Contract Manufacturing & Research Players:

Indian CRAMS Players

No. of
Experience
Player Plants Approvals Client Base
Since
*
Dishman Solvay, Merck, Astra
5 U.S. FDA 1999
Pharma Zeneca, GSK, KRKA
Jubilant U.S. FDA, CoS of Syngenta, 15 of the top 20
8 1992
Organosys Europe, TGA Australia global Pharma companies
Piramal U.S. FDA, UK MHRA,
8 2003 Pfizer, AMO, Boots, Wyeth
Healthcare Korean FDA, MCC SA
Over five Big Pharma
Dr Reddy’s
2 U.S. FDA 2001 companies and over 25
Labs
emerging pharma companies
U.S. FDA, MEB
Netherlands, TGA Relationship with 20 of the
Divi's Labs 3 Australia, AIFA Italy, 1990 25 top players in global
DGMP Belgium, Health market
Canada, PMDA Japan
U.S. FDA, UK MHRA, Technology licensing to
Shasun
5 UK MCA, TPD Canada, 2006 Merck & Co., U.S. and H.
Pharma
EDQM Lunbeck, the Netherlands
Suven Life Eli Lilly pre-clinical CNS
3 U.S. FDA 1994
Sciences molecule
Cadilla Nycomed, Hospira, Madaus
2 U.S. FDA 2004
Health care AG
Hikal 1 U.S. FDA 2001 Pfizer, Alpharma

* Not necessarily engaged in CRAMS activities, Source: Anand Rathi Research June 2008

Edge to Indian Players:

• At present, India has about 75 U.S FDA approved plants. This is the highest number of
U.S. FDA approved plants outside the U.S. India has now established itself globally as a
cost effective drug manufacturer. Further, the presence of MNCs in India has brought in
high international standards of quality and understanding of GMP.
• The introduction of product patents in January 2005 gave a significant boost to India’s
pharmaceutical manufacturing outsourcing industry, since this TRIPS compliant
regulatory framework has instilled confidence of multinational pharmaceutical companies
in the Indian market.
 • India’s capital efficiency:
Cost of manufacturing in India and Europe:
US 100
Europe 85-90
India
– US FDA 35-40
– Others 25-30
China 20-25

The cost of manufacturing in India is a fraction of the cost of manufacturing in the U.S.
or in Europe. India has one of the lowest costs of manufacturing and one of the lowest
manpower rates in the world.
• Labor cost comparison:

• Basically if we look at the cost in Europe and U.S., with all the laws like maximum 40
hours working per week and the hostile weather conditions, working in second and third
shifts is getting difficult. It’s not only that the cost of manpower is high, finding the
manpower resources is equally challenging. And to run the plant on a 24X7 basis is
extremely difficult. The productivity that an Indian or a Chinese plant can give is far
more than what they get from their own plants.

India therefore demonstrates strong credentials and holds an excellent value proposition to play a
critical role in the global contract manufacturing opportunity. However more investments need to
channeled into this industry to scale up the operational and regulatory infrastructure in order to
capitalize well on the India advantage and seize a larger share of the market opportunity.

The Indian contract manufacturing industry typically comprises of:

• Old generics and old molecules
• Specialized generics
• Patented drugs, custom synthesis and scale-ups
• Experienced Indian CRAMS players are now acquiring better technologies and
developing expertise in niche segments that offer higher margins and have higher entry
barriers, thereby creating a niche for themselves.