Biocon Biologics' Drug Substance Facility in Bengaluru Classified as Voluntary Action Indicated

The U.S. Food and Drug Administration (FDA) CDER-OC, Office of Manufacturing Quality, has classified Biocon Biologics' Drug Substance Facility at Biocon Campus, located in Bengaluru, Karnataka, as Voluntary Action Indicated (VAI).

This relates to the inspection conducted by the agency between 26 August to 03 September 2025, and pertains to the manufacture and supply of Human Recombinant Insulin (rh- Insulin) and Biosimilar Pegfilgrastim Drug Substance to the United States.

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