USFDA concludes inspection of Biocon's insulin drug substance manufacturing facility

07 Mar 2019 Evaluate

US Food and Drug Administration (USFDA) has concluded a pre-approval inspection of Biocon's insulin drug substance manufacturing facility triggered by a New Drug Application (NDA).

The inspection at the Bengaluru facility took place on February 25 - March 05, 2019, resulting in a Form 483 with six 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.

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