ratlam training report

IPCA, RATLAM

“F ORMULATION” JULY-2009

SUBMITTED TO

P.P. DUBEY(DGM-HR & ADMIN)

LAKSHMI NARAIN COLLEGE OF PHARMACYBHOPAL

Industrial training: IPCA, Ratlam- 1 -

SUBMITTED BY:

ARUN KUMAR TRIPATHISHISHIR KAWDE

INDEXIndustrial training: IPCA, Ratlam

- 2 -

This training project report has been completed and we would like to extend our heartfelt gratitude to all those associated with it. This report is an outcome of our hard and consistent efforts. However we shall fail in our duties if we fail to thank all those involved with this project. Therefore we take this opportunity to express our sincere gratitude to all those without whom this project would never have been accomplished.

Firstly we would like to thank Mr. P.P. Dubey, (DGM-HR &admin) for providing the platform to complete our training in IPCA, RATLAM.

I would also like to thank Mr. D.K. Singhai, Mr. Akhilesh Pandey, Mr.Rajeev Jain, Mr. Sunil Achaliya for guiding us through the whole course of training who has given us valuable support and knowledge in making our project better and also helping in every way and at every possible step of my work and providing his valuable suggestions.

I am also extremely thankful to the employee of the various department of the organization to help me to come out with flying colors in this report and help me bring out the best I could.

SNO CONTENT PAGE NO.

1. INTRODUCTION …4

2. HISTORY

3.

4.

5.

6.

7.

8.

9.

10.

11.

12.

13.

INTRODUCTION


Ipca is a fully integrated, rapidly growing Indian

pharmaceutical company with a strong thrust on

exports. Ipca's APIs and Formulations produced at

world class manufacturing facilities are approved by

leading drug regulatory authorities including the US-

Food and Drug Administration (FDA), UK-Medicines

and Healthcare products Regulatory Agency (MHRA),

South Africa-Medicines Control Council (MCC), Brazil-Brazilian National Health

Vigilance Agency (ANVISA) and Australia-Therapeutic Goods Administration (TGA).

With operations in over 100 countries, exports account for over 52% of the

company's income.

Forbes, a leading US business magazine, selected Ipca in 2003 among its top 200

successful, rising companies outside USA, with sales under USD 1 Billion. Over 19,000

companies were considered by Forbes, and of the 18 companies from India that figured in

this list, only four were from the 'Indian Pharmaceutical Sector'. Ipca happens to be one

of them. Subsequently, Ipca was selected by FORBES in this prestigious list for two

consecutive years; 2004 and 2005.

From a modest income of Rs. 0.54 crores in 1975-76, the net income has soared to Rs.

753.30 crores in 2005-06 with exports accounting for Rs. 401.83 crores. The net profit for

the year ending 31st March, 2006 stood at Rs. 63.98 crores. Formulations constitute 67

percent of the total income for 2005-06. Today, Ipca is one of the biggest manufacturers

in the world of APIs Atenolol (Antihypertensive), Chloroquine Phosphate (Antimalarial),

Furosemide (Diuretic) and Pyrantel Salts (Anthelmintic) right from the basic stage. Ipca

is also one of the largest suppliers of these APIs and their intermediates world over.


HISTORY

One of the first modern pharma factories of yesteryears was commissioned by Ipca at Mumbai in 1969.

The company was originally promoted by a group of medical professionals and businessmen and was incorporated as 'The Indian Pharmaceutical Combine Association Limited.' in October 1949.

The present management took over in November 1975 when the total turnover of the company was just Rs. 0.54 crores.

Currently, this premise where Ipca started its operations, houses the Registered Office of the company. Key departments like International Marketing, R&D (Formulations) and Analytical Development Lab are located here.

MILESTONES

2008

January - 'Ipca Who' Brochure wins ABCI Gold Award, (Association of Business Communicators of India) 48th annual Awards for Excellence in Creative Business Communications.

-Ipca's, Altus division launches Gardcef, a novel combination of Ceftazidime + Sulbactam.

February - Tonira Pharma's Nandesari unit (API plant at Baroda) receives US-FDA approval.

March - Ipca-Piparia, formulation manufacturing unit receives MHRA-UK approval. This is the 3rd plant after Athal and Kandla receiving this qualification.

April - WHO prequalify Ipca's dossier of ARTESUNATE + AMODIAQUINE Co Blister making Ipca the 2nd company in the world and the first Indian company to receive this prequalification.

-Ipca-Piparia formulation manufacturing unit receives US-FDA approval.


-Ipca-Ratlam (API Division) receive US-FDA re-approval.

May - WHO-Geneva re-approved Ratlam API manufacturing unit for the third time.

-Ipca Labs has been awarded third position in case-study presentation during the "10th National Suggestion Summit" organized by INSSAN-Northern Indian Chapter (NIC), New Delhi.

-Ipca-Ratlam got approval from Pharmaceutical and Medical Devices Agency (PMDA), Japan.

-Ipca completes management acquisition of Tonira Pharma Ltd. through public offer.

-Ipca-Ratlam, formulations manufacturing unit receive approval from Colombia Invima.

June - Ipca Labs became the first company to launch formulation brand HCQS (Hydroxy Chloroquine Sulphate) in Kenya after innovator brand.

-Ipca Labs bags Topmost Exporter Award. D&B - ECGC Indian Exporters Excellence Award - Topmost Exporter of Pharmaceutical Large Sector.

-Ipca Labs receive approval from US Food and Drugs Administration to manufacture Propranolol Hydrochloride Tablets.

July - Clinton Foundation announces New Agreements on Supply of anti-malarial Drugs, inter-alia, with Ipca.

August - Dr. Paul Bacon, Professor Emeritus, University of Birmingham, UK, a world renowned authority in Rheumatoid arthritis, addressed leading clinicians in six metro towns in the country.

November - 'Ipca Contact' wins Silver medal in ABCI's (Association of Business Communicators of India) 48th annual Awards for Excellence in Creative Business Communications.

-'Breakthrough in the treatment of Migraine', a public seminar sponsored by Ipca


Laboratories for Migrainers.

December - Ipca-Hycare division wins 'The Best Participation Award' at the conference of CSI (Cardiological Society of India) 2008.

-Tonira Pharma's API manufacturing plants situated at Ankleshwar and Nandesari receive PMDA-Japan approval.

2007

January - Ipca - Ranbaxy Alliance received U.S. FDA marketing approval for Atenolol Tablets

March - Ipca launched eighth domestic marketing division, 'Altus' which caters to intensivists and surgeons.

-Ipca's New Biotech Research & Development Unit was inaugurated at Mumbai.

June - Ipca - Ranbaxy Alliance received U.S. FDA marketing approval for Hydroxychloroquine Sulfate Tablets (HCQS).

July - Ipca - Ranbaxy Alliance received U.S. FDA marketing approval for Hydrochlorothiazide (HCTZ) Tablets.

August - Ipca - Ranbaxy Alliance received U.S. FDA marketing approval for Metformin HCl Tablets.

September - Acquisition of 100% shareholding of Formulation Dossier registration holding companies in Australia and New Zealand. The Australian company is currently holding 5 formulation registration dossiers in that country.

October - Ipca has been awarded by Forbes Inc., as one of the 'Best under a Billion' Forbes Global's 200 Best Small Companies, 2007. In the past, company has received same award for three consecutive years' 2003, 2004 and 2005.

December - Ipca - Ratlam received 2nd prize in the 'National Energy conservation award-2007' in Drug and Pharmaceuticals sector from the Bureau of Energy efficiency under the Ministry of Power, Government of India, New Delhi.

2006 Ipca launches Fixed dose ACT combination and stops manufacturing of single


ingredient Oral Artemisinin derivatives. Ipca enters into strategic alliance with Ranbaxy Pharmaceuticals Inc. for the U.S market.

Ipca's new plant at Dehradun commenced operation on 5th May, 2006.

2005

Merger of Innotech Pharma Limited with Ipca Laboratories Limited in August, 2005.

Ipca enters into Joint Venture with Holley Group of China for marketing Artemisinin based API and Formulation. Joint Venture setup in SAIF Zone, Sharjah, U.A.E. and named as ACTIVA Pharmaceuticals FZC.

Acquires Cardiac brand ISORDIL from Wyeth Limited.

Forbes Asia, a leading US business magazine selected Ipca, for the third consecutive year as one among the first 200 'Best under a Billion Company' in Asia.

2004

Commissioned new formulation plant at Silvassa.

Received 'Lifetime Achievement Award' for the year 2002-03 from CHEMEXIL (Basic Chemicals, Pharmaceuticals & Cosmetics Export Promotion Council) for export promotion over the years.

CDRI licenses novel Antimalarial compound to Ipca.

API manufacturing facility at Ratlam (M.P.) inspected by US-FDA and the facility was found to be in compliance with global GMP requirements. The plant and the facilities have been recommended for manufacturing Atenolol, Propranolol Hydrochloride, Hydroxychloroquine Sulphate and Chloroquine Phosphate.

Forbes Asia, a leading US business magazine selected Ipca<, for the second


consecutive year as one among the first 200 'Best under a Billion Company' in Asia.

2003

Launched new domestic marketing division, , dedicated to Rhematology Care. First Company in India to have such division for marketing superspeciality molecules.

Launched new domestic marketing division, , dedicated to Cardio-Diabetology segments.

Wholly owned subsidiary ‘Ipca Pharmaceuticals Inc.’ incorporated in United States of America.

Wholly owned subsidiary ‘Ipca Laboratories (UK) Ltd.’ incorporated in United Kingdom.

Forbes, a leading US business magazine, selected among its top 200 successful, rising companies outside USA, with sales under USD 1 Billion.

2002 Launched new domestic marketing division, , to promote established brands with a focus on micro-interior marketing.

Wholly owned subsidiary ‘Laboratories Ipca Do Brasil Ltd.’ incorporated in Brazil.

2001

Awarded 'Trishul' the highest award conferred by CHEMEXIL (Basic Chemicals, Pharmaceuticals & Cosmetics Export Promotion Council) for outstanding export performance.

Launched new domestic marketing division, , to promote speciality products in therapeutic segments of Psychiatry, Neurology and Dermatology.

Wholly owned subsidiary ‘Solway Investments Ltd.’ incorporated in Mauritius.

Wholly owned subsidiary ‘Sundridge Management Ltd.’ incorporated in Mauritius.


Stepdown subsidiary ‘National Druggists (Pty) Ltd.’ acquired in South Africa.

Stepdown subsidiary ‘Ipca Pharma Nigeria Ltd.’ incorporated in Nigeria.

2000 Received ISO 9001 certification for Athal Plant.

1999 First to introduce formulation of Hydroxychloroquine Sulphate under brand name 'HCQS' in India.

1997

Launched (Comprehensive Cardiac Care) Domestic Marketing Division, dedicated to promote cardiac care products.

Athal plant received prestigious approval from UK-Medicines and Healthcare products Regulatory Agency (MHRA) formerly known as UK- Medicines Control Agency (MCA).

Athal, Kandla and Ratlam plants received the prestigious approval from MCC (Medicines Control Council) South Africa.

1996 Commissioned new API R&D Centre at Mumbai.

1995 Commissioned modern formulations plant at Athal (Silvassa).

1994 Maiden Public Issue of shares. Acquired APIs Plant from BDH Pharmaceuticals (a subsidiary of E-Merck) at

Indore.

1993 Acquired Hoechst India's formulations unit at Kandla.

1986 Ipca's First APIs Plant for manufacturing of Chloroquine Phosphate, set up at Ratlam.


Production of Atenolol, for the first time in India commenced at Ratlam.

1985 Production of Pyrantel Pamoate API commenced for the first time in India. Commenced manufacturing of Injectables at the Ratlam formulations unit.

1984 First APIs plant commissioned at Ratlam. Ipca’s second formulations plant commissioned at Ratlam.

1982 The first company, after Eli Lilly, to develop a preconstituted formulation of Erythromycin Estolate (Eltocin® Liquid).

1981 R&D Active Pharmaceutical Ingredients and R&D Formulation development department set up to provide technology based products.

1980 Launched formulations of Bromhexine for the first time in India.

1978 Launched formulations of Metoclopramide under brand namd 'Perinorm®' for the first time in India.

Launched Ipca - Contact, Company's in-house Magazine.

1976 Started domestic marketing operations, the first company to offer sugarcoated Chloroquine tablets.


CHAIRMAN

Mr. R. S. Hugar

MANAGING DIRECTOR

Mr. Premchand Godha

EXECUTIVE DIRECTORS

Mr. A. K. Jain

Mr. Pranay Godha

DIRECTORS

Mr. M. R. Chandurkar

Mr. Babulal Jain

Dr. V. V. Subba Rao

Mr. V. A. Gore


http://www.ipcalabs.com/aboutus/bod.php

http://www.ipcalabs.com/aboutus/bod.php

PREM CHAND GODHA (63)

Chief Executive officer, Managing Director,Director and Member of Shareholders & Investors Grievance Committee, Ipca Laboratories Ltd.

This person is connected to 9 board members in 2 different organizations across 2 different industries.

BACKGROUND*

Premchand Godha has been Managing Director of Ipca Laboratories Ltd. since 1983 and serves as its Chief Executive Officer. Mr. Godha was in professional practice for five years before joining Ipca Laboratories Ltd. Under his leadership Ipca Laboratories Ltd. has made tremendous growth in all spheres of activities and has brought Ipca to the forefront of the Indian Pharmaceutical industry. Mr. Godha serves as a Director of Brescon Corporate Advisors Ltd and Kaygee Investments ...

BOARD OF DIRECTORS MEMBERSHIPS*1983-PresentChief Executive officer, Managing Director, Director and Member of Shareholders & Investors Grievance CommitteeIpca Laboratories Ltd.Director, Member of Audit Committee and Member of Remuneration CommitteeBrescon Corporate Advisors Ltd.

OTHER AFFILIATIONS*

Brescon Corporate Advisors Ltd.Kaygee Investments Pvt. Ltd.


http://investing.businessweek.com/research/stocks/snapshot/snapshot.asp?capId=38783596





AJITKUMAR BHANWARLAL JAIN B.SC., A.C.A. (54)

Chief Financial Officer, Head of Accounts, Head of Information Technology,Head of Costing & Taxation, Chemical R & D and Executive Director, Ipca Laboratories Ltd. 6

Total Annual Compensation: 2,280,000 INRThis person is connected to 6 board members in 1 different organizations across 1 different industries.

BACKGROUND*

Ajitkumar Bhanwarlal Jain B.Sc., A.C.A, serves as Chief Financial Officer of Ipca Laboratories Ltd. Mr. Jain serves as the Head of Accounts, IT, Costing & Taxation, Chemical R & D at Ipca Laboratories Ltd. Mr. Jain joined Ipca Laboratories Ltd. as Chief Accountant in 1980. He has been Executive Director of Ipca Laboratories Ltd., since August, 1994. Mr. Jain is a Science graduate and a Chartered Accountant.

BOARD OF DIRECTORS MEMBERSHIPS*

1994-PresentChief Financial Officer, Head of Accounts, Head of Information Technology, Head of Costing & Taxation, Chemical R & D and

Executive DirectorIpca Laboratories Ltd.

.

ANNUAL COMPENSATION*

Salary 2,280,000Total Annual Compensation 2,280,000

STOCK OPTIONS*

All Other Compensation 7,146,000

TOTAL COMPENSATION*

Total Annual Cash Compensation 2,280,000

Total Short Term Compensation 2,280,000

Other Long Term Compensation 7,146,000

Total Calculated Compensation 9,426,000




R. S. HUGAR (69)Chairman, Ipca Laboratories Ltd. 25

This person is connected to 25 board members in 3 different organizations across 3 different industries.

BACKGROUND*

R. S. Hugar served as Managing Director of Global Trust Bank Ltd. since April 12, 2001. Mr. Hugar served as Managing Director of Corporation Bank for 3 yrs. Mr. Hugar's illustrious career in Banking started at Bank of Maharashtra from January, 1967 where he worked for over 25 years in various capacities. He served as General Manager and Chief Vigilance Officer of Union Bank of India, Mumbai, a special assignment from Government of India for 3 ½ years, he made significant ...


2007-PresentIndependent Director and Chairman of Remuneration CommitteeVRL Logistics Ltd2002-PresentChairmanIpca Laboratories Ltd.2002-PresentDirector, Chairman of Audit Committee and Member of Remuneration & Compensation CommitteeDewan Housing Finance Corp. Ltd.2000-PresentFormer Chairman and Managing DirectorGlobal Trust Bank Ltd.Former Director and Member of Remuneration CommitteeZicom Electronic Security Systems Ltd.








EDUCATION

Master's Degree University of Pune

OTHER AFFILIATIONS

Global Trust Bank Ltd.University of PuneZicom Electronic Security Systems Ltd.Dewan Housing Finance Corp. Ltd.VRL Logistics Ltd







BABULAL JAIN (58)

Non-Executive Independent Director, Chairman of Audit Committee, Chairman of Shareholders / Investors Grievance Committee and Chairman of Remuneration & Compensation Committee, Ipca Laboratories Ltd.6This person is connected to 6 board members in 1 different organizations across 1 different industries.

BACKGROUND*

Babulal Jain has been Non-executive Independent Director of Ipca Laboratories Ltd. since 1988. Mr. Jain is a practicing Chartered Accountant by profession. He has professional experience of nearly 33 years years in the field of Audit, Finance, Company Law and Taxation. His professional knowledge and vast experience has been of immense benefit to Ipca Laboratories Ltd.


1988-PresentNon-Executive Independent Director, Chairman of

Audit Committee, Chairman of Shareholders / Investors Grievance Committee and Chairman of

Remuneration & Compensation CommitteeIpca Laboratories Ltd.

.

.

TOTAL COMPENSATION

Total Annual Cash Compensation 150,000

Total Calculated Compensation 150,000

VARANASI VENKATA SUBBA RAO (69)




Non-Executive Independent Director, Member of Remuneration & Compensation Committee and Member of Audit Committee, Ipca Laboratories Ltd. This person is connected to 6 board members in 1 different organizations across 1 different industries

BACKGROUND*

Varanasi Venkata Subba Rao served as Advisor to the Department of Science & Technology (DSIR), Government of India. Dr. Rao has rich experience of 35 years in the field of science and technology. He has been a Non-Executive Independent Director of Ipca Laboratories Ltd. since September 2000. Mr. Rao is a postgraduate in Chemistry from Andhra University and PhD in Chemistry from University of Pune and has also carried out post-doctoral research in Surface Chemistry in ...


2000-PresentNon-Executive Independent Director, Member of Remuneration & Compensation Committee and

Member of Audit CommitteeIpca Laboratories Ltd.

.

.

TOTAL COMPENSATION*

Total Annual Cash Compensation 130,000Total Calculated Compensation 130,000

EDUCATION*PhD

University of PuneMaster's Degree

Andhra University

OTHER AFFILIATIONS*

University of PuneAndhra University

M. R. CHANDURKAR (71)Non Executive Director and






Member of Shareholders / Investors Grievance Committee, Ipca Laboratories Ltd.This person is connected to 6 board members in 1 different organizations across 1 different industries.

BACKGROUND*

M. R. Chandurkar served as Managing Director of Ipca Laboratories Ltd. from 1983 to March 2008. Mr. Chandurkar served as Resident Manager of Navbharat, a Hindi Daily before he joined Ipca Laboratories Ltd. Under his leadership Ipca Laboratories Ltd. Mr. Chandurkar has been a Non Executive Director of Ipca Laboratories Ltd. since 1975. He has made tremendous growth in the International Marketing. Mr. Chandurkar is a Commerce graduate.


1983-PresentNon Executive Director and Member of

Shareholders / Investors Grievance Committee

Ipca Laboratories Ltd. .

ANNUAL COMPENSATION*

Salary 3,360,000Total Annual Compensation 3,360,000

STOCK OPTIONS*

All Other Compensation 9,656,000

TOTAL COMPENSATION*

Total Annual Cash Compensation 3,360,000Total Short Term Compensation 3,360,000Other Long Term Compensation 9,656,000Total Calculated Compensation 13,016,000

V. A. Gore 70




Independent Non-Executive Director, Chairman of Audit Committee and Chairman of Share Transfer & Shareholders Grievance Committee, Apar Industries Limited

18 This person is connected to 18 board members in 4 different organizations across 4 different industries

BACKGROUND*

V. A. Gore has been Non-executive Independent Director of Ipca Laboratories Ltd. since April, 2000. Mr. Gore has been a Director of Uniflex Cables Ltd. since August 30, 2008. He has been Independent Non-Executive Director of Apar Industries Limited since September 18, 2004. He serves as an Independent Non-Executive Director of Gujarat Borosil Ltd. He started his career as an Assistant Administrative Officer with Life Insurance Corporation of India, where he worked in ...


2008-PresentDirector, Chairman of Shareholders/Investors

Grievance Committee and Member of Audit Committee

Uniflex Cables Ltd.2000-Present

Non-Executive Independent Director, Member of Audit Committee and Member of Remuneration &

Compensation CommitteeIpca Laboratories Ltd.

1994-PresentIndependent Non-Executive Director, Chairman of Audit Committee and Chairman of Share Transfer

& Shareholders Grievance CommitteeApar Industries Limited

Independent Non-Executive Director, Chairman of Remuneration Committee and Member of Audit

CommitteeGujarat Borosil Ltd.

TOTAL COMPENSATION*

Total Annual Cash Compensation 182,500Total Calculated Compensation 182,500







EDUCATION*

Master's DegreeJamnalal Bajaj Institute of Management Studies

Other EducationUniversity of Mumbai

OTHER AFFILIATIONS*

Ipca Laboratories Ltd.Jamnalal Bajaj Institute of Management Studies

University of MumbaiGujarat Borosil Ltd.Uniflex Cables Ltd.







CORPORATE SOCIAL RESPONSIBILITY (CSR) &EMPLOYEE SOCIAL SERVICE (ESS)

We are committed to ensure that our business is conducted in all respects according

to ethical, professional and legal standards.

HEALTH

We are committed to implement a programmer of activities to achieve continuous improvement in health and safety performance of our employees and society at large.

Illustration:-

- Free Medicine distribution.

- Blood donation by employees.

- Medical checkups.

- Medical camps.

- Doctor's education etc.

SAFETY

We are committed to put our efforts to find out unsafe places and unsafe acts for improving safety of the people at workplace and road safety for general public.

ILLUSTRATION:-

- Organization wide safety awareness drives to improve safety.- A series of training sessions for safe working practices.- Road safety campaign for general public.


EMPLOYEES:-

We will deliver a competitive and fair employment environment and the opportunity to develop and advance subject to personal performance and business opportunity.

ILLUSTRATION:- - Employee education and skill development programs.- Personal effectiveness programs.

CUSTOMERS:-

Our business and existence depend upon our customers. Every employee is responsible for ensuring that any contact with our customers and the public at large reflects professionalism, efficiency and honesty. We will constantly strive to provide high quality service, products and good value for money.ILLUSTRATION:-

- Health awareness programs.- Product knowledge.- Ensuring security of our drugs from manufacturing to supply.- Providing quality products.- Prompt service.ENVIRONMENT:-

Our objective is to reduce impact on the environment through a committed continual improvement projects for Environment Management systems.

ILLUSTRATION:-

- Tree plantations inside and outside manufacturing sites.- Safe effluent treatment management.- Rain water harvesting.- Ecology balance awareness to the workmen, school and college students.- Water conservation.- Energy conservation.


SUPPLIERS: -

We regard suppliers as our partners and work with them to help us achieve our policy aspirations in the delivery of our products and services.We will encourage our suppliers and contractors to adopt responsible business policies and practices for mutual benefit.

ILLUSTRATION:-

- To work closely to encourage for CSR policy development and implementation.

COMMUNITY AT LARGE :-

We are being a responsible corporate citizen and will support for appropriate social and non-political projects. For this purpose our organization will focus charities in following areas.

- Education and Training.- Employment.- Social Welfare of underprivileged sections.- Environment.- Rural development.- Help Organizations who serve Leprosy & Cancer Patients.

PRODUCT LISTFormulations > BELARUS > Brand Names


http://www.ipcalabs.com/products/formulations/index.php

Brand Names Generic Names Therapeutic Group Strength Pack SizeLomflox Tablets

Lomefloxacin Antiinfectives 400mg Tabs 1X5's

Nemocid Suspension

Pyrantel Pamoate Gastroenterologicals 250mg per 5ml 1X10ml

Nemocid Tablets

Pyrantel Pamoate Gastroenterologicals 250mg Tabs 10X3's

Normax Eye / Ear Drops

Norfloxacin Antiinfectives 0.3% w/v + 0.02% v/v

1X5ml

Normax Tablets

Norfloxacin Antiinfectives 400mg Tabs 1X6's

Perinorm Injection

Metoclopramide Gastroenterologicals 5mg per 1ml 1X50X2ml

Perinorm Tablets

Metoclopramide Gastroenterologicals 10mg Tabs 10X10's

Solvin Elixir Bromhexine Drugs for Respiratory System

4mg per 5ml 1X120ml

Solvin Tablets Bromhexine Drugs for Respiratory System

8mg Tabs 10X10's

Talcef Injection

Cefotaxime Antiinfectives 1gm 1X1gm

Tenolol Tablets

Atenolol Cardiovascular 100mg Tabs 10X10's

Tenolol Tablets

Atenolol Cardiovascular 100mg Tabs 2X14's

Tenoric Tablets

Atenolol + Chlorthalidone

Cardiovascular 50mg+12.5mg/ 100mg+25mg Tabs

2X14's

Formulations > BURUNDI > Brand Names

GENERIC NAMES

BRAND NAME

THERAPEUTIC GROUP

STRENGTH PACK SIZE

Cinkona Injection

Quinine Dihydrochloride

Antimalarials 300mg per 1ml 10X10X2ml

Nemozole Tablets

Albendazole Gastroenterologicals 200mg Tabs 50X2's

Formulations > Cambodia > Brand Names

GENERIC BRAND THERAPEUTIC STRENGTH PACK




NAMES NAME GROUP SIZEAmpicillin IpcacillinCapsules Antiinfectives 500mg Caps 10x10's

Formulations > D.R.Congo > Brand Names

BRAND NAME

GENERIC NAMES

THERAPEUTIC GROUP

STRENGTH PACK SIZE

Amodiaquine Hydrochloride

Amodiaquine Hydrochloride

Antimalarials 200mg Tabs 1x1000's

Cinkona Tablets

Quinine Sulphate Antimalarials 300mg Tabs 10x6's

Giardyl Infusion

Metronidazole Benzoate

Antiinfectives 5mg per 1ml 1x100ml

Giardyl Iv Infusion

Metronidazole Intravenous

Antiinfectives 500mg per 100ml

1x100ml

Larither Injection

Artemether Antimalarials 80mg per 1ml 6x1ml

Nemocid Suspension

Pyrantel Pamoate Gastroenterologicals 250mg per 5ml 1x15ml

Nemocid Tablets

Pyrantel Pamoate Gastroenterologicals 250mg Tabs 10x3's

Nimica Suspension

Nimesulide Antiinflammatory/ Analgesic

50mg per 5ml 1x60ml

Nimica Tablets Nimesulide Antiinflammatory/ Analgesic

100 dt Tabs 10x10's

Perinorm Injection

Metoclopramide Gastroenterologicals 5mg per 1ml 10x2ml

Perinorm Syrup

Metoclopramide Gastroenterologicals 5mg per 5ml 1x30ml

Formulations > Ghana > Brand Names

BRAND NAME

GENERIC NAMES

THERAPEUTIC GROUP

STRENGTH PACK SIZE

Ampicillin Ampicillin Antiinfectives 500mg Caps 100x10's / 1000's

Cloxacillin Cloxacillin Antiinfectives 250mg Caps 100x10'sLarither Injection

Artemether Antimalarials 40mg/80mg per 1ml

6x1ml

Nemozole Suspension

Albendazole Gastroenterologicals 100mg/250mg per 5ml

1x20ml

Nemozole Albendazole Gastroenterologicals 400mg Tabs 10x1x1's




Tablets

Formulations > India > Brand Names BRAND NAME

GENERIC NAMES

THERAPEUTIC GROUP

STRENGTH PACK SIZE

Acera Caps Rabeprazole + Domperidone

Sustained Release

Gastroenterologicals 20+30 mg Foil Strip of 10's

Acutret Caps Isotretinoin Dermatologicals 5mg/10mg/20mg Blister of 10's

Adiff Gel Adapalene Dermatologicals 0.1 gm Tube of 15 gm

Azibact Tabs Azithromycin Antiinfectives 250 mg / 500 mg250mg

Blister of 6's & 500

mg:Blister of 3's

Azifast Gel Azithromycin Antiinfectives 2% gel Tube of 20gm

Azifast Tabs Azithromycin Antiinfectives 250 mg / 500 mg250mg

Blister of 6's & 500

mg:Blister of 3's

Betamotil Inj . Beta Arteether Antimalarials 150 mg/2ml Ampoule of 2 ml

Bromhexine Elixir Susp

Bromhexine 4 mg

Drugs for Respiratory System

4mg/5 ml 100 ml bottle

Bromhexine Tabs.

Bromhexine HCl


8mg Blister of 10's

Bronchosolvin Susp

Terbutaline + Bromhexine + Guaiphenesin


1.25mg + 4mg + 50mg

60 ml/100 ml Bottle

Bronchosolvin Tabs.

Terbutaline + Bromhexine + Guaiphenesin


2.5mg + 8mg + 100 mg

Blister of 10's

Calchek L tabs Amlodipine + Lisinopril

Cardiovascular 2.5+ 2.5 / 5 + 5 mg

Foil Strip of 10's

Calchek Tabs Amlodipine Cardiovascular 10mg/2.5mg/5mg Foil Strip of 10's

Calten CapsCalcitriol+Calc

ium Carbonate+Zin

Nutritionals 0.25mcg+500mg+7.5mg

Blister of 10's



cCalten D Tabs Calcium

Carbonate+Vitamin D3+Zinc

Nutritionals 1250mg+250IU+7.5mg

Blister of 10's

Cardioplus Caps.

Anti-oxidant vitamins + Minerals

Nutritionals Blister of 10's

Celedol Caps. Celecoxib Antiinflammatory/ Analgesic

100 mg, 200 mg Blister of 10's

Cinkona Injection Quinine

Dihydrochloride + Benzyl

Alcohol

Antimalarials 300 mg / 2 ml Ampoule of 2 ml

Cinkona Suspension

Quinine Sulphate

Antimalarials 150 mg/ 5 ml 60 ml bottle

Cinkona Tabs Quinine Sulphate

Antimalarials 100mg/600mg/ 300mg100/600mg

Foil strip of 10's &

300mg: F.S of 6's

Citinova Inj Citicoline Cerebral Activator 250mg/ml Ampoule of 2ml/4ml

Citinova Tabs Citicoline Cerebral Activator 500 mg Foil Strip of 10's

Clarbact Tabs. Clarithromycin Antiinfectives 250 mg, 500 mg Foil strip of 4's

Clopact A Caps Clopidogrel + Aspirin

Cardiovascular 75+150 mg / 75+75mg

Foil strip of 10's

Clopact Tabs Clopidogrel Cardiovascula r 75mg Foil Strip of 10's

CNN Tabs Minocycline Antiinfectives 50mg/100mg Blister of 10's

Cutinorm Cream White soft paraffin+Light liquid paraffin

Dermatologicals 15%+6% Tube of 40gm

Cutinorm Lotion Glycerine Dermatologicals 10% Bottle of 50ml

Cutisoft Cream Hydrocortisone acetate -

Steroid 1% 10 mgTube of 10 gm

Cytovit Capsules Anti-oxidant vitamins + Minerals

Nutritionals Blister of 10's

Diasol Caps Foil

DiacereinDMD 50mg Strip of 10's


Divalrate ER Tabs

Divalproex Sodium

Extended Release

Antiepileptic 125mg/250mg/500mg

Foil Strip of 10's

Domperi DT Foil Domperidone Dispersible

Tabs.

Gastroenterologicals Tabs. 5 mg, 10 mg

Strip of 10's

Domperi OD Caps

Domperidone Sustained Release

Gastroenterologicals 30 mg Blister of 10's

Domperi Susp. Domperidone Gastroenterologicals 5 mg / 5 ml 30 ml. Bottle

Donica Caps Indomethacin Antiinflammatory/ Analgesic

25 mg Blister of 10's

Donica-SR Caps Indomethacin Sustained Release

Antiinflammatory/ Analgesic

75 mg Blister of 10's

Eltocin - DS. Erythromycin Estolate

Antiinfectives Tabs 500 mg/ tab Blister of 10's

Eltocin Kid. Erythromycin Estolate

Antiinfectives Tabs. 125 mg/ tab Foil strip of 10's

Eltocin Susp. Erythromycin Estolate

Antiinfectives 125 mg/5 ml 60 ml bottle

Eltocin Tabs Erythromycin Estolate

Antiinfectives 250mg Blister of 10's

Emnorm Tabs Metformin Hydrochlor

Antidiabetics 250mg/500mg/850mg

Emnormlg ER Tabs Metformin Extended Release

Antidiabetics 1000mg Blister of 10's

Emotrip Tabs Amytryptilline+ Chlordiazepoxi

de

Psychotropics 12.5 mg / 25 mg Blister of 10'

Epictal Tabs Levetiracetam Antiepileptic 250mg/500mg/750mg

Blister of 10's

Etova Tabs Etodolac Antiinflammatory/ Analgesic

200mg/300mg/400mg

Alu-Alu Strip of 10's

Fexova Tabs. Fexofenadine Antiallergic 120 mg, 180 mg Blister of 10's

Folitrax Tabs. DMD

Methotrexate I.P

2.5 mg, 5 mg, 7.5 mg,10 mg

Blister of 10's

Folitrax-15 Inj..DMD

Methotrexate I.P

15 mg/ml Ampoule of 1 ml

Folitrax-50 Inj.. Methotrexate DMD 50mg/2ml Vial of 1ml


I.PFoloup 50 Dry

Syrup Cefpodoxime

ProxetilAntiinfectives 50 mg / 5 ml Bottle of 30

mlFoloup DT Tabs Cefpodoxime

ProxetilAntiinfectives 100mg Foil Strip of

10'sFoloup Tabs Cefpodoxime

ProxetilAntiinfectives 200 mg Foil strip of

6'sGlycinorm M

MR Tabs Gliclazide + Metformin

Antidiabetics 30 + 500 mg/60 + 500 mg


Glycinorm M Tabs.

Gliclazide + Metformin

Antidiabetics 40mg/80mg Blister of 10's

Glycinorm OD Tabs

Gliclazide Modified Release

Antidiabetics 30mg/60 mg Alu-Alu Strip of 10's

Glycinorm Tabs: Gliclazide Antidiabetics 40mg/80mg/160mg40/80mg

Blister of 10's &

160mg:Foil Strip of 10's

Glyree M Forte Glimepiride + Metformin Extended Release

Antidiabetics 2mg+1000mg Alu-Alu Strip of 10's

Glyree M Tabs Glimepiride+Metformin

Antidiabetics 1mg+500mg/ 2mg+500mg


Glyree MP Tabs Glimepiride + Metformin Extended Release +

Pioglitazone

Antidiabetics 1+500+15mg/2+500+15mg

Blister of 10's

Glyree Tabs. Glimepiride Antidiabetics 1mg/2mg/3mg/4mg

Foil Strip of 10's

HCQS Tabs Hydroxychloroquine Sulfate

DMD 200mg Blister of 10's

Hyphoral Lotion Ketoconazole 2% + Zinc

Pyrithione 1%

Dermatologicals 50 ml. Plastic bottle

Hyphoral Tabs Ketoconazole Antiinfectives 200 mg Foil Strip of 10's

Inditor SR Tabs r .Indapamide Sustained Release

Cardiovascula 1.5mg Foil Strip of 10's

Inditor Tabs Foil Indapamide Cardiovascular 2.5mg Strip of 10's

Inosert Tabs Sertraline Psychotropics 25mg / 50mg/ 100mg

Blister of 10's


Inosert Tabs Sertraline Psychotropics 25mg / 50mg / 100mg

Blister of 10's

Intigem Tabs Gemifloxacin Mexylate

Antiinfectives 320mg Blister of 5's

Isordil Tabs: Isosorbide Dinitrate

Cardiovascular 5mg/10mg5mg Blister of 10's & 10mg:

Blister of 100's

Keftra 0.25 Inj Ceftriaxone Antiinfectives 250 mg Vial of 250 mg

Keftra 0.50 Inj Ceftriaxone Antiinfectives 500 mg Vial of 500 mg

Keftra 1 Inj Ceftriaxone Antiinfectives 1 gm Vial of 1 gmKeftra 1.25 Inj Ceftriaxone Antiinfectives 125 mg Vial of 125

mgKeftragard Ceftriaxone +

SulbactamAntiinfectives 125mg+62.5 mg

0.1875 InjVial of

0.1875 gmKeftragard 0.375

Inj Ceftriaxone +

SulbactumAntiinfectives 250mg+125mg Vial of

0.375 gmKeftragard 0.75

Inj Ceftriaxone +

SulbactumAntiinfectives 500mg+250mg Vial of 0.75

gmKeftragard 1.5

Inj Ceftriaxone +

Sulbactum Antiinfectives 1000mg+500mg Vial of 1.5

gm


MARKETING

THE INDIAN MARKET

A country of 1.06 billion people spanning a whole subcontinent, across 3,287,590 sq. km, 29 states and 6 union territories, speaking 15 different official languages, with myriad distinct cultures, and a heritage that goes back 5000 years, India is a country of diversity and depth like no other in the world.

Ipca has a dynamic team of professionals who cater to the demands and requirements of the International business. In 2007-08, Ipca's products were marketed to over 110 countries across the globe, contributing around 50% of the Company's turnover.

Ipca is 16th largest Pharmaceutical Company in India. (Source Economic Times ET-500 Oct-07 issue).

Ipca is the 2nd highest wealth creator in Indian pharmaceutical industry based on returns. (Source Economic Times ET-500 Oct-07 issue)

Ipca has been awarded by Forbes Inc., as one of the "Best under a Billion" Forbes Global 200 Best Small Companies, 2007. In the past, we have been awarded, for 3 consecutive years 2003, 2004 and 2005.

Ipca is a "Recognised Trading House" with an export turnover of about US$ 134 million for the year 2007-08.

Formulations account for 64% of export turnover. Ipca is among India's largest formulation exporters with a growth of 11% in 2007-08.

Region-wise FormulationsExports 2007-08 (in Percentage)

Therapeutic Group-wise FormulationsExports 2007-08 (in Percentage)


Formulations are registered / under registrations in 69 countries.

Ipca has overseas offices in Russia, Kazakhstan, Ukraine, Vietnam, Kenya, Philippines, Columbia & Sri Lanka.

Ipca also has subsidiaries in USA, U.K., South Africa, Nigeria, Brazil, Mexico, Australia and New Zealand.

The current focus is on registering dossiers in UK, EU, CEE, South Africa, Australia, New Zealand and filing on ANDAs in USA. Sales of generics to regulated markets constituted 64% of total formulations exports during 2007-08.

Ipca's field force promotes its formulation brands in Cambodia, Kenya, Kazakhstan, Mauritius, Myanmar, Oman, Russia, Sri Lanka, Sudan, Tanzania, Ukraine, Vietnam, Yemen and a few other countries. Sales of Branded formulations has steadily grown from around 16% of formulations export in 2000-01 to 36% in 2007-08.

The R & D expenditure during the financial year 2007-08 was Rs.42.9 crores (4% of turnover). Around 152 patents have been filed, out of which 27 patent applications have been granted which includes 25 from India and 2 from US. Ipca's stature as a quality-driven pharmaceutical major, and therefore a dependable and dynamic partner continues to grow with each passing day - bringing it closer to its vision to be a Global generic player in all major developed and developing markets, through enhanced geographical reach and product expansions.

The company's dynamism and foresight is evident in its strong thrust on backward integration by manufacturing the APIs for many of its Finished Dosage Forms. Thus, ensuring cost competitiveness and reliability of supplies giving it a distinct advantage in the Pharmaceutical Industry. Ipca's facilities have been approved by most of the discerning regulatory authorities including UK-MHRA, Australia-TGA, South Africa-MCC and Brazil-ANVISA.

In the United Kingdom, Ipca's Finished Dosage Forms are already being sold. The company has already initiated dossier filings for several generic products backed up by a strong pipeline which will also be offered in EU countries and other developed nations.

Ipca has a strong International presence in Antibacterials, Pain Management, Lifestyle Therapeutic segments like Cardiovasculars, Antidiabetics, Psychotropics etc.

In Anti-Malarials, which has been a traditional strong hold, Ipca has kept pace with the


latest concepts of Artemesenin based combination therapy (ACT) based on recommendations from International forums including WHO.

Gastroenterologicals, Cold and Cough Preparations, Dermatologicals are the other main segments.

This is Ipca’s domestic market.

Our domestic product range spans Formulations, Active Pharmaceutical Ingredients (API) and Drug Intermediates across therapeutic segments: Antimalarials, Antiemetics, Antibiotics, Analgesics, Antiarthritics, Antidiabetics, Cardiac Care, Cough & Cold Therapy, Dermatology, and Neuropsychiatry segments. Ipca manufactures over 150 formulations in virtually every dosage form: tablets, capsules, oral liquids, dry powders for suspension, and injectables (liquid and dry).Our finished formulations are available in over 400,000 retail shops, catered to by a network of over 1500 wholesalers. 1500 sales and marketing personnel service over 200,000 doctors across the country.

DOMESTIC APIs AND DIs

Ipca has been playing a leading role in the domestic Active Pharmaceutical Ingredients (APIs) and Drug Intermediates (DIs) market, with over 20 years of experience in the Antimalarial and Antihypertensive therapeutic segments. We are the first manufacturer in India for APIs like Atenolol, Pyrantel Pamoate and Hydroxychloroquine Sulfate. Our domestic pharmaceutical customers include Alembic, Bayer, Cipla, Dr.Reddy’s, Merck, Nicholas Piramal, Pfizer, Ranbaxy, and Wockhardt, among others.

FORMULATIONS MARKETING

The speciality-focussed restructuring of Ipca’s domestic marketing strategy has given birth to 8 self-administered marketing divisions. Results are encouraging; in 2007, our domestic formulations business has grown at the rate of 16% against an industry growth of 14% during the same period (ORG-IMS).Brands like Glycinorm, HCQS, Lariago, Malirid, Movon, Pari, Perinorm, Ramcor, Solvin, Sultax, Tenolol, Tenoric, and Zerodol have become brand leaders in their respective therapeutic segments, and 4 of these are also rated among the Top 300 Indian Brands (all categories) by ORG-IMS.


DOMESTIC DIVISIONS

Division

The largest of Ipca’s divisions, handling the largest number of brands, this division manages our newer Antimalarials, Antihypertensives, Antibacterials, Non Steroidal Anti-Inflammatory Drugs (NSAIDs) and Cough preparations. Recently it launched Zerodol (Aceclofenac), a country first. Some of the other leading brands managed by this division are: Tenolol (Atenolol), Larither (Artemether), Roxeptin (Roxithromycin), and Tenoric (Atenolol + Chlorthalidone).

Division

Ipca’s second largest division, Intima’s marketing focus is on established Anti-Infectives, and mature brands of Ipca in the Antimalarial and Antiemetic segment. Of the several brands that Intima handles 2 are ranked among India ’s Top 250 brands (cross category). Some of Intima’s leading brands are: Lariago (Chloroquine Phosphate), Perinorm (Metoclopramide), Pacimol (Paracetamol), Nemocid (Pyrantel Pamoate) and Eltocin (Erythromycin Estolate).

Division

The focus of this division is on Cardiovascular and Antidiabetic segments and it currently manages 24 brands. Through the introductions of newer dose and dosage forms, the division focuses on fulfilling the need for dose-titration, which is an essential component in the management of diabetes and cardiovascular diseases. Some of the leading brands managed by it are: Glycinorm (Gliclazide), Glycinorm-M (Gliclazide + Metformin), Lisoril (Lisinopril), Simlo (Simvastatin), Calchek (Amlodipine), Piomed (Pioglitazone), Metagard CR (Trimetazidine Controlled Release) and X’tor (Atorvastatin).

Division

Bionova’s focus area is Dermatology. It has already made its mark by leading in the oral anti-acne segment with brands like Azifast (Azithromycin) and Acutret (Isotretinoin). Also


offered are fast growing brands like Leset (Levocetirizine) and Nipcan (Fluconazole).

Division

Innova marks Ipca’s entry into the Indian Neuropsychiatry segment. Already to its credit are segment leaders such as Pari (Paroxetine), Sove (Zolpidem), and Ozapin MD (Olanzapine Mouth Dissolving). Recently, Innova launched Pari CR – India ’s first Paroxetine with Controlled Release Technology, an international patent for which have been filed.

Division

A super-speciality division, Activa was the countries first Rheumatology and Orthopaedic – focused division. It markets a growing portfolio of dynamic brands, including: HCQS (Hydroxychloroquine Sulfate), Folitrax (Methotrexate), Saaz (Sulfasalazine), and Movon (Aceclofenac), the first Aceclofenac in India . Today, Activa is a leader in its segment with a 39% market share, and is also Ipca’s fastest growing division.

Division

The marketing focus of this division is on the growing need for Cardiac and Antidiabetic products. HyCare markets all major molecules for the management of cardiovascular disease, Type II diabetes and its related complications. Glyree (Glimepiride), Glyree-M (Glimepiride + Metformin) and Zilast (Cilostazole) are some of the leading brands of HyCare.

Division

Ipca's youngest division, Altus caters to the need of intensivists, both surgical and non-surgical, with a basket of oral and injectable Antibiotics like Keftragard, Keftragard V, Lactagard, Lactagard 2:1, Tazofast, Primegard, Keftra, Foloup, Supraheal and Sultax (Sulbactum + Cefotaxime), a world first.


M ANUFACTURING FACILITIES

Ipca has cGMP complying manufacturing facilities at the following locations in India.

Athal (Silvassa-Union Territory of Dadra & Nagar Haveli) Operational since 1995.

Formulations plant manufacturing tablets and capsules.

ISO 9001 certified. Facility approved by UK-Medicines and Healthcare

products Regulatory Agency (MHRA), Australia-Therapeutic Goods Administration (TGA), South Africa-Medicines Control Council (MCC), Brazil-Brazilian National Health Surveillance Agency (ANVISA), Geneva-World Health Organisation (WHO), Oman-Ministry of Health (MOH), Uganda-National Drug Authority (NDA) and Tanzania-Food & Drugs Authority (FDA). »»


Aurangabad (Maharashtra) Operational since 1997.

Manufacturing plant for Active Pharmaceutical Ingredients and Drug Intermediates.

One of the largest manufacturers of Drug Intermediates;3,4-Trimethoxy Toulene (TMT) and 6-Methoxy-2-Napthaldehyde (6MNA). »»

Dehradun (Uttaranchal)

Operational since 2006.

Formulations plant manufacturing tablets and capsules. »»

Indore (Madhya Pradesh)

Acquired from E. Merck in 1994.

Manufacturing plant for Active Pharmaceutical Ingredients and Drug Intermediates.

One of the world's largest manufacturing plant of API-Chloroquine Phosphate.

Facility approved by Geneva-World Health Organization (WHO). »»

Kandla (Gujarat) Operational since 1993. Facility approved by UK-Medicines and Healthcare products

Regulatory Agency (MHRA), Australia-Therapeutic Goods Administration (TGA), South Africa-Medicines Control Council


(MCC), Brazil-Brazilian National Health Surveillance Agency (ANVISA), Oman-Ministry of Health(MOH), Uganda-National Drug Authority (NDA) and Tanzania-Food & Drugs Authority (FDA).

Formulations manufacturing plant for betalactam tablets, capsules and dry powders. »»

Ratlam (Madhya Pradesh) Active Pharmaceutical Ingredients Plant Operational since 1985. Facility approved by US-Food and Drug Administration (FDA), Australia-Therapeutic Goods Administration (TGA), Geneva-World Health Organization (WHO) and Europe-European Directorate of the Quality of Medicines (EDQM).

Formulations Plant Operational since 1983.

Formulations plant manufacturing Tablets, Liquids and

Injectables. Facility approved by Brazil-Brazilian National Health Surveillance Agency (ANVISA), South Africa-Medicines Control Council (MCC), Geneva-World Health Organisation (WHO), Uganda-National Drug Authority (NDA), Oman-Ministry of Health (MOH) and Tanzania-Food & Drugs Authority (FDA). »»

Silvassa (Union Territory of Dadra & Nagar Haveli) Operational since February, 2004. Formulations plant manufacturing tablets. »»


Pithampur Formulations plant manufacturing Oral Solid dosage forms. »»

RESEARCH AND DEVELOPMENT

Located at Mumbai, Ipca’s research center is focused on generics in regulated markets, specifically in Europe and USA. The center has expertise in Active Pharmaceutical Ingredients, Drug Intermediates and Formulation Development which includes NDDS and ANDA.

Ipca’s Research and Development comprises of two sections:

1.Active Pharmaceutical Ingredients and Drug Intermediates

2. Formulation Development

Both the departments are supported by the Analytical Development cells which are fully equiped with all modern instruments (like NMR, LC-MSMS, GCMS etc) required to carry out research on day-to-day basis. Units are geared to continuously innovate and remain competitive by developing/acquiring abilities to find simple and effective solutions to practical problems, solutions which are free from Patent Infringement issues.

1. Active Pharmaceutical Ingredients/Drug Intermediates

The Active Pharmaceutical Ingredients/Drug Intermediates Research and Development department at Mumbai is supported by two more units located at Ratlam and Indore. All the R&D units are recognized by the Department of Science and Industrial Research, Government of India.

Research & Development units at Ratlam and Indore are also supported by facilities required for scale up of the processes from grams to kilo as well as to Pilot level.

Strengths:

Innovative chemistry-driven process research leading to the generation of non-infringing routes for APIs/Drug Intermediates and Intellectual Property. Ipca has highly qualified and experienced groups of people capable of handling patent-related issues, which includes various aspects of patenting and patent evaluations.

Impurity Profiling of APIs:


This includes identification and characterization as well as structural elucidation of unknown impurities (present in APIs), followed by their synthesis.

Analytical developments:New method developments.Method validations for getting products registered in Regulated Markets.

Process Research:

Process development/improvements to make products competitive and profitable in the long run by giving major emphasis on:

Non-infringing processesAlternative cost effective routesIncreasing plant friendliness. Improving selectivity/reducing impurity levels by sensitive chemistry inputs. Reducing effluent generation.

2. Formulation Development

Our Formulation Development Laboratory located at Mumbai has been gearing up for a state-of-the-art R&D facility (in line with the US-FDA requirements). The current R&D activities are also approved by the Department of Science and Technology, Government of India. The laboratory is well equipped with various ultramodern equipments and technologies required for conducting high quality research activities.

Some of the equipments available in the R&D are: High Sheer Mixer (GMP model)Fluid Bed Drier Fluid Bed ProcessorGanscoata Walk-in Stability Chambers Dissolution Apparatus with intrinsic dissolution assembly Bilayer Tablet Compression Machine Equipments for liquid orals and semi-solidHard gel capsule facilityBlister packing machine with Alu-Alu facility Press-cota


Roll compactorPelletisation facilityFacility for Effervescent tablets (low RH area)Reverse laminar flow

The key activities of R&D-Formulations are:Novel Drug Delivery System (NDDS):

R&D in this area attempts to improve the efficiency with which the medicine is absorbed in the body. Novel Drug Delivery Systems (NDDS) efforts are directed towards:

1. Controlled Release:

Ipca’s Research concentrates on sustained, delayed and pulsatile release. The company introduced a novel bilayer tablet for an antidiabetic combination.

2. Novel Dosage Formulations:In the novel dosage form, the company concentrates on the following therapeutic segments.

Cardiac Care Anti-infectiveAntidiabetics

Ipca’s R & D laboratory has filed patents across the world for products based on the NDDS. Ipca’s strength in this segment of R&D puts the company in an excellent position to compete in the growing markets for generic drugs in Europe and USA.

Abbreviated New Drug Application (ANDA):The filing of ANDAs received a major boost after Ipca opened its wholly owned subsidiary in New Jersey, USA. The company will now be working on ANDAs to address the growing opportunity in USA. Ipca’s research endeavors are well supported by worldclass infrastructure comprising:

Analytical Research Clinical Research International Regulatory Affairs Corporate Quality AssuranceIntellectual Property Cell


Manufacturing of generic products for registration in UK/EU/South Africa/Brazil and many other countries

CLINICAL RESEARCH

Clinical research is an integral part of pharmaceutical development and hence importance of clinical research is self evident. It has been the endeavour at Ipca to publish the clinical trials, which are being carried out by Ipca. Publication of clinical studies in peer reviewed journals validates the scientific work and keeps us on the path of improvement.Following are the clinical trial publications in the area of malaria, rheumatoid arthritis, osteoarthritis, dermatology and hypertension.

1. Clinical effectiveness of low-dose chlorthalidone (6.25mg) + atenolol combination in stage I hypertensive patients: a multicenter, randomized, controlled study. - Curr Med Res Opin. 2008 May 13.

2. Comparative study of efficacy and safety of hydroxychloroquine and chloroquine in polymorphic light eruption: a randomized, double-blind, multicentric study. - Indian J Dermatol Venereol Leprol. 2008 Jan-Feb;74(1):18-22.

3. Efficacy and safety of hydroxychloroquine sulphate in rheumatoid arthritis: a randomized, double-blind, placebo controlled clinical trial-an Indian experience. - Curr Med Res Opin. 2007 Sep; 23(9):2227-34.

4. Efficacy and safety of beta-arteether and alpha/beta-arteether for treatment of acute Plasmodium falciparum malaria. - Am J Trop Med Hyg. 2006 Jul;75(1):139-42.

IPCA’S


http://www.ipcalabs.com/clinical/crp-article4.php











WORLD-CLASS FACILITIES APPROVALS:

USFDA

The U.S. Food and Drug Administration (FDA or USFDA) is an

agency of the United States Department of Health and Human Services and is responsible for regulating and supervising the safety of foods, dietary supplements, drugs, vaccines, biological medical products, blood products, medical devices, radiation-emitting devices, veterinary products, and cosmetics. The FDA also enforces section 361 of the Public Health Service Act and the associated regulations, including sanitation requirements on interstate travel as well as specific rules for control of disease on products ranging from pet turtles to semen donations for assisted reproductive medicine techniques.

MHRA-UK

The Medicines and Healthcare products Regulatory Agency (MHRA) is the UK government agency which is responsible for ensuring that medicines and medical devices work and are acceptably safe. The agency was formed on 1 April 2003 with the merger of the Medicines Control Agency (MCA) and the Medical Devices Agency (MDA). It is an executive agency of the Department of Health.

TGA AUSTRALIA


http://en.wikipedia.org/wiki/Department_of_Health_(UK)

http://en.wikipedia.org/wiki/Executive_agency

http://en.wikipedia.org/wiki/2003

http://en.wikipedia.org/wiki/April_1

http://en.wikipedia.org/wiki/Medical_device


http://en.wikipedia.org/wiki/Medicine

http://en.wikipedia.org/wiki/Semen

http://en.wikipedia.org/wiki/Turtles

http://en.wikipedia.org/wiki/Sanitation

http://en.wikipedia.org/wiki/Public_Health_Service_Act

http://en.wikipedia.org/wiki/Public_Health_Service_Act

http://en.wikipedia.org/wiki/Cosmetics

http://en.wikipedia.org/wiki/Electromagnetic_radiation


http://en.wikipedia.org/wiki/Blood_transfusion

http://en.wikipedia.org/wiki/Biopharmaceutical

http://en.wikipedia.org/wiki/Vaccine

http://en.wikipedia.org/wiki/Medication

http://en.wikipedia.org/wiki/Dietary_supplement

http://en.wikipedia.org/wiki/Food

http://en.wikipedia.org/wiki/United_States_Department_of_Health_and_Human_Services

http://en.wikipedia.org/wiki/Government_agency

The Therapeutic Goods Administration or TGA is the regulatory body for therapeutic goods (including medicines, medical devices, gene technology, and blood products) in Australia. It is a Division of the Australian Department of Health and Ageing established under the Therapeutic Goods Act 1989 (Cth). The TGA is responsible for conducting assessment and monitoring activities to ensure that therapeutic goods available in Australia are of an acceptable standard and that access to therapeutic advances is in a timely manner.

MCC SOUTH AFRICA

The Medicines Control Council (MCC) is a statutory body that was established in terms of the Medicines and Related Substances Control Act, 101 of 1965, to oversee the regulation of medicines in South Africa. It is appointed by the Minister of Health and its main purpose is to safeguard and protect the public through ensuring that all medicines that are sold and used in South Africa are safe, therapeutically effective and consistently meet acceptable standards of quality.

NIP HUNGARY


http://en.wikipedia.org/wiki/Department_of_Health_and_Ageing_(Australia)

http://en.wikipedia.org/wiki/Australia

The Hungarian regulatory authority responsible for granting marketing authorization for the medicines including pharmaceuticals biological blood products radiopharmaceutical, homeopathic product and herbal preparation with therapeutic effects. Sera vaccines and bacterial toxins for human use are authorized by the executive officers of the National Chief Medical Officer. In hungry, serious adverse events that are unexpected or those events associated with a drug preventing its use must be reported to he NIP by the marketing authorization holder or by doctors who observed the effect or has knowledge of its onset in an expedited manner. The Hungarian decree 12/2001(IV.12) EiiM of the minister of health in the registration and authorization to place medical product for human use on the market brought Hungarian pharmacovigilance procedure for marketed product in line with EU procedure

ANVISA BRAZIL

(AGENCY NATIONAL FOR VIGILANCE SANITAIRE)

The National Health Surveillance Agency (Anvisa) was established by Law 9.782, of January 26, 1999. The Agency is designated an autonomous agency operating under a special regime. This means that ANVISA is an independently administered, financially-autonomous regulatory agency, with security of tenure for its directors during the period of their mandates. The Agency is managed by a Collegiate Board of Directors, comprised of five members. Within the structure of Federal Public Administration, the Agency is linked to the Ministry of Health, under a Management Contract.


http://www.saude.gov.br/

http://www.anvisa.gov.br/legis/law_9782.htm

The agency incorporated additional attributions: coordination of the

National Sanitary Surveillance System (SNVS), the National Program of Blood and Blood

Products and the National Program of Prevention and Control of Hospital Infections;

monitoring of drug prices and prices of medical devices; attributions pertaining to

regulation, control and inspection of smoking products; technical support in granting of

patents by the National Institute of Industrial Property. The institutional purpose of the

agency is to foster protection of the health of the population by exercising sanitary control

over production and marketing of products and services subject to sanitary surveillance. The

latter embraces premises and manufacturing processes, as well as the range of inputs and

technologies concerned with the same. In addition, the Agency exercises control over ports,

airports and borders and also liaises with the Brazilian Ministry of Foreign Affairs and

foreign institutions over matters concerning international aspects of sanitary surveillance.

INVIMA COLOMBIA Industrial training: IPCA, Ratlam

- 47 -

http://www.anvisa.gov.br/system/index.htm

INSTITUTO NACIONAL DE VIGILANCIA DE MEDICAMENTOSY ALIMENTOS

(NATIONAL INSTITUTE FOR DRUGS AND FOOD SURVEILLANCE)

MOH MALAWI/NAMIBIA/ZAMBIA

PIC GERMANY


http://www.thepigsite.com/focus/561/

TRAINING SCHEDULEDIndustrial training: IPCA, Ratlam

- 49 -

SNO. DEPARTMENT

01. TRAINING02. GRANULATION03. COMPRESSION04. COATING05. PRIMARY PACKING06. FINAL PACKING07. LIQUID

TRAINING


In the field of human resource management, training and development is the field concerned with organizational activity aimed at bettering the performance of individuals and groups in organizational settings. It has been known by several names, including employee development, human resource development, and learning and development.[1]

Harrison observes that the name was endlessly debated by the Chartered Institute of Personnel and Development during its review of professional standards in 1999/2000. "Employee Development" was seen as too evocative of the master-slave relationship between employer and employee for those who refer to their employees as "partners" or "associates" to be comfortable with. "Human Resource Development" was rejected by academics, who objected to the idea that people were "resources" — an idea that they felt to be demeaning to the individual. Eventually, the CIPD settled upon "Learning and Development", although that was itself not free from problems, "learning" being an overgeneral and ambiguous name. Moreover, the field is still widely known by the other names.[1]

Training and development encompasses three main activities: training, education, and development. Garavan, Costine, and Heraty, of the Irish Institute of Training and Development, note that these ideas are often considered to be synonymous. However, to practitioners, they encompass three separate, although interrelated, activities:[1][2][3]

TRAININGThis activity is both focussed upon, and evaluated against, the job that an individual currently holds.[3]

EDUCATIONThis activity focusses upon the jobs that an individual may potentially hold in the future, and is evaluated against those jobs.[3]

DEVELOPMENTThis activity focusses upon the activities that the organization employing the individual, or that the individual is part of, may partake in the future, and is almost impossible to evaluate.[3]

The "stakeholders" in training and development are categorized into several classes. The sponsors of training and development are senior managers. The clients of training and development are business planners. Line managers are responsible for coaching, resources, and performance. The participants are those who actually undergo the processes. The facilitators are Human Resource Management staff. And the providers are specialists in the field. Each of these groups has its own agenda and motivations, which sometimes conflict with the agendas and motivations of the others.[4]


http://en.wikipedia.org/wiki/Training_and_development#cite_note-3

http://en.wikipedia.org/wiki/Training_and_development#cite_note-IITD-2





http://en.wikipedia.org/wiki/Training_and_development#cite_note-Harrison-0


http://en.wikipedia.org/wiki/Chartered_Institute_of_Personnel_and_Development

http://en.wikipedia.org/wiki/Chartered_Institute_of_Personnel_and_Development


http://en.wikipedia.org/wiki/Human_resource_management

The conflicts are the best part of career consequences are those that take place between employees and their bosses. The number one reason people leave their jobs is conflict with their bosses. And yet, as author, workplace relationship authority, and executive coach, Dr. John Hoover[5] points out, "Tempting as it is, nobody ever enhanced his or her career by making the boss look stupid." [1] Training an employee to get along well with authority and with people who entertain diverse points of view is one of the best guarantees of long-term success. Talent, knowledge, and skill alone won't compensate for a sour relationship with a superior, peer, or customer.

The initial training was to visit the plant and get acquaint with the officials and the work conditions there, we reported to the concerned department and the our concerned incharge told us about the different procedures to be performed in the formulation area.

GOWNING:It is the procedure to be followed by the individual before entering the concerned area

of manufacturing or production area. The individual has to perform following procedure.1. Wear a neat and clean apron.2. Wear head cover, nose mask, shoes/ shoe cover.3. Sterilize the hands with disinfectant solution.4. On exit remove the apron and the other accessory in the gowning room and put in

thrash bin.

The procedure helps in preventing and injury to the employee and avoid and contamination of product with hair, fibers dirt and dust. The whole procedure is written in room as the SOP(standard operating procedure). And the instruction in the SOP should be strictly followed and reviewed periodically.

Then the instruction to be followed in the production area was instructed as follows:1. Material should not handle with naked hands, only after the gloves are put.2. Don’t handle the machine which you don’t know how to operate.3. Maintain discipline and abide by the rules and regulations.

GRANULATION


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Granulation is the process in which the raw materials are mixed and the mixed with the slurry and a paste is made which is then fed to dryer and then fed to granulator. This is finally converted to granules of suitable size. Granulation helps to get the mass of the give size which can be compressed as per the specification

FLOW DIAGRAM OF GRANULATION Order requisition Raw material QC/QA certified (Dispensed and stored)

Sifting (Size separation)

Granulator (Slurry + raw material)

Fluid Bed Dryer (Drying of granules)

Blender (Mix lubricant and granules)

Granules forward to compression

ORDER REQUISITION


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Order requisition document which contain the records of the details of the new batch

or order to be taken. It is the BMR of the whole batch which contains the information and

basic procedure which need to be done. The whole details of BMR is taken in coming

section.

The order requisition is sent to the raw material department which dispense the

required quantity of material and label it. There are two labels on the material

On individual material

On container.

Once the material arrives it is kept in RW day store. And depending on batch requirement

send to the formulation.

Raw material is dispensed in the lot size after the clearance from the QC/QA department

and are labeled with following details.

LABEL:

Once the material is handed to the supervisor its his duty to weigh the material and

mention in the BMR, if the weight are correct as per the given specification the material is

forward to sifting.


Date:AR No. Material Name: Weight: Gross Wt. Batch No: Id No.: Tare Wt. Batch Size: Stage: Net Wt.

Checked By Dispensed By

SIFTINGSifting is the process in which the mixer is passed trough the sieve of suitable

size and the separation is done on the basis of the particle size. These is a technique of making the material of same size and attain good mixing and remove any other particles.

SIFTER:

VACUUM SIFTER VIBRATOR SIFTER

Sifter is equipment which contains an arrangement of sieve of different size which helps in the separation of the material. Sifters are of following types:

VACUUM SIFTER

Vacuum sifters are the one shown in figure above, and make the use of the vacuum for the separation process.It contains following parts Lid: to cover the assembly so as to create a vacuum and aid siftingOutlet: connected to granulator so as to transfer the material to granulator.Sieve: it is the main part it is fitted with different size sieve so that proper size can be

separated.Inlet: material is feed from this part; the material is sucked through the pipe under

vacuum.WORKING

The sifter uses the vacuum concept in which the material; is sucked in through the inlet and passed through sieve and then the material of required is passed through and the remaining particles are left.


VIBRATOR SIFTERThe figure is shown above, this sifter makes the use of vibration and the material is separated by the vibration. The vibration moves the particles in random motion and then this helps to separate them.

It contains following parts:Lid: to cover the sieve so that material is saved from spilling. Sieve: to separate the material.Inlet: the material poured in here by hand.Outlet: from here the separated material is collected.

Working The material is poured on the sieve and vibrator is switched on, the particles

moves in random direction and the particles get separated. The separated particles get collected in the outlet.

GRANULATOR

Rapid Mixer Granulator(RMG) is designed to achieve excellent mixing and consistent granules at lower operating cost along with higher productivity. Better mixing and closed control of granule size leads to faster Tableting speeds with improved quality and least rejections.

Salient Features:

Homogeneous binder distribution, Short batch time and reduce cleaning time. Maximize CIP effectiveness. Air purges sealing system for main stirrer shaft and granulator shaft. All


internal contact parts are polished to the mirror finish. PLC based operating panel for precise control of process & automation. A high-speed granulator is inserted horizontally through wall of bowl to assist blending of powder and to break the product to the granules of required size. The seal housing and drive shaft may be flushed with cleaning water, which is then drained away from the machine through built in drain tubes. Granulator motor is provided with removable stainless steel shrouds, which covers the motor and simplifies cleaning. The impeller sets the entire mixture in a whirling-rising tumbling motion ensuring a quick and even distribution of all dry components which leads to an even distribution of all dry components which leads to an even wetting of every granule. The large lumps occurred during wet mixing are broken up, by the strategically located chopping tool rotating at 1440/2880 RPM. The mix can be discharged with the impeller running through the outlet located on the side of the mixing bowl flush to the bottom. Easy accessibility for cleaning is guaranteed by the low profile. The mixing tool is easily removed from the drive shaft providing an unobstructed mixing area which may be cleaned very easily. All moving parts of the machine are totally enclosed to eliminate accident. The machine cannot be started unless and until the mixer cover is properly closed. Models are available in SS 304 / SS 316 quality. Flush wall type discharge valve eliminates pockets at the port of discharge valveGranulators are the equipment in which the material and slurry is mixed to produce a wet mass and which on drying yields the granules. The granulators contain the blade which mixes the material. The granulator contains following parts:Controls: these are controls which control the different parameter like temperature,

speed of granulator, time for granulation, outlet of material.Lid: it simply helps to cover the granulator so that material to don’t come out

it contains a sensor, once the lid is open the machine stops to rotate.Granulator: it is a container which have blade which rotate at given speed which

helps in the mixing of the slurry.Outlet: it is use to collect the mass from the granulator.

WORKING:The working is as follows, the material is feed from the vacuum sifter and

collected in the container and then the speed and time is set and it is allowed to rotate, after that the slurry is made and poured in it and rotated again for proper mixing. Once the time is completed the mass is analyzed and then taken out.


FLUID BED DRYER

FLUID BED DRYER

A fluidized bed is formed when a quantity of a solid particulate substance

(usually present in a holding vessel) is placed under appropriate conditions to cause the

solid/fluid mixture to behave as a fluid. This is usually achieved by the introduction of

pressurized fluid through the particulate medium. This results in the medium then having

many properties and characteristics of normal fluids; such as the ability to free-flow under

gravity, or to be pumped using fluid type technologies.

The resulting phenomenon is called fluidization. Fluidized beds are used for

several purposes, such as fluidized bed reactors (types of chemical reactors), fluid

catalytic cracking, fluidized bed combustion, heat or mass transfer or interface

modification, such as applying a coating onto solid items.


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http://en.wikipedia.org/wiki/Fluidized_bed_combustion

http://en.wikipedia.org/wiki/Fluid_catalytic_cracking

http://en.wikipedia.org/wiki/Fluid_catalytic_cracking

http://en.wikipedia.org/wiki/Chemical_reactors

http://en.wikipedia.org/wiki/Fluidized_bed_reactor

http://en.wikipedia.org/wiki/Fluidization

http://en.wikipedia.org/wiki/Fluid

http://en.wikipedia.org/wiki/Solid

PARTS OF FBD Inlet: there is an arrangement for the air inlet.Container: it is a perforated container in which there is the material is kept for

drying. The air is blown in it to create a fluidized bed and which cause drying.

Fluid state: it is the chamber which contains the fluid state of material to dry.Outlet: it is the pipe used to exit the used air.Controls: they are the different switches to control the operation like temperature

of inlet and outlet speed of inlet and outlet, time of cycle.

WORKING:

The slurry is taken in the container and then fixed in the given position in the FBD and the parameter is set and then at regular interval sampling is done and LOD is check so that optimum drying can be done. Once the required LOD is attained the material is send for blending.

In Process Quality ControlIn this the material is sampled at regular interval and the LOD is calculated and when the required level is attained the drying is stopped. The LOD is important because over dried mass will not be compressed and wet mass will show sticking and capping.

BLENDER


Sample is placed in the sample holder and the temperature is set at 1050C and the machine is switched on the final reading is displayed on the display

OCTAGONAL BLENDER

Blending is the process in which two parts are mixed together and a homogenous mass is produced. The lubricant is mixed here and the final granulation is completed then it is ready for compression. The blender contains following parts Inlet: it is connected to a pump from were the material is feed in the granulator.Blender: it the container were the actual mixing is done, it is octagonal in shape. Control: it contains basic control which is used to adjust the speed, time and

temperature.Outlet: it is the spot from were the material is taken out.

WORKINGThe material is sucked in the container by pump and then the controls are set as per the given parameter. On the completion of the cycle the material is send to the compression unit.

SLURRY


It is the mixer of the binder and paste forming agent it is used to produce a mass with paste like consistency which is mixed to the powder and which then forms the granulation mass.The slurry is made in a simple steam jacketed pan(as shown in fig) the temperature is maintained by the steam and ingredients are added in the pan and then paste is formed and then taken out In the container and then added to the granulator.

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COMPRESSION


Tablets are made by compressing a formulation containing a drug or drugs with excepients on stamping machines called presses. Tablets compression machines or tablets presses are designed with the following basic components:

1. Hopper for holding and feeding granulation to be compressed.2. Dies that define the size and shape of the tablets.3. Punches for compressing the granulation within the dies.4. Cam tracks for guiding the movement of the punches.5. A feeding mechanism for moving granulation from the hopper in to the

dies.

Tablet presses are classified as either 1. Single-punch or 2. Multi-station rotatory presses.

Tablet compression machine is of two typesSimple tablet compression machineCompression machine for bi layered tablets

Granules

Hopper

Die

Punch

Exit

COMPRESSION MACHINE FOR BI LAYERED TABLETS


Bilayered tablets are the tablets which contain 2 drugs which are compressed in one tablet. The idea of Bilayered tablets is that two drugs can be administered in one shots. The machine used to prepare Bilayered tablet is shown in the fig above, the design is similar to one used for the simple tablet compression machine the only difference is the single cycle in the Bilayered one and two cycle in simple one.

The machine contains following parts: Hoper 1& 2: These hoppers are feed with the two granules which while form the two

layers. Press: it produce the required force for tablet compression.Die and punch: this helps in the compression of the tablet, the size and shape of die and

punch can be changed as per the required eg oval, round, ovoid etc.Control: it helps to control the process for eg, compression force, speed, die fill

size etc.

WORKING

The material is filled in the hoper and the required die and punch set is arranged in the position. The machine is set with the require parameter, now the material from H1 comes in the die cavity and is compressed slightly so that it can hold the 2nd layer, this completes the half cycle, now the material from H2 is poured in the die with the downward movement of die to accommodate 2nd granules. Now the final punching is done so as to attained the final.

SIMPLE TABLET COMPRESSION MACHINE


The machine is simple design, the machine contain a die and punch which is used to compress the tablet to give parameter, the figure of machine is shown in the fig above. It is two hoppers and produces 2 tablets in round. The machine contain following parts.

Hopper 1&2: it the container in which material is filled.Drum punch and die: this assembly is used for the compression of tablet.Controls: This is used to set the required parameters to attained required

tablet.WORKING: The working is simple, in which the granules are filled in the hopper and the required punch and die is fixed and controls are set to a given parameter. The granule then comes in the die cavity and then they are compressed by the punch to produce the tablets.

IPQCThe” ipqc” parameters in the tablet compression are the


TABLET HARDNESS

Digital Hardness Meter Simple Mechanical Hardness Meter

The hardness is the important parameter in the tablet and is analyzed by two apparatus:Digital hardness meter: the tablet is placed in the cavity provide in the meter and then

gradually force is applied to it and the force at which the tablet breaks is noted.

Simple Mechanical Hardness: Meter the tablet is placed in the cavity given and the knob is rotated until the tablet is fixed this is initial reading, now the knob is tightened until the tablet breaks; this is final reading, from which the harness is calculated

Hardness = Final – initial (kg/inch2)

TABLET DIMENSIONSVERNIER CALIPERS

WEIGHT VARIATION


The tablet is placed in the cavity and the knob is rotated until is stops to moves further, the digital meter will show the reading in the inch or mm

20- 25 tablets are taken and their individual and combined weight is taken and weight variation is calculated, if the values are under limit the batches is passed and if not in limit suitable changes are done.

DISINTEGRATION TIME

BULK DENSITY

COATING


The tablet is placed in the holder and allowed to dip in the beaker for given period of time. The temperature is set to 370C and the disintegration is time is calculated if the time is under the limit the batch is said to be passed

The granules are filled in the beaker and the no. of tapping is made and the density checked.

There are many ways to coat tablets. Sugar coating was one of the earliest methods, and the process is still widely used in the confectionery industry. Wurster coating is another means. It employs a cylindrical chamber in which tablets are suspended by air and a coating solution is introduced into the air stream. Fluid-bed coating is a similar process. Dry coating is the technique of making a tablet within a tablet. But the principle means of applying a coating to pharmaceutical and nutraceutical

COATING SOLUTIONSFilm coatings are a mixture of solids and liquids. For many years, the liquid component of coatings was a volatile solvent, such as alcohol or other quick-drying substances like methylene chloride. While solvent-based coatings performed well in many respects, they presented problems in handling, operator safety, recovery, and odor. They could even make the finished tablets smell like solvent, which is not a desirable side effect. Solvent-based coatings are still used in some applications, but water based, or aqueous, coatings have largely replaced them .As a result, coating has become much more challenging, because water-based coatings are much less forgiving. You must apply the coating and remove the water before it can jeopardize the integrity of the tablet.

Coating equipmentA modern tablet coating system combines several components: a coating pan, a spraying system, an air handling unit, a dust collector, and the controls. The coating pan is actually a perforated drum that rotates within a cabinet. See Figure 1. The cabinet enables you to control airflow, air temperature, air pressure, and the coating application. The spraying system consists of several spray guns mounted on a manifold, a solution pump, a supply tank and mixer, and an air supply. The pump delivers the coating solution to the guns, where it combines with atomizing air to create a fine mist that is directed at the bed of tablets in the coating pan. The air handling unit heats and filters the air used to dry the coating on the tablets. Depending on your circumstances, it may include a humidifier or dehumidifier. The dust collector extracts air from the coating pan and keeps a slightly negative pressure within the cabinet. The controls enable you to orchestrate the operation of all the components to achieve the desired results. of the liquid component. It might think of film-coating tablets as spray-painting a bunch of golf balls. You can envision that it’s best to spray them lightly and evenly so that successive light coatings lock together. That’s how tablet coating works. Once the base coating is applied, you can increase the rate of solution addition and the pan speed proportionately. Typically, it takes about 20 minutes before you can increase the spray rate and pan speed significantly. Soft tablets and tablets that are very porous may require an


initial spray rate that is slower than the average of 100 milliliters per minute per gun. Be sure to monitor spraying to see whether the spray pattern changes. If it does, there is likely a buildup of solids on the gun tips. You can correct this only by cleaning the tips, which means stopping the spray and the pan. The images on page 20 show tablet coating spray nozzles being cleaned.

COATING MACHINE


The machine is shown in figure and can be studied as follows

CONSTRUCTION

PAN (DRUM)

The machine contains a huge drum of various sizes 60inch, 48inch, 36inch. With varying capacity. The drum is made of stainless steel. The pans are perforated so that the air can move in and out it contains baffles which helps in the mixing of the tablets and easy and even coating.

SPRAY GUN

The spray gun is shown in the figure above it is a nozzle type assembly used to spray the coating solution on the tablet. The tablets are constantly in firing line of spray gun and get coated by the solution.

CONTROLS The controls contains the parameter setting for the temperature of inlet, outlet to attain a good and dried coat with low moisture content, time of cycle, no. of cycles, RPM of pan spray volume spray time.

WORKING

The fig of working can be seen above. The solution is placed in container and feed to spray gun, the tablet is feed in the pan the parameter is set as per given specifications and the machine is switched on regularly the sample is taken out and checked for weight gain.


IPQC FOR COATING

Weight gain parameter: The weights of 20-25 tablets are taken and the initial weights are subtracted and the calculated value is matched with standard.

Appearance: the physical appearance is checked at regular interval of time for any visual imperfection


PRIMARY PACKING Primary packing is the packing of the tablet in the strips of unit size which can protect the

tablet and helps in the easy administration dose. The packing can strips of aluminum of blisters of aluminum or PVC. The machines used in the packing can be shown below and can be explained as follows. The goal of primary packing is to protect the drug and helps in easy administration of drug and easy transportation.

SIMPLE STRIP PACKING MACHINE The machine contains the hoper from were the tablet is filled in the cavity form by thermal procedure and then the sealing is done the controls are provided which maintains the speed and temperature. The cutter is available which cut the strip in the given dimension. The man is needed to check the strip and verify if any “NRR’ or” RR” are there and collect the strip for final packing.There is a stereo which contain the print details like mfg date, bat no, exp date cost. It is embossed in the alu. Film and then on the pack.


ALU-ALU PACKING MACHINE

This is machine which is used as the pack the material using both side aluminum foil. The design is shown in the figure it contains following parts and the working can be explained as below:

The film which is used to form the blister is the thick one and the sealing film is thin one. The

thick film is subjected to thermal treatment to produce the blisters of required dimensions.

Once the blisters are formed the tablet is filled in the blisters and then the covering film is

put, finally the sealing is done with suitable temperature.

The controls are available which is used to set the parameter of the machine related to speed

temperature and size of blisters.


SIMPLE BLISTER PACKING MACHINE

The machine is show in the figure and contains the simple parts the working can be

explained below.

The tablet is feed from the hopper the PVC foil is subjected to thermal treatment which

produces the blisters in the foil and then the tablet is filled in the blister and then the sealing

is done with the aluminum foil. The controls are available to set the process parameters.

Once the pack is sealed the cutter cuts the strips of given size and then send to final packing

Here the man is need to check the tablets and sort them out and remove the malformed.


BQS PAM - PAC

The machine is used as a blister packing machine; the important quality is that it can be used to pack both PVC and aluminum packing. The most widely used machine today due to its versatility.

The working is similar to other blister packing machine there is same slot for the aluminum foil and PVC foil the temperature is set and blister are produce and the process is similar to that of the simple blister packing machine.

The tablet is feed from the hopper the PVC foil is subjected to thermal treatment which produces the blisters in the foil and then the tablet is filled in the blister and then the sealing is done with the aluminum foil. The controls are available to set the process parameters.Once the pack is sealed the cutter cuts the strips of given size and then send to final packingHere the man is need to check the tablets and sort them out and remove the malformed.


FINAL PACKING

SHRINK PACKING MACHINEFinal packing is the packing of the product In the cartoons and cardboard packs so as to

sort then and aid their transportation, the material is packed as per the requirement of the

order like cardboard, plastics, shrink packs etc.

The final packing contains the details of the following types.

Manufacture date:

Expiry date:

Cost:

Batch no:

Lot no:

The details are in the form of rubber stereo which is printed on the cartoon and other packs.


The procedure of packing is as follows


Material request

The material for packing is ordered as per the size of the lot and the request is made by the proper order form which is send to material manager which is then relive the material. In the case when the material is in excess the left material is send back to the material manager which is mentioned in the form provided by the MM.The material then arrives in the quarantine area which is verified and then send for the printing.

Printing of the cartoons:

A rubber stereo is the one which contains the details engraved on it and it is embossed on the paper or the given surface.A special printing machine is used to print the stereo in which the labels and cartoons both can be printed. The labels and the cartoons are arranged in the slot and the machine prints the details on the material regularly ink levels are checked and refilling is done.

The stereo is available which contains the details of the Manufacture date:

Expiry date:

Cost:

Batch no:

Lot no:

Product verification:

The product to be packed (tablet/ capsules strips) are verified so that no empty strip can be packed this is done by two persons who physically inspect the product so that it don’t contain can empty strip or any breakage of any printing errors or the other errors, the product with errors are removed. In case the empty strip or the cartoon with less no of strip goes the weight variation helps to sort out them.

Product packing

The product is then packed in the outer cartoon in the given request and then sealing is done is per requirement. The helps the product to pack easily and then transport and storage


Weighing for variation

The cartoons are then weighted so that in case there is less material or more material it can be sorted out. This is done by simple balance. The weight of one pack is standardized and then all are verified on the basis of that reading. This sorts out the any anomaly in the product.

C artoon packing

Now the cartoon are packed in the big cartoon and they are labeled in such a way as per given specification. And sent to the ware house from there it is dispatched as per the deliver specification.


LIQUIDS


The bottles are received and verified and then is subjected to washing the washing is done with water at 600C and then dried at 1200C and then send to filling chamber it is then enter the filling unit and required about of liquid is filled and then the sealing is done and then send to capping and the label is stick on it and then filled in primary cartoon and then in final packing

LIQUID FILLING MACHINE

The fig above shows a simple liquid filling machine the working of which is as follows:

The liquid to be filled is stored in a big tank above and then desired quantity is released to be filled in the bottles. The bottles which are initially cleaned and washed are arranged in the required fashion by the concerned labor and then the bottle flow to the filling unit and the liquid is filled in the bottles. After that the bottles are then send forward were they are capped and incase plastic caps are to be placed are put on it. Nextly they are sent to the labeling assembly and were label is placed on then, and finally they are packed in individual container and then finally packed in cartoons with suitable details mentioned on then like

Batch no.Date of manufactureDate of expiry Address of manufacturer


Last, concluding my industrial training report, I am to say that my visit to IPCA, LABS RATLAM was a pleasant and knowledgeable experience in term of both theoretical and practical knowledge.

I’ ve got a golden chance to have a close view to processes involved in the production of pharmaceutical goods. I gathered brief information about equipments and materials included in the process.

This tour also tackled me with the disciplinary and co-operative qualities of the employees. It also taught me carness and attentiveness during the manufacturing and finishing the projects.

CONCLUSION


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