USFDA Bans Import From Sun Pharma's Gujarat Unit; Shares Tank

NEW DELHI: 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.
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