TORRENT PHARMACEUTICALS LTD. - USFDA Pre-Approval Inspection Of Oral Oncology Manufacturing Facility, Gujarat

The USFDA conducted Pre-Approval Inspection [PAI] 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 stipulated timeline and work closely with USFDA to address the observation at the earliest.