Sun Pharma receives warning letter from USFDA


Chennai: Drug major Sun Pharmacuetical Industries Ltd on Saturday said it has received a warning letter from USFDA relating to its facility in Halol in Gujarat.

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The letter was a result of the inspection done by the US Food and Drug Administration (USFDA) at Halol plant in September 2014.

In a statement Sun Pharma said it would respond to the warning letter with a detailed plan within the stipulated timeframe.

“While our team is working hard to ensure that the commitments made to the USFDA in September 2014 are fully completed, we will continue to cooperate with the USFDA and undertake any additional steps necessary to ensure that the US agency is completely satisfied with our remediation of the Halol facility,” Dilip Shanghvi, managing director, was quoted as saying in the statement.

Post the September 2014 inspection, the USFDA has withheld future product approvals from the Halol facility.