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.