Biocon has received an Establishment Inspection Report (EIR) from the U.S. Food and Drug Administration (USFDA), for its greenfield API facility (Site 6), located at Visakhapatnam, Andhra Pradesh.
This is based on a pre-approval inspection conducted by the agency between June 10 and 14, 2024, and now allows the company to commence commercial supplies from this facility to the U.S. market.
Biocon is India’s largest and Asia’s leading Biotechnology Company with a strategic focus on biopharmaceuticals and research services. It is a fully integrated, innovation driven biopharma enterprise offering affordable solutions for chronic diseases to patient's worldwide.