USFDA issues zero observations to Biocon Pharma Bengaluru facility
Bangalore: Biocon Pharma Limited has received zero observations from the US Food and Drug Administration (USFDA) at the conclusion of the inspection at its Bengaluru facility.
“This is to inform you that the US FDA concluded a surveillance and pre-approval inspection of Biocon Pharma Limited Oral Solid Dosage formulations manufacturing facility at Bengaluru on 2nd June 2023, with no observations,” the company stated in a BSE filing.
Medical Dialogues team had earlier reported that Biocon Biologics’ integrated, multi-product, monoclonal antibodies (mAbs) Drug Substance manufacturing facility (B3) at Biocon Park, Bengaluru, had received a Certificate of GMP Compliance for an additional product, biosimilar Bevacizumab, from the representative European inspection authority, Health Products Regulatory Authority (HPRA), Ireland.
Read also: Biocon Biologics Bengaluru facility gets EU GMP certification for Bevacizumab
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.
Read also: Biocon gets zero UFSDA observations for Hyderabad facility
