Drug major Sun Pharmacuetical Industries Ltd has received a warning letter from US Food and Drug Administration (USFDA) relating to its facility in Halol in Gujarat.
The letter was a result of the inspection done by the USFDA at Halol plant in September 2014.
In a statement Sun Pharma said, "We would respond to the warning letter with a detailed plan within the stipulated timeframe."
‘Post the September 2014 inspection, the USFDA has withheld future product approvals from Sun Pharma's Halol facility in Gujarat.’
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.