Dr Reddy's Mexican unit to be inspected by USFDA this month

20 Mar 2012 Evaluate

Dr Reddy's Laboratories has been informed of an inspection by the U.S. Food and Drug Administration (USFDA) for its Mexican facility during the last week of this month. The drug regulator had in June last year banned imports of some active pharmaceutical ingredients and steroids made at the company’s unit into the US, citing violation of manufacturing practice rules.

The company is now working collaboratively with the FDA to resolve the regulatory issues concerning the Mexican facility. However, in a statement to the Securities and Exchange Commission of USA, the company reported that it believes that the detention without physical examination (DWPE) alert issued by USFDA is of a temporary nature and that it is not expected to have a material long term effect on the company's Mexican operations.

Nonetheless, the company cannot be assured that satisfying the USFDA's concerns will not take longer than currently anticipated or that the USFDA will not request additional corrective actions that would result in the DWPE remaining in effect longer than currently anticipated.

The Mexico facility, which produces drug ingredients and intermediates, is part of Dr Reddy's pharmaceutical services and active ingredients business.

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