USFDA completes PAI, GMP inspection at Biocon’s Bengaluru facility

27 Jan 2020 Evaluate

US Food and Drug Administration (USFDA) has completed Pre-Approval Inspection (PAI) and GMP inspection at Biocon’s API Manufacturing Facility at Bengaluru. At the conclusion of the inspection of the Bengaluru facility, which took place between January 20 and January 24, 2020, the agency issued a Form 483, with five observations.

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.

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