Biocon Biologics’ Drug Substance Facility in Bengaluru Classified as Voluntary Action Indicated (VAI)

  • Posted by: Biocon Biologics

NOTIFICATION TO STOCK EXCHANGE

COMPANY STATEMENT

Bengaluru, Karnataka, India, November 27, 2025

“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 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.”

– Company Spokesperson

Author: Biocon Biologics
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