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US FDA bans imports from Sun Pharma’s Gujarat facility

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US FDA bans imports from Sun Pharma’s Gujarat facility
US FDA bans imports from Sun Pharma’s Gujarat facility

Sun Pharmaceuticals, on Thursday, said it had received an import alert from the U.S. Food and Drug Administration (US FDA) for its cephalosporin facility located at Karkhadi in Gujarat, for non-compliance of good manufacturing practice.

In the recent past, leading pharmaceutical players such as Ranbaxy Laboratories and Wockhardt have received warnings and import bans from the US FDA for quality and compliance issues.

Sun Pharmaceuticals makes active pharmaceutical ingredients (API) and formulations at its Karkhadi unit.

In a statement, the company said, “This import alert was issued by the US FDA 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.’’

The company said it remained fully committed to compliance, and had already initiated several corrective steps to address the observations made by the US FDA. “The contribution of this facility to Sun Pharma’s consolidated revenues is negligible. Sun Pharma maintains its 2013-14 consolidated sales growth guidance,’’ it said.

The news would not have major impact financially, as the plant’s contribution to the overall sales is not significant, Sarabjit Kour Nangra, Vice-President (Research, Pharma), Angel Broking, said, adding that “as a fact, as on March, 2013, the company had 12 US FDA facilities, with six in the U.S., three in India and one in Canada, Israel and Hungary, respectively. Thus, the company has a well diversified manufacturing infrastructure to cater to the U.S. markets, which contribute around 54 per cent of its sales (2012-13). Also, its subsidiaries of the likes of Taro, Caraco and the recent acquisitions contribute a major chunk of the sales and growth.’’

Shares of Sun Pharmaceutical Industries, on Thursday, fell by over 5 per cent after the ban. Sun Pharma’s scrip ended the day at Rs.573.60, down 5.03 per cent on the Bombay Stock Exchange.

During the day, the drug firm’s stock declined by 6.35 per cent to Rs.565.60. At the NSE, the scrip plunged by 5.12 per cent to settle at Rs.573.35.

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