USFDA lifts import alert from Dr Reddys' Chemical Manufacturing Facility at Mexico

30 Jul 2012 Evaluate

Dr Reddy’s Laboratories - wholly owned subsidiary - Quimicas Falcon de Mexico SA de C.V., the company’s manufacturing facility located at Cuernavaca in Mexico’s import alert has been lifted. Dr. Reddy’s has received a clearance from the United States Food and Drug Administration (USFDA) on July 26, 2012.

The company’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. The company worked with USFDA to resolve the observations in the Warning Letter.

Further, an inspection report after the last inspection from March26 - 30, 2012 indicated that USFDA are satisfied with all the outstanding action points that the company 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.

Dr Reddy's 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 - the company offers a portfolio of products and services including APIs, custom pharmaceutical services, generics, bio-similars, differentiated formulations and NCEs. 

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