The US Food and Drug Administration (USFDA) has completed a pre-approval inspection at Biocon’s manufacturing facility in Malaysia and issued a Form 483 with 6 observations. The company intends to respond with a corrective and preventive action plan in a timely manner.
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.