US Food and Drug Administration (USFDA) has completed inspection at Biocon’s Insulin Glargine Drug Substance, Drug Product and Device assembly facilities in Malaysia. A per-approval inspection by USFDA was carried out from June 24 and July 5, 2019. The inspection across these 3 units concluded with 12 observations issued on the Form 483.
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.