United States Food and Drug Administration (USFDA) has inspected FDC’s manufacturing unit located at Roha, District Raigad, Maharashtra that manufactures Active Pharmaceutical Ingredient (APIs) products from March 20, 2023 to March 24, 2023. The said audit has been successfully completed by the USFDA with 'No observations' (Zero 483's). The Active Pharmaceutical Ingredients product manufactured at the said facility continues to be marketed in USA.
FDC made a modest beginning with marketing of vitamins and a range of prescription formulations. The company subsequently set up their formulations manufacturing facility and also pioneered the manufacture of specialized ophthalmic formulations in India.
