The USFDA conducted a Pre-Approval Inspection (PAI) and a GMP inspection at Torrent Pharmaceuticals Limited’s manufacturing facility situated in Indrad, Gujarat from 03-Jun-24 to 12-Jun-24.

At the end of the inspection, the company was issued a Form 483 with 5 (five) observations. There was no observation related to data integrity reported. We will respond to the USFDA within the prescribed time-frame and will work in close collaboration with the agency to address the observations at the earliest possible time.