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USFDA concludes pre-approval inspection at Torrent Pharmaceuticals’ Gujarat facility

12 Dec 2023 Evaluate

The United States Food and Drug Administration (USFDA) has concluded Pre-Approval Inspection (PAI) at Torrent Pharmaceuticals’ Oral-Oncology manufacturing facility at Bileshwarpura, Gujarat. The Inspection was conducted from December 05, 2023 to December 11, 2023. 

At the end of the inspection, the Company was issued a Form 483 with 5 procedural observations. There was no observation related to data integrity reported. 

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.

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