains:-
Virus bursitidis
avium, strain IBDV
OP-1, min. 104.0
TCID50-
max.105.2 TCID50
(Vaccine).
31-Oct-11
Deposited
fee
100000
Balance Fee
Nil
CoPP No.
DML No.
Free Sale
Certificate
Indications
Deffered
for strain
for
pakistani
Market By
following
experts
Prof Dr
Khushi
Muhamma
d
Prof Dr
Masood
Rabani
Dr Arshad
Dr
Manzoor
(M-240)
Defered for
testing of
extraneous
pathogens
Minutes for 253rd
Registration Board Meeting 453
by NVL at
the cost of
applicant.
(M-241)
The report
of NVL is
attached
on the last
page of
Agenda. As
per report
“The
sample
submitted
and
referred
above
complies
the test
requireme
nts”
26. Marush
(Pvt)
Limited, K-
123, Model
Town,
Lahore.
Laboratorios
Hipra S.A.
Avda. La
Selva Amer
(Girona)
Spain.
HipraBovis-4
Each dose contains:
- Inactivated
Infectious Bovine
Rhinotracheitis
Virus (IBR),
strain LA
…………………..
≥ 107 TCID50
- Inactivated
Parainflenza-3
Virus (PI-3), starin
SF4... ≥ 480 HAU
- Inactivated
Bovine Diarrhoea
Virus (BVD),
Strain NADL
……..….. ≥ 106
TCID50
Freeze-dried
fraction:
- Live Bovine
Respiratory
Syncitial Virus,
Strain LYM P56
……..….. ≥ 104
TCID50
(Biologicals)
26-Nov-11
Deposited
fee
15000
Balance Fee
35000
CoPP No.
N 2772 ESP
DATED 09-4-
2013
Indications:
For Cattle
Bovine
Rhinotracheitis
Virus (IBR),
Bovine
Respiratory
Syncitial Virus
(BRSV),
Parainfluenza
3(PI3)
New
Molecule
Minutes for 253rd
Registration Board Meeting 454
27. Ghazi
Brothers
Karachi.
Kofavet
Special Inc
Korea
BIOTECTOR S1 W
BACTERIOPHAG
E….1.0X10PFU
15-Dec-11
Deposited
fee
15000+
35000
Balance Fee
50000
CoPP No.
DML No.
Free Sale
Certificate
Indications
Check for
fee and Me
too status
28. Ghazi
Brothers
Karachi.
BIOTECTOR S1
BACTERIOPHAG
E
15-Dec-11
Deposited
fee
15000
Balance Fee
35000
CoPP No.
DML No.
Free Sale
Certificate
Indications
New
Molecule
29. Saadat
Internationa
l, Lahore.
Laboratoire
Porte Des
Alpes, Saint
Priest, France.
Nemovac Vaccine
Each dose of
vaccine contains:-
Attenuated Swollen
Head Syndrome
virus, PL21 strain,
at least 102.3
CCID50
(Biological
Products).
18-Apr-12
Deposited
fee
100000
Balance Fee
Nil
CoPP No.
DML No.
Free Sale
Certificate
Indications
Check for
Me too
i.Izovac
SHS Live
by IZO
II.Hipra
VIAR SHS
by Marush
30. Marush
(Pvt)
Limited, K-
123, Model
Town,
Lahore.
Ceva
Phylaxia
Biological Co.
Ltd., Budapest,
Hungary.
Cevac Corymune 4
K Injectable
Contains:-
-Avibacterium
paragallinarum
Serotype A….Min.
7 Log10 CFU
before inactivation.
-Avibacterium
paragallinarum
Serotype B….Min.
7 Log10 CFU
before inactivation.
-Avibacterium
paragallinarum
Serotype C….Min.
7 Log10 CFU
before inactivation.
-Salmonella
Enteritidis
(SE)……induce
min 5 log2 MAT
(Biological)
23-Apr-12
Deposited
fee
100000
Balance Fee
Nil
Certificate of
Origin and Free
Sale No.
MA-
HU/06V/2006
/M21
Indications:
For Poultry
Avian Coryza
(AB&C),
Salmonella
Enteritidis.
Confirmed
Mee too
i.HEMOV
AX Reg
No.011485
by Marial
ii.
IZOVAC
Coryza by
IZO
iii.
MULTIM
UNE ABC
Reg
No.035030
by
BIOMUNE
Minutes for 253rd
Registration Board Meeting 455
31. Marush
(Pvt)
Limited, K-
123, Model
Town,
Lahore.
Phylaxia
Biological Co.
Ltd., Budapest,
Hungary
Cevac Corymune 7
K Injectable
Contains:-
-Newcastle Disease
(ND) virus, strain
“SZ”
Lasota…..induced
min.6 log2 HI with
1 dose or min.4
log2 HI with 1/50
dose or min..50
PD50
-Infectious
Bronchitis (IB)
virus, “M-
41”…..induce
min….6 log2 HI
-Egg Drop
Syndrome, 76
(EDS) virus, strain
“B8/78”….induce
min.7 log2 HI
-Avibacterium
paragallinarum
Serotype A….Min.
7 Log10 CFU
before inactivation.
-Avibacterium
paragallinarum
Serotype B….Min.
7 Log10 CFU
before inactivation.
-Avibacterium
paragallinarum
Serotype C….Min.
7 Log10 CFU
before inactivation.
-Salmonella
Enteritidis
(SE)……induce
min 5 log2 MAT
(Biological)
23-Apr-12
Deposited
fee
100000
Balance Fee
Nil
Certificate of
Origin and Free
Sale No.
MA-
HU/06V/2006
/M21
Indications.
For Poultry
Newcastle
Disease (ND),
Infectious
Bronchitis (IB),
Egg Drop
Syndrome
(EDS), Avian
Coryza
(AB&C).
Solmonella
Enteritidis (SE)
me too
status
Confirmed
i. IZOVAC
ND EDS
hg3 by IZO
ii.
LAYERM
UNE 3
Reg. No.
020125 by
BIOMUNE
Minutes for 253rd
Registration Board Meeting 456
32. Marush
(Pvt)
Limited, K-
123, Model
Town,
Lahore.
CEVA-
PHYLAXIA
vetneriary
Biologicals
Co.Ltd
Hungary
Cevac IBird
Each dose contains:
1.1 Active
substance
Avian infectious
bronchitis virus,
variant strain 1/96
at least 2.8 log 10
EID50 Ph. Eur.
0442
1.2 Virus protecting
components of the
excipients
Gelatine max. 10µg
Ph. Eur. 0330
Hydroxypropylbeta
dex max. 100µg Ph.
Eur. 1804
Sucrose max.
200µg Ph. Eur.
0204
(Biologicals)
17-May-12
Deposited
fee
50000
Balance Fee
Nil
Certificate of
Origin and Free
Sale No.
MA-
HU/06V/2006
/M21
Free Sale
Certificate No.
3378/1-4/13
Indications.
For Poultry Use
Infectious
Bronchitis (IB)
Variants
New
Molecule
33. Marush
(Pvt)
Limited, K-
123, Model
Town,
Lahore.
Laboratorios
Hipra S.A.
Avda. La
Selva Amer
(Girona)
Spain.
Toxipra S7
Each dose contains:
β toxoid of
Clostridium
perfringens type B,
C and D …> 10 UI
antitoxine β/ml of
serum
ε toxoid of
Clostridium
perfringens type B,
C and D ….> 5
UIantitoxine ε/ml
of serum
α toxoid of
Clostridium novyi
type B
…………………..>
3.5 UI antitoxine
α/ml of serum
α toxoid of
Clostridium
septicum
….………………
…..> 2.5 UI
antitoxine α/ml of
serum
Anaculture of
Clostridium
6-Aug-12
Deposited
fee
15000+
35000
Balance Fee
Nil
CoPP No.
N 2770 ESP
Prod License
No. 2770ESP
Dated 09-4-
2013
GMP No.
ES/030/14
Dated 04-3-
2014
F
ree Sale
Certificate No.
Dated 04-12-
2014
Indications.
For Cattle,
Sheep & Goat.
Clostridium
infections
caused by CL
Perfringens
(BCD), CL
Septicum, CL
New
Molecule
Minutes for 253rd
Registration Board Meeting 457
chauvoei
......................100%
protection in guinea
pig
Anaculture of
Clostridium
sordellii
........................100
% protection in
guinea pig
(Biologicals)
Chauvoei, CL
Sordellii
34. Marush
(Pvt)
Limited, K-
123, Model
Town,
Lahore.
Laboratorios
Hipra S.A.
Avda. La
Selva Amer
(Girona)
Spain.
Hipraviar –
Clon/H120
Injectable Each per
dose (0.03ml)
ocular- nasal route)
contains:-
Live Newcastle
Disease Virus,
CL/79
clon…….> 106.5
EID50 Live
Infectious
Bronchitis Virus,
strain H-
120…….>103
EID50
(Biologicals).
27-Jun-12
Deposited
fee
100000
Balance Fee
Nil
CoPP No.
N 2275 ESP
Dated 04-12-
2014
Indications.
For Poultry Use
Newcastle
Disease (ND
Clone),
Infectious
Bronchitis (IB).
Confirmed
Mee too
status
i. NOBILIS
ma5
+Clone 30
by MSE
ii.
IZOVAC
CHB by
IZO
35. Marush
(Pvt)
Limited, K-
123, Model
Town,
Lahore.
Laboratorios
Hipra S.A.
Avda. La
Selva Amer
(Girona) Spain
Hipraviar ILT
Each dose contains:
Live Avian
Infectious
Laryngotracheitis
Virus, strain CHP
50 … > 103 – 103.5
EID50
(Biologicals)
Hipraviar ILT
Each dose contains:
Live Avian
Infectious
Laryngotracheitis
Virus, strain CHP
50 … > 103 – 103.5
EID50
(Biologicals)
28-Jun-12
Deposited
fee
100000
Balance Fee
Nil
CoPP No.
N 2237 ESP
DATED 16-2-
2011
DML No.
Free Sale
Certificate
Dated 04-12-
2014
Indications. For
Poultry Use.
Avian
Infectious
Laryngotracheit
is Virus (ILT)
Me too
Confirmed
i. NOBILIS
ILT by
MSD
ii.
IZOVAC
ILT by IZO
iii. CEVAC
LTL Reg
No. 022791
by Selva
iv.VECTO
RMUNE
FP LT Reg
No. 039931
by
BIOMUNE
Minutes for 253rd
Registration Board Meeting 458
36. Marush
(Pvt)
Limited, K-
123, Model
Town,
Lahore.
CEVA-
Biomune
Veterinary
Biologicals
Company,
Lenexa, KS
USA.
Vectormune HVT
AIV Injectable
Each dose
contains:-
HVT/AIV virus in
CP#1…50- 90%
Cryoprotectant
#2……10-50%
(Biologicals).
29-Jun-12
Deposited
fee
50000
Balance Fee
Nil
Free Sale
Certificate No.
1500379
DML No. 368
Indications. For
Poultry Use.
It is transported
in special
containers fill
with Liquid
Nitrogen Gas
Avian Influenza
– H5 (Bird
Flue)
Reply
Deffered
for
clarificatio
n regarding
technical
details
about
transportati
on and the
compositio
n and
review by
already
constituted
committee
and
veterinary
expert of
ECBD.(M-
241) 37. Vet.
Pharma
Trading
Company,
New Steel
Market,
Near
Regent
Cinema,
G.T. Road,
Gujranwala
- Pakistan./
KBNP, Inc.
Dugok-ri,
Sinam, Yesan,
Chungnam,
Korea.
Himmvac Dalguban
SG9R Live Vaccine
Each dose
contains:-
Salmonella
gallinarum 9R
strain……..at least
2x107 CFU/dose
(Poultry Vaccine).
19-Jul-12
Deposited
fee
15000
Balance Fee
85000
CoPP No.
DML No.
Free Sale
Certificate
Indications
Check for
fee and
Mee too
status
Minutes for 253rd
Registration Board Meeting 459
38. Hilton
Pharma
(Pvt) Ltd.,
Karachi.
PT. MEDION
JI. Raya
Batujajar
Cimareme,
Kabupaten
Bangdung,
Indonesia.
Medivac ND-
Gumboro Emulsion
Vaccine
Each dose (0.5ml)
of vaccine
contains:-
Inactivated
Newcastle disease
virus of LaSota
strain at least 50
PD50
Inactivated
infectious bursal
disease virus of
Winterfield 2512
strain at least 800
serum
neutralization (SN).
(Freeze dried live
vaccine against
infectious
Laryngotracheitis
(ILT) in poultry
(broilers, roosters,
layers and
breeders).
(For Veterinary
Use).
2-Sep-12
Deposited
fee
50000
Balance Fee
Nil
CoPP No.
DML No.
Free Sale
Certificate
Indications
Confirmed
Mee too
status
i. IZO
VAC ND
IBD by
Ghazi
Brothers
from IZO
England
ii. HYPRA
GUMBOR
OBPL 2.
By Marush
from
HYPRA
Germany.
39. Vet.
Pharma
Trading
Company,
New Steel
Market,
Near
Regent
Cinema,
G.T. Road,
Gujranwala
- Pakistan./
KBNP, INC,
Dugok-ri,
Sinam, Yesan,
Chungnam,
Korea
Himmvac ND Oil
Vaccine Each vial
contains:-
Inactivated ND
virus (B1)…..30%
(At least 108.8
EID50/dose)
(Biological
Products).
(For Veterinary
Use).
10-Sep-12
Deposited
fee
15000+
35000+
65000
Balance Fee
Nil
CoPP No.
DML No.
Free Sale
Certificate
Indications
Check for
earlier
proceeding
s, may be
approved
product of
240 or 241
Minutes for 253rd
Registration Board Meeting 460
40. Ghazi
Brothers
Karachi.
IZO S.p.A.,
Via A. Bianchi
9, Brescia,
Italy.
Izovac CHB
Multidose Freeze-
Dried Bottle
Each dose of
vaccine contains:-
Live attenuated
Newcastle Disease
Virus Strain
Clone…..106
EID50
Live Attenuated
Infectious
Bronchitis Strain
Massachusetts
H120……103EID5
0
Live Attenuated
Infectious
Bronchitis Strain
28/86…..103EID50
(Immunological)
7-Oct-12
Deposited
fee
15000
Balance Fee
35000
CoPP No.
DML No.
Free Sale
Certificate
Indications
Check for
fee and
Mee too
status +
Court case
with IZO
Italy and
IZO
Pakistan
Lahore
41. Marush
(Pvt)
Limited, K-
123, Model
Town,
Lahore.
CEVA-
Biomune
Veterinary
Biologicals
Company,
Lenexa, KS
USA.
Circomune W Oral
Each dose of
vaccine contains:-
Chickem Anemia
Virus…at >
……106.2
TCID50/dose
(Biologicals).
10-Jul-12
Deposited
fee
100000
Balance Fee
Nil
CoPP No.
DML No.
Free Sale
Certificate
Indications
Application
is
withdrawn
by the
company
May be
withdrawn
42. Marush
(Pvt)
Limited, K-
123, Model
Town,
Lahore.
CEVA-
Biomune
Veterinary
Biologicals
Company,
Lenexa, KS
USA.
Circomune
Injectable
Each dose of
vaccine contains:-
Chicken Anemia
Virus……at
>…..104.9
TCID50/dose
Glycerol…………
……………2 0%
20% BVlue Dye
Solution…….1%
(Biologicals).
10-Jul-12
Deposited
fee
15000 +
60000
(Nov. 2010)
Balance Fee
20000
Manufacturing
License No.
368
Dated 23-12-
1988
Free Sale
Certificate No.
1402568
Indications. For
Poultry Use
Disease.
Chicken
Anemia Virus
(CAV)
USDA
Approved.
Mee too
status
Confirmed
i. NIBULIS
CE by
MST
ii.
AVIPRO
THYMOV
AC by
LOWMAN
Minutes for 253rd
Registration Board Meeting 461
43. ICI
Pakistan
Limited,
Karachi.
Intervet
GesmbH,
Siemensstrabe
107, A 1210
Wien Austria
Revalor XS Implant
Each implant (10
pellets contains:-
Trenbolone
acetate……..200mg
17 β-
Estradiol….40mg.
For Veterinary
Use).
12-Oct-12
Deposited
fee
100000
Balance Fee
Nil
CoPP No.
LCN 480.912-
0020 (Austria)
Dated 26-11-
2010
Prod Reg No.
141-269 (USA)
Dated 19-1-
2007
New
Molecule
44. ICI
Pakistan
Limited,
Karachi.
Intervet Inc.
Corner of
Delaware
Avenue and
Monroe Street
Millsboro,
Delaware
19966 USA.
Fortegra Vaccine
(Coccidiosis
Vaccine Live
Oocysts)
The amount of
antigenic material
per dose in the final
container :-
Minimum of
sporulated oocysts
throughout dating
Eimeria
acervulina….600
Eimeria maxima
…...200 Eimeria
maxima MFP
……………………
.100
Eimeria
mivati……400
Eimeria
tenella…….200
(For Veterinary
Use).
12-Oct-12
Deposited
fee
100000
Balance Fee
Nil
DML No. 165A
Dated 10-2-
2011
Free Sale
Certificate No.
1102354
Dated 09-8-
2011
New
Molecule
45. ICI
Pakistan
Limited,
Karachi.
Schering-
Ploug Animal
Health
Limited.
Newzeland
COVEXIN 10
Clostridium
Vaccine for Sheef
Beef and Diary.
12-Oct-12
Deposited
fee
100000
Balance Fee
Nil
Prod Reg No.
A9028
Dated 23-5-
2011
GMP No
NZ262V/2010
Dated 23-3-
2011
New
Molecule
Minutes for 253rd
Registration Board Meeting 462
46. Hi-Tech
Pharmaceut
icals,
Lahore.
Pfizer Animal
Health (Pfizer
Inc), 2000
Rockford
Road, Charles
City, Iova,
USA.
Poulvac ® ST
Vaccine
Illustration of a
0.005ml dose
contains:-
Bacterial Culture….
≥3.0 x 107
CFU/Dose at
release
LP
Stabilizer…0.00125
ml Sterile
PBS…..0.00125ml
For Veterinary
Use).
29-Oct-12
Deposited
fee
100000
Balance Fee
Nil
U.S. Veterinary
License No.
190
Certificate No.
1302587
Indications
Salmonella
Mee too
confirmed
47. Hi-Tech
Pharmaceut
icals,
Lahore.
Pfizer Animal
Health (Pfizer
Inc), 2000
Rockford
Road, Charles
City, Iova,
USA.
Poulvac ® SE
Vaccine
Illustration of a
0.5ml dose
contains:-
Salmonella
enteritidis Phase
Type 4……….
…..RP….
≥1.0/dose at
release. Salmonella
enteritidis Phase
Type 8…RP………
…….≥1.0/dose at
release. Salmonella
enteritidis Phase
Type 13a…RP……
…….≥1.0/dose at
release.
37% Formaldehyde
Solution………0.0
006ml White
Oil……0.1995ml
Arlacel-
83…..0.1105ml
Tween-
80…..0.00168ml
Saline………q.s to
0.3ml For
Veterinary Use).
29-Nov-12
Deposited
fee
100000
Balance Fee
Nil
U.S. Veterinary
License No.
190
48. Mustafa
Brothers
Faisalabad.
Federal
Governmental
Budgetary
Institution
“Federal
Centre for
Animal
Dry Live vaccine
against Newcastle
disease from strain
La Sota.
Contains:-
One intranasal
(ocular) dose of the
6-Dec-12
Deposited
fee
15000
Balance Fee
Prod Reg No.
1047796296437
dated 11-8-
2011.
DML No. 0011-
1-001221 dated
Deffered
for strain
for
pakistani
Market By
following
experts
Minutes for 253rd
Registration Board Meeting 463
Health” (FGBI
“ARRIAH”,
Vladimir,
Russia.
vaccine contains at
least 6.7 1g
EID50/head of ND
vaccine strain
(strain La Sota)
(Vaccine).
85000
11-8-2011. Prof Dr
Khushi
Muhamma
d
Prof Dr
Masood
Rabani
Dr Arshad
Dr
Manzoor
(M-240)
Deffered
for
clarificatio
n of strain
and review
by already
constituted
committee
and
veterninary
experts
ofECBD.(
M-241) 49. Mustafa
Brothers
Faisalabad.
Federal
Governmental
Budgetary
Institution
“Federal
Centre for
Animal
Health” (FGBI
“ARRIAH”,
Vladimir,
Russia.
Virus Vaccine
against infectious
bursal disease from
BG strain
Contains:-
Infectivity of the
virus vaccine shall
be at least 104.5
EID50/cm3 One
dose of the vaccine
shall contain 103
EID 50
(Vaccine).
12-Jun-12
Deposited
fee
15000
Balance Fee
85000
Prod Reg No.
1047796296437
dated 11-8-
2011
DML No.00-
11-1-001221
dated 11-8-
2011
Check for
fee and Me
too status
50. Mustafa
Brothers
Faisalabad.
Federal
Governmental
Budgetary
Institution
“Federal
Centre for
Animal
Health” (FGBI
“ARRIAH”,
Vladimir,
Russia.
Vaccine against
infectious chicken
bronchitis from
strain “H-120” dry
live
Contains:-
One immunizing
vaccine dose
contains not less
than 104 EID50 of
IB virus (Strain H-
120) (Vaccine).
12-Jun-12
Deposited
fee
15000
Balance Fee
85000
Prod Reg No.
1023/30128372
0
Dated 26-7-
2011
GMP No.
1047796296437
Dated 26-12-
2011
Check for
fee and Me
too status
51. Mustafa
Brothers
Faisalabad.
Federal
Governmental
Budgetary
Associated Vaccine
Against Newcastle
Disease
12-Jun-12
Deposited
DML No. 00-
11-1-001220
Dated 11-8-
Check for
fee and
Mee too
Minutes for 253rd
Registration Board Meeting 464
Institution
“Federal
Centre for
Animal
Health” (FGBI
“ARRIAH”,
Vladimir,
Russia.
Infectious Chicken
Bronchitis and egg
drop syndrom-76
inactivated
emulsion
fee
15000
Balance Fee
85000
2011.
Free Sale
Certificate No.
N4-4056
Dated 11-10-
2011
status
52. Mustafa
Brothers
Faisalabad.
Federal
Governmental
Budgetary
Institution
“Federal
Centre for
Animal
Health” (FGBI
“ARRIAH”,
Vladimir,
Russia.
Virus vaccine
against Winterfield
Disease 2512 strain
(Missing)
12-Jun-12
Deposited
fee
15000
Balance Fee
85000
Prod Reg No.
1023301283720
Dated 26-7-
2011
GMP No. 0011-
1-001221
26-12-2011
Free Sale
Certificate No.
4-4078
Check for
fee and Me
too status
The Board was of the opinion that as per policy the products originating from the reference
countries shall be registered with peer review of valid CoPP and Free Sale Certificate issued by
the concerned regulatory body shall be preferred for registration.
Decision: Registration Board deliberated and deferred the case for technical opinion of
Dr.Muhammad Arshad (Member, Registration Board- veterinary expert) as he was not
present in the meeting.
Minutes for 253rd
Registration Board Meeting 465
Case No. 05 Cases of Imported Products Of Human Biological Drugs Originating From
SRA Countries.
Registration Board considered following cases and decisions are recorded in last column. The
approval is subject to inspection of manufacturer abroad as per policy, verification of storage
facilities and price fixation / calculation by the Pricing Division.
S.#
.
Name of
Indenter/
Manufactu
rer
Manufactu
rer
Name of Drug
(s)/ Composition
& Therapeutic
Group
Date of
application /
Fee status
Documentar
y Details
Remarks Decision
1. GlaxoSmith
Kline
Pakistan
Limited,
Karachi.
GlaxoSmith
Kline
Biologicals,
S.A.
Belgium
Twinrix
Suspension for
injection (Pre-
filled) Each pre-
filled syringe
contains:-
Inactivated
Hepatitis A
virus…720
ELISA Units
Hepatitis B
surface antigen
(rDNA)......20
micrograms
(Combined viral
vaccine for
protection against
Hepatitis A and
B).
(For Human Use)
Date of
application
03.11.2010
Deposited Fee
15000+
35000
Balance Fee
Nil
EMA CoPP
No.
06/12/54421
Dated
23.5.2012
EU/1/96/020/
001-009
Dated
20.9.1996
New
Molecule
Recommen
ded ECBD
Deferred
for expert
opinion of
Gen ®
Karamat
Gen ®
Tasawar
Birg ®
Najmi Prof
Umar. (M-
240)
Registration
Board
deliberated
that it is an ir-
rational
formulation.
Thus the Board
rejected the
application.
2. Barrett
Hodgson
Pakistan
(Private)
Ltd
Allergan
Pharmaceut
icals
Ireland.
BOTOX 50 mg
Allergan Units
Powder for
solution for
Injection.
Date of
application
10.12.2010
Deposited Fee
15000+
35000
Balance Fee
Nil
CoPP No.
148/60/2.
GMP.2678
dated
31/10/2002.
Free Sale
Certificate
Indications
Botax 100
mg is
already
regisreted
under reg
N. 018959,
dated
07.4.1996
(M-118)
Deferred for
expert opinion
of Big.Dr.
Najmi and Dr.
Akhtar Saeed.
for newly
applied
strengths of 50
mg and 200 mg
Minutes for 253rd
Registration Board Meeting 466
3. Sind
Medical
Stores,
Karachi.
Bharat
Biotech
Internationa
l Limited,
Hyderabad,
Andhra
Pradesh,
India.
Biopolio
(Trivalent) Oral
solution (2ml
vial)
Each 1 dose =
0.1ml (2 drops)
contains:-
Polio virus
(Sabin)
-Type 1 > 106.0
CCID50
-Type 2 > 105.0
CCID50
-Type 3 > 105.5
CCID50
(Vaccine).
Date of
application
18.05.2011
Deposited fee
15000+
85000
Balance Fee
Nil
CoPP
No.16684/20
14/11/6551/2
8587 valid
till dated
17/03/2016
GMP No
2776/AB
(M#/T.S/201
4. Dated
16/09/2014.
Free Sale
Certificate.
9657/M3B/2
013. Dated
17/07/2013.
Indications
Polio
eradication
Me too,
252nd
Meeting
for EPI
As EPI has
recommended
registration of
formulation,
thus
registration
was
approved
4. Sind
Medical
Stores,
Karachi.
Bharat
Biotech
Internationa
l Limited,
Hyderabad,
Andhra
Pradesh,
India.
Biopolio B1/3
Oral solution
(2ml vial)
Each dose of
100ul (2 drops;
0.1ml) of the
vaccine contains:-
Polio virus
(Sabin)
-Type 1 > NLT
10 6.0 CCID50
-Type 3 > NLT
10 5.8 CCID50
(Vaccine)
Date of
application
18.05.2011
Deposited fee
15000+
85000
Balance Fee
Nil
CoPP
No.16684/20
14/11/6551/2
8587 valid
till dated
17/03/2016
GMP No
2776/AB
(M#/T.S/201
4. Dated
16/09/2014.
Free Sale
Certificate.
9657/M3B/2
013. Dated
17/07/2013.
Indications:
Polio
eradication
Me too,
252nd
Meeting
for EPI
As EPI has
recommended
registration of
formulation,
thus
registration
was
approved
5. Sind
Medical
Stores,
Karachi.
Bharat
Biotech
Internationa
l Limited,
Hyderabad,
Andhra
Biopolio M1 Oral
solution (2ml
vial)
Each dose of
100ul (2 drops;
0.1ml) of the
Date of
application
18.05.2011
Deposited fee
CoPP
No.16684/20
14/11/6551/2
8587 valid
till dated
17/03/2016
Me too,
252nd
Meeting
for EPI
As EPI has
recommended
registration of
formulation,
thus
registration
Minutes for 253rd
Registration Board Meeting 467
Pradesh,
India.
vaccine contains:-
Polio virus
(Sabin)
-Type 1 > NLT
106.0 CCID50
(Vaccine).
15000+
85000
Balance Fee
Nil
GMP No
2776/AB
(M#/T.S/201
4. Dated
16/09/2014.
Free Sale
Certificate.
9657/M3B/2
013. Dated
17/07/2013.
Indications
Polio
eradication
was
approved
6. Eastern
Trade &
Distribution
Co. (Pvt)
Ltd.,
Karachi.
CANGENE
CORPORA
TION,
Innipeg,
Manitoba,
Canada,
R3T 5Y3
WinRho ® SDF
Liquid Injection
Each 3ml vial
contains:- Anti-
Rho (D)…..600
IU (120mcg)/vial
Anti-Rhd
(D)…1500 IU
(300mcg)/vial
(Biologics).
Date of
application
17.08.2011
Deposited fee
100000
Balance Fee
Nil
CoPP No.
59723 dated
24/02/2015
validity 1
year
Product Lisc
No.02302578
. dated
16/06/2008.
Indications.
Anti-Rho (D
Product
Manufactur
er by
CANGEN
E
corporation
Manitoba,
Canada,
R3T 5Y3
confirmed
COPP
provided
No. 59723
from
Canada.
Approved
7. Popular
Internationa
l (Pvt) Ltd.,
Karachi.
Kedrion
S.p.A Loc.
Ai Conti,
Castelvecch
io Pascoli-
Barga
(LU), Italy.
Uman Albumin
Solution for
Infusion 250g/L-
50ml vial Each
50ml vial
contains:- Human
Plasma Proteins
containing at least
95%
Albumin……….1
2.5g (Plasma
Protein Solutions
(Human).
Date of
application
20.08.2011
Deposited fee
15000+
85000
Balance Fee
Nil
CoPP No.
NCCP
/2012/423
.
Product Reg
No.
021111087.
Dated
05/05/1984
Free Sale
Certificate
Indications.
(Plasma
Protein
deficiencies
(Human).
Recommen
ded by 4th
ECBD as
per SRA
Deferred
for
Clarificatio
n of
Similar
Formulatio
n in
Pakistan
Mee Too +
Firm has
submitted
clarificatio
n
(M-240),
Status in
Approved
Minutes for 253rd
Registration Board Meeting 468
252
Meeting
i. Reg No
007967
from
GRIFOLS
INC by
Popular
Internation
al.
8. Popular
Internationa
l (Pvt) Ltd.,
Karachi.
Kedrion
S.p.A Loc.
Ai Conti,
Castelvecch
io Pascoli-
Barga
(LU), Italy
Uman Albumin
Solution for
Infusion 200 g/L-
100ml vial Each
100ml vial
contains:- Human
Plasma Proteins
containing at least
95%
Albumin……….2
0g (Plasma
Protein Solutions
(Human).
Date of
application
20.08.2011
Deposited fee
15000+
85000
Balance Fee
Nil
CoPP No.
NCCP /2011
/ 1133
.
Product Reg
No.
02111101.
Dated
24/07/2002
Free Sale
Certificate
Indications.
(Plasma
Protein
deficiencies
(Human).
Recommen
ded by 4th
ECBD as
per SRA
Deffered
for
Clarificatio
n of
Simillar
Formulatio
n in
Pakistan
Mee
Too+Firm
has
submitted
clarificatio
n (M-240),
Status in
252
Meeting
i. Reg
No.023674
Human
Albumine
20% from
CSL
Bahring by
Hakimsons
ii. Reg No.
007967
Plasbmin-
20 from
Grifols
Therapeuti
cs
by Popular
Internation
al .
Approved
Minutes for 253rd
Registration Board Meeting 469
9. Novartis
Pharma
(Pakistan)
Limited,
Karachi./
Sandoz
GmbH
Biochemies
tr. Kundl,
Austria.
ZARZIO 30
MU/0.5ML PFS
Each PFS
contains:-
Filgrastim 30MU/
0.5ml
SOLUTION FOR
INFUSION or
INJECTION .
Date of
application
11.10.2011
Deposited fee
15000+
35000+
Balance Fee
85000
EMA CoPP
No.43015/09/
11/4833.
Dated
05/10/2011
Product Reg
No.
EU/1/08/495/
001-016.
Dated
06/02/2009.
Free Sale
Certificate
Indications.
Neutorpenia.
EMA and
US FDA
approved,
Bio-similar
product,
FDA
approved.
Approved.
10. Barrett
Hodgson
Pakistan
(Private)
Ltd
Allergan
Pharmaceut
icals
Ireland.
BOTOX 200 mg
Allergan Units
Powder for
solution for
Injection.
Date of
application
12.12.2011
Deposited fee
15000+
35000
Balance Fee
Nil
CoPP No.
148/60/2.
GMP.2678
dated
31/10/2002.
Free Sale
Certificate
Indications
New
Molecule Deferred
Product for
expert opinion
of Big.Dr.
Najmi and Dr.
Akhtar Saeed.
for newly
applied
strengths of 50
mg and 200 mg
Status
Deferred
11. Novartis
Pharma
(Pakistan)
Limited,
Karachi./
Sandoz
GmbH
Biochemies
tr. Kundl,
Austria.
Omnitrope
5mg/1.5ml
Solution for
Injection
Each cartridge
contains:- 1.5ml
corresponding to
5mg Somatropin
(15 IU)
(Growth
Hormones)
Date of
application
27.03.2012
Deposited fee
15000+
35000+
50000
Balance Fee
Nil
CoPP
No.43015/04/
1148232.05/1
0/2011
Product Lisc
No.EU/1/06/
332/004-012.
Dated
20/04/2007
Indications.
Growth
Hormones
deficiencies
EMA and
FDA
approved,
Biosimilar
product.
Approved.
Minutes for 253rd
Registration Board Meeting 470
12. Novartis
Pharma
(Pakistan)
Limited,
Karachi./
Sandoz
GmbH
Biochemies
tr. Kundl,
Austria.
Omnitrope
10mg/1.5ml
Solution for
Injection
Each cartridge
contains:- 1.5ml
corresponding to
10mg Somatropin
(30 IU)
(Growth
Hormones)
Date of
application
27.03.2012
Deposited fee
15000+
35000+
50000
Balance Fee
Nil
CoPP
No.43015/04/
1148232.05/1
0/2011
Product Lisc
No.EU/1/06/
332/004-012.
Dated
20/04/2007
Indications.
Growth
Hormones
deficiencies
EMA and
FDA
approved,
Biosimilar
product,.
Approved
13. Novartis
Pharma
(Pakistan)
Limited,
Karachi./
Sandoz
GmbH
Biochemies
tr. Kundl,
Austria.
ZARZIO 48
MU/0.5ML PFS
SOLUTION FOR
INFUSION OR
INJECTION
Date of
application
27.03.2012
Deposited fee
50000+
35000+
15000
Balance Fee
Nil
EMA
No.43015/09/
11/4833.
Dated
05/10/2011
Product Reg
No.
EU/1/08/495/
001-016.
Dated
06/02/2009.
Indications.
Neutorpenia.
EU
approved
Biosimilar
product,
FDA
approved.
Approved.
14. Novartis
Pharma
(Pakistan)
Limited,
Karachi./
Sandoz
GmbH
Biochemies
tr. Kundl,
Austria.
BINOCRIT
10000 IU/1ML
SOL FOR
INJECTION PFS
EPOETIN ALFA
84UG.1ML
Date of
application
27.03.2012
Deposited fee
15000+
35000+
50000
Balance Fee
Nil
EMA CoPP
No.08/11/482
35.
Dated
05/10/2011.
Product Reg
No.
EU//1/07/410
/001-052.
Indications:
anti cancer
EU
approved,
me-2,
Kundal
Austria,
Biosimilar
product,
FDA
approved.
Approved
15. Novartis
Pharma
(Pakistan)
Limited,
Karachi./
Sandoz
GmbH
Biochemies
tr. Kundl,
Austria.
BINOCRIT
4000IU/0.4ML
SOL FOR
INJECTION PFS
EPOETIN ALFA
33.6UG/ML
27.03.2012
Deposited fee
15000+
35000+
50000
EMA CoPP
No.08/11/482
35.
Dated
05/10/2011.
Product Reg
No.
EU
approved,
me-2,
Kundal
Austria,
Biosimilar
product,
Approved
Minutes for 253rd
Registration Board Meeting 471
Balance Fee
Nil
EU//1/07/410
/001-052.
Indications:
anti cancer
FDA
approved.
16. Novartis
Pharma
(Pakistan)
Limited,
Karachi./
Sandoz
GmbH
Biochemies
tr. Kundl,
Austria.
BINOCRIT
40000 IU/1ML
SOL FOR INJ IN
PFS
EPOETIN336UG
/1ML
27.03.2012
Deposited fee
15000+
35000+
50000
Balance Fee
Nil
EMA CoPP
No.08/11/482
35.
Dated
05/10/2011.
Product Reg
No.
EU//1/07/410
/001-052.
Indications:
anti cancer
EU
approved,
me-2,
Kundal
Austria,
Biosimilar
product,
FDA
approved.
Approved
17. Novartis
Pharma
(Pakistan)
Limited,
Karachi./
Sandoz
GmbH
Biochemies
tr. Kundl,
Austria.
BINOCRIT
1000IU/0.5ML
PFS
EPOETIN ALFA
27.03.2012
Deposited fee
15000+
35000+
50000
Balance Fee
Nil
EMA CoPP
No.08/11/482
35.
Dated
05/10/2011.
Product Reg
No.
EU//1/07/410
/001-052.
Indications:
anti cancer
EU
approved,
me-2,
Kundal
Austria,
Biosimilar
product,
FDA
approved.
Approved
18. Novartis
Pharma
(Pakistan)
Limited,
Karachi./
Sandoz
GmbH
Biochemies
tr. Kundl,
Austria.
BINOCRIT
2000IU/1 ML
PFS
EPOETIN ALFA
27.03.2012
Deposited fee
15000+
35000+
50000
Balance Fee
Nil
EMA CoPP
No.08/11/482
35.
Dated
05/10/2011.
Product Reg
No.
EU//1/07/410
/001-052.
Indications:
anti cancer
EU
approved,
me-2,
Kundal
Austria,
Biosimilar
product,
FDA
approved.
Approved
Minutes for 253rd
Registration Board Meeting 472
19. Merck
(Private)
Limited,
Quetta.
Merck
Serona S.A.
Succurale
D‟Aubonne
,
Switerzland
.
Luveris ® 75 IU
Powder for
injection
Each vial of
powder for
injection
contains:-
75 IU (3.0
Micrograms) of
Lutropin Alfa
(Recombinant
Human
Iuteinising
Hormone) (r-
hLH)
(Gonadotropins)
24.04.2012
Deposited fee
15000.
Balance Fee
85000
EMA CoPP
No.
06/11/48772.
Dated
09/12/2011.
Prod Reg No.
EU/1/00/155/
001-006.
Dated
29/11/2000.
Indications.
Hormone
replacement
therapy.
New
Molecule Deferred for
confirmation of
balance fee and
expert opinion
of Gynecologist
Dr. Ghazala,
PIMS,
Islamabad and
Dr. Seyada
Batool Mazhar,
PIMS,
Islamabad
20. Sanofi-
aventis
Pakistan
Limited,
Karachi.
Manufactur
ed by
Sanofi -
Anantus
Germany
Licence
holder
Sanofi -
Avantes
USA
Exporting
Countary
(Germany)
ZALTRAP
AFLIBERCEPT
25MG/ML +
CONCENTRATE
SOLUTION FOR
INFUSION
200/8.0ML
(NOMINAL
CONCENT)
29.03.2013
Deposited fee
100000
Balance Fee
Nil
EMA CoPP
No.02/14/744
33. Dated10/
01/2013
Prod Reg
No.
EU/1/12/814/
003,
Dated.13/03/
2014.
Indications
Anticancer.
US FDA
approved
EMA
approved.
Me too
confirmed
Approved
21. Sanofi-
aventis
Pakistan
Limited,
Karachi.
Manufactur
ed by
Sanofi -
Anantus
Germany
Licence
holder
Sanofi -
Avantes
USA
Exporting
Countary
(Germany)
ZALTRAP
25MG/ML
AFLIBERCEPT
25MG/ML
CONCENTRATE
SOLUTION FOR
INFUSION
100/4.0ML
(NOMINAL
CONCENT)
29.03.2013
Deposited fee
100000
Balance Fee
Nil
EMA CoPP
No.02/14/744
32.
Dated
13/03/2014
Prod Reg
No.
EU/1/12/814/
003,
Dated.01/02/
2013.
Indications
Anticancer
US FDA
approved
EMA
approved.
Me too
confirmed
Approved
Minutes for 253rd
Registration Board Meeting 473
22. PFIZER
Pakistan
Limited,
Karachi./
Pfizer
Canada Inc.
Saint-
Laurent,
Quebec,
Canada.
Premarin Vaginal
Cream Each gram
of the cream
contains:-
Conjugated
Estrogens………
0.625mg
(Repelacement
hormone,
Antineoplastic,
Antiosteoporotic).
07.06.2013
Deposited fee
100000
Balance Fee
Nil
Health
Canada
Prod Lisc.
No.
02043440.
Dated
31/12/1994.
FDA ref No.
FEI30028064
39.
Indications.
Replacement
hormone,
Me too Deferred
Referred for
expert opinion
of Gynecologist
Dr. Ghazala,
PIMS,
Islamabad and
Dr. Syada
Batool Mazhar,
PIMS,
Islamabad
23. Hakimsons
(Impex)
Pvt.
Limited,
Karachi.
CSL
Behring
AG
Wankdorfst
rasse ,Berns
Switzerland
.
Albu Rx 100 ML
HUMAN
ALBUMIN 20 %
12.08.2013
Deposited fee
50000+
50000
Balance Fee
Deposited on
01/09/2015.
Balance Fee
Nil
CoPP No.
DML No.
Free Sale
Certificate
Indications
New
Molecule,
Approved
in USA
Germany,
Switzerlan
d And EU,
New
Molecule
confirmatio
n
Approved
24. Hakimsons
(Impex)
Pvt.
Limited,
Karachi.
P.T Bio
farma
(Persero)
Jalan
Pasteur,Ban
dung
Indonesia.
BIVALENT
ORAL
POLIOMYELITI
S VACCIN
1VIAL
BIOVALENT
ORAL
POLIOMYELITI
S VACCINE
TYPE 1&3
10.10.2013
Deposited fee
50000
Balance Fee
Nil
CoPP No
PN.01.05.31.
313.05.10.44
2. Dated
25/05/2010
validity10
yrs.
Indications.
Polio
Eradication.
New
Molecule,
WHO
Approved,
New
Molecule
confirmatio
n
Approved
25. Novo
Nordisk,
Karachi.
Novo
Nordisk
A/S
Denmark.
TRESIBA
FLEXTOUCH
200UNIT/ML
INSULIN 03 PF
SYRINGS
FLEXTOUCH
DEGLUDEC PFP
CONTAIN 1200
NMOL
17.12.2013
Deposited fee
50000
Balance Fee
Nil
GMP by
Danish
Health &
Med
Authority.
EMA CoPP
04/15/89702.
Dated
15/07/2015.
Prod reg No.
EU/1/ 12/
807/013.
Dated
21/01/2013
Indication
Diabetis.
NEW
MOLECU
LES, CoPP
EMA
Approved
Minutes for 253rd
Registration Board Meeting 474
26. Novo
Nordisk,
Karachi.
Novo
Nordisk
A/S
Denmark.
TRESIBA
PENFILL 100
UNIT/ML
INSULIN
DEGLUDEC
05 CARTRIDGE PENFILL FOR
INJ
600 NMOL
30.1.2014
Deposited fee
50000
Balance Fee
Nil
GMP by
Danish
Health &
Med
Authority.
EMA CoPP .
03/15/90807.
Dated
07/08/2015.
Prod reg No.
EU/1/ 12/
807/007.
Dated
21/01/2013
Indication
Diabetis.
NEW
MOLECU
LES, CoPP
EMA
Approved
27. Novo
Nordisk,
Karachi.
Novo
Nordisk
A/S
Denmark.
RYZODEG
FLEXTOUCH
SOLUTION FOR
INJECTION
INSULIN
DEGLUDEC/INS
ULIN ASPART
(420
DEGLUDEC +
180 ASPART)
05PF SYRINGES
(FLEXTOUCH)
100 UNIT/ML
17.12.2013
Deposited fee
50000
Balance Fee
Nil
GMP by
Danish
Health &
Med
Authority.
EMA CoPP
03/15/89703.
Dated15/07/2
015.
Prod reg No.
EU/1/12/806/
004. Dated
21/01/2013.
Indication.
Diabetes
NEW
MOLECU
LES,
CoPP
EMA
Approved
28. Hakimsons
(Impex)
Pvt.
Limited,
Karachi.
CSL
Behring
AG
Wankdorfst
rasse ,Berns
Switzerland
.
PRIVIGEN
2.5G/25ML
BOTTLE
HUMAN
NORMAL
IMMUNOGLOB
ULIN
02.01.2014
Deposited fee
50000
Balance Fee
Nil
Swiss Medic
CoPP
No.12005530
Dated
15/09/2011.
Prod Lisc
No.5831401.
Dated
19/03/2010.
No.
Indications.
Immunodefic
iency
syndrome.
Leukemia.
Congenital
AIDS.
New
Molecule,
Approved
in USA
Germany,
Switzerlan
d And EU
Deferred for
expert opinion
of Brig.
Mukaram
Bashir, AFIP,
Rawalpindi
and Brig. Dr.
Tahir Aziz,
AFIP,
Rawalpindi
Minutes for 253rd
Registration Board Meeting 475
29. Novo
Nordisk,
Karachi.
Novo
Nordisk
A/S
Denmark.
TRESIBA
FLEXTOUCH
100UNIT/ ML
SOL FOR INJ
05 PF
SYRINGES
FLEXTOUCH
PFP CONTAIN
600NMOL
17.12.2013
Deposited fee
50000
Balance Fee
Nil
CoPP No.
05/15/89701
Dated 15-07-
2015
Prod Reg No.
EU/1/12/807/
004
Dated 21-1-
2013
Indications
Dibeties
NEW
MOLECU
LES, CoPP
EMA
Approved
30. Novo
Nordisk,
Karachi.
Novo
Nordisk
A/S
Denmark.
RYZODEG
PENFILL
100UNIT ML
SOL FOR INJ
05
CARTRIDGE PENFILL
CONTAIN 600
UNITS NMOL
OF (420
DEGLUDEC
+180 ASPART
INSULIN)
30.01.2014
Deposited fee
50000
Balance Fee
Nil
CoPP No.
02/15/89704
Dated 15-7-
2015
Prod Reg No.
EU/1/12/806/
007 Dated
21-1-2013
Indications
Diabetes
NEW
MOLECU
LES, CoPP
EMA
Approved
31. Roche
Pakistan
Limited, 37-
C, Block 6,
PECHS,
Karachi/
F.
Hoffmann-
La Roche
Ltd, Basel,
Switzerland
Roche
Diagnostic,
Mannheim
Germany.
PERJETA
CONCENTRATE
FOR SOLUTION
FOR INFUSION.
Each vial
contains:-
420MG/14ML
PERTUZUMAB
25.02.2014
Deposited fee
100000
Balance Fee
Nil
EMA CoPP
No.13/13/654
22
Dated
24.5.2013
Prod Reg No.
EU/1/13/813/
001
Dated
04.3.2013
Indications
Anti Cancer
Monoclonal
Antibody
New
Molecule
FDA EMA
Approved
Deferred for
expert opinion
of Maj. Gen,
Naeem Naqvi,
CMH, Lahore,
Brig. Iftikhar
and Dr.
Saleema
Siddique, Shifa
Hospital ,
Islamabad
32. Sanofi-
aventis
Pakistan
Limited,
Karachi.
Sanofi
Pasteur,
SA, Lyon,
France.
INSUMAN comb
30 100 IU/ml
Suspension for
Injection.
5 cartridges of
3ml
01.04.2014
Deposited fee
100000
Balance Fee
Nil
EMA CoPP
No.02/13/663
76. Dated
18/06/2013.
Prod Reg No
EU/01/97/
030 / 174,
Dated
19/02/2009
Indications.
Diabetes.
EMA
Approved Approved
Minutes for 253rd
Registration Board Meeting 476
33. Sanofi-
aventis
Pakistan
Limited,
Karachi.
Sanofi
Pasteur,
SA, Lyon,
France.
INSUMAN
COMB 30
100IU/ML
SUSPENSION
FOR INJ 1VIAL
OF 5ML
01.04.2014
Deposited fee
100000
Balance Fee
Nil
EMA CoPP
No.03/13/663
75.
Dated
18/06/2013.
Prod Reg No
EU/01/97/
030 / 170.
Dated
03/07/2012
Indications.
Diabetes.
EMA
Approved Approved
34. Sanofi-
aventis
Pakistan
Limited,
Karachi.
Sanofi
Pasteur,
SA, Lyon,
France.
INSUMAN
COMB
30/100IU/ML
VIAL
SUSPENSION
FOR INJ 1VIAL
OF 10ML
01.04.2014
Deposited fee
100000
Balance Fee
Nil
EMA CoPP
No.
03/13/66375.
Dated.18/06/
2013
Prod reg No.
EU/1/97/030/
200. Dated
03/07/2012.
Indications
Diabetes
EMA
Approved Approved
35. Novartis
Pharma
(Pakistan)
Limited,
Karachi./
Vetter
Pharma
Fertigun
ng Gmbh &
Co. KG
Langenarg.
Germany.
Lucentis
Ranibizumab,
Pre Filled
Syringes
20.06.2014
Deposited fee
50000
Balance Fee
50000
EMA CoPP
09/14/75812
Dated
22.4.2014
Prod Reg No.
EU/01/06/37
4/003
Dated
24.10.2013
Indications
Anti Cancer
Monoclonal
Antibody
New
Molecule
Fee
confirmatio
n
Deferred for
expert opinion
of Maj. Gen,
Naeem Naqvi,
CMH, Lahore,
Brig. Iftikhar
and Dr.
Saleema
Siddique, Shifa
Hospital ,
Islamabad
36. Novartis
Pharma
(Pakistan)
Limited,
Karachi./
Vetter
Pharma
Fertigun
ng Gmbh &
Co. KG
Langenarg.
Germany.
XOLAIR 75MG
Prefilled Syringes
Omalizumab
09.02.2015
Deposited fee
50000
Balance Fee
CoPP No.
02/15/84060
Dated 16-1-
2015
Prod Reg No
EU/1/05/319/
EMA
CPP,GMP
CERTIFIC
ATE.
Deferred due to
paucity of time.
Minutes for 253rd
Registration Board Meeting 477
50000 005/010
Dated 10-2-
2009
Indications
Treatment of
Chornic
Spontaneous
Urticaria
(CSU)
37. Lilly
Pakistan,
Karachi.
Lilly
France
Basaglar 100
units/ml
Kwik Pen
Lilly France
09.02.2015
Deposited fee
100000
Balance Fee
Nil
CoPP No.
DML No.
Free Sale
Certificate
Indications
Bio
Similar,
EMA
Deferred due to
paucity of time.
38. Novartis
Pharma
(Pakistan)
Limited,
Karachi./
Novartis
Pharma
Switzerland
.
Cosentyx 150mg
Vial ,
Powder for
solution fro
injection
11.02.2015
Deposited fee
50000
Balance Fee
Nil
CoPP No.
01/15/84304
Dated 28-1-
2015
Prod Reg No.
EU/1/14/980/
001
Dated 15-1-
2015
Indications.
Treatment of
moderate-to-
severe plaque
psoriasis
EU,EMA
CPP,GMP
CERTIFIC
ATE.
New
Molecule.
Deferred due to
paucity of time.
39. Novartis
Pharma
(Pakistan)
Limited,
Karachi./
Novartis
Pharma
Switzerland
.
Cosentyx 150mg
Pre-filled syringe
11.02.2015
Deposited fee
50000
Balance Fee
Nil
CoPP No.
01/15/84317
Dated 28-1-
2015
Prod Reg No.
EU/1/14/980/
002-005
Dated 15-1-
2015
Indications.
Treatment of
moderate-to-
severe plaque
psoriasis
EU,EMA
CPP,GMP
CERTIFIC
ATE.
New
Molecule.
Deferred due to
paucity of time.
Minutes for 253rd
Registration Board Meeting 478
40. Lilly
Pakistan,
Karachi.
Lilly
France
Basaglar 100
units/ml
Cartridge
Lilly France
23.02.2015
Deposited fee
100000
Balance Fee
Nil
CoPP No.
DML No.
Free Sale
Certificate
Indications
Bio
Similar,
EMA
Deferred due to
paucity of time.
41. Lilly
Pakistan,
Karachi.
Lilly USA Trulicity
0.75mg/0.5ml
Single Dose Pen
Lilly USA.
05.03.2015
Deposited fee
50000
Balance Fee
Nil
CoPP No.
DML No.
Free Sale
Certificate
Indications
New
Molecule
FDA
Aproved
Deferred due to
paucity of time.
42. Lilly
Pakistan,
Karachi.
Lilly USA Trulicity
01.5mg/0.5ml
Single Dose Pen
Lilly USA.
05.03.2015
Deposited fee
50000
Balance Fee
Nil
CoPP No.
DML No.
Free Sale
Certificate
Indications
New
Molecule
FDA
Aproved
Deferred due to
paucity of time.
43. OBS
Pharma
(Pvt) Ltd.,
Karachi. /
Merck
Sharp &
Dohme
Corp, US,
Sumneytow
n Pike,
West Point,
PA
USA.
ROTATEQ Oral
Solution 2ml I
Rotavirus
Vaccine,Live,
Oral Pentavalant
1 Single Dose
Tube.
20.03.2015
Deposited fee
100000
Balance Fee
Nil
CoPP No.
DML No.
Free Sale
Certificate
Indications
Me too Deferred due to
paucity of time.
44. Sanofi-
aventis
Pakistan
Limited,
Karachi.
Genzyme
Ireland Ltd
IDA
Industrial
Park Old
Kilmeaden
Road
Waterford,
Ireland.
Imported
Countary
(United
Kingdom)
MYOZYME
(ALGLUCOSID
ASE ALFA)
Genzyme
Flanders bvba
Cipalstraat 8
9/6/2015
Deposited fee
100000
Balance Fee
Nil
CoPP No.
DML No.
Free Sale
Certificate
Indications
New
Molecule,
Compositio
n
Confirmati
on
Deferred due to
paucity of time.
Minutes for 253rd
Registration Board Meeting 479
45. Sanofi-
aventis
Pakistan
Limited,
Karachi.
SHAN - 5
Diptheria,
Tetanus, Bivalent
Pertussis,
Hepititus B and
Haemophilus
Influenzae Type b
Conjugate
Vaccine
(adsorbed)
03.06.2015
Deposited fee
100000
Balance Fee
Nil
CoPP No.
DML No.
Free Sale
Certificate
Indications
Re-
confirmatio
n from the
company
as similar
name
products
are already
approved.
Deferred due to
paucity of time.
46. Genesis
Pharmaceuti
cals (Pvt)
Ltd, Lahore
Cantt./
Stichting
Sanquin
Bloedvoorz
iening
Plesmanlaa
n,
Amsterdam
, The
Netherlands
. Marketing
Authorizati
on Holder:-
Oxbridge
Pharma
Ltd. United
Kingdom.
Aragam 50mg
Solution for
Infusion
Human Normal
Immunoglobulin
……..50mg/ml
Deposited fee
15000
Balance Fee
Check fee
CoPP No.
DML No.
Free Sale
Certificate
Indications
Documents
confirmatio
n
Deferred due to
paucity of time.
47. Amtul
Pharmaceuti
cals,
Lahore. /
.
CP
Pharmaceut
icals Ltd.
Wrexham
Industrial
Estate, Ash
Road
North,
Wrexham,
United
Kingdom
D-Clot Heparin
Sodium Injection
5000 IU/5ml Vial
Each 5ml
contains:-
Heparin
Sodium……….50
00 iu (Heparin
/Anticoagulant).
No Data
Date of
application
Deposited fee
Balance Fee
CoPP No.
DML No.
Free Sale
Certificate
Indications
Documents
confirmatio
n
Deferred due to
paucity of time.
Minutes for 253rd
Registration Board Meeting 480
48. Sanofi-
aventis
Pakistan
Limited,
Karachi.
Sanofi
Pasteur,
SA, Lyon,
France.
Vivaxim*-
Suspension and
Solution for
injection in a
Prefilled dual-
chamber syringe
Each dose of
reconstituted
vaccine (1ml)
contains:-
Vi capsular
polysaccharides
of Salmonella
typhi (Ty2
strain)…….25
micrograms)
Hepatitis A virus,
GBM strain*
(inactivated**)…
….160 units***
(Bacterial and
Viral Vaccine)
No Data
Date of
application
Deposited fee
Balance Fee
CoPP No.
DML No.
Free Sale
Certificate
Indications
Recommen
ded by
ECBD. RB
Deferred
for expert
opinion of
Gen ®
Karamat
Gen ®
Tasawarn
Birg ®
Najmi.
Prof Umar
Deferred due to
paucity of time.
49. Novity
Pharma
Distributors,
Lahore./
SuperGener
ics, Inc.
Phoenix,
AZ, USA.
C-Vaxin Injection
Each injection
contains:-
Hepatist C
Vaccine…….50m
cg (……………..)
No Data
Date of
application
Deposited fee
Balance Fee
CoPP No.
DML No.
Free Sale
Certificate
Indications
The board
deferred
these cases
and
advised to
get
clarificatio
n/
justificatio
n from the
applicant
about
sources of
API,
product,
details and
statements
on
company's
website.
Complete
confirmaio
n of
documents
needed.
Deferred due to
paucity of time.
Minutes for 253rd
Registration Board Meeting 481
50. RG
Pharmaceuti
ca (Pvt)
Ltd.,
Karachi-
75400.
Laboratorie
s EFFIK,
France.
Manufactur
ed by:
Capsugel
(Pfizer
Group)
Ploermel-
France.
Progeffik 100mg
Soft Gel Capsule
Each Soft Gel
Capsule
contains:-
Progesterone……
…..100mg
(Genito-Urinary
system and sexual
hormones).
Date of
application
Deposited fee
15000
Check
Balance Fee
CoPP No.
DML No.
Free Sale
Certificate
Indications
The firms
claims that
they have
already
registered
product. It
is proposed
to check
their
registration
process.
Deferred due to
paucity of time.
51. RG
Pharmaceuti
ca (Pvt)
Ltd.,
Karachi-
75400.
Laboratorie
s EFFIK,
France.
Manufactur
ed by:
Capsugel
(Pfizer
Group)
Ploermel-
France.
Progeffik 200mg
Soft Gel Capsule
Each Soft Gel
Capsule
contains:-
Progesterone……
…..200mg
(Genito-Urinary
system and sexual
hormones).
Date of
application
Deposited fee
15000
Check
Balance Fee
CoPP No.
DML No.
Free Sale
Certificate
Indications
The firms
claims that
they have
already
registered
product. It
is proposed
to check
their
registration
process.
Deferred due to
paucity of time.
52. RG
Pharmaceuti
ca (Pvt)
Ltd.,
Karachi-
75400.
Cerbios-
Pharma SA
Barbengo/L
ugano,
Switzerland
.
NewFlora
Capsule Each
capsule contains:-
75 million
Enterococcus
faecium …SF68,
per capsule
Excipients
Lactose, Excip.
Pro gelatin caps.
(ATC code:
A07FA01)
No Data
Date of
application
Deposited fee
Balance Fee
CoPP No.
DML No.
Free Sale
Certificate
Indications
The firms
claims that
they have
already
registered
product. It
is proposed
to check
their
registration
process.
Deferred due to
paucity of time.
53. FK Pharma
Lahore.
LFB
Biomedica
ments
Courtaboue
f Cedex,
France
Vialebex
Injection Each
vial contains:-
Serum Human
Albumin
20%................100
ml
(Biological Blood
Fractions).
No Data
Date of
application
Deposited fee
Check
Balance Fee
CoPP No.
DML No.
Free Sale
Certificate
Indications
General
Decision Deferred due to
paucity of time.
Minutes for 253rd
Registration Board Meeting 482
54. FK Pharma
Lahore.
Exporter
Avenir
Pharma and
Manufactur
ed :
Labtech
Pharma
S.A.
Geneva,
Switzerland
.
Immunoplex-N
Sublingual
Tablets
Each tablets
contains:-
Interferon alpha
2b…………….20
0 i.u (Anti-viral).
No Data
Date of
application
Deposited fee
Check
Balance Fee
CoPP No.
DML No.
Free Sale
Certificate
Indications
The board
after
discussion
decided to
refer back
to ECBD
for re-
evaluation
and
preparation
of detailed
report for
considerati
on of
Registratio
n Board.
Deferred due to
paucity of time.
55. Martin Dow
Pharmaceuti
cals
Limited,
Karachi.
Laboratorio
Italiano
Biochimico
Farmaceuti
co S.P.A
Italy
Calco 100IU
Ampoule Each
ampoule contains:
- Salmon
Calcitonin
…100IU
(Calcium
Regulatory)
No Data
Date of
application
Deposited fee
Check
Balance Fee
CoPP No.
DML No.
Free Sale
Certificate
Indications
04th ECBD
Deferred
for
confirmatio
n of
documents
Deferred due to
paucity of time.
56. Sanofi-
aventis
Pakistan
Limited,
Karachi.
Sanofi
Pasteur,
SA, Lyon,
France.
INSUMAN
COMB 30
100IU/ML SUSP
SUSPENSION
FOR INJECTION
Date of
application
Deposited fee
100000
Balance Fee
Nil
CoPP No.
DML No.
Free Sale
Certificate
Indications
Deferred due to
paucity of time.
57. Sanofi-
aventis
Pakistan
Limited,
Karachi.
Sanofi
Pasteur,
SA, Lyon,
France.
INSUMAN
COMB 25
100IU/ML
SUSPENSION
FOR INJECTION
Date of
application
Deposited fee
15000
Check
Balance Fee
CoPP No.
DML No.
Free Sale
Certificate
Indications
Deferred due to
paucity of time.
Minutes for 253rd
Registration Board Meeting 483
58. Sanofi-
aventis
Pakistan
Limited,
Karachi.
Sanofi
Pasteur,
SA, Lyon,
France
INSUMAN
BASAL
100IU/ML
SUSPENSION
FOR INJECTION
Date of
application
Deposited fee
15000
Check
Balance Fee
CoPP No.
DML No.
Free Sale
Certificate
Indications
Deferred due to
paucity of time.
59. GlaxoSmith
Kline
Pakistan
Limited,
Karachi.
GlaxoSmith
Kline
Biologicals,
S.A.
Belgium
NIMENRIX
VACCIN
MENINGOCOC
CAL
Date of
application
Deposited fee
50000
Check
Balance Fee
CoPP No.
DML No.
Free Sale
Certificate
Indications
Product
compositio
n
confirmatio
n
Deferred due to
paucity of time.
60. GlaxoSmith
Kline
Pakistan
Limited,
Karachi.
GlaxoSmith
Kline
Biologicals,
S.A.
Belgium.
POLIORIX
VACCINE
40D ANTIGEN
UNITS OF TYPE
1 (MAHONEY),
8D ANTIGEN
UNITS OF TYPE
2 (MEF-1) AND
32D (SAUKETT)
Date of
application
Deposited fee
15000
Check
Balance Fee
CoPP No.
DML No.
Free Sale
Certificate
Indications
Status
confirmatio
n from the
company
Deferred due to
paucity of time.
61. Roche
Pakistan
Limited, 37-
C, Block 6,
PECHS,
Karachi/
F. Hoffman
-La Roche
Ltd, Basel
Switzerland
Kadcyla Vial
Each vial
contains:-
Trastuzumab
Emtansine
(Powder)…...100
mg
20mg/ml after
reconstitution
Breast cancer
(Anti-cancer)
09.06.2015
Deposited fee
50000
Balance Fee
Nil
CoPP No.
DML No.
Free Sale
Certificate
Indications
EMA
APPROVE
D, New
Molecule,
Strength
reconfirmat
ion,,, two
products
Deferred due to
paucity of time.
62. Roche
Pakistan
Limited, 37-
C, Block 6,
PECHS,
Karachi/
F. Hoffman
-La Roche
Ltd, Basel
Switzerland
Kadcyla Vial
Each vial
contains:-
Trastuzumab
Emtansine
(Powder)…...100
mg
20mg/ml after
reconstitution
Breast cancer
(Anti-cancer)
09.06.2015
Deposited fee
50000
Balance Fee
Nil
CoPP No.
DML No.
Free Sale
Certificate
Indications
EMA
APPROVE
D, New
Molecule,
Strength
reconfirmat
ion,,, two
products
Deferred due to
paucity of time.
Minutes for 253rd
Registration Board Meeting 484
63. Ali Gohar
& Co,
Karachi
Patheon
UK Ltd,
Kingfisher
Drive
Covin
Gham
Swindon
Wiltshire
Uk
Jetrea solution for
Injection
Each vial
contains:-
Ocriplasmin….0.
5mg/ 0.2ml
For
Vitreomacular
traction
(rDNA )
Date of
application
10.06.2013
Deposited fee
50000
Balance Fee
Nil
CoPP No.
DML No.
Free Sale
Certificate
Indications
EMA
APPROVE
D, New
Molecule
Deferred due to
paucity of time.
64. Novartis
Pharma
(Pakistan)
Limited,
Karachi./
Novartis
Pharma
Switzerland
.
Cosentyx 150mg
Pre-filled Pen Date of
application 11.02.2015
Deposited fee
50000
Balance Fee
Nil
CoPP No.
01/15/84316
Dated 28-1-
2015
Prod Reg No.
EU/1/14/980/
002-005
Dated 15-1-
2015
Indications
Treatment of
moderate-to-
severe plaque
psoriasis
EU,EMA
CPP,GMP
CERTIFIC
ATE.
Ne
Molecule.
Deferred due to
paucity of time.
Minutes for 253rd
Registration Board Meeting 485
Case No. 06. Miscellaneous Cases
Case No. a Pending cases of 249th
meeting of Registration Board related to M/S.
Vetline International, Lahore.
The following applications of veterinary biological drugs were placed before the Board in
its 249th
, 250th
and 251st Meeting of the Registration Board.
S.No
.
Name of
applicant and
name of
exporter
Name of drug and its
composition
Date of
applicatio
n
Applicatio
n form
and Fee
Pack size Shelf life
1. Vet line
International
Lahore
License Holder
Laprovet
Hungary
Veterinay
Pharmaceutical
s Ltd.
Hungary,
Manufactured
by
Ceva-Phylaxia
Hungary with
manufacturing
contract with
Lapro vet
France.
ITA NEW (ND)
Each dose contains:-
Inactivated Newcastle
disease virus (NDV-
SZ) LaSota
strain………………
…..
Min 50PD50
24.06.2010 Form 5 A
Rs.
100,000
Mee too
status
confirmed
i. Reg
No.044901
GALLAMI
NE ND
Injection
by Marush
from
Marial
Italy
1000
doses vial
2 years
2. Vet line
International
Lahore
License Holder
Laprovet
Hungary
Veterinay
Pharmaceutical
s Ltd.
Hungary,
Manufactured
by
Ceva-Phylaxia
Hungary with
manufacturing
contract with
AVI POX
Live, freeze dried fowl
pox vaccine
Each dose contains:-
Fowl pox virus, cutter
strain min. 102‟7
EID50
(Live vaccine)
24.06.2010 Form 5 A
Rs.
100,000
Mee too
status
confirmed
i.
POXIMUN
E Injection
Reg No.
035031 by
Biomune
company
USA
1000
doses vial
30months
Minutes for 253rd
Registration Board Meeting 486
Laprovet
France.
marketed
Better
Traders
Faisalabad
3. Vet line
International
Lahore
License Holder
Laprovet
Hungary
Veterinay
Pharmaceutical
s Ltd.
Hungary,
Manufactured
by
Ceva-Phylaxia
Hungary with
manufacturing
contract with
Lapro vet
France.
AVI-
ND LASOTA + IB
Each dose contains:-
Newcastle disease
virus LaSota
strain…Min
105.5
EID50
Infectious bronchitis
virus B-48
strain…..Min
102.6
EID50
(Live vaccine)
ITEM NO.
VICASEOF M/s.
GRATON
PHARMA,
KARACHI FOR
THE
REGISTRATION
OF INTERFERON
ALFA 2B 3000IU
/VIAL (LIPHERON
FROM BEIJING
SHANGLU, CHINA)
The firm M/s.
Graton Pharma,
Karachi has informed
that they applied for
the registration of
Interferon Alfa 2b
300MIU injections
22.6. 2011 but their
application has not
been considered in any
meeting till date .The
firm has provided
evidence of
documents and fee
challans submitted by
them.
2. The case of the
24.06.2010 Form 5 A
Rs.
100,000
Mee too
status
confirmed
i. BIOVAC
ND IB
VACCINE
by Well
Pharma
Lahore
(NEUVA
VETERIN
ARY
BIOLOGI
CAL,
ITALY
Reg No.
018806.
ii. CEVA
NB Reg
No, 023401
by Marush.
iii.
EVIPRO
ND IB
SOHOL
Reg No.
011073 by
Lohman
Germany
(Golden
Harvest)
1000
doses vial
18months
Minutes for 253rd
Registration Board Meeting 487
The Registration Board in its 251st Meeting decided as under;
firm belongs to pre
devolution at the time
to Drugs Control
Organization, Ministry
of Health. The section
tried to retrieve the
application from old
record but still the
record is not found.
Copy of GMP shows
its validity till
14.03.2015. Copy of
CoPP has also been
provided by the
company.
Decision of the
Board: The
Board deferred the
case for completion
of documents by the
firm and to present
the case with all
available details in
the next meeting of
Registration Board.
4. Vet line
International
Lahore
License Holder
Laprovet
Hungary
Veterinay
Pharmaceutical
s Ltd.
Hungary,
Manufactured
by
Ceva-Phylaxia
Hungary with
manufacturing
contract with
Lapro vet
France.
AVI IBD PLUS
Each dose contains:-
IBD virus Winterfield
2512, G-61 strain,
min. 2.0 log 10 EID50
(Live vaccine)
29.06.2010 Form 5 A
Rs.
100,000
Mee too
status
confirmed
i.
CALAVA
C
GUMBOR
O PLUS
Reg
No.043517
from CA
Lab
Venzvella
by Khyber
Poultry
Faisalabad.
500,1000
and 2500
doses vial
24months
Minutes for 253rd
Registration Board Meeting 488
Decision 251st Meeting : The Board deferred the case and advised firm to provide evidence/free
sale certificate/CoPP clearly indicating all the manufacturing sites involved in the
manufacturing process, issued by the regulatory authority of Hungary, duly notarized/ legalized
by embassy of Pakistan in Hungary. Moreover, Dr. Amanullah Khan, Director DTL, Quetta
requested to share above registration applications with him before further processing of the
case.
The firm has submitted notarized, legalized and attested required documents by Pakistan
Embassy, Budapest Hungry. The letter is issued by Veterinary Drugs Controlling Authority
(National Food Chain Safety Office, Directorate of Veterinary Medicinal Products, Budapest
Hungary) certifying that Laprovet Hungary Veterinary Pharmaceuticals Ltd. 1107 Budapest,
Horog u. 32-34. Hungary (Wholly owned and subsidiary of Laprovet, France) is licensed to
manufacture veterinary biologicals. List of fully registered and freely sold vaccines are
exclusively contract manufactured in Hungary by CEVA-PHYLAXIA Hungary. List of vaccine
in the letter includes above mentioned four vaccines. The complete copy of set of dossiers is also
available for sharing with member registration board Dr. Amanullah Khan as per decision of the
Board please.
Decision: Registration Board deliberated and deferred the case for technical opinion of
Dr.Muhammad Arshad (Member, Registration Board- veterinary expert) as he was not
present in the meeting.
Case No. b. Registration of drugs of M/s. Excel Pharma-Inspection abroad already
conducted
M/s Excel Health Care, Karachi has applied for registration of their following products. The
company has deposited an amount of Rs 100,000/- against each product: -
S.#. Applicant
Product
Specifications
Exporting Company Inspection abroad
report
Team Members
Mr. Adnan Faisal
Saim (DDC)
Mr. Asif Jalil
(ADC)
1. Excel Health
Care
Laboratories
(Pvt) Ltd,
Karachi
MENSTROL
tablets (Levonorgestrel
0.5 mg
Estradiol 2mg)
Furen Pharmaceutical
Group Co., Ltd, China
Recommended by the
panel
2. Excel Health Care
Laboratories (Pvt) Ltd,
Furen Pharmaceutical
Group Co., Ltd, China
Recommended by the
panel
Minutes for 253rd
Registration Board Meeting 489
Karachi FEMININ tablets (Cyproterone
Acetate 2mg &
ethinyloestradiol
35mcg)
3. Excel Health Care
Laboratories (Pvt) Ltd,
Karachi
MENOCARE
tablets (Estradiol valerate
2mg and cyproterone
acetate 1mg)
Furen Pharmaceutical
Group Co., Ltd, China
Recommended by the
panel
4. Excel Health Care
Laboratories (Pvt) Ltd,
Karachi
ANDROL tablets (Cyproterone
Acetate 50mg)
Furen Pharmaceutical
Group Co., Ltd, China
Recommended by the
panel
5. Excel Health Care
Laboratories (Pvt) Ltd,
Karachi
GESTON INJ (Natural
Progesterone
50mg/ml)
Furen Pharmaceutical
Group Co., Ltd, China Injectable facility
was separate and
under construction.
Not recommended
by the panel.
6. Excel Health Care
Laboratories (Pvt) Ltd,
Karachi
GONACOR INJ
2000IU (Human Chorionic
Gonadotropin)
Yantai Beifang
Pharmaceutical Co.,
Ltd. China
Recommended by the
panel
7. Excel Health Care
Laboratories (Pvt) Ltd,
Karachi
GONACOR INJ (Human Chorionic
Gonadotropin
5000IU)
Yantai Beifang
Pharmaceutical Co.,
Ltd. China
Recommended by the
panel
8. Excel Health Care
Laboratories (Pvt) Ltd,
Karachi
HMG MASSONE (Human Menopausal
Gonadotropin 75IU)
Yantai Beifang
Pharmaceutical Co.,
Ltd. China
Recommended by
the panel. However
the panel has given
composition as FSH
75IU +LH 75IU
9. Excel Health Care
Laboratories (Pvt) Ltd,
Karachi
HMG MASSONE (Human Menopausal
Gonadotropin
150IU)
Yantai Beifang
Pharmaceutical Co.,
Ltd. China
Recommended by
the panel. However
the panel has given
composition as FSH
150IU +LH 150IU
10. Excel Health Care
Laboratories (Pvt) Ltd,
Karachi
MENORIN 0.3mg (Conjugated
Estrogen)
Xinjiang Nuziline Bio-
pharmaceutical Co.,
Ltd. China
Recommended by the
panel.
11. Excel Health Care
Laboratories (Pvt) Ltd,
Karachi
ENDRALIN (Alarelin 150ug-Gnrh)
Maa‟nshan Fengyuain
Pharmaceutical Co.,
Ltd Chian
Recommended by the
panel.
12. Excel Health Care
Laboratories (Pvt) Ltd,
Karachi
LUTRONE INJ
100UG (Gonadorelin 10‟s)
Maa‟nshan Fengyuain
Pharmaceutical Co.,
Ltd China.
Recommended by the
panel.
Minutes for 253rd
Registration Board Meeting 490
The policy of advance parallel inspection was discussed in 237th
Meeting of Registration Board;
however, the policy was revised in 238th
Meeting of Registration Board. Meanwhile, the inspection
abroad was conducted which is summarized above. Earlier the case was placed in 244th
Meeting of
Registration Board where in it was decided that the case is in complete and should be processed
through ECBD.
Registration Board in its 249th
Meeting directed the Biological Division to evaluate the submitted
dossiers of products including resemblance of brand names.
The evaluation is tabulated as below;
S. No. Product Specifications
Exporting Company Inspection abroad
report
Team Members
Mr. Adnan Faisal
Saim (DDC)
Mr. Asif Jalil
(ADC)
Evaluation by the
Directorate of
Biological Drugs
1. MENSTROL tablets (Levonorgestrel
0.5 mg
Estradiol 2mg)
Furen Pharmaceutical
Group Co., Ltd, China
Recommended by the
panel
The firm has
submitted
application on Form
5 A along with
required fee.
FSC, GMP and
CoPP provided,
however,
documents are out
dated due to non
decision from so
many years. The
firm has pledged to
provide valid
documents before
the issuance of
registration letter.
The product is also
combo packed with
plain Estradiol 2mg
tablets which is not
mentioned in CoPP
or FSC. Similar
product is already
registered in the
name of M/s.
Schering AG,
Karachi having
plain Estradiol 2mg
tablets.
Minutes for 253rd
Registration Board Meeting 491
2. FEMININ tablets (Cyproterone Acetate 2mg
& ethinyloestradiol
35mcg)
Furen Pharmaceutical
Group Co., Ltd, China
Recommended by the
panel
Mee too, similar
formulation of
Schering AG is
already registered
with Brand name
Diane-35
The firm has
submitted
application on Form
5 A along with
required fee.
FSC, GMP and
CoPP provided,
however,
documents are out
dated due to non
decision from so
many years. The
firm has pledged to
provide valid
documents before
the issuance of
registration letter.
3. MENOCARE tablets (Estradiol valerate 2mg and
cyproterone acetate 1mg)
Furen Pharmaceutical
Group Co., Ltd, China
Recommended by the
panel
Mee too, similar
product Climen is
already registered in
the name of M/s.
Schering AG,
Karachi having plain
Estradiol 2mg tablets.
The firm has
submitted
application on Form
5 A along with
required fee.
FSC, GMP and
CoPP provided,
however,
documents are out
dated due to non
decision from so
many years. The
firm has pledged to
provide valid
documents before
the issuance of
registration letter.
The product is also
combo packed with
plain Estradiol 2mg
tablets which is not
mentioned in CoPP
or FSC.
4. ANDROL tablets (Cyproterone Acetate 50mg)
Furen Pharmaceutical
Group Co., Ltd, China
Recommended by the
panel
Mee too, similar
product Androcur is
already registered in
the name of M/s.
The firm has
submitted
application on Form
5 A along with
required fee.
FSC, GMP and
CoPP provided,
however,
documents are out
Minutes for 253rd
Registration Board Meeting 492
Bayer, Karachi. dated due to non
decision from so
many years. The
firm has pledged to
provide valid
documents before
the issuance of
registration letter.
5. GESTON INJ (Natural Progesterone
50mg/ml)
Furen Pharmaceutical
Group Co., Ltd, China Injectable facility
was separate and
under construction.
Not recommended
by the panel.
Panel has not
recommended the
product. May be
rejected.
6. GONACOR INJ 2000IU (Human Chorionic
Gonadotropin)
Yantai Beifang
Pharmaceutical Co.,
Ltd. China
Recommended by the
panel
Mee too, similar
product IVF-C is
already registered in
the name of M/s.
Galaxy Karachi in
5000iu.
The firm has
proposed new brand
name as HCG-Excel
The firm has
submitted
application on Form
5 A along with
required fee.
FSC, GMP and
CoPP provided,
however,
documents are out
dated due to non
decision from so
many years. The
firm has pledged to
provide valid
documents before
the issuance of
registration letter.
7. GONACOR INJ (Human Chorionic
Gonadotropin 5000IU)
Yantai Beifang
Pharmaceutical Co.,
Ltd. China
Recommended by the
panel
Mee too, similar
product IVF-C is
already registered in
the name of M/s.
Galaxy Karachi in
5000iu.
The firm has
proposed new brand
name as HCG-Excel
The firm has
submitted
application on Form
5 A along with
required fee.
FSC, GMP and
CoPP provided,
however,
documents are out
dated due to non
decision from so
many years. The
firm has pledged to
provide valid
documents before
the issuance of
registration letter.
Minutes for 253rd
Registration Board Meeting 493
8. HMG MASSONE (Human Menopausal
Gonadotropin 75IU)
Yantai Beifang
Pharmaceutical Co.,
Ltd. China
Recommended by
the panel. However
the panel has given
composition as FSH
75IU +LH 75IU
Mee too, similar
product IVF-M is
already registered in
the name of M/s.
Galaxy Karachi in
75iu.
The product is
combination of75iu
of FSH and 75iu LH.
The firm has
proposed new brand
name Menopour
The firm has
submitted
application on Form
5 A along with
required fee.
FSC, GMP and
CoPP provided,
however,
documents are out
dated due to non
decision from so
many years. The
firm has pledged to
provide valid
documents before
the issuance of
registration letter.
9. HMG MASSONE (Human Menopausal
Gonadotropin 150IU)
Yantai Beifang
Pharmaceutical Co.,
Ltd. China
Recommended by
the panel. However
the panel has given
composition as FSH
150IU +LH 150IU
Mee too, similar
product IVF-M is
already registered in
the name of M/s.
Galaxy Karachi in
150 iu.
The product is
combination of 150iu
of FSH and 150iu
LH.
The firm has
proposed new brand
name as
Menopour
The firm has
submitted
application on Form
5 A along with
required fee.
FSC, GMP and
CoPP provided,
however,
documents are out
dated due to non
decision from so
many years. The
firm has pledged to
provide valid
documents before
the issuance of
registration letter.
10. MENORIN 0.3mg (Conjugated Estrogen
0.3mg tablet)
Xinjiang Nuziline Bio-
pharmaceutical Co.,
Ltd. China
Recommended by the
panel.
The firm has
submitted
application on Form
5 A along with
required fee.
FSC, GMP and
CoPP provided,
however,
documents are out
dated.
Similar product
Premarin is already
registered in the
name of M/s. Pfizer
Karachi.
Minutes for 253rd
Registration Board Meeting 494
Decision in 250th Meeting: Registration Board deferred request of the firm for clarifications
of CoPP for co-pack products, details of already registered drugs in the name of company and
review of new molecules applied by the company.
The firm has provided following documents for Menorin tablets 0.3mg, Menocare and
Menstrol Tablets and . The case details as under;
S.
No.
Name and
Composition of the
Drug
Name of
Manufacturer
Panel Inspection
Report
Earlier
Evaluation
Latest
Documents
submitted
by the firm
1. MENORIN
0.3mg (Conjugated Estrogen 0.3mg
tablet)
Xinjiang Nuziline
Bio-pharmaceutical
Co., Ltd. China
Recommended
by the panel.
The firm has
submitted
application on
Form 5 A along
The firm
has
submitted
fresh CoPP,
11. ENDRALIN (Alarelin 150ug-Gnrh)
Maa‟nshan Fengyuain
Pharmaceutical Co.,
Ltd Chian
Recommended by the
panel.
The firm has
submitted
application on Form
5 A along with
required fee.
FSC, GMP and
CoPP provided,
however,
documents are out
dated.
The product is new
molecule may be
treated as per
policy.
12. LUTRONE INJ 100UG (Gonadorelin 10‟s)
Maa‟nshan Fengyuain
Pharmaceutical Co.,
Ltd China.
Recommended by the
panel.
The firm has
submitted
application on Form
5 A along with
required fee.
FSC, GMP and
CoPP provided,
however,
documents are out
dated.
The product is new
molecule may be
treated as per
policy.
Minutes for 253rd
Registration Board Meeting 495
Form 5A
Fee Rs.100000/-
Demanded price
Rs. 600/ pack
Pack size 14‟s
Mee too status
Premarin 0.3mg
Registered of
M/s. Pfizer,
Karachi.
with required
fee.
FSC, GMP and
CoPP provided,
however,
documents are
out dated.
Similar product
Premarin is
already
registered in
the name of
M/s. Pfizer
Karachi.
GMP and
FSC.
2. MENOCARE
tablets (Estradiol valerate
2mg and
Cyproterone acetate
1mg)
Furen Pharmaceutical
Group Co., Ltd, China
Recommended
by the panel
The firm has
submitted
application on
Form 5 A along
with required
fee.
FSC, GMP and
CoPP provided,
however,
documents are
out dated.
The product is
also combo
packed with
plain Estradiol
2mg tablets
which is not
mentioned in
CoPP or FSC.
Similar product
Climen is
already
registered in
the name of
M/s. Schering
AG, Karachi
having plain
Estradiol 2mg
tablets.
The firm
has
submitted
fresh CoPP,
GMP and
FSC and co
pack
justification.
3. MENSTROL
tablets (Levonorgestrel
0.5 mg
Estradiol 2mg)
Furen Pharmaceutical
Group Co., Ltd, China
Recommended
by the panel
The firm has
submitted
application on
Form 5 A along
with required
fee.
FSC, GMP and
CoPP provided,
The firm
has
submitted
fresh CoPP,
GMP and
Minutes for 253rd
Registration Board Meeting 496
however,
documents are
out dated.
The product is
also combo
packed with
plain Estradiol
2mg tablets
which is not
mentioned in
CoPP or FSC.
Similar product
is already
registered in
the name of
M/s. Schering
AG, Karachi
having plain
Estradiol 2mg
tablets.
FSC and co
pack
justification.
Case of above mentioned three (3) products is placed before the Board for a decision.
Decision: Registration Board deferred due to paucity of time.
Case No. c Local manufacturing of biological drugs of M/s. Macter Internatioanl
Karachi
Sr.
no.
Documents/ data as per
requirement of DRB 246
Documents / data submitted
by Macter
Remarks
1. Legalized GMP certificate of
biological drug as evidence that
manufacturer is an authorized
manufacturer of that particular
biological drug in its country of origin
Legalized GMP certificate no.
CN20110019 issued by State
Food and Drug administration
issued on 09/10/2011 and valid
up to 08/10/ 2016.
Legalized COPP no. 15009 for
finished drug 25 mg issued by
Shanghai Municipal Food and
Drug Administration. Issued on
29/01/2015 and valid up to
29/01/2017.
Original duly
Notarized and
Legalized
GMP
certificate no.
CN 20110019
ISSUED BY
State Food and
Drug
administration
indicating
etanercep
(Recombinant
Human Tumor
Necrosis
Factor-a
Receptor II-
Minutes for 253rd
Registration Board Meeting 497
IgG FC fusion
protein) issued
on 09/10/2011
and valid up to
08/10/2016.
Original duly
notarized and
legalized
COPP no.
15009 for
finished drug
25 etanercept
(Recombinant
Human Tumor
Necrosis
Facter-a
Receptor II-
IgG
2. Structural similarity of subject
biological drug product (ready to fill
bulk) with reference biological
product (innovator).
Structural similarity:
Primary structure/Identity.
Comparison of cDNA of
Momentum with Enbrel,
Comparison of amino acid
sequence by LCMS, N-
Terminal sequencing by Edman
degradation, C terminal
sequencing by LC-MS/MS,
UPLC peptide mapping.
Secondary structure by Circular
Dichorism, UV/visible
spectrophotometry. N-
Glycosylation analysis.
Identity by ELISA, Peptide
mapping.
Purity:
Purity comparison with
reference drug by
SEC- HPLC
SDS PAGE (Purity)
IEX analysis for charged
moieties
IEF analysis,
Western blotting
Safety testing of :
Host Cell DNA,
Host Cell protein,
Endotoxin levels.
Studies are
available in
provided DMF
by
manufacturer
Protein
sequence
compared with
WHO
sequence.
Minutes for 253rd
Registration Board Meeting 498
Biological activity:
Comparative biological activity
Momentum vs Enbrel by TNF
sensitive L929 cell cytotoxicity
neutralization assay.
3. Biocomparability studies including
identity testing to parent molecule,
purity testing, in vitro biological
activity / potency testing and toxicity
with support of IEF data, gel
electrophoresis, western blot and other
analytical methods and stability
studies of finished drug.
Comparative analysis of locally
produced drug product with
Reference medicinal product
(Enbrel- Wyeth).
Identity: Isoelectric focusing,
Purity: SDS PAGE
Potency: ELISA
General safety tests
Bacterial Endotoxin test,
Sterility test and abnormal
toxicity test.
Real time stability and
accelerated stability studies.
Stability
studies reports
of local
batches
provided.
4. Others Animal toxicity studies done
by CP Goijian, China:
Study 301-07
Acute (single dose) Toxicity of
rhTNFR: Fc for injection in Mice.
Study 301-08 Repeat dose toxicity
study of rhTNFR-Fc fusion
protein administered
to Rhesus by subcutaneous
injection.
Genotoxicity.
Carcinogenicity (including
supportive toxicokinetics
evaluations).
Reproductive and Developmental
Toxicity.
Study 301-09 Local toxicity study
of rhTNFR:Fc in rabbits.
Study 301-10 Hemolytic study of
recombinant human TNFR-
antibody fusion
Protein.
Animal
Toxicity
studies are part
of DMF
provided.
Bioequivalence
studies,
efficacy
clinical trials
and post
marketing
surveillance
studies done
by Shanghai
CP Goujian are
provided.
Minutes for 253rd
Registration Board Meeting 499
Bioequivalence and efficacy
Clinical trials data is
submitted:
Reports of
Biopharmaceutical Studies. Reports of Studies Pertinent to
Pharmacokinetics using Human
Biomaterials.
Reports of Human
Pharmacokinetic (PK) Studies.
Reports of clinical trials for
Efficacy and Safety Studies.
Reports of Post-Marketing
Experience.
Case Report Forms and Individual
Patient Listings.
Animal
Toxicity
studies are part
of DMF
provided.
Bioequivalence
studies,
efficacy
clinical trials
and post
marketing
surveillance
studies done
by Shanghai
CP Goujian are
provided.
Decision: The case was deferred for the requirement of section, manufacturing/ testing facilities
required for the particular product of the firm.
The firm has section approval for the manufacturing of recombinant human DNA protein
drugs. Etanercept is a recombinant human DNA protein drug. The firm has provided details
of manufacturing process and related equipments of each manufacturing step and detail of
trained persons. List of testing method required for quality testing and related QC
equipments and trained persons. Copy of last inspection report is provided verifying all the
equipment mentioned above. Firm has provided import documents of the procured
reference standard (WHO & EP), and reagents required for quality control of the product.
Manufacturing schedule on campaign basis of register products is also provided. The
manufacturing schedule shows that facility is having vacant capacity for 09 months
allowing ample time of clearance during product switch over facility also has disposable
flow path of drug which eliminates the risk of cross contamination facilities has validated
cleaning procedure.
Decision: Registration Board deferred the case due to paucity of time.
Minutes for 253rd
Registration Board Meeting 500
Case No. d Change in the concentration of Thiomersal from 0.01% to 0.005% for the
WHO PQ, registered products i.e. Tetanus Toxoid vaccine adsorbed – 0.5ml
Amp. (Reg. No. 059004), 5ml Vial (Reg. No. 053815) and 10ml Vial (Reg. No.
074631).
M/s. Hospital Services & Sales, Karachi has submitted an application on dated 13th
Aug‟ 2015
for the approval of “Change in the concentration of Thiomersal from 0.01% to 0.005% for a WHO PQ
following registered products” i.e.
1. Tetanus Toxoid Vaccine Adsorbed – 0.5ml Ampoule. (Reg. No. 059004),
1. Tetanus Toxoid Vaccine Adsorbed – 5ml Vial (Reg. No. 053815)
2. Tetanus Toxoid Vaccine Adsorbed – 10ml Vial (Reg. No. 074631)
The above products are manufactured by M/s. Serum Institute of India Ltd., India.
In letter, manufacturer has stated that “To support global drive of reducing exposure of Mercury,
they have reduced the concentration of Thiomersal in some of our vaccines including Tetanus
Toxoid Vaccine Adsorbed – 0.5ml Amp., 5ml Vial and 10ml Vial from existing 0.01% to
0.005%. The reduction of Thiomersal concentration does not have any impact on the product
efficacy and quality as they are using “Thiomersal” as a preservative to prevent microbial growth
in the final product.”
The above change in the registration has already been approved in the country of origin by the
concerned regulatory authority and reflecting at the WHO website also.
M/s. Hospital Services & Sales, Karachi has submitted the following documents along with the
request letter for approval:
1- DRAP fee as per relevant SRO.
2- Copy of registration letters and renewal status of the products.
3- Specification of existing and proposed concentration of Thiomersal.
4- Legalized Copy of approval for the proposed change in the concentration of Thiomersal
from the concerned regulatory authority in the country of origin (Pak Embassy attested).
5- Justification letter for the said changes / amendments on manufacturer‟s letter head duly
signed and stamped.
6- Legalized copy of CoPP reflecting the said changes (attested by Pak Embassy India).
7- Technical documents related to the said variation including stability data.
8- WHO approval in form of WHO website printouts for the said variation in the products.
Decision: Registration Board approved request of the firm for change Change in the
concentration of Thiomersal from 0.01% to 0.005% as per CoPP of the
country of origin and WHO Approval.
Minutes for 253rd
Registration Board Meeting 501
Case. No. e: shelf life extension Enbrel (Etaneracept) 50mg pre-Filled Syringe Injection
M/s Wyeth Pakistan Ltd has intimated that manufacturer abroad has extended
shelf life of their registered product from 24 month to 30 month based on the stability data on
long-term/recommended storage condition of 5oC +/- 3
oC and at the accelerated storage
condition of 25oC +/- 2
oC as detail below:-
Product Name Generic Dosage Form Strength Reg. No. Fee Deposit
Enbrel etanercept Injection 50mg 062228 Rs. 1000 &
4000/- on
12.3.2012 &
24.4.2013
2. Stability data presented supports 30 months expiry for Enbrel 50mg SFP Pre-Filled
Syringe at recommended storage of 2-8oC. Detailed Stability data have been is available for
perusal of the board.
Decision: Registration Board approved the extension of shelf life as per CoPP of the
country of origin.
Case. No. f. Change of Manufacturer Name
M/s ICI Pakistan has informed that the manufacture name the following registered
Animal Health Vaccines has been changed without change of manufacturing site and location.
Existing name of manufacturer:
Schering Plough Animal Health USA.
New name of manufacturer:
Intervet Inc., USA (doing business as Merck /MSD Animal Health)
S. No. REG NO. NAME OF PRODUCTS
1 039919 NEWCASTLE N-79
2 039920 NEWCASTLE N-63
3 039924 LT-IVAX
4 039925 ENTER5OVAX
5 039984 COCCIVAC-D
Minutes for 253rd
Registration Board Meeting 502
6 041296 COCCIVAC-B
7 057112 F VAX MG
8 028572 BURSA-VAC
9 028573 UNIVAX-BD
2. The firm has submitted following:
i. Fee of Rs 50,000/- per product.
ii. Copies of initial registration letters.
iii. Original legalized GMP/FSC of the products and statement letter
iv. Renewal status of products/copies of form 5B of the above 09 products
Decision: Regiatrtion Board approved request of firm for change in manufacturing site as per
above details.
Case. No. g. Case of M/s. Graton Pharma, Karachi for the registration of
Interferon Alfa 2b 3000iu /Vial (Lipheron From Beijing Shanglu, China)
The firm M/s. Graton Pharma, Karachi has informed that they applied for the registration
of Interferon Alfa 2b 300MIU injections 22.6. 2011 but their application has not been considered
in any meeting till date .The firm has provided evidence of documents and fee challans submitted
by them.
The case of the firm belongs to pre devolution at the time to Drugs Control Organization,
Ministry of Health. The section tried to retrieve the application from old record but still the
record is not found. Copy of GMP shows its validity till 14.03.2015. Copy of CoPP has also been
provided by the company. Registration Board in 252nd
meeting decided as follows:
“The Board deferred the case for completion of documents by the firm and to
present the case with all available details in the next meeting of Registration Board.”
M/s Graton Pharma, Karachi as has requested in the previous meeting for the import of
their interferon. The case was considered and deferred for provision of original documents. The
firm has submitted photocopies of their documents. In the instant shifting of record of biological
division and touring abroad of DDC (BIO) their file are not traceable instantly.
The firm has also submitted documents regarding registration of steroil water for
injection for their products. They have provided on form-5 CD version of registration dossiers,
Minutes for 253rd
Registration Board Meeting 503
certificate of pharmaceutical product (Photocopy). However the firm has not submitted
additional fee required for water for injection and that promised to submitted at the earliest
before issuance of any letter regarding inspection abroad are registration letter.
The Board may consider their case on merit, whereas biological division is retrieving
their documents and shall present before the Board as soon as they are available. Meanwhile the
process of foreign inspection as per import policy may be considered and the firm may be
directed to give undertaking on judicial stamp paper that outcome of the inspection what so ever
will not confer the right of consideration if the firm could not qualify for the GMP certification.
The firm shall be exempted from inspection, if their inspection has waiver as per import policy.
Decision: Registration Board deferred the case for completion of documents by the
firm and to present the case with all available details in the next meeting of Registration
Board.
Minutes for 253rd
Registration Board Meeting 504
B. Medical Devices.
Case No.07. Applications for Registration of Medical Devices for Import.
Registration Board considered the following applications of medical devices for
import and decided as mentioned against each. Approved applications have already been
recommended by Expert Committee on Medical Devices and are subject to inspection of
manufacturer abroad, verification of storage facilities etc as per policy:-
a) CATHETERS:
S.No Name of Importer and
Manufacture/Exporter.
Name of Medical
Device
Price & Pack
size
Shelf
life
Decision
1. M/s Johnson & Johnson Pakistan
(Pvt) Limited, Fl.19, Sub Plot
F-1, Kehkashan Scheme No.5,
Main Boat Basin, Clifton,
Karachi.
Legal Manufacturer: M/s Cordis Cashel, Cahir Road,
Cashel, Co. Tipperary, Ireland.
Physical Manufacturer: M/s Cordis de Mexico,
S.A. de C.V. Circuito Interior
Norte # 1820 Parque Industrial
Salvarcar Ciudad Juarez,
Chihuahua CP 32574 Mexico.
MaxiLD
PTA Dilatation
Catheter
(Product codes and
sizes as per Free
Sale Certificate)
Decontrolled
till policy
decision by the
Federal
Government
1‟s
18
month Approved.
2. M/s Johnson & Johnson Pakistan
(Pvt) Limited, Fl.19, Sub Plot
F-1, Kehkashan Scheme No.5,
Main Boat Basin, Clifton,
Karachi.
Legal Manufacturer: M/s Cordis Corporation, 14201
North West 60th Avenue, Miami
Lakes, Florida 33014, USA.
Assembler: M/s Cordis de Mexico,
S.A. de C.V. Circuito Interior
Norte # 1820 Parque Industrial
Salvarcar Ciudad Juarez,
Chihuahua CP 32574 Mexico.
Powerflex Pro
PTA Dilatation
Catheter
(Product codes and
sizes as per Free
Sale Certificate)
Decontrolled
till policy
decision by
Policy Board/
Federal
Government
1‟s
3 years Approved.
Minutes for 253rd
Registration Board Meeting 505
b) STENTS:
S.No Name of Importer and
Manufacture/Exporter.
Name of Medical
Device
Price &
Pack size
Shelf
life
Decision
1. M/s Johnson & Johnson Pakistan
(Pvt) Limited, Fl.19, Sub Plot
F-1, Kehkashan Scheme No.5,
Main Boat Basin, Clifton,
Karachi.
Legal Manufacturer: M/s Cordis Cashel Cahir Road
Cashel, Co. Tipperary, Ireland
Manufactured by: M/s Burpee Material Technology
LLC, 15 Christopher way,
Eatontown, New Jersey, 07724,
USA.
S.M.A.R.T Flex
Vascular Stent
System
(Sizes and product
codes as per Free
Sale Certificate)
Decontrolled
till policy
decision by
Policy Board/
Federal
Government
1‟s
2
years Approved.
2. M/s Intek Corporation,
# 30,1st Floor, Al-Amin Plaza,
The Mall, Rawalpindi.
Legal Manufacturer
M/s Terumo Europe N.V.,
Interleuvenlaan 40, 3001 Leuven,
Belgium.
Manufacturing Site Ashitaka Factory of Terumo
Corporation,
150, Maimaigi-cho, Fujinomiya
City, Shizuoka Prefecture 418-
0015, Japan.
Nobori Drug
Eluting Stent
System
(Biolimus A-9
Eluting Stent)
Expanded Stent
nominal Length
(mm): 8, 14, 18,
24, 28.
Expanded Stent
Nominal Inner Dia
(mm): 2.25, 2.50,
2.75, 3.0, 3.50, 4.0.
(Different product
codes as per FSC)
Decontrolled
till policy
decision by
Policy Board/
Federal
Government
1‟s
18
months Approved.
3. M/s Intek Corporation,
No.30, 1st Floor, Al-Amin Plaza,
The Mall, Rawalpindi/
Legal Manufacturer
M/s Terumo Europe N.V.,
Interleuvenlaan 40, 3001 Leuven,
Belgium.
Manufacturing Site Ashitaka Factory of Terumo
Corporation,
150, Maimaigi-cho, Fujinomiya
City, Shizuoka Prefecture 418-
0015, Japan.
Design Site Terumo Corporation, R&D
Ultimaster
Sirolimus Eluting
Coronary Stent
System
Non expanded
nominal Stent
Length (mm): 9,
12, 15,18, 24, 28,
33, 38.
Nominal expanded
Stent Inner Dia
(mm): 2.25, 2.50,
2.75, 3.0, 3.50, 4.0.
Decontrolled
till policy
decision by
Policy Board/
Federal
Government
1‟s
2 years Approved.
Minutes for 253rd
Registration Board Meeting 506
Centre, 1500, Inokuchi, Nakai-
Machi, Ashigarakami-gun,
kanagawa, Perfecture, Japan.
(Different product
codes as per FSC)
4. M/s Otsuka Pakistan Ltd,
30-B, S.H.C.H.S, Karachi/
Manufacturer: M/s Shanghai MicroPort
Medical (Group) Co. Ltd, 501
Newton Road, ZJ Hi-Tech Park,
Pudong New Area, Shanghai,
China.
Production and packaging site:
501 Newton Road, ZJ Hi-Tech
Park, Pudong New Area,
Shanghai, China.
Tube Extrusion Site: 1601-Zhangdong Rd, ZJ Hi-Tech
Park, Pudong New Area,
Shanghai, China.
Sterilization Site: Building #.4, 51 Hangfan Rd,
Hangtou Town, Pudong New
Area, Shanghai, China.
Firehawk
Rapamycin Target
Eluting Coronary
Stent System
Stent Length (mm):
13, 16, 18, 21, 23,
26, 29, 31, 33, 35,
38.
Stent Dia (mm):
2.25, 2.50, 2.75,
3.0, 3.5, 4.0.
Different product
codes as per Free
Sale Certificate.
Decontrolled
till policy
decision by
Policy Board/
Federal
Government
1‟s
12
months Approved.
5 M/s Cardiovascular Medical
System, 202, 2nd
Floor, Eden
Heights, Jail Road, Lahore.
Owner/Legal Manufacturer: M/s amg International GmbH
Lohnfeld 26, D-21423 Winsen-
Luhe, Germany.
Manufactured by:
M/s QualiMed Innovative
Medizinprodukte GmbH,
BoschstraBe 16, 21423, Winsen-
Luhe, Germany.
ITRIX Rapamycin
Eluting Coronary
Stent Implantation
System
Stent Length (mm):
10, 14, 18, 24, 28,
34, 38.
Balloon Dia (mm):
2.00, 2.25, 2.50,
2.75, 3.00, 3.25,
3.50, 4.00.
Different product
codes as per Free
Sale Certificate.
Decontrolled
till policy
decision by
Policy Board/
Federal
Government
1‟s
12
months Approved.
6 M/s Cardiovascular Medical
System, 202, 2nd
Floor, Eden
Heights, Jail Road, Lahore.
Owner/Legal Manufacturer: M/s amg International GmbH
Lohnfeld 26, D-21423 Winsen-
Luhe, Germany.
Manufactured by:
ARTHOS Pico
Stent
Implantation
System
Stent Length (mm):
8, 10, 12, 14, 16,
18, 19, 24, 28, 34,
38.
Balloon Dia (mm):
Decontrolled
till policy
decision by
Policy Board/
Federal
Government
1‟s
12
months Approved.
Minutes for 253rd
Registration Board Meeting 507
M/s QualiMed Innovative
Medizinprodukte GmbH,
BoschstraBe 16, 21423, Winsen-
Luhe, Germany.
2.00, 2. 25, 2.50,
2.75, 3.00, 3.25,
3.50, 4.00.
Different product
codes as per Free
Sale Certificate.
c) INFUSION SETS:
S.No Name of Importer and
Manufacture/Exporter.
Name of Medical
Device
Price & Pack
size
Shelf
life
Decision
1. M/s IBL HealthCare Limited,
9th Floor, N.I.C. Abbasi Shaheed,
Karachi./
Manufactured by: M/s Ultra for Medical Products
Co. (ULTRAMED), Industrial
Area, Arab El-Awamer, Abnoub,
Assiut-Egypt.
Kari Fusion I.V
Infusion Set.
Decontrolled
till policy
decision by the
Policy Board/
Federal Govt.
1‟s
5 Years Approved.
d) BLOOD TRANSFUSION SETS:
S.No Name of Importer and
Manufacture/Exporter.
Name of Medical
Device
Price & Pack
size
Shelf
life
Decision
1. M/s IBL HealthCare Limited,
9th Floor, N.I.C. Abbasi Shaheed,
Karachi./
Manufactured by: M/s Ultra for Medical Products
Co. (ULTRAMED), Industrial
Area, Arab El-Awamer,
Abnoub, Assiut-Egypt.
Kari Flex Blood
Administration Set
Decontrolled
till policy
decision by the
Policy
Board/Federal
Government
1‟s
5
years Approved.
e) SYRINGES:
S.No Name of Importer and
Manufacture/Exporter.
Name of Medical
Device
Price & Pack
size
Shelf
life
Decision
1. M/s Hashir Surgical Services
(Pvt) Ltd,
1st Floor, House No.16, Street 1,
Sector F-2, Phase-6, Hayatabad,
Peshawar
ABC Conventional
Syringe
Decontrolled
till policy
decision by the
Policy Board/
Federal
5 years Rejected due to
poor physical
parameters like the
piston of the
syringe is not
Minutes for 253rd
Registration Board Meeting 508
Manufactured By: M/s Revital Healthcare (EPZ)
Ltd, Plot No. MN/V/225 & 226,
Post Box -80713-80100,
Mombasa, Kenya.
Government
(1ml, 2ml, 3ml,
5ml, 10ml,
20ml)
operating smoothly
inside the barrel.
The marking on the
barrel of the
syringe is not
permanent and is
with delible ink.
2. M/s Universal Enterprises,
29-Block-3 Overseas Co-
operative Housing Society
Stadium Road, Karachi
Manufactured by:
Terumo Corporation,
44-1, 2-Chome, Hatagaya,
Shibuya-ku, Tokyo, Japan.
Manufacturing Site:
Kofu Factory of Temumo
Corporation, 1727-1, Tsuijiarai,
Showa-cho, Nakakoma-gun,
Yamanashi Perfecture, Japan.
Terumo Syringe Decontrolled
till policy
decision by the
Policy Board/
Federal
Government
(50 ml)
5 years Approved.
Case No.08. Withdrawal of Registration Applications of Medical Devices.
M/s. Trans Angio System, Karachi-75400 is withdrawing their registration applications of
following medical devices as mentioned against each. :-
S.No Name of Importer and
Manufacture/Exporter.
Name of Medical
Device (s)
Demanded
price & Pack
size
Shelf
life
Remarks
1. M/s. Trans Angio System,
Karachi-75400
Manufactured by
M/s. Translumina GmbH,
Neue Rottenburger
Hecingen, Germany.
Yukon Choice 4DES+
Coronary
Stent System
Decontrolled. 03
years
Firm has informed that
they are withdrawing
their application
submitted on 5th April,
2011 for the registration
of Yukon Choice +4 DES
Coronary Stent System.
The application is being
withdrawn due to
obsolete design and
technology which is
being replaced with the
newer one.
2. M/s. Trans Angio System,
Karachi-75400
Manufactured by
M/s. Translumina GmbH,
Neue Rottenburger
Hecingen, Germany.
Yukon Choice 4
Coronary Stent
System
Decontrolled. 03
years
Firm has informed that
they are withdrawing
their application
submitted on 5th April,
2011 for the registration
of Yukon Choice 4
Coronary Stent System.
Minutes for 253rd
Registration Board Meeting 509
The application is being
withdrawn due to
obsolete design and
technology which is
being replaced with the
newer one.
Decision: Registration Board considered the request of the firm for withdrawal of its
applications for registration of above mentioned medical devices and approved
the request.
Case No.09. Misclellaneous cases.
a) Change of Importer’s Address.
M/s Johnson & Johnson Pakistan (Pvt) Ltd, Karachi has informed that in continuation to
their ongoing Business Model change in Pakistan it is brought into your kind notice that M/s
Johnson & Johnson Pakistan (Pvt) Ltd, Karachi local office address have been changed.
Following is the change in office address:-
Previous Address New address
M/s Johnson & Johnson Pakistan (Pvt)
Ltd, Plot No.10 & 25, Sector 20 Korangi
Industrial Area, Karachi-74900.
M/s Johnson & Johnson Pakistan (Pvt)
Ltd, Fl-19, Sub-Plot F-1, Kehkashan
Scheme No.5 Main Boat Basin, Clifton,
Karachi-75600.
The firm has submitted the following documents:-
(i) Fee challan of Rs.5000/-.
(ii) Drug Sale License of new address.
Decision: Registration Board approved the new address of M/s Johnson & Johnson
Pakistan (Pvt) Ltd i.e. Fl-19, Sub-Plot F-1, Kehkashan Scheme No.5
Main Boat Basin, Clifton, Karachi-75600 subject to verification of local
storage facility.
b) Change of Extension names of already registered medical devices for import.
M/s Atco Pharma International (Private) Limited, Karachi have requested for approval of
change of extension names of their already registered medical devices for import:-
S.No. Reg. No. Existing/Approved brand
Names with extension
names
Requested Extension
Names.
Minutes for 253rd
Registration Board Meeting 510
1. 074718 Alvision TM
Cardiovascular
Angiographic Catheter.
Alvision TM
Interventional
Cardiology Diagnostic
Catheter.
2. 074719 Invader TM
CTO Coronary
Angioplasty Balloon
Catheter.
Invader TM
CTO Balloon
Dilatation Catheter.
3. 074720 Invader TM
PTCA Coronary
Angioplasty Balloon
Catheter.
Invader TM
PTCA Balloon
Dilatation Catheter.
4. 074721 Turquoise TM
PTCA
Coronary Angioplasty
Balloon Dilatation Catheter.
Turquoise TM
PTCA
Balloon Dilatation Catheter
5. 074722 Commander TM
Coronary
Stent Delivery System.
Commander TM
CoCr Bare
Metal Stent
6. 074723 Ephesos-II Coronary Stent
Delivery System.
Ephesos TM
II Bare Metal
Stent
7. 074725 Constant TM
Coronary Stent
Delivery System.
Constant TM
Bare Metal
Stent
The firm has stated that due to marketing strategy, their principal manufacturer M/s Alvi
Medica Tibbi Urunler San. Ve Dis. Tic, A.S. Istanbul, Turkey has changed extension names of
the above mentioned products. The principal manufacturer has clarified that product
specification, raw material, production process and brand names will remain unchanged.
Furthermore, M/s Alvi Medica has also informed that due to same marketing strategy, their all
cardiovascular products are manufactured with new design of product boxes and labels.
The firm has submitted the following supporting documents:-
(i) Fee Challan of Rs. 50,000/- for each product.
(ii) Form 5-A for each product.
(iii) Copies of Registration Certificates of medical devices.
(iv) Original Free Sale Certificate from Regulatory Body of country of origin with
new extension names (Embassy attested).
(v) CE certificate mentioning new extension names.
(vi) Copy of Design Examination certificate mentioning new extension names.
(vii) Justification letter issued by principal manufacturer for change of extension
names and new design of product boxes and labels.
(viii) Copy of Drug Sale License.
(ix) Copy of CRF clearance letter.
(x) Undertakings (i) that there is no other change in the product except extensions (ii)
that proposed label of products complies all provisions of Drugs (Labeling and
Packing) Rules, 1986 (iii) that proposed names do not resemble with already
Minutes for 253rd
Registration Board Meeting 511
registered brand. In case of resemblance/similarity of brand name and packaging
of applied product with any other registered brand, they would be liable to change
the brand name and packaging of their product (iv) that dosage, administration,
indication and direction for use etc on the label is in line with that of
registration/marketing authorization and (v) That we have never imported our
registered medical devices with new brand names.
(xi) Old and new Artwork and difference between them.
Decision: Registration Board discussed the case and approved the new design of product
boxes and labels and above mentioned new extension names of already
registered medical devices for import of M/s Atco Pharma International (Private)
Limited, Karachi. All other terms and conditions of registration shall remain the
same.
c) Inspection of Manufacturer Abroad M/s Sumbow Medical Instruments Co.
Ltd, China.
Registration Board in its 242nd
meeting held on 24th
& 25th
February, 2014 considered and
approved the following medical devices of M/s BNS Trading Est, Lahore subject to inspection of
manufacturer abroad, verification of storage facilities etc as per policy:-
S.# Name of Importer and
Manufacturer/Exporter
Name of Medical Device Pack size Shelf
Life
(i) M/s BNS Trading Est,
244-Allama Iqbal Road,
Mustafabad, Lahore.
Manufactured by M/s Sumbow Medical Instruments
Co. Ltd, 16F Chengtou Building,
No.68 Heji Street, Jiangdong
District, China.
Safe 1 Brand IV Cannula
(Pen Type)
(14G, 16G, 18G, 20G,
22G, 24G)
1‟s 3 years
(ii) -do- 3S Safe Infusion Set 1‟s 3 years
Dr. Sheikh Akhtar Hussain, Deputy Director General, DRAP, Lahore and Mr. Khalid
Mahmood, the then DDC (QC), DRAP, Islamabad were nominated for inspection of aforesaid
manufacturer. The panel conducted inspection on 25th
& 26th
May, 2015 and submitted the
report.
The applicant firm submitted the documents in registration application dossier including
Form 5-A, ISO 13485 certificate, EC certificate (Production Quality Assurance), Credential of
manufacturer abroad, Free Sale Certificate issued by SFDA, China and letter of authorization
claiming M/s Sumbow Medical Instruments Co., Ltd, 16F Chengtou Building, No.68 Heji
Minutes for 253rd
Registration Board Meeting 512
Street, Jiangdong District, China as the manufacturer of the applied products. The inspection
letter was also issued with aforesaid manufacturer‟s name and address but in the inspection
report manufacturer name was not clear and site address was also different. The name and
address of manufacturer in the inspection report was mentioned as M/s Sumbow Medical
Instruments Co. Ltd, Jiangsu Webest Medical Product Co. Ltd, No.5, Yingchun Road,
Industrial Park, Xuyi, Jiangsu, China. In the inspection report the address “16F Chengtou
Building, No.68 Heji Street, Jiangdong” is shown as postal address. Furthermore, all the
documents attached with the inspection report including copy of Free Sale Certificate, copies of
bill of lading, stability study data and other documents written in Chinese language have been
stamped by M/s Jiangsu Webest Medical Product Co. Ltd. The panel recommended the above
products for registration.
In this regard both panel members were requested to clarify regarding status of
manufacturer. Both the members of panel have submitted as under:-
Mr. Khalid Mahmood, FID-II, DRAP, Islamabad. “You have desired to clarify that in the inspection report manufacturers name is not
clear and site address is also different for M/s Sumbow Medical Instruments Co.,
Limited, China. I have already clarified that there are number of firms working in the
China in the name and style of Sumbow Medical Instruments, China and the one we
have visited for inspection was Sumbow Medical Instruments. It was further clarified
that the Division of Medical Devices and Medicated Cosmetics need to go by the book.
The firm which we have inspected submitted the report accordingly (The report is
submitted by Dr. Sheikh Akhter Hussain from Lahore). Further it is necessary to
clarify that the credentials already submitted by M/s Sumbow Medical Instruments
Company Limited, China through its importer M/s B.N.S Trading Est, Lahore needs to
be matched and if some anomalies are found then the case may be decided as per
prevailing law/SOPs etc. It is further clarified that the report is submitted in accordance
with the tour arranged by the importers of Pakistan from China and the panel is not
conversant with the geographical limits of provinces in China. The panel submitted the
reports in accordance with the facilities visited and provided with the names of their
sites/cities/provinces in China and no facts have been concealed in writing the reports
that is why you may be experiencing in variation of documents/information submitted
by M/s B.N.S. Trading Est, Lahore. It is therefore again requested that the report is
submitted in accordance with the Manufacturer got visited by the importer to us. The
copies of pictures of the plant addresses, disposable packs are attached for your further
necessary action as per law. Any further clarification may be solicited if desired so and
the firm M/s B.N.S.Trading Est, Lahore may also be intimated as may be the exporter
name is M/s Sumbow Medical Instruments Limited, China.”
Minutes for 253rd
Registration Board Meeting 513
Dr. Sheikh Akhter Hussain, DDG, DRAP, Lahore. “It is to inform you that name and address of the manufacturer has been misinterpreted
by considering two different names as one, as “M/s Sumbow Medical Instrument Co.,
Limited, Jiangsu Webest Medical Product Co., Ltd, No.5, Yingchum Road, Industrial
Park, Xuyi, Jiangsu, China”. The factual position with regard to name and addresses of
these two concerns is clarified that M/s Jingsu Webest Medical Product Co., Ltd., No.5,
Yingchum Road, Industrial Park, Xuyi, Jiangsu, China is the manufacturer and M/s
Sumbow Medical Instruments Co., Ltd., is a sister concern, hence referred to
documents, attached with the inspection report, have been stamped by the
manufacturer. A copy of the certificate, dated 11-03-2014, signed by the manufacturer
as well as sister concern thereof, which is self-explanatory with respect to status of both
the said concerns, is attached herewith for further clarification in this regard. It would
not be out of place to mention here that the inspection report submitted by the
nominated panel is based on facts observed by it during the inspection/visit.”
Furthermore, the certificate by the manufacturer and exporter attached with the
clarification, is reproduced as under:-
“It is certified that M/s Sumbow Medical Instruments Co., Add:16F, Chengtou
Building, No.68 Heji Street, Jiangdong District, Ningbo 315041 China is a sister
concern of M/s Jiangsu Webest Medical Products Co., Ltd, Yingchun Rd, Industrial
Park, Xuyi, Jiangsu, China. All the goods supplied, distributed and exported are
manufactured by M/s Jiangsu Webest Medical Products Co., Ltd, Yingchun Rd,
Industrial Park, Xuyi, Jiangsu, China. Registered office of M/s Sumbow Medical
Instruments Co is 16F, Chengtou Building No.68 Heji Street, Jiangdong District,
Ningbo 315041 China and manufacturing site with the name of M/s Jiangsu Webest
Medical Products Co., Ltd located at Yingchun Rd, Industrial Park, Xuyi, Jiangsu,
China. The products manufactured by M/s Jiangsu Webest Medical Products Co., Ltd,
located at Yingchun Rd, Industrial Park, Xuyi, Jiangsu, China are exported to Pakistan
through the sole rights of M/s Sumbow Medical Instruments Co., is 16F, Chengtou
Building No.68 Heji Street, Jiangdong District, Ningbo 315041 China.”
Decision: Deferred for discussion in the next meeting of Registration Board.
d) Grant of Additional Size of registered imported medical devices.
M/s Mana & Co, Karachi has requested to grant additional size of their following
registered imported medical devices as mentioned below:-
S.No Regn.
No
Name of Product Existing
Approved
Sizes
Demanded
Additional
Sizes.
Name of
Manufacturer
1. 074703 Medicare Sterile
Syringe for Single Use.
1ml
2ml
5ml
10ml
20ml
3ml Changzhou Jiafeng
Medical Equipment
Co. Ltd, Jiangsu
Province, China.
Minutes for 253rd
Registration Board Meeting 514
2. 074812 Medicare + Disposable
Syringe
1ml
2ml
5ml
10ml
20ml
3ml M/s Jiangyin Medical
Devices Co. Ltd,
Jiangsu, China
The firm has submitted following documents:-
(i) Fee challan of Rs.5000/- for each product.
(ii) Copies of registration letter of each product.
(iii) Copy of Drug Sale License.
(iv) Original Free Sale Certificates by SFDA China (Embassy attested) mentioning 3
ml size of syringes.
Decision: Registration Board approved additional size of 3ml Medicare Sterile Syringe
for Single Use (Reg. No. 074703) and additional size of 3ml Medicare + Disposable Syringe
(Reg. No. 074812). All other terms and conditions of registration shall remain the same.
Registration Board deferred remaining agenda due to paucity of time.
Meeting ended with a vote of thanks to and from the chair.
End of Document
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