After Ranbaxy, Sun Pharmaceutical (Sun Pharma) has now come under US Food and Drug Administration’s (USFDA) scanner. In a recent blow, the American drug regulator has issued a ban on import of drugs from Sun Pharma’s Karkhadi facility in Gujarat for violation of manufacturing norms.
As per the official statement issued by the company, “This import alert was issued by the USFDA 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.” While the company assured complete compliance and added, “Already initiated several corrective steps to address the observations made by the USFDA.” Sun Pharma, which is lndia’s biggest drug manufacturer by value, said the import ban would have negligible affect on the company’s revenues.
“The contribution of this facility to Sun Pharma’s consolidated revenues is negligible. Sun Pharma maintains its FY 2013-14 consolidated sales growth guidance,” the statement further added. The company’s Karkhadi facility manufactures antibiotics and active pharmaceutical ingredients (APIs). The company has 10 manufacturing sites in India. Earlier this week, Sun Pharma 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. As an impact of the ban, company’s share prices on Bombay Stock Exchange crashed by over 5 per cent to Rs 573.60 per share.
USFDA has been cracking down heavily for non-compliance of manufacturing norms and various facilities of companies like Ranbaxy and Wockhardt have already been banned from importing drugs into the US market. While all plants of Daiichi Sankyo controlled Ranbaxy laboratories in India have been banned from exporting drugs to the US, Wockhardt has also faced similar actions on its two plants in the country.