19/12/2015 4:09 PM IST | Updated 29/08/2016 7:06 PM IST

FDA Finds Problems With Sun Pharma's Manufacturing Unit In Gujarat

Bloomberg via Getty Images
An employee cleans a sign outside the Sun Pharmaceutical Industries Ltd. corporate office in the Andheri suburb of Mumbai, India, on Monday, April 7, 2014. Sun Pharmaceutical, India's largest drugmaker by market value, agreed to buy Ranbaxy Laboratories Ltd. for $3.2 billion in stock, the biggest purchase by an Indian company in two years. Photographer: Amit Madheshiya/Bloomberg via Getty Images

MUMBAI -- The U.S. Food and Drug Administration has issued a warning letter to Sun Pharmaceutical Industries Ltd about its Halol facility after an inspection revealed problems with its manufacturing processes, the firm said on Saturday.

The U.S. drug watchdog has withheld product approvals from the unit in western India since the inspection in September 2014.

Sun Pharma said in a statement that it was taking steps to address the problems outlined by the FDA and that it would request a re-inspection of the Halol facility once it had completed the remedial steps.


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