The United States Food and Drug Administration (USFDA) has completed Pre-Approval Inspection (PAI) and a GMP inspection at Torrent Pharmaceuticals’ manufacturing facility situated in Indrad, Gujarat. The Inspection was conducted from June 03, 2024 to June 12, 2024.
At the end of the inspection, the Company was issued a Form 483 with 5 observations. There was no observation related to data integrity reported. The company 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.
Torrent Pharmaceuticals is flagship company of the Torrent group, a leader in cardiovascular and central nervous system segments. It also has presence in gastro-intestinal, diabetology, anti-infective and pain management segments.
