FDC Roha facility successfully concludes USFDA audit

Written by Ruchika Sharma Published On 2023-03-29T10:00:26+05:30 | Updated On 29 March 2023 11:25 AM IST

FDC Roha facility successfully concludes USFDA audit

Mumbai: FDC has announced that the US Food and Drug Administration (USFDA) has successfully concluded the audit with no observations (Zero 483’s) at the company's Maharashtra manufacturing unit.

The inspection was conducted from 20th March 2023 to 24th March 2023.

"This is to inform you that our manufacturing unit located at Roha, Dist.- Raigad, Maharashtra that manufactures Active Pharmaceutical Ingredient (APIs) products has been inspected by US FDA from 20th March 2023 to 24th March 2023," the company stated in a BSE filing.

The Active Pharmaceutical Ingredients (API’s) product manufactured at the above facility continues to be marketed in USA.

Founded in 1936, FDC Limited is the pharmaceutical company headquartered in India. This facility is dedicated for Bulk APIs manufacturing. The Plant received the US-FDA approval 9 times in a row, since 1985. 90% of the APIs, manufactured at the Roha facility, are being exported to the USA, Canada, Japan, Malaysia, Europe and the Middle East countries

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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