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IPCA, RATLAM

“FORMULATION”
JULY-2009

SUBMITTED TO SUBMITTED BY:


P.P. DUBEY ARUN KUMAR TRIPATHI
(DGM-HR & ADMIN) SHISHIR KAWDE

LAKSHMI NARAIN COLLEGE OF PHARMACY


BHOPAL

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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.

INDEX

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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

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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.

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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.

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- 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

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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.

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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

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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.
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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).
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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
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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

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*

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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-Present
Chief Executive officer, Managing Director, Director and Member of Shareholders &
Investors Grievance Committee
Ipca Laboratories Ltd.
Director, Member of Audit Committee and Member of Remuneration Committee
Brescon Corporate Advisors Ltd.

OTHER AFFILIATIONS*
Brescon Corporate Advisors Ltd.
Kaygee Investments Pvt. Ltd.

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 INR


This 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

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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.

ANNUAL COMPENSATION*
BOARD OF DIRECTORS Salary 2,280,000
MEMBERSHIPS* Total Annual Compensation 2,280,000

1994-Present STOCK OPTIONS*


Chief Financial Officer, Head of Accounts,
Head of Information Technology, Head of All Other Compensation 7,146,000
Costing & Taxation, Chemical R & D and
Executive Director TOTAL COMPENSATION*
Ipca Laboratories Ltd.
. 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 ...

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BOARD OF DIRECTORS MEMBERSHIPS*
2007-Present
Independent Director and Chairman of Remuneration Committee
VRL Logistics Ltd
2002-Present
Chairman
Ipca Laboratories Ltd.
2002-Present
Director, Chairman of Audit Committee and Member of Remuneration & Compensation
Committee
Dewan Housing Finance Corp. Ltd.
2000-Present
Former Chairman and Managing Director
Global Trust Bank Ltd.
Former Director and Member of Remuneration Committee
Zicom Electronic Security Systems Ltd.

EDUCATION
Master's Degree
University of Pune

OTHER AFFILIATIONS
Global Trust Bank Ltd.
University of Pune
Zicom Electronic Security Systems Ltd.
Dewan Housing Finance Corp. Ltd.
VRL Logistics Ltd

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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.
6
This 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.

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BOARD OF DIRECTORS
MEMBERSHIPS* TOTAL COMPENSATION

1988-Present Total Annual Cash Compensation 150,000


Non-Executive Independent Director, Chairman of Total Calculated Compensation 150,000
Audit Committee, Chairman of Shareholders /
Investors Grievance Committee and Chairman of
Remuneration & Compensation Committee
Ipca Laboratories Ltd.

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 ...

BOARD OF DIRECTORS
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MEMBERSHIPS* TOTAL COMPENSATION*
2000-Present Total Annual Cash Compensation 130,000
Non-Executive Independent Director, Member of Total Calculated Compensation 130,000
Remuneration & Compensation Committee and
Member of Audit Committee
Ipca Laboratories Ltd.

.
EDUCATION*
PhD
University of Pune
Master's Degree
Andhra University

OTHER AFFILIATIONS*

University of Pune
Andhra 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.

ANNUAL COMPENSATION*
BOARD OF DIRECTORS Salary 3,360,000

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Total Annual Compensation 3,360,000
MEMBERSHIPS*
STOCK OPTIONS*
1983-Present
Non Executive Director and Member of All Other Compensation 9,656,000
Shareholders / Investors Grievance
Committee TOTAL COMPENSATION*
Ipca Laboratories Ltd.
. Total Annual Cash
3,360,000
Compensation
Total Short Term Compensation 3,360,000
Other Long Term Compensation 9,656,000
13,016,00
Total Calculated Compensation
0

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 ...
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BOARD OF DIRECTORS
MEMBERSHIPS*
2008-Present
Director, 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 Committee
Ipca Laboratories Ltd.
1994-Present
Independent Non-Executive Director, Chairman of
Audit Committee and Chairman of Share Transfer
& Shareholders Grievance Committee
TOTAL COMPENSATION*
Apar Industries Limited
Independent Non-Executive Director, Chairman of Total Annual Cash Compensation 182,500
Remuneration Committee and Member of Audit Total Calculated Compensation 182,500
Committee
Gujarat Borosil Ltd.

EDUCATION*
Master's Degree
Jamnalal Bajaj Institute of Management Studies
Other Education
University of Mumbai

OTHER AFFILIATIONS*
Ipca Laboratories Ltd.
Jamnalal Bajaj Institute of Management Studies
University of Mumbai
Gujarat Borosil Ltd.
Uniflex Cables Ltd.

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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.

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- 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:-

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- 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:-

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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 LIST
Formulations > BELARUS > Brand Names

Brand Names Generic Names Therapeutic Group Strength Pack Size


Lomflox Lomefloxacin Antiinfectives 400mg Tabs 1X5's
Tablets
Nemocid Pyrantel Pamoate Gastroenterologicals 250mg per 5ml 1X10ml
Suspension
Nemocid Pyrantel Pamoate Gastroenterologicals 250mg Tabs 10X3's
Tablets
Normax Eye / Norfloxacin Antiinfectives 0.3% w/v + 0.02% 1X5ml
Ear Drops v/v
Normax Norfloxacin Antiinfectives 400mg Tabs 1X6's
Tablets
Perinorm Metoclopramide Gastroenterologicals 5mg per 1ml 1X50X2m
Injection l
Perinorm Metoclopramide Gastroenterologicals 10mg Tabs 10X10's
Tablets
Solvin Elixir Bromhexine Drugs for Respiratory 4mg per 5ml 1X120ml

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System
Solvin Tablets Bromhexine Drugs for Respiratory 8mg Tabs 10X10's
System
Talcef Cefotaxime Antiinfectives 1gm 1X1gm
Injection
Tenolol Atenolol Cardiovascular 100mg Tabs 10X10's
Tablets
Tenolol Atenolol Cardiovascular 100mg Tabs 2X14's
Tablets
Tenoric Atenolol + Cardiovascular 50mg+12.5mg/ 2X14's
Tablets Chlorthalidone 100mg+25mg Tabs

Formulations > BURUNDI > Brand Names

GENERIC BRAND THERAPEUTIC STRENGTH PACK


NAMES NAME GROUP SIZE
Cinkona Quinine Antimalarials 300mg per 1ml 10X10X2ml
Injection Dihydrochloride
Nemozole Albendazole Gastroenterologicals 200mg Tabs 50X2's
Tablets

Formulations > Cambodia > Brand Names


GENERIC BRAND THERAPEUTIC STRENGTH PACK
NAMES NAME GROUP SIZE
Ampicillin IpcacillinCapsules Antiinfectives 500mg Caps 10x10's

Formulations > D.R.Congo > Brand Names

BRAND GENERIC THERAPEUTIC STRENGTH PACK


NAME NAMES GROUP SIZE
Amodiaquine Amodiaquine Antimalarials 200mg Tabs 1x1000's
Hydrochloride Hydrochloride

Cinkona Quinine Sulphate Antimalarials 300mg Tabs 10x6's


Tablets
Giardyl Metronidazole Antiinfectives 5mg per 1ml 1x100ml
Infusion Benzoate
Giardyl Iv Metronidazole Antiinfectives 500mg per 1x100ml
Infusion Intravenous 100ml
Larither Artemether Antimalarials 80mg per 1ml 6x1ml

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Injection
Nemocid Pyrantel Pamoate Gastroenterologicals 250mg per 5ml 1x15ml
Suspension
Nemocid Pyrantel Pamoate Gastroenterologicals 250mg Tabs 10x3's
Tablets
Nimica Nimesulide Antiinflammatory/ 50mg per 5ml 1x60ml
Suspension Analgesic
Nimica Tablets Nimesulide Antiinflammatory/ 100 dt Tabs 10x10's
Analgesic
Perinorm Metoclopramide Gastroenterologicals 5mg per 1ml 10x2ml
Injection
Perinorm Metoclopramide Gastroenterologicals 5mg per 5ml 1x30ml
Syrup

Formulations > Ghana > Brand Names

BRAND GENERIC THERAPEUTIC STRENGTH PACK


NAME NAMES GROUP SIZE
Ampicillin Ampicillin Antiinfectives 500mg Caps 100x10's /
1000's
Cloxacillin Cloxacillin Antiinfectives 250mg Caps 100x10's
Larither Artemether Antimalarials 40mg/80mg per 6x1ml
Injection 1ml

Albendazole Gastroenterologicals 100mg/250mg 1x20ml


Nemozole
per 5ml
Suspension
Nemozole Albendazole Gastroenterologicals 400mg Tabs 10x1x1's
Tablets

Formulations > India > Brand Names


BRAND GENERIC THERAPEUTIC STRENGTH PACK
NAME NAMES GROUP SIZE
Acera Caps Rabeprazole + Gastroenterologicals 20+30 mg Foil Strip of
Domperidone 10's
Sustained
Release
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 Blister of
mg250mg 6's & 500
mg:Blister
of 3's

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Azifast Gel Azithromycin Antiinfectives 2% gel Tube of
20gm
Azifast Tabs Azithromycin Antiinfectives 250 mg / 500 Blister of
mg250mg 6's & 500
mg:Blister
of 3's
Betamotil Inj . Beta Arteether Antimalarials 150 mg/2ml Ampoule of
2 ml
Bromhexine Bromhexine 4 Drugs for 4mg/5 ml 100 ml
Elixir Susp mg Respiratory System bottle
Bromhexine Bromhexine Drugs for 8mg Blister of
Tabs. HCl Respiratory System 10's
Bronchosolvin Terbutaline + Drugs for 1.25mg + 4mg + 60 ml/100
Susp Bromhexine + Respiratory System 50mg ml Bottle
Guaiphenesin
Bronchosolvin Terbutaline + Drugs for 2.5mg + 8mg + Blister of
Tabs. Bromhexine + Respiratory System 100 mg 10's
Guaiphenesin
Calchek L tabs Amlodipine + Cardiovascular 2.5+ 2.5 / 5 + 5 Foil Strip of
Lisinopril mg 10's
Calchek Tabs Amlodipine Cardiovascular 10mg/2.5mg/5mg Foil Strip of
10's

Calcitriol+Calc Nutritionals 0.25mcg+500mg Blister of


Calten Caps
ium +7.5mg 10's
Carbonate+Zin
c
Calten D Tabs Calcium Nutritionals 1250mg+250IU+ Blister of
Carbonate+Vit 7.5mg 10's
amin D3+Zinc
Cardioplus Anti-oxidant Nutritionals Blister of
Caps. vitamins + 10's
Minerals
Celedol Caps. Celecoxib Antiinflammatory/ 100 mg, 200 mg Blister of
Analgesic 10's
Cinkona Injection Antimalarials 300 mg / 2 ml Ampoule of
Quinine 2 ml
Dihydrochlorid
e + Benzyl
Alcohol
Cinkona Quinine Antimalarials 150 mg/ 5 ml 60 ml bottle
Suspension Sulphate
Cinkona Tabs Quinine Antimalarials 100mg/600mg/ Foil strip of
Sulphate 300mg100/600mg 10's &

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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 + Cardiovascular 75+150 mg / Foil strip of
Aspirin 75+75mg 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 Dermatologicals 15%+6% Tube of
paraffin+Light 40gm
liquid paraffin
Cutinorm Lotion Glycerine Dermatologicals 10% Bottle of
50ml
Cutisoft Cream Hydrocortisone Steroid 1% 10 mgTube
acetate - of 10 gm
Cytovit Capsules Anti-oxidant Nutritionals Blister of
vitamins + 10's
Minerals
Diasol Caps DiacereinDMD 50mg Strip of 10's
Foil

Divalrate ER Divalproex Antiepileptic 125mg/250mg/50 Foil Strip of


Tabs Sodium 0mg 10's
Extended
Release
Domperi DT Domperidone Gastroenterologicals Tabs. 5 mg, 10 Strip of 10's
Foil Dispersible mg
Tabs.
Domperi OD Domperidone Gastroenterologicals 30 mg Blister of
Caps Sustained 10's
Release
Domperi Susp. Domperidone Gastroenterologicals 5 mg / 5 ml 30 ml.
Bottle
Donica Caps Indomethacin Antiinflammatory/ 25 mg Blister of
Analgesic 10's
Donica-SR Caps Indomethacin Antiinflammatory/ 75 mg Blister of
Sustained Analgesic 10's
Release
Eltocin - DS. Erythromycin Antiinfectives Tabs 500 mg/ tab Blister of

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Estolate 10's
Eltocin Kid. Erythromycin Antiinfectives Tabs. 125 mg/ tab Foil strip of
Estolate 10's
Eltocin Susp. Erythromycin Antiinfectives 125 mg/5 ml 60 ml bottle
Estolate
Eltocin Tabs Erythromycin Antiinfectives 250mg Blister of
Estolate 10's
Emnorm Tabs Metformin Antidiabetics 250mg/500mg/85
Hydrochlor 0mg
Emnormlg ER Tabs Metformin Antidiabetics 1000mg Blister of
Extended 10's
Release
Emotrip Tabs Amytryptilline+ Psychotropics 12.5 mg / 25 mg Blister of
Chlordiazepoxi 10'
de
Epictal Tabs Levetiracetam Antiepileptic 250mg/500mg/75 Blister of
0mg 10's
Etova Tabs Etodolac Antiinflammatory/ 200mg/300mg/40 Alu-Alu
Analgesic 0mg Strip of 10's
Fexova Tabs. Fexofenadine Antiallergic 120 mg, 180 mg Blister of
10's
Folitrax Tabs. Methotrexate 2.5 mg, 5 mg, 7.5 Blister of
DMD I.P mg,10 mg 10's
Folitrax-15 Methotrexate 15 mg/ml Ampoule of
Inj..DMD I.P 1 ml

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


I.P
Foloup 50 Dry Cefpodoxime Antiinfectives 50 mg / 5 ml Bottle of 30
Syrup Proxetil ml
Foloup DT Tabs Cefpodoxime Antiinfectives 100mg Foil Strip of
Proxetil 10's
Foloup Tabs Cefpodoxime Antiinfectives 200 mg Foil strip of
Proxetil 6's
Glycinorm M Gliclazide + Antidiabetics 30 + 500 mg/60 Alu-Alu
MR Tabs Metformin + 500 mg Strip of 10's
Glycinorm M Gliclazide + Antidiabetics 40mg/80mg Blister of
Tabs. Metformin 10's
Glycinorm OD Gliclazide Antidiabetics 30mg/60 mg Alu-Alu
Tabs Modified Strip of 10's
Release
Glycinorm Tabs: Gliclazide Antidiabetics 40mg/80mg/160m Blister of
g40/80mg 10's &
160mg:Foil
Strip of 10's

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Glyree M Forte Glimepiride + Antidiabetics 2mg+1000mg Alu-Alu
Metformin Strip of 10's
Extended
Release
Glyree M Tabs Glimepiride+M Antidiabetics 1mg+500mg/ Alu-Alu
etformin 2mg+500mg Strip of 10's
Glyree MP Tabs Glimepiride + Antidiabetics 1+500+15mg/2+ Blister of
Metformin 500+15mg 10's
Extended
Release +
Pioglitazone
Glyree Tabs. Glimepiride Antidiabetics 1mg/2mg/3mg/4m Foil Strip of
g 10's
HCQS Tabs Hydroxychloro DMD 200mg Blister of
quine Sulfate 10's
Hyphoral Lotion Ketoconazole Dermatologicals 50 ml. Plastic
2% + Zinc bottle
Pyrithione 1%
Hyphoral Tabs Ketoconazole Antiinfectives 200 mg Foil Strip of
10's
Inditor SR Tabs .Indapamide Cardiovascula 1.5mg Foil Strip of
r Sustained 10's
Release
Inditor Tabs Foil Indapamide Cardiovascular 2.5mg Strip of 10's

Inosert Tabs Sertraline Psychotropics 25mg / 50mg/ Blister of


100mg 10's
Inosert Tabs Sertraline Psychotropics 25mg / 50mg / Blister of
100mg 10's
Intigem Tabs Gemifloxacin Antiinfectives 320mg Blister of
Mexylate 5's
Isordil Tabs: Isosorbide Cardiovascular 5mg/10mg5mg Blister of
Dinitrate 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 gm
Keftra 1.25 Inj Ceftriaxone Antiinfectives 125 mg Vial of 125
mg
Keftragard Ceftriaxone + Antiinfectives 125mg+62.5 mg Vial of
Sulbactam 0.1875 Inj 0.1875 gm

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Keftragard 0.375 Ceftriaxone + Antiinfectives 250mg+125mg Vial of
Inj Sulbactum 0.375 gm
Keftragard 0.75 Ceftriaxone + Antiinfectives 500mg+250mg Vial of 0.75
Inj Sulbactum gm
Keftragard 1.5 Ceftriaxone + Antiinfectives 1000mg+500mg Vial of 1.5
Inj Sulbactum 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).

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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 Formulations Therapeutic Group-wise Formulations


Exports 2007-08 (in Percentage) Exports 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.
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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).

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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

Divisio
n
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

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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).

Divisio
n
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.

Divisio
n

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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.

MANUFACTURING FACILITIES

Ipca has cGMP complying manufacturing facilities at the following locations in

India.

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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. »»

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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

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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
.

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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 processes

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Alternative cost effective routes
Increasing 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 Processor
Ganscoata
Walk-in Stability Chambers
Dissolution Apparatus with intrinsic dissolution
assembly
Bilayer Tablet Compression Machine
Equipments for liquid orals and semi-solid
Hard gel capsule facility
Blister packing machine with Alu-Alu facility
Press-cota
Roll compactor
Pelletisation facility
Facility 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:

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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-infective
Antidiabetics

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 Assurance
Intellectual 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

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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
WORLD-CLASS FACILITIES APPROVALS:

USFDA

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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

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
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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

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

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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.

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

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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
INSTITUTO NACIONAL DE VIGILANCIA DE MEDICAMENTOSY ALIMENTOS

(NATIONAL INSTITUTE FOR DRUGS AND FOOD SURVEILLANCE)

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MOH MALAWI/NAMIBIA/ZAMBIA

PIC GERMANY

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TRAINING SCHEDULED

SNO. DEPARTMENT

01. TRAINING
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02. GRANULATION
03. COMPRESSION
04. COATING
05. PRIMARY PACKING
06. FINAL PACKING
07. 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]

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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]

TRAINING
This activity is both focussed upon, and evaluated against, the job that an individual
currently holds.[3]
EDUCATION
This activity focusses upon the jobs that an individual may potentially hold in the
future, and is evaluated against those jobs.[3]
DEVELOPMENT
This 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]

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

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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
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

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FLOW DIAGRAM OF GRANULATION

Order requisition Raw material QC/QA certified


(Dispensed and stored)
IN PROCESS QUALITY CONTROL

Sifting
(Size separation)

Granulator
(Slurry + raw material)

Fluid Bed Dryer


(Drying of granules)

Blender
(Mix lubricant and granules)

Granules forward to compression

ORDER REQUISITION

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.
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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:

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

Checked By Dispensed By

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.

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SIFTING
Sifting 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 sifting
Outlet: 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.

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VIBRATOR SIFTER
The 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

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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
valve
Granulators 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.

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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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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 Control


In 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.

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

BLENDER
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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.

WORKING
The 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

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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.

COMPRESSION

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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 types
Simple tablet compression machine
Compression machine for bi layered tablets

Granules

Hopper

Die

Punch

Exit

COMPRESSION MACHINE FOR BI LAYERED TABLETS

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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

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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.

IPQC
The” ipqc” parameters in the tablet compression are the
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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 DIMENSIONS
VERNIER CALIPERS

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


WEIGHT VARIATION combined weight is taken and weight variation is
calculated, if the values are under limit the
Industrial
batches is passed and iftraining:
not in IPCA, Ratlam
limit suitable
changes are done. - 65 -
DISINTEGRATION TIME

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

BULK DENSITY

The granules are filled in the beaker and the


no. of tapping is made and the density
checked.

COATING
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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 SOLUTIONS
Film 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 equipment
A 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

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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

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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.

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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

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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.

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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.

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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.

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

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FINAL PACKING

SHRINK PACKING MACHINE


Final 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.

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The procedure of packing is as follows

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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

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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.

Cartoon 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.

Industrial training: IPCA, Ratlam


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LIQUIDS

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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 manufacture
Date of expiry
Address of manufacturer
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CONCLUSION

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.

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