The US Food and Drug Administration (USFDA), may re-inspect Dr Reddy’s Laboratories’ (DRL) Mexico

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plant by June 2012.

The unit received a four-item warning letter in June 2011. The Hyderabad-based drugmaker has last month sent the re-inspection request to the USFDA and hopes to hear from it by June. Upon satisfactory review of our response, the USFDA is expected to re-inspect the plant shortly, said a top DRL official.

The Mexico facility produces intermediates and bulk drugs. The US drug regulator was unhappy with the corrective actions taken by the DRL management after it identified significant deviations from the current good manufacturing practice (CGMP) for bulk drugs at the unit during an inspection in November 2010.

The facility is supposed to have niche steroidal bulk drug capacities. It has the world’s largest capacity for sodium naproxen. The drugmaker manufactures drug worth around $60 million a year from this facility.