Torrent Pharma Receives USFDA Clearance for Pithampur Facility with VAI Classification
Mumbai: Torrent Pharmaceuticals Limited has announced that the company received an Establishment Inspection Report (EIR) from the United States Food and Drugs Administration (USFDA) for its manufacturing facility at Pithampur, Madhya Pradesh.
The USFDA has classified the site under ‘Voluntary Action Indicated’ (VAI), marking the successful closure of the regulatory inspection carried out from 16th September to 20th September 2024.
"...USFDA has issued Establishment Inspection Report (“EIR”) with Voluntary Action Indicated (“VAI”) classification for the said manufacturing facility and the inspection has now been successfully closed by the USFDA," Torrent Pharma said in a filing.
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The USFDA's Establishment Inspection Report (EIR) provides a summary of the findings from a facility inspection, including compliance observations and discussions held during the visit.
A Voluntary Action Indicated (VAI) classification indicates that any identified issues are minor and can be addressed by the company without the need for further regulatory or administrative action.
The USFDA examined Torrent’s manufacturing plant in Pithampur during the September quarter and issued a Form 483 with one observation.
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Torrent Pharmaceuticals, headquartered in Ahmedabad, Gujarat, is a prominent Indian pharmaceutical company known for developing, manufacturing, and marketing branded and generic medications. It operates across various therapeutic areas, including cardiovascular, central nervous system, and diabetes care, with a strong presence in both regulated and emerging global markets.
