The US Food and Drug Administration (US FDA) has brought another Indian drug maker under its scanner. The regulatory body has issued an import alert on generic drugs company Sun Pharmaceuticals’ Karkhadi (Gujarat) plant.
In recent times, the US FDA has issued import alerts on all of Ranbaxy’s plants and two of Wockhardt’s manufacturing facilities in the country.
Commenting on the development, a company statement said, “Sun Pharmaceutical Industries Ltd announced an import alert from the US FDA for its cephalosporin facility located in Karkhadi, Gujarat. The import alert was issued by the US FDA as a follow up to the last inspection of the facility, during which some non-compliance of current Good Manufacturing Practice (CGMP) regulations were identified”.
An import alert allows detention without physical examination of drugs from manufacturers who have not met the norms set out by the US FDA.
The share price of Sun Pharma plunged by 5 per cent or Rs 30 to Rs 573.60 on Thursday.
Commenting on the fall, investment advisor S P Tulsian said that the cephalosporin plant in question at Gujarat made a small contribution to the company’s turnover and that the active pharmaceutical ingredient could be sourced from elsewhere. “The only worry is that the import alert should not spread to other plants of the company,” he added.
A few days ago, the drug maker on its own volition had recalled 2,528 bottles of its generic diabetes drug Glumetza from the US as there had been a customer complaint.
Sun Pharma played down the US FDA alert stating that the contribution of the Karkhadi facility to the company’s consolidated revenue is negligible and that it maintained its sales guidance for the 2013-14 financial year.
The company has 10 manufacturing facilities in India and the Karkhadi plant makes antibiotic and active pharmaceuticals ingredients (API).