USFDA concludes inspection with no 483 observations at Divi's Labs Telangana facility
Telangana: Divi's Labs has announced that the US Food and Drug Administration (USFDA) has concluded an inspection with no 483 observations at the Company's Unit-I facility at Lingojigudem Village, Choutuppal Mandal, Yadadri Bhuvanagiri district, Telangana.
Established in the year 1990, Divi’s is a manufacturer of Active Pharmaceutical Ingredients offering products to over 95 countries. Divi’s manufactures Generic APIs, Nutraceutical Ingredients and offers Custom Synthesis of APIs to Big Pharma. The Company currently operates two manufacturing locations that are compliant with global regulatory standards and capable of producing annual requirements ranging from 10’s of kilos to 1000’s of tons. It complies with cGMP guidelines for both the manufacturing units, having been inspected numerous times by FDA, EU GMP , HEALTH CANADA, TGA, ANVISA , COFEPRIS, PMDA and MFDS health authorities.
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