Torrent Pharma s Bileshwarpura Facility Gets Form 483 Observation During Inspection

Ahmedabad-based Torrent Pharmaceuticals reported Friday that the USFDA inspected its oral oncology manufacturing facility in Bileshwarpura, Gujarat from March 13 to 17, the pharmaceutical company said in a regulatory filing.

Ahmedabad-based Torrent Pharmaceuticals reported Friday that the USFDA inspected its oral oncology manufacturing facility in Bileshwarpura, Gujarat from March 13 to 17, the pharmaceutical company said in a regulatory filing.

The drug company said the USFDA issued 'Form 483' with a remark, which the company says is procedural in nature. He said he will respond and work closely with the USFDA to address the issue as soon as possible.

"The USFDA conducted a pre-approval inspection of our oral oncology manufacturing facility in Bileshwarpura, Gujarat from March 13, 23 to March 17, 23. At the conclusion of the inspection, we were issued a "Form 483" with 1 comment, which is procedural in nature. We will respond to the USFDA within the stipulated time frame and will work closely with the USFDA to address the comment as soon as possible," Torrent said.

The company's shares were trading 1.44 percent lower on Friday at Rs 1,530.50 per token as of 11:57 a.m. IST.




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