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26 May 2011

About CPS

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Custom Pharmaceutical Services (CPS), a Strategic Business Unit of Dr. Reddy’s, draws on the company’s expertise in pharmaceutical development and manufacturing to provide custom development and manufacturing services to innovators worldwide. To achieve its business objectives, CPS executes cost effective and time bound projects for its customers, providing cGMP compliant products manufactured in USFDA inspected and ISO certified facilities. For developmental needs, we have dedicated R&D facilities and pilot plants at UK and India. For high volume manufacturing, we have plants in UK, Mexico and India. We have sales and marketing offices in UK, France, Switzerland, USA, India and Japan.


Services offered by CPS include:

1.         Process development, scale-up and commercial manufacture of API's including highly potent compounds

2.         Formulation development, clinical trial manufacturing and commercial scale manufacturing of finished dosages including oral solids and fill-finish for highly potent compounds

3.         CMC support for IND, NDA and DMF filings.

The CPS competitive advantage lies in its entrepreneurial set-up, which can act fast and flexibly to provide the client from small-scale clinical trial quantities to commercial scale quantities. The end-to-end services offering coupled with competitive pricing offer a compelling value proposition.

Here is a snap-shot of CPS' capabilities:

  • Chemical- Chemistry skills from development to commercial manufacturing, including regulatory filling support.
  • Dosage- Prototype development to commercial manufacturing, including regulatory filling support.
  • Manufacturing- 8 commercial API ( Drug substance) manufacturing and 6 dosage (Drug product) manufacturing facilities in and outside India. 6 API plants located in India, 1 in Mexico (Manufacturing Hormones and Steroids) and 1 in Mirfield, UK. All 8 API manufacturing plants have been audited by USFDA on several occasions. All 6 finished dosage plants are located in India, one of them being audited and approved by USFDA.
  • Proteins- a scale-up experience of an octa-peptide in laboratory and this precedence proves CPS' expertise in peptide synthesis.
  • High potent/Cyto-toxic ingredients and dosage- development & scale-up services. Towards this CPS has 2 commercial API plants for high potent/cytotoxic molecules & 1 formulation plant for oral solid, lyo filling and soft gelatine cytotoxic products manufacture.
  • Capability of handling steroids both at R&D level and commercial scale-up at our plant in Mexico (Acquired from Roche in 2005).
  • In 2008 CPS acquired Dow Pharma's small molecule facilities & technology in UK, which give it expertise toward use of proprietary bio-catalysts, chemocatalysts, asymmetrical hydrogenation etc used in highly complex chiral chemistries.
  • CPS can also leverage our presence across geographies for marketing any of innovator's products.

    Capabilities that include product development, commercial manufacturing, IP management, regulatory filling and sales & marketing presence across the globe therefore gives attractive blend of CPS' services to our business partners.

CPS' Robust Quality Management systems with core Standard Operating Procedures detailed across all the manufacturing units ensure that only the best quality products leave its facilities. Compliance with global quality standards of cGMP, USFDA and European regulatory authorities reiterates CPS' emphasis on quality as a key Dr. Reddy's value. For more information, log on to: www.drreddys-cps.com

About Dr. Reddy's Laboratories Ltd.

Established in 1984, Dr. Reddy's Laboratories Ltd. (NYSE: RDY) is an integrated global pharmaceutical company, committed to providing affordable and innovative medicines for healthier lives. Through its three businesses - Pharmaceutical Services and Active Ingredients, Global Generics and Proprietary Products - Dr. Reddy's offers a portfolio of products and services including APIs, custom pharmaceutical services, generics, biosimilars, differentiated formulations and NCEs. Therapeutic focus is on gastro-intestinal, cardiovascular, diabetology, oncology, pain management, anti-infective and pediatrics. Major markets include India, USA, Russia and CIS, Germany, UK, Venezuela, S. Africa, Romania, and New Zealand. Dr. Reddy's Laboratories' strong portfolio of businesses, geographies and products gives it an edge in an increasingly competitive global market and allows it to provide affordable medication to people across the world, regardless of geographic and socio-economic barriers. With revenues of $1.6B in FY2009-10, Dr. Reddy's is one of the largest pharmaceutical companies in India

For more information, log on to: www.drreddys.com


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