Hyderabad, India, June 14, 2011: 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.
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