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 countrys growing importance as a supplier to the US.