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Sun Pharma shares fall after report about FDA queries

The US FDA could not be immediately reached for comment.

Written by Reuters | Mumbai | Published: October 29, 2013 2:57:46 am

Shares of Sun Pharmaceutical fell as much as 2.1 per cent after Bloomberg News reported it had received queries from the US Food and Drug Administration over quality control at a US subsidiary.

Sun received two so-called Form 483s,issued when the US regulator has queries,for its Detroit-based Caraco Pharmaceutical Laboratories Ltd following inspections in January and May this year,Bloomberg reported on Monday,citing a Freedom of Information Act request.

A Sun Pharma spokeswoman said in an email that the company “had responded” to the Form 483s “a long time back,” and called them “minor observations”.

Bloomberg reported the FDA inspectors had found temperature control lapses,some improperly sealed containers and a deviation of quality control procedures.

The US FDA could not be immediately reached for comment. Indian drugmakers have been battered this year by a rash of US regulatory rebukes,and have faced closer FDA scrutiny,reflecting the country’s growing importance as a supplier to the US.

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