Biocon’s subsidiary -- Biocon Biologics India has received the Establishment Inspection Report (EIR) from the US Food and Drug Administration (USFDA) for the Pre-Approval Inspection (PAI) at two of its biologics manufacturing facilities in Bengaluru. The inspection was conducted between September 10 and September 19, 2019. Biocon Biologics has responded to the regulator on the eight observations from this inspection, in the month of October 2019.
Subsequent to the above inspection, Biocon Biologics has received approvals for the two products Trastuzumab (Drug Product) and Pegfilgrastim (Drug Substance) from the USFDA in 2019. The receipt of the EIR indicates a successful closure of the inspection. This is an endorsement of the company’s commitment to global standards of Quality and Compliance.
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.
