Torrent Pharma gets USFDA OAI status for Gujarat facility

Written by Ruchika Sharma Published On 2023-01-24T15:14:10+05:30 | Updated On 24 Jan 2023 3:14 PM IST

Torrent Pharma Receives USFDA Clearance for Pithampur Facility with VAI Classification

Ahmedabad: Torrent Pharma has announced that the Company has received a communication from the US Food and Drug Administration (USFDA) determining the inspection classification of the manufacturing facility at Indrad, Gujarat as “Official Action Indicated” (OAI).

Official Action Indicated (OAI) which means regulatory and/or administrative actions will be recommended.

"This inspection classification will not have impact on existing supplies or revenues from this facility. Torrent Pharma continues to cooperate with the USFDA and will undertake all necessary remedial steps to resolve these issues to the satisfaction of the regulator," Torrent stated in a BSE filing

"Torrent Pharma remains committed to being cGMP compliant quality standards across all its facilities," the company added.

Read also: Torrent Pharma collaborates with Boehringer Ingelheim India to co-market its anti-diabetic drug, its fixed dose combinations in India

Medical Dialogues team had earlier reported that the USFDA had issued a "Form 483" with 3 observations at the end of the inspection at Torrent Pharma's manufacturing facility at Indrad, Gujarat.

Read also: Torrent Pharma gets 3 observations from USFDA for Gujarat facility

Torrent Pharma is an Indian multinational pharmaceutical company headquartered in Ahmedabad, India. The company specializes in the therapeutic segments of cardiovascular (CV), central nervous system (CNS), gastrointestinal (GI), and women healthcare (WHC). The Company also has significant presence in diabetology, pain management, gynaecology, oncology, and anti-infective segments. The Company also has significant presence in diabetology, pain management, gynaecology, oncology and anti-infective segments.

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Ruchika Sharma

Ruchika Sharma joined Medical Dialogue as an Correspondent for the Business Section in 2019. She covers all the updates in the Pharmaceutical field, Policy, Insurance, Business Healthcare, Medical News, Health News, Pharma News, Healthcare and Investment. She has completed her B.Com from Delhi University and then pursued postgraduation in M.Com. She can be contacted at editorial@medicaldialogues.in Contact no. 011-43720751