The US Food and Drug Administration (USFDA) has concluded two pre approval inspections of Biocon's manufacturing facilities in Bengaluru. There were no observations and no form 483 was issued after the pre-approval inspection of Biocon's Oral Solid Dosage Facility conducted between February 11-15, 2019.
The pre-approval inspection of the company's additional, new injectable manufacturing line for a biologic drug product, conducted between February 7-15, 2019, resulted in a form 483 with two observations. Biocon intends to address these expeditiously.
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.
