The United States Food and Drug Administration (USFDA) has concluded a pre-approval inspection (PAI) at Biocon’s two of new Biologics Manufacturing facilities in Bengaluru. The inspection was conducted from September 10 to September 19, 2019. The inspection included a new Drug Substance (DS) and a Drug Product (DP) unit.
At the conclusion of the inspection, the company has received a Form 483 with four observations for the new DS facility, three observations for the new DP facility and one general observation.
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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