Dr Reddy's Mexican arm receives USFDA warning letter

15 Jun 2011 Evaluate

Drug maker Dr Reddy's Laboratories’s Mexican arm has received a warning letter from the US health regulator for violation of current goods manufacturing practice regulations. Industrias Quimicas Falcon de Mexico SA has received a warning letter -- on four counts -- from the US Food and Drug Administration (USFDA). The four counts include non-validation of analytical methods used to test APIs.

The company's Mexico facility produces intermediates and active pharmaceutical ingredients.The USFDA had inspected Dr Reddy's Mexico facility in November 2010 and later sought certain explanations from the company. However, the regulator issued the warning letter dated June 3, citing 'lack of corrective actions' by the firm.

The pharmaceutical services and active ingredients business accounted for a little more than a fourth of Dr. Reddy's consolidated sales of Rs 74.69 billion in the last fiscal year ended March 31. North America contributed 16% of this business segment's sales.crackcrack

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