Torrent Pharma gets USFDA OAI status for Gujarat facility

Published On 2023-01-24 09:44 GMT   |   Update On 2023-01-24 09:44 GMT

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...

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AhmedabadTorrent 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.

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.

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.

Read also: Torrent Pharma to buy Curatio Healthcare for Rs 2,000 crores

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