Application Number

Date of submission of the

dossier

Name of the 1st

Evaluator Signature

Name of the 2nd

Evaluator Signature

Date of 1st evaluation

Date of 2nd Evaluation

Number of files

received

CONCLUSION OF THE ASSESSMENT

RECOMMENDED (no outstanding issues)

QUERY RAISED (Indicate the sections where query is

raised)

REJECTED (indicate the module(s) that led to the

rejection)

(Please delete which does not apply)

TYPE OF APPLICATION – HUMAN, BIOLOGICAL OR VETERINARY PRODUCT

(Please delete / change which does not apply)

MODULE 1: ADMINISTRATIVE INFORMATION

SECTION 1: PARTICULARS OF THE PRODUCT

1.1 Name and address of Applicant

(Company) Name: NEM LABORATORIES PVT. LTD:

Address: 133, Krishna Ind. Estate, Navghar Rd.,Vasai (E), Dist. Thane- 401210

Country : INDIA

Telephone: 0250-239002/3

Telefax: 0250-2392905

E-Mail: nemlabs@gmail.com

For PPB use only

1.2 Trade Name of the product (Proprietary Product Name): AZYCIN-500 Tablets

For PPB use only

1.3 International Non-proprietary Name (INN) of the Active Pharmaceutical Ingredient (API) : Azithromycin

dihydrate BP

For PPB use only

1.4 Strength of Active Pharmaceutical Ingredient (API) per unit dosage of the product:

Azithromycin dihydrate

Eq. to Azithromycin BP…500 mg

For PPB use only

1.5 Pharmaceutical Dosage form and route of administration of the product

1.5.1 Pharmaceutical Dosage form of the product: Tablet

1.5.2 Route(s) of administration (use current list of standard terms - European Pharmacopoeia): Solid Oral

Dosage form For PPB use only

1.6 Packing/pack size of the product: 1x3Tablets

For PPB use only

1.7 Visual description of the product: Orange colour, oval shape film coated tablets with both sides

plain.

For PPB use only

1.8 Proposed shelf life (in months): 36 months

1.8.1 Proposed shelf life (after reconstitution or dilution): Not Applicable

1.8.2 Proposed shelf life (after first opening container): Not Applicable

1.8.3 Proposed storage conditions: Store in a cool dry place away from the reach of children.

1.8.4 Proposed storage conditions after first opening: Not Applicable For PPB use only

1.9 Pharmacotherapeutic group and ATC Code

1.9.1 Pharmacotherapeutic group: Antibacterials for systemic use, macrolides

1.9.2 ATC Code: J01FA10 (Please use current ATC code)

1.9.3 If no ATC code has been assigned, please indicate if an application for ATC code has been made: For PPB use only

1.10 Legal category

1.10.1 Proposed dispensing category/classification: Product is subject to medical prescription or not subject to medical

prescription (Please delete which does not

apply)

1.10.2 For products subject to medical prescription: Controlled Drug Substance or Prescription Only Medicine, POM

(Please delete which does not apply)

1.10.3 For products not subject to medical prescription: The product will be dispensed from Non-pharmacy outlets and

pharmacies ( if applicable ) or Pharmacies only (Please delete which does not apply) For PPB use only

1.11 Country of origin or country of release: INDIA

For PPB use only

1.12 Product Marketing Authorisation in the country of origin and other countries. (Attach certificate of

pharmaceutical product from competent regulatory authority) If not registered, state reasons : Refer

Module 1, Section 1.12

Authorised

Country:INDIA

Date of authorisation (dd-mm-yyyy):

11thMay2000

Proprietary name: AZYCIN-500

Authorisation number:793

Refused

Country:

Date of refusal (dd-mm-yyyy):

Reason for Refusal:

Withdrawn (by applicant after authorisation)

Country:

Date of withdrawal (dd-mm-yyyy):

Proprietary name:

Reason for withdrawal:

Suspended/revoked (by competent authority)

Country:

date of suspension/revocation (dd-mm-yyyy):

Reason for suspension/revocation:

Proprietary name: For PPB use only

1.13 Pre-registration analysis of the product

(Attach certificate of analysis from a recognized WHO Prequalified Quality Control Laboratory in Kenya and

within the Region )

For PPB use only

1.14 Name(s) and complete address(es) of the manufacturer(s)

1.14.1 Name(s) and complete address(es) of the manufacturer(s) of the finished pharmaceutical product (FPP),

including the final product release if different from the manufacturer. (Add as many rows as necessary)

Name: Mr. Dhaval Talati

Company name : NEM LABORATORIES PVT. LTD:

Address: 133, Krishna Ind. Estate, Navghar Rd.,Vasai (E), Dist. Thane- 401210

Country :INDIA

Telephone: 0250-239002/3

Telefax: 0250-2392905

E-Mail: nemlabs@gmail.com

If the manufacturer is different to 1.1 above, explain the relationship: Not Applicable

1.14.2 Name(s) and complete address(es) of the manufacturer(s) of the active pharmaceutical ingredient(s) (API)

(Add as many rows as necessary)

Name: Azithromycin BP

Company name: MEHTA PHARMACEUTICAL INDUSTRIES

Address: Unit No. III, Kopri Village Naka, Veer Savarkar Marg, Chandansar, Virar (East),401 305 Dist. Thane,

(M.S.)

Country: INDIA.

Telephone: 2673 0751/ 6692 6545

Telefax: (022) 2673 3485

E-Mail:---- For PPB use only

1.15 Good Manufacturing Practice (GMP) status of the manufacturer (s) of the FPP :

Refer Module 1, Section 1.12

For PPB use only

1.16 Name and complete address of the Local Technical Representative of Manufacturer

Name :

Company Name: PHARMAX AFRICA LTD

Address: 1ST FLOOR, METRO TOWERS OGINGA ,ODINGA STREET, P.O. BOX: 5471-30100 ,ELDORET.

Country : KENYA

Telephone: 0532030142

Telefax: -----

E-Mail: sales@pharmaxafric.com /www.pharmaxafrica.com

If the Local Technical Representative is different to 1.1 above, explain and provide evidence for the relationship: For PPB use only

1.17 Summary Product Characteristics (SPC) : Refer Module 1, Section 1.17

For PPB use only

1.18 Batch number(s) of the FPPs used in (Add as many rows as necessary)

Clinical/bioequivalence studies Not Applicable

Stability studies AZI-1 AZI -2 AZI -3

Validation/production scale batches AOD-1 AOD-2 AOD-3

Comments [e.g., batch size, explanation of NA (not applicable) answers] ---

Composition of clinical, primary stability and validation/production FPP batches (kg)

Ingredients

Administration

Unit

Bioequivalence

˂batch number˃

Primary stability

batch number: AZI-1

Production

batch number: AOD-1

Mg %* Kg %* Kg %* kg %*

Core tablet / capsule contents / injections / suspensions, etc.

Active

Azithromycin Dihydrate B.P.

eq. to Azithromycin base B.P. 550.0 76.017 -- -- 68.75 76.017 68.75 76.017

Excipient

Maize Starch BP 56.781 7.847 -- -- 7.097 7.847 7.09 7.847

Lactose BP 30.00 4.146 -- -- 3.75 4.146 3.75 4.146

Microcrystalline Cellulose BP 10.00 1.382 -- -- 1.25 1.382 1.25 1.382

Polyvinyl pyrollidone K-30 BP 14.00 1.934 -- -- 1.75 1.934 1.75 1.934

Colloidal anhydrous silica BP 1.00 0.138 -- -- 0.125 0.138 0.125 0.138

Magnesium Stearate BP 8.00 1.105 -- -- 1.00 1.105 1.00 1.105

Cross povidone BP 20.00 2.764 -- -- 2.5 2.764 2.5 2.764

Talcum BP 10.0 1.382 1.25 1.382 1.25 1.382

Purified water BP 0.124

ml -- 15.5 lit. -- 15.5 lit. --

Subtotal 1 699.90 -- -- -- 87.49 -- 87.49 --

Film coat / capsule shell / printing ink

Proprietary Film-coating

mixture**

Titanium Dioxide BP 2.94 0.406 -- -- 0.3675 0.406 0.3675 0.406

Polyethylene glycol 400 USP 4.90 0.677 0.6125 0.677 0.6125 0.677

Isopropyl Alcohol BP 0.1178 0.016 -- -- 0.0147 0.016 0.0147 0.016

Hydroxypropyl methylcellulose

BP

12.376

1.710

1.547

1.710

1.547

1.710

Propylene Glycol BP 2.94 0.406 0.3675 0.406 0.3675 0.406

Colour Sunset yellow IHS 0.0495 0.006 -- -- 0.0061 0.006 0.0061 0.006

Methylene Chloride 0.2970 0.041 0.0371 0.041 0.0371 0.041

Subtotal 2 23.62 -- -- -- 2.95 -- 2.95 --

Grand total 723.52 --- -- -- 90.44 --- 90.44 ---

NOTE : Water and Solvents evaporate during process

Equivalence of the composition or justified

differences

Composition is same for Stability study, Process validation study

and Commercial batch .

* Each ingredient is expressed as a percentage of the grand total.

** All components of the proprietary mixture are described in the compendia

For PPB use only

OVERALL QUERIES AND RECOMMENDATIONS FOR THIS MODULE

MODULE 2: CHEMICAL, PHARMACEUTICAL, NON-CLINICAL AND

CLINICAL OVERVIEWS AND SUMMARIES -

2.1 OVERALL TABLE OF CONTENTS OF MODULES 2, 3, 4, AND 5

2.2 INTRODUCTION

2.2.1 Proprietary name:

AZYCIN-500

2.2.2 Non-Proprietary name or Common name of drug substance:

Azithromycin Tablets 500mg

2.2.3 Company Name:

M/s. NEM LABORATORIES PRIVATE LTD.

2.2.4 Dosage form (s) of the product

Tablet

2.2.5 Strength(s) of the product:

500 mg

2.2.6 Route of Administration:

Oral

2.2.7 Proposed Indication (s):

It is indicated Azithromycin is indicated for the following bacterial infections induced by

micro-organisms susceptible to azithromycin

- Acute bacterial sinusitis (adequately diagnosed)

- Acute bacterial otitis media (adequately diagnosed)

- Pharyngitis, tonsillitis

- Acute exacerbation of chronic bronchitis (adequately diagnosed)

- Mild to moderately severe community acquired pneumonia

- Infections of the skin and soft tissues of mild to moderate severity e.g. folliculitis, cellulitis,

erysipelas

- Uncomplicated Chlamydia trachomatis urethritis and cervicitis

2.3 OVERALL QUALITY SUMMARY For PPB use only

2.3.1 OVERVIEW OF ACTIVE PHARMACEUTICAL INGREDIENT(S) [API(S)]

2.3.1.1 General Information of the API(S)

2.2.1.1.1 Nomenclature : - (2R,3S,4R,5R,8R,10R,11R,12S,13S,14R)-13-[(2,6-Dideoxy-3-C-methyl-3-

O-methyl-a-L-ribohexopyranosyl)oxy]-2-ethyl-3,4,10-trihydroxy-3,5,6,8,10,12,14-eptamethyl-

11-[[3,4,6-trideoxy-3-(dimethylamino)-β-D-xylo-hexopyranosyl]oxy]-1- oxa-6-

azacyclopentadecan-15-one.

For PPB use only

2.2.1.1.2 Structure

For PPB use only

2.2.1.1.3 General Properties of the API(s)

Physio-Chemical Characterization:

Physical Form : White or almost white powder.

Solubility : Practically insoluble in water,

Freely soluble in anhydrous ethanol

and in Methylene chloride.

Specific Optical rotation : - 45 to – 49 For PPB use only

2.3.1.2 Manufacture of the API(S)

2.3.1.2.1 Name and address of API(s) Manufacturer

MEHTA PHARMACEUTICAL INDUSTRIES

Unit No. III, Kopri Village Naka, Veer Savarkar Marg, Chandansar, Virar (East),401 305 Dist. Thane,(M.S.)

For PPB use only

2.3.1.2.2 Description of Manufacturing Process and Process Controls - This information pertains to closed part DMF

only.

2.3.1.2.3 Control of Materials used in Manufacture of API - This information pertains to closed part DMF only.

2.3.1.2.4 Controls of Critical Steps and Intermediates- This information pertains to closed part DMF only.

2.2.1.2.5 Process Validation and/or Evaluation- This information pertains to closed part DMF only.

For PPB use only

2.3.1.3 Characterization of the API(S)

Azithromycin is reported in British Pharmacopoeia. Each batch is routinely identified.

The structure of Azithromycin was separately elucidated by Elemental analysis, UV

spectrum, IR spectrum, NMR spectrum and Mass spectrum studies, refer Section

3.2.S.3.1 of DMF

Azithromycin is powder in nature.

The impurity limits are based upon British Pharmacopoeia monograph. For details refer

the section 3.2.S.3.2 of DMF

2.3.1.4 Control of the API(S))

Azithromycin is official in British Pharmacopoeia. Specification of Azithromycin is as

per in British Pharmacopoeia. The methods followed are also exactly those of the British

Pharmacopoeia The limits specified for Residual solvent are those of the ICH guidelines.

For detail information refer DMF, Section 3.2.S.4

2.3.1.5 Reference Standards or Materials of the API(S)

For Reference standard details and COA refer DMF section 3.2.S.5

2.3.1.6 Container Closure System of the API(S)

The material is packed in food grade double polythene bags. (Inner white and outer

black) which is then packed in HDPE drums.

2.3.1.7 Stability of the API(S)

Stability study was initiated on marketable production batches samples.

The study was performed:

Long term study at 25°C ± 2°C and 60 % + 5 % RH.at an interval of initial, 3,

6 ,9,12,18,24,36 ,48 and 60month.

Accelerated Stability Study at 40°C + 2°C and 75 % + 5 % RH at an interval of initial, 1,

3 and 6 month.

Test carried out:

1. Description

2. Solubility

3. Identification

4. Appearance of solution

5. pH

6. Specific optical rotation

7. Related substances

8. Heavy Metals

9. Water

10. Sulphated ash

11. Assay

For detail information, refer DMF, section 3.2.S.7.3

For PPB use only

2.3.2 OVERVIEW OF FINISHED PHARMACEUTICAL PRODUCT(S) [FPP(S)]

Description and Composition of the FPP(S)

Orange colour, oval shape film coated tablets with both sides plain.

Composition:

Each film-coated tablet Contains:

Azithromycin Dihydrate

Eqv. to Azithromycin BP 500 mg

Approved Colour used.

Type of Container closure system:

1x 3 (3 tablets in one blister, such 1 blister is packed in one Carton)

Sr. No. Ingredients and specifications Qty./Tab in

mg

Function

1

Azithromycin Dihydrate B.P. eq. to

Azithromycin base B.P.

550.0 Active

2 Maize Starch BP 56.781 Binder

3 Lactose BP 30.00 Filler

4 Microcrystalline Cellulose BP 10.00 Diluent

5 Polyvinylpyrrolidone K 30 BP 14.00 Binder

6 Colloidal silicon dioxide BP 1.00 Glidant

7 Magnesium Stearate BP 8.00 Lubricant

8 Cross povidone BP 20.00 Disintegrant

9 Talcum BP 10.0 Glidant

10 Purified water BP 0.124 ml Vehicle

11 Titanium Dioxide BP 2.94 Pigment

12 Polyethylene glycol 400 USP 4.90 Plasticizer

13 Isopropyl Alcohol BP 0.1178 Solvent

14 Hydroxypropyl methylcellulose BP 12.376 Film former

15 Propylene Glycol BP 2.94 Solvent

16 Colour Sunset yellow IHS 0.0495 Colorant

17 Methylene Chloride 0.2970 Solvent

2.3.2.2 Pharmaceut1ical Development of the FPP(S)

To develop a robust, stable formulation of AZYCIN-500 which is pharmaceutical

equivalent and to optimize the manufacturing formula of AZYCIN-500.

The final formulation of the drug product is shown in Dossier, section 2.3 2.1.

The details of the study is provided in Dossier, section 3.2.2.2

2.3.2.3 Manufacture of the FPP(S)

Mfg’s Name : NEM LABORATORIES (P) LTD.

Address : 133, Krishna Indl. Estate,

Navghar, Vasai Road (E),

Thane - 401 210. Maharashtra

INDIA.

Phone : + 91 (250) 2390002/03/3386/2798

Fax : + 91 (250) 2392905, 2393046

2.3.2.4 Control of Excipients for the FPP(S)

All excipients were control based on Pharmacopoeial monograph.

Selection of excipients describes all the tests and acceptance criteria. For details, refer the

Dossier, section 3.2. 2.4.1

2.3.2.5 Control of the FPP(S)

AZYCIN-500 (Azithromycin Tablets 500) is In-House specific. Specification of all tests

done are set as per In-house specifications. For details, refer the Dossier, section 3.2.2.5

2.3.2.6 Reference Standards or Materials of the FPP(S)

For the analysis of AZYCIN-500 (Azithromycin Tablets 500) working standard is used. A

certificate of analysis is included, which is valid for one year. Every year new working

standard is prepared from a commercial batch sample and compared with the standard

material. For detail, refer the Dossier, section 3.2.2.5.

2.3.2.7 Container Closure System of the FPP(S)

PRIMARY PACKAGING MATERIAL: P.V.C. Film, Aluminum foil.

2.3.2.8 Stability of the FPP(S)

Batch selection:

The following batches were submitted to the stability study:

Batch no. Mfg. date Study

initiated on

Intervals tested and Stability study condition

AZI-1 Jul.2010 27/07/2010

Intervals Long term: Initial, 3, 6,9,12,18,24 and 36 and

36 month

Intervals Accelerated: Initial, 1, 2, 3 and 6

month

Long term: 300C+20C / 65%+5%

Accelerated: 400C+20C / 75%+5%

AZI-2 Sep.2010 29/09/2010

AZI-3 Oct.2010 01/10/2010

2.3.3 APPENDICES

2.3.3.1 Facilities and Equipment - NOT APPLICABLE

2.3.3.2 Adventitious Agents Safety Evaluation - NOT APPLICABLE

2.3.3.3 Novel Excipients -NOT APPLICABLE For PPB use only

2.4 SUMMARY OF NON-CLINICAL DOCUMENTATION AND CLINICAL

DOCUMENTATION

2.4.1 FOR NEW CHEMICAL ENTITIES

2.4.1.1 Non-clinical overview - NOT APPLICABLE

2.4.1.2 Non-clinical written and tabulated summaries- NOT APPLICABLE

2.4.1.3 Clinical overview- NOT APPLICABLE

2.4.1.3 Clinical summary- NOT APPLICABLE For PPB use only

2.4.2 GENERIC DRUG APPLICATIONS

2.4.2.1 Clinical Overview and Summary - NOT APPLICABLE

2.4.2.1.1 Product Development Rationale - NOT APPLICABLE

2.4.2.1.2 Overview of Biopharmaceutics Studies- NOT APPLICABLE

2.4.2.1.3 Summary of Biopharmaceutics Studies and Associated Analytical Methods - NOT APPLICABLE

2.4.2.1.4 Overview and Summary of In Vitro Dissolution Tests complementary to Bioequivalence Studies- NOT

APPLICABLE

2.4.2.1.4 Overview and Summary of In Vitro Dissolution Tests in support of a Biowaiver – Refer Dossier, Section

5.2.1.2

For PPB use only For PPB use only

OVERALL QUERIES AND RECOMMENDATIONS FOR THIS MODULE

MODULE 3: CHEMICAL-PHARMACEUTICAL DOCUMENTATION

3.1 TABLE OF CONTENTS OF MODULE 3

3.2 BODY OF DATA

3.2.1 PARTICULARS OF ACTIVE PHARMACEUTICAL INGREDIENT(s) [API(s)]

3.2.1.1 General Information of the API(S)

3.2.1.1.1 Nomenclature

Recommended International : Azithromycin

Non-proprietary Name

Chemical Name : (2R,3S,4R,5R,8R,10R,11R,12S,13S,14R)-13-[(2,6-

Dideoxy-3-C-methyl-3-O-methyl-a-L-

ribohexopyranosyl)oxy]-2-ethyl-

3,4,10-trihydroxy-3,5,6,8,10,12,14-heptamethyl-11-[[3,4,6-

trideoxy-3-(dimethylamino)-β-D-xylo

-hexopyranosyl]oxy]-1-oxa-6-azacyclopentadecan--

15-one.

Compendial names : Azithromycin

[CAS] Registry number : [83905-01-5].

3.2.1.1.2 Structure

Molecular formula : C38H72N2O12, H2O

Molecular Weight : 749

Structural formula

:

3.2.1.1.3 General Properties of API(s)

Physio-Chemical Characterization:

Physical Form : White or almost white powder.

Solubility : Practically insoluble in water,

Freely soluble in anhydrous ethanol

and in Methylene chloride.

Specific Optical rotation : - 45 to – 49

3.2.1.2 Manufacture of the API(S)

Name and Address of : MEHTA PHARMACEUTICAL INDUSTRIES

Manufacturing Facility Unit No. III, Kopri Village Naka,

Veer Savarkar Marg,

Chandansar,

Virar (East),401 305

Dist. Thane,(M.S.)

3.2.1.3 Characterization of the API(S)

Azithromycin is reported in British Pharmacopoeia. Each batch is routinely identified.

The structure of Azithromycin was separately elucidated by Elemental analysis, UV

spectrum, IR spectrum, NMR spectrum and Mass spectrum studies, refer Section 3.2.S.3.1 of DMF

Azithromycin is powder in nature.

The impurity limits are based upon British Pharmacopoeia monograph.

For details refer the Dossier, section 3.2.1.3

3.2.1.4 Control of the API(S))

Azithromycin is official in British Pharmacopoeia. Specification of Azithromycin is as per in

British Pharmacopoeia. The methods followed are also exactly those of the British Pharmacopoeia

The limits specified for Residual solvent are those of the ICH guidelines.

For detail information refer Dossier, Section 3.2.1.4

3.2.1.5 Reference Standards or Materials of the API(S)

For details refer the Dossier, section 3.2.1.5

3.2.1.6 Container Closure System of the API(S)

The primary packing components are food grade and nontoxic having prime virgin properties.

Following are the list of packaging material used for the packing of finished product.

1. Polythene bag (Low density) (Suitable to 25 Kg and 50 Kg pack)

2. HDPE drum (10mm x 10mm x 10mm)

3.2.1.7 Stability of the API(S)

I] Long Term Stability Study:(REALTIMESTABILITYSTUDY)

Long Term stability study was initiated on marketable production batches samples. The samples are

packed in double polythene bags and then preserved in HDPE drums in a manner that it simulates the

marketed packing at 25 ± 2°C and 60%+ 5 %RH).

From February 2010 storage condition is changed to (30 ± 2°C and 65%+ 5 %RH) as per WHO guideline

for climatic zone III rd and IV th. They are protected from light. The samples preserved as above are

analysed after every 3 months for the first year. The study is scheduled to be conducted every 6 months for

the second year. Thereafter, it shall be analysed annually for the third, fourth and fifth year. The analysis is

scheduled up to 60 months (i.e. up to expiry of drug substance).

II] Accelerated Stability Study (40 oC + 2 oC and 75%+ 5 %RH)

The above samples were also subjected to stability testing at accelerated conditions of 40 oC + 2 oC and

75%+ 5 %RH. This study was conducted on the samples preserved at the above conditions and were

analysed after every month for first 3months and then after 6months.

Test carried out:

1. Appearance

2. Solubility

3. Identification

4. Appearance of solution

5. pH

6. Specific optical rotation

7. Related substances

8. Heavy Metals

9. Water

10. Sulphated ash

11. Assay

Conclusion: From the data of accelerated stability study (6months) and those of long term stability

study of marketable production batches (up to 60 months) it can be concluded that the product is

quite stable up to 60months.

For Details, refer Dossier, section 3.2.1.7

3.2.2 PARTICULARS OF FINISHED PHARMACEUTICAL PRODUCT(S) [FPP(S)]

3.2.2.1 Description and Composition of the FPP(S) - Refer Dossier, section 3.2.2.1

3.2.2.2 Pharmaceutical Development of the FPP(S) - Refer Dossier, section 3.2.2.2

3.2.2.3 Manufacture of the FPP(S) - Refer Dossier, section 3.2.2.3

3.2.2.4 Control of Excipients for the FPP(S) - Refer Dossier, section 3.2.2.4

3.2.2.5 Control of the FPP(S) - Refer Dossier, section 3.2.2.5

3.2.2.6 Reference Standards or Materials of the FPP(S) - Refer Dossier, section 3.2.2.6

3.2.2.7 Container Closure System of the FPP(S) - Refer Dossier, section 3.2.2.7

3.2.2.8 Stability of the FPP(S) - Refer Dossier, section 3.2.2.8

3.2.3 APPENDICES

3.2.3.1 Facilities and Equipment - Not Applicable 3.2.3.2 Adventitious Agents Safety Evaluation- Not Applicable

3.2.33 Novel Excipients- Not Applicable

MODULE 4: NON-CLINICAL STUDY REPORTS FOR NEW CHEMICAL

ENTITIES ONLY

4.1 TABLE OF CONTENTS OF MODULE 4

4.2 STUDY REPORTS - Not Applicable

4.3 LITERATURE REFERENCES- Not Applicable as our product is not a new chemical entity.

MODULE 5: CLINICAL STUDY REPORTS

5.1 NEW CHEMICAL ENTITIES ONLY 5.1.1 Table of Contents of Module 5 - Not Applicable

5.1.2 Tabular Listing of All Clinical Studies - Not Applicable

5.1.3 Clinical Study Reports - Not Applicable

5.1.4 Literature References- Not Applicable

5.2 INTERCHANGEABILITY OF GENERIC DRUGS – (GENERIC DRUG

APPLICATIONS ONLY)

5.2.1 REPORTS OF BIOPHARMACEUTIC STUDY(IES) Not Applicable

5.2.1.1 Bioavailability (BA) study report Not Applicable

5.2.1.2 In Vitro Dissolution Tests - Refer Dossier, Section 5.2.1.2

5.2.2.1.1 In vitro dissolution tests complementary to bioequivalence studies Not Applicable

5.2.2.1.2 In vitro dissolution tests in support of biowaiver Not Applicable

5.2.3 Other Clinical study data done to support efficacy and safety of the product – Published literature enclosed in

Dossier

5.3 SAFETY AND RESIDUES DOCUMENTATION (FOR VETERINARY PRODUCTS

ONLY) – Not Applicable 5.3.1 Requirements for Animal Safety - Not Applicable

5.3.1.1 Laboratory Animal Studies- Not Applicable

5.3.1.2 Target Animal Safety Studies- Not Applicable

5.3.2 Requirements for Human Safety- Not Applicable

5.3.2.1 Laboratory Animal Toxicity Studies- Not Applicable

5.3.2.2 Microbiological Safety Studies (for antimicrobial products) - Not Applicable

5.3.2.3 Veterinary Antimicrobial Products - Not Applicable

5.3.2.4 Residue (Chemistry) Studies/data for food producing species only- Not Applicable

DECLARATION BY AN APPLICANT

1. I, the undersigned certify that all the information in this application form and accompanying

documentation is correct, complete and true to the best of my knowledge.

2. I further confirm that the information referred to in my application dossier is available for

verification during current GMP inspection.

3. I agree that the undersigned has not marketed or advertised this product in Kenya and will follow

the PPB requirements for advertisements of medicines.

4. I also agree that I am obliged to follow the requirements of the Pharmacy and Poisons Act, which

are related to pharmaceutical products.

5. I also consent to the processing of information provided by the Pharmacy and Poisons Board.

Name: Mr. DHAVAL A. TALATI

Position in the company: DIRECTOR

Signature:

Date:31/05/2017

Official stamp: