Biocon’s arm gets voluntary action indicated classification for Bengaluru facility
Biocon Biologics remains committed to global standards of Quality and Compliance
U.S. Food and Drug Administration (USFDA) CDER-OC, Office of Manufacturing Quality has classified Biocon’s subsidiary -- Biocon Biologics’ (BBL) 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.
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.
