Manufacturing Woes Continue To Plague Dr Reddy’s; Are Generic Gleevec Launch Plans Under Threat?

Dr Reddy’s Laboratories was battered on Indian bourses on March 9 after one of the firm’s formulation sites failed to get a clean chit from the FDA, piling up pressure on important US generic launch timelines.

Pharmaceutical production

Frontline Indian firm Dr. Reddy's Laboratories Ltd. continues to grapple with manufacturing compliance issues at its Indian sites, with its formulation manufacturing unit in Duvvada at Visakhapatnam failing to make the cut on re-inspection by the US FDA.

The company informed the Bombay Stock Exchange that the site had been issued a Form 483 with 13 observations, which...

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