Chapter 1

Introduction

HISTORY OF THE COMPANY

Cadila pharmaceuticals limited is One of India’s most reputed, Research-based, Tech-savvy

pharmaceutical companies focusing on areas – Formulations (Human & Veterinary), New
Drug Discovery, Novel Drug Delivery, Active Pharmaceutical Ingredients, Analytical
Research, Phytochemistry, Biotechnology, Plant Tissue Culture, Biosynthesis, Genetic
Engineering, Vaccines, Immunoglobulins – the entire gamut of a Company. Diversified
operations encompass Hospital Disposables & Instrumentation, Diagnostics, Specialty
Chemicals, Soft gel, Pharma Machinery, Telecommunications, Travel & Leisure .
Incorporated in 1951 as a quality
pharmaceuticals manufacturer in India, Cadila Pharmaceuticals over the last 53 years has
grown to the size and status of an integrated pharmaceutical company. The distilled wisdom
and competence of the group, encompassing over five decades has branched out into various
spheres. We offer services to research-based companies of all sizes in all major sectors of
pharmaceuticals. Our studies are used for the registration of products not only in India but
also in Brazil, South Africa, and other European countries.
 Cadila Laboratories was founded in 1952 by Shri Ramanbhai Patel (1925-2001),
formerly a lecturer in the L.M. College of Pharmacy, and his business partner Shri
Indravadan Modi. The company evolved over the next four decades into one of India's
established pharmaceutical companies.

 In 1995 the Patel and Modi families split, with the Modi family's share being moved
into a new company called Cadila Pharmaceuticals Ltd. and Cadila Healthcare
became the Patel family's holding company. Cadila Healthcare did its IPO on the
Bombay Stock Exchange in 2000. Its stock code on the Bombay exchange is 532321.
PHARMACEUTICAL INGREDIENT PLANTS
The company makes active pharmaceutical ingredients at three sites in India:

Ankleshwar plants - Zydus Cadila's plant complex at Ankleshwar in Bharuch District of

Gujarat, has been producing drug material since 1972. There are around 10 plants in the
complex, which are ISO 9002 and ISO 14001 certified as well as FDA Approved. The total
plant capacity at Ankleshwar is around 180 million tonnes.

Vadodara plant - Zydus Cadila's plant at Dhabhasa, in Vadodara District's Padra taluka (in
the eastern part of the district) in Gujarat, was commissioned in 1997 by a company called
Banyan Chemicals and acquired by Zydus Cadila in 2002. The plant has a 90 million tonnes
capacity. It is an FDA-approved facility that is also approved by WHO GMP guidelines.

Patalganga plant - Zydus Cadila acquired an API plant at Patalganga in Maharashtra state,
70 km from Mumbai, in the 2001 German Remedies deal. This plant operates to WHO GMP
standards.

FORMULATION PLANTS
The company operates formulation plants at six locations:

Moraiya plant - Zydus Cadila's formulation plant at Moraiya in Sanand taluka on the
outskirts of Ahmedabad is the largest in India. The plant became Food and Drug
Administration (FDA)-approved in 2004/2005. The plant makes tablets, capsules, and soft gel
capsules as well as injectable drugs in both sterile liquid and lyophilized form. Zydus Cadila
also runs a large R&D operation at Moraiya.

Vatwa plant - Zydus Cadila's plant at Vatwa, an industrial suburb of Ahmedabad, makes
nutraceuticals. The plant was acquired by German Remedies.
Changodar plant - Zydus Cadila's plant at Changodar, 20 kilometers from Ahmedabad on
the city's outskirts, manufactures fine chemicals. Zydus is currently constructing a facility at
Changodar to make vaccines for hepatitis B and Rabies.
Navi Mumbai plant - This operation, at Navi Mumbai in Maharashtra, is a 50/50 joint venture
with Germany's Altana Pharma AG, making intermediates of the drug pantoprazole.

Goa plant - The Company’s plants at Ponda in the southern Indian state of Goa do
formulation work as well as manufacture oncology drugs and herbal laxative branded
Agiolax based on Psyllium seeds.

MILESTONES
Today, Cadila is proud of its achievements —
 State-of-the-art formulations manufacturing facility, built to the exacting
specifications of USFDA, TGA, MCA & MCC.
 One of the best R & D set-ups in the country, manned by a 150-strong scientists' pool.
 Strong Formulations Development base.
 A host of 'Biotech' products were launched, including many 'Firsts in India'.
 World's First manufacturer of Immuvac- a unique Immunomodulator.
 USFDA approvals for Fluoxetine & Ethambutol manufacturing facilities.
 ISO 9002 approved Bulk Actives (APIs) manufacturing facility, offering facilities for
contract research.
 Asia's only manufacturer of 'SULFOLANE' (Tetramethylene Sulfone).
 Significant global presence.
 Leadership in Domestic Marketing and Distribution Management.
 Leader in Indian Generics Market.

INTERNATIONAL BUSINESS

In line with the vision to be a significant global player by 2010 A.D., Cadila Pharmaceuticals
is fast emerging as a true Indian multinational.
As part of our strategy, we have wholly-owned subsidiaries, joint ventures, strategic
alliances, contract manufacturing, own marketing offices in 4 countries, and have a
significant presence in over 46 countries across the globe. Our business revolves around the
exports of formulations, bulk actives, hospital disposables, veterinary formulations, and
pharmaceutical machinery manufacturing.
Besides a significant presence in the Americas, CIS Countries, Africa, Central, and South-
East Asia, Oceanic Countries, Japan, Middle East, and Europe, the company has offices in
the USA, Japan, Kenya, Nigeria, and Russia, Kazakhstan, and Ukraine. The International
SBU plans to expand operations to more than 100 countries by 2010.

Alliances exist with regional majors in the form of international marketing, joint ventures,
and contract manufacturing. More such collaborations are underway to expand the supply
chain network and facilitate extensive market coverage. An ultra-modern formulations
manufacturing facility conforming to the exacting standards of WHO-GMP, USFDA,
MHRA-UK, MCC-South Africa, TGA-Australia, ANVISA- Brazil, EU GMP, ISO 9002, and
Japanese GMP is a value-addition to the International SBU in flexing its muscles in the
overseas arena. This SBU has been honored with the Chemexcil Award, 2000-01, and Niryat
Shree Award from FIEO, for the year 2001-02.
With its basic philosophy of giving the best to the world at an affordable price, Cadila
Pharmaceuticals continues to make a difference in the lives of millions, while carving a niche
for Indian Pharmaceuticals exports, globally

MANUFACTURING EXCELLENCE

Pursuant to its corporate philosophy of striving for continuous improvement and betterment,
the Company has relocated its manufacturing operations to the state-of-the-art plant at
Dhokla, located 50 km from Ahmedabad, the commercial capital of Gujarat. Spread over 44
acres of verdant, picturesque surroundings, amidst lush green lawns and thick foliage, the
new locale is the most envied pharmaceutical installation in the Asian sub-continent.
Truly unique in every sense of the term, the Plant’s standards and facilities can match any
other, worldwide. Seven ‘zones of cleanliness’ have been defined and adhered to, as per the
1997 GMP guidelines of the European Union. Some of the salient features of the design
concepts:
 No wood or asbestos component.
 Each zone has separate AHUs (Air Handling Units), dehumidification units, and dust
extraction systems.
 Segregation of every critical processing activity in each zone, to avoid cross-
contamination.
 Respective zones, areas, and even uniforms are marked with specific colors of the
rainbow (‘Indradhanush’ in the vernacular), to ensure total segregation.
 The air environment is conditioned in each area with respect to temperature, humidity,
filtration, particle counts, etc.
 Confirmation of each processing stage with US Federal Standard 209E class of
cleanliness; viz. 100, 1,000, 10,000, 100,000 with respect to room air changes,
pressure, particle count, flow direction etc.
 Zero-discharge Effluent Treatment Plant constructed using technology from Advent
Integrated System, USA.
 Environment-friendly VAHP chillers.
 Rigvent heat extraction devices and Natural Skylit system in raw material, packing
material, and finished goods stores.
 Isolated and dedicated production facilities for B-Lactam and Cephalosporin dosage
forms.
The complex also houses its own full-fledged R&D center, set up at a cost of Rs. 200 million.
The Plant is equipped with modern high-speed machines and integrated packaging lines to
be cost-efficient. Extensive use of non-fill devices, collators, Brevetti visual inspection
machines, multi-station tablet presses, FFS machines, and high-speed vial/ampoule
filler/sealers are some examples. The plant—with high capacities and scope for future
expansion—can manufacture all dosage forms viz. Tablets, Capsules, Liquid Orals, Dry
Syrups, Aseptic Liquid and Solid preparations, Sachets, etc.