USFDA Inspects Torrent's Bileshwarpura Facility, Issues 'Form 483'
Ahmedabad-based Torrent Pharmaceuticals on Friday informed that the USFDA inspected its oral oncology manufacturing plant at Bileshwarpura, Gujarat from March 13th to March 17th, the pharmaceutical company said in a regulatory filing
Ahmedabad-based Torrent Pharmaceuticals on Friday informed that the USFDA inspected its oral oncology manufacturing plant at Bileshwarpura, Gujarat from March 13th to March 17th, the pharmaceutical company said in a regulatory filing.
The pharma company said that USFDA has issued 'Form 483' with one observation, which the company said is procedural in nature. It said that it will respond and work closely with USFDA to address the issue at the earliest.
"The USFDA conducted Pre-Approval Inspection of our Oral-Oncology manufacturing facility at Bileshwarpura, Gujarat from 13-Mar-23 to 17-Mar-23. At the end of the inspection, we have been issued a “Form 483” with 1 observation, which is procedural in nature. We will respond to the USFDA within the stipulated timeline and work closely with USFDA to address the observation at the earliest," Torrent said.
The company stock was trading 1.44 per cent lower on Friday at Rs 1530.50 per scrip as of 11:57 IST.