Biocon Biologics’ Drug Substance Facility in Bengaluru has been classified as Voluntary Action Indicated (VAI) by the U.S. Food and Drug Administration (FDA). This classification resulted from an inspection conducted between August 26 and September 3, 2025. The VAI relates to the manufacture and supply of Human Recombinant Insulin and Biosimilar Pegfilgrastim Drug Substance for the United States.
Bengaluru Facility Update
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). The announcement was made on November 27, 2025.
Inspection Details
This classification follows an inspection conducted by the agency between August 26 and September 3, 2025. The inspection pertained to the manufacture and supply of Human Recombinant Insulin (rh- Insulin) and Biosimilar Pegfilgrastim Drug Substance to the United States.
Commitment to Standards
Biocon Biologics remains committed to maintaining global standards of Quality and Compliance.
Source: BSE