Biocon Biologics’ Drug Substance Facility in Bengaluru Classified as Voluntary Action Indicated (VAI) by U.S. FDA

Biocon Biologics’ Drug Substance Facility at Biocon Campus in Bengaluru, Karnataka, has been classified as Voluntary Action Indicated (VAI) by the U.S. Food and Drug Administration (FDA) CDER-OC, Office of Manufacturing Quality. This classification is based on the inspection conducted by the agency between August 26 to September 3, 2025, and pertains to the manufacture and supply of Human Recombinant Insulin (rh- Insulin) and Biosimilar Pegfilgrastim Drug Substance to the United States. Biocon Biologics remains committed to global standards of Quality and Compliance.