USFDA Lifts Import Alert from Dr. Reddy's Chemical Manufacturing Facility at Cuernavaca, Mexico
Dr. Reddy's Laboratories Ltd. (NYSE: RDY) today announced that the import alert at 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 been lifted. Dr. Reddy's received a clearance from the United States Food and Drug Administration (USFDA) on 26 July, 2012.
Dr. Reddy's Mexico facility was inspected by USFDA in November 2010. Based on observations by the USFDA, a Warning Letter was shared on June 14, 2011 with the company.
Dr. Reddy's worked with USFDA to resolve the observations in the Warning Letter. An inspection report after the last inspection from 26 – 30 March, 2012 indicated that they are satisfied with all the outstanding action points that Dr. Reddy's has submitted.
With the satisfactory closure of observations in the warning Letter and the lifting of the import alert, Dr. Reddy's can now start importing products to the US from this facility.
The Mexico facility produces Intermediates and Active Pharmaceutical Ingredients.
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.
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 - , and – 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: