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Sun Pharma unit gets warning from USFDA

This article was posted on Aug 31, 2010 and is filed under Press Releases

The US unit of Indian drugmaker Sun Pharmaceutical has received a warning letter from the United States Food and Drug Administration (USFDA) after its New Jersey manufacturing plant was inspected.Sun plans to respond to the USFDA within 15 days, and the company would work “cooperatively and expeditiously” to resolve the matters mentioned in the warning letter, Sun said in a statement, without giving details.

Mumbai-based Sun said the USFDA letter was issued as a follow-up to the inspection of the manufacturing facility in New Jersey in February, during which the regulator had identified violations of manufacturing regulations.

The company said it maintained its consolidated sales growth guidance for the current fiscal year to March 2011. Sun Pharmaceutical had said last month it expected to meet its guidance of 18-20 per cent revenue growth in 2010-11.

source: Business-Standard

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