Sun Pharma's US arm resolves issues with health regulator

New Delhi: Sun Pharmaceutical Industries today said its US arm has resolved issues raised by the country's health regulator regarding violation of manufacturing standards.

"The US Food and Drug Administration (USFDA) has informed Sun Pharmaceutical Industries, Inc... that after a June, 2011, re-inspection of its Cranbury, New Jersey, US manufacturing facility, the site has an acceptable regulatory status," Sun Pharma said in a statement. Therefore, the issues noted in the USFDA's August 25, 2010, warning letter are considered to be resolved, it said.

The USFDA had pulled up the US arm of Sun Pharma for violation of manufacturing standards, such as its inability to produce batches of consistent quality and lack of sufficient corrective actions.

Sun Pharma, however, said its other US-based subsidiary, Caraco, is yet to resolve similar issues.

"Caraco, now wholly owned by Sun Pharma, continues to work with consultants to resolve issues raised by the USFDA at its Detroit plant," the company said.

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In June, 2009, USFDA officials had seized 33 drugs manufactured at Caraco's Detroit unit and temporarily stopped all manufacturing activities. The regulator had also seized all drugs manufactured by Caraco, including raw materials and active pharmaceutical ingredients.

Since then the health regulator had stopped the firm from further distributing them until the company complied with good manufacturing requirements.

Scrips of Sun Pharma were trading at Rs 475.50 per share on the BSE at mid-day, down 2.47 percent from their previous close.

PTI