And now, USFDA bans imports from Sun Pharma unit
13 Mar 2014
The US Food and Drugs Administration (USFDA), the US drug regulator had issued an import alert on Sun Pharmaceutical Industries' Karkhadi plant in Gujarat, which would lead to 'detention of import consignments in the US without physical examination of drugs from firms which have not met drug GMPs'.
The USFDA action comes as the first import alert for any of Sun Pharma's plants. The US regulator had been cracking down heavily on Indian generic pharmaceutical firms such as Ranbaxy and Wockhardt for alleged failure to comply with its 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 said it remained fully committed to compliance and had already initiated several corrective steps to address the observations made by the USFDA.
According to the drugmaker, lndia's biggest by value, the import ban would have negligible effect 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 web site, an import alert enables 'detention without physical examination of drugs from firms which have not met drug manufacturing norms'.
Sun Pharma had, earlier this week, voluntarily recalled 2,528 bottles of its generic version of diabetes drug Glumetza in the US market following a customer complaint.
Meanwhile, a number of facilities of companies like Ranbaxy and Wockhardt remain banned for import of drugs into the US market.
Daiichi Sankyo controlled Ranbaxy Laboratories in India had had all its facilities banned for exports of drugs to the US. Similar action had been taken by the US regulator against Wockhardt at two of its plants in the country.
Shares of Sun Pharmaceuticals today tanked as much as 6.5 per cent after the USFDA imposed a ban on import of products made at its Karkhadi plant in Gujarat for manufacturing norms violation.
The stock opened on a positive note, but the drug firm's shares plunged after the ban and were down 6.35 per cent to Rs565.60 on the BSE.
On the NSE, the stock fell 6.42 per cent to Rs565.50.
