USFDA concludes inspection of Dr. Reddy's Laboratories R&D centre in Bachupally with zero observation

United States Food & Drug Administration (USFDA) today completed a routine Good Manufacturing Practice (GMP) inspection at Dr. Reddy's Laboratories our R&D centre (Integrated Product Development Organisation or IPDO) in Bachupally, Hyderabad. The inspection was conducted from 16th September to 20th September, 2024. The inspection closed with zero observations.

Torrent Pharmaceuticals receives Form 483 from USFDA for Pithampur facility

Torrent Pharmaceuticals Ltd has announced that the United States Food & Drug Administration (USFDA) conducted a routine GMP inspection of our Formulation manufacturing facility located at Pithampur, Madhya Pradesh between 16-Sep-24 to 20-Sep-24.

At the end of the Inspection, the Agency issued a Form FDA 483 with one observation which is procedural in nature. We will respond to the USFDA within the prescribed time-frame and will work in close collaboration with the Agency to address the observation at the earliest possible time.