In yet another blow to the Indian pharmaceutical sector, the US Food and Drug Administration has banned import of drugs from Sun Pharma’s Karkhadi facility in Gujarat for violation of manufacturing norms.
“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,” Sun Pharmaceutical Industries said in a statement.
The company remains fully committed to compliance and has already initiated several corrective steps to address the observations made by the USFDA, it added.
Sun Pharma, which is lndia’s biggest drugmaker 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,” it said.
The company’s Karkhadi facility manufactures antibiotics and active pharmaceutical ingredients (APIs). The company has 10 manufacturing sites in India.
According to the information available on USFDA website, an import alert enables ‘detention without physical examination of drugs from firms which have not met drug manufacturing norms’.
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.
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.
Reacting to the development, the Sun Pharma scrip had tanked as much as 6.5 per cent.