USFDA ban import from Sun Pharmaceuticals

Mar 14, 2014 11:30 IST

Sun Pharmaceuticals on 13 March 2014 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. Cephalosporin is a anti-infective drug.

Sun Pharmaceuticals is the largest drugmaker of India by market capitalization. Sun Pharmaceuticals makes active pharmaceutical ingredients (API) and formulations at its Karkhadi unit.

imageIn 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.

The company had already initiated several corrective steps to address the observations made by the US FDA.

 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).

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