Sun Pharma gets partial US FDA clearance to resume US operations

29 Aug 2012

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Indian drug maker Sun Pharmaceutical Industries Ltd's American unit, Caraco Pharmaceuticals Laboratories Ltd, has been allowed by the US drug regulator to partially resume operations.

The permission by US Food and Drug Administration (FDA) comes after a near total closure of operations of the company's US subsidiary in June 2009 for non-compliance with quality norms.

According to Sun's statement yesterday, the FDA had notified that Caraco may resume operations at its manufacturing facility and packaging sites in Detroit and Wixom, Michigan.

Sun Pharma shares were up 1.69 per cent to Rs681.15 on BSE, in response to the announcement.

The operations though, would be limited to the production and sales of only two products - blood pressure medicine Carvedilol and antibiotic Paromomycin.

Caraco had taken corrective actions and signed a consent decree with FDA for resolution of the issue. The company cut many jobs which impacted the revenue of the Indian company over the past several quarters.

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