FDA bans Sun Pharma products made at Gujarat plant

Indian drug major Sun Pharma has been hit by a ban on import of products made at its Karkhadi plant in Gujarat by the US Food and Drug Administration due to violation of manufacturing norms. [caption id=“attachment_1065953” align=“alignleft” width=“380”] Representational Image. Reuters[/caption] According to the information available on USFDA website, the regulator has issued an import alert, which enables ‘detention without physical examination of drugs from firms which have not met drug GMPs (Good Manufacturing Practices)’. Comments from the company could not be obtained immediately. This is the first import alert for any of Sun Pharma’s plants from the USFDA, which has been cracking down heavily on firms such as Ranbaxy and Wockhardt that have not complied with its manufacturing norms. While all plants of Ranbaxy in India have been banned from exporting drugs to the US, Wockhardt has also faced similar actions on its two plants in India. As per Sun Pharmaceutical Industries’ website, Karkhadi plant manufactures active pharmaceutical ingredients and formulations. The company has 10 manufacturing sites in India. Earlier this week the company had voluntarily recalled 2,528 bottles of its generic version of diabetes drug Glumetza in the US market on the basis of a customer complaint. It was found that some bottles of Glumetza contained medicines to treat epilepsy. Sun Pharma scrip tanked 3.97 per cent from the previous close in the afternoon trade, quoting at Rs 580 on the BSE. PTI