US FDA imposes ban on products made at Sun Pharmas Gujarat plant

The US Food and Drug Administration (FDA) has issued an import alert on generic drug maker Sun Pharmaceutical Industries's plant at Karkhadi in Gujarat. The import alert was imposed after FDA inspection of the facility, where they found some non-compliance of current Good manufacturing practice (cGMP) regulations.

The plant makes small quantity of antibiotics (cephalosporin bulk and formulations). The import alert is issued for all products manufactured at Karkhadi unit. An "import alert" results in the detention without physical examination of drugs from firms that have not met good manufacturing practices, according to the FDA website. Sun Pharma operates some 12 US-approved factories. With around six in the US, three in India and one each in Canada, Israel and Hungry. Sun Pharma spokesman said that the Company remains fully committed to compliance and has already initiated several corrective steps to address the observations made by the US FDA.

Earlier this week, Company has issued a voluntary recall for 2,528 bottles of its generic version of diabetes drug Glumetza from US-based Santarus Inc after complaints of bottling mix-ups. Sun Pharma began recalling of bottles of Metformin hydrochloride extended-release tablets in US market, after a customer complained that that one of the bottles contained tablets of epilepsy drug Gabapentin, a drug used to treat seizures. This batch was manufactured in April 2013 and was set to expire in March 2016. The FDA declared the recall as a Class II, which signifies a remote chance of severe adverse consequences or death due to the product flaw.