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USFDA classifies drug substance facility of Biocon’s arm as voluntary action indicated

31 Oct 2024 Evaluate

The U.S. Food and Drug Administration (USFDA) has classified Biocon’s subsidiary -- Biocon Biologics’ Drug Substance Facility at Biocon Campus, (Site 1) located in Bengaluru, Karnataka, as Voluntary Action Indicated (VAI).

This relates to the cGMP inspection conducted by the agency between February 20- 28, 2024 and pertains to the supply of rh-Insulin (rhI) Drug Substance to the United States. Biocon Biologics remains committed to global standards of Quality and Compliance.

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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