Drug major Sun Pharmacuetical Industries Ltd said it has received a warning letter from USFDA relating to its facility in Halol in Gujarat.
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‘Post the September 2014 inspection, the USFDA has withheld future product approvals from Sun Pharma's Halol facility in Gujarat.’
In a statement Sun Pharma said, "We would respond to the warning letter with a detailed plan within the stipulated timeframe." Dilip Shanghvi, managing director, said, "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."
Post the September 2014 inspection, the USFDA has withheld future product approvals from the Halol facility.
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