US FDA makes public warning for Ranbaxy's US facility

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US FDA makes public warning for Ranbaxy's US facility

The US Food and Drug Administration has written a warning letter to Ohm Laboratories, which is one of Ranbaxy’s US facilities. Ohm, which operates three US-based manufacturing facilities, sells generic and branded private label drugs. The move is significant as the US is one of Ranbaxy’s largest markets.

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The US Food and Drug Administration has made public the warning letter issued in December to Ohm Laboratories, which is one of Ranbaxy 's US facilities. Ohm, which operates three US-based manufacturing facilities, sells generic and branded private label drugs. The US is one of Ranbaxy's largest markets.

On December 24, 2009, Ranbaxy had received a warning letter citing violations at Ohm's liquid manufacturing facility in Gloversville, New York. The FDA had conducted site inspections at the plant in July and August 2009.

The generic drug maker has seen its share price more than halve from its all-time highs last year after a US ban on some of its products. In February, the regulator had hauled Ranbaxy for selling misbranded or adulterated drugs in the US.

But post acquisition by Daiichi Sankyo, things were beginning to look up for the company. The Japan's No 3 drugmaker had replaced the then Chairman and CEO Malvinder Singh with one of its own executives. At 12:02 pm, Ranbaxy Laboratories was quoting Rs 438.85, up Rs 0.10, or 0.02%. Yesterday, the share closed down 0.49%, or Rs 2.15, at Rs 438.75.

Turn to Page 2 for Vikas Dandekar of Pharmaasia.com views on the issue.