FDC Limited announced that our manufacturing unit located at Roha, Dist.- Raigad, Maharashtra that manufactures Active Pharmaceutical Ingredient (APIs) products has been inspected by USFDA from 20th March 2023 to 24th March 2023, via an exchange filing.
The said audit has been successfully completed by the USFDA with “No observations” (Zero 483’s).
The Active Pharmaceutical Ingredients (API’s) product manufactured at the above facility continues to be marketed in USA.