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Dr. Reddy's Laboratories, Inc. (RDY)'s Mexican Arm Receives FDA Warning Letter


6/14/2011 9:59:52 AM

HYDERABAD, India--(BUSINESS WIRE)--Dr. Reddy’s Laboratories Ltd. (NYSE:RDY) announced today that Industrias Quimicas Falcon de Mexico SA de C.V. (Dr. Reddy’s chemical manufacturing facility at Cuernavaca, Mexico), a wholly owned subsidiary of Dr. Reddy’s Laboratories Limited, has received a four item Warning Letter from the United States Food and Drug Administration (USFDA).

The USFDA inspected Dr. Reddy’s Mexico facility in November 2010. That Inspection resulted in issuance of Form FDA 483, with observations. Dr. Reddy’s felt it responded to the 483 observations by implementing a number of corrective actions. However, the USFDA has asked for additional data and corrective actions to the items listed in the Warning Letter. Dr. Reddy’s takes these matters seriously and will respond to the USFDA within the stipulated timeframe. Dr. Reddy’s looks forward to working collaboratively with the USFDA to resolve the matters contained in the Warning Letter.

The Mexico facility produces Intermediates and Active Pharmaceutical Ingredients.

Disclaimer

This press release includes forward-looking statements, as defined in the U.S. Private Securities Litigation Reform Act of 1995. We have based these forward-looking statements on our current expectations and projections about future events. Such statements involve known and unknown risks, uncertainties and other factors that may cause actual results to differ materially. Such factors include, but are not limited to, changes in local and global economic conditions, our ability to successfully implement our strategy, the market acceptance of and demand for our products, our growth and expansion, technological change and our exposure to market risks. By their nature, these expectations and projections are only estimates and could be materially different from actual results in the future.

About Dr. Reddy’s

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



   

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