Biocon gets EU GMP compliance certificate for Bangalore facility

Published On 2023-06-09 05:45 GMT   |   Update On 2023-06-09 06:35 GMT

Bangalore: Biocon Limited has informed in a recent BSE filing that its Active Pharmaceutical Ingredient (API) manufacturing facility located in Bangalore has received a certificate of GMP compliance from the Competent Authority of Germany, following an EU GMP inspection that was conducted in February 2023.

Medical Dialogues team had earlier reported that Biocon Pharma Limited had received zero observations from the US Food and Drug Administration (USFDA) at the conclusion of the inspection at its Bengaluru facility.

Read also: USFDA issues zero observations to Biocon Pharma Bengaluru facility

Biocon Limited is an Indian biopharmaceutical company headquartered in Bangalore. It was founded by Kiran Mazumdar-Shaw in 1978. It has developed and commercialized novel biologics, biosimilars, and complex small molecule APIs in India and several key global markets as well as Generic Formulations in the U.S. and Europe. It also has a pipeline of novel assets in immunotherapy under development. Biocon’s biosimilars business is through its subsidiary, Biocon Biologics Ltd.

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Read also: Biocon Biologics Bengaluru facility gets EU GMP certification for Bevacizumab




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