US Food and Drug Administration (USFDA) has conducted a pre-approval inspection (PAI) of Biocon’s subsidiary -- Biocon Sdn. Bhd's Insulins manufacturing facility based in Malaysia, for Insulin Glargine, between February 10 and February 21, 2020. At the conclusion of the inspection, the agency has issued a Form 483 with 3 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.