The U.S. FDA has banned imports from Indian generic drugmaker Sun Pharmaceutical Industries' plant in Karkhadi in Gujarat, India.
The plant manufacturers the antibiotic cephalosporin, which is similar to penicillin.
The the alert was issued after an FDA inspection of the facility identified “some non-compliance of current good manufacturing practice regulations,” Sun Pharma said in a statement e-mailed to Bloomberg. The FDA issued an import alert against the factory on Wednesday, adding the factory to the FDA "Red List." The FDA defines this alert as, "detention without physical examination of drugs from firms which have not met drug GMPs."
The Karkhadi plant is one of Sun Pharma's 25 manufacturing plants, 11 of which are in India. Three of those plants, including the Karkhadi plant, are in Gujarat.
Sun Pharma, who also just announced a recall of generic diabetes meds manufactured at its Detroit-based facility, joins the growing list of Indian drugmakers, including major players Ranbaxy and Wockhardt, now facing U.S. bans due to compliance issues.
Read the Reuters press release
