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...
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.
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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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