Biocon's Bengaluru drug manufacturing facility gets 'Voluntary Action Indicated' classification

Biocon Biologics, global subsidiary of Biocon Limited, informed on Thursday that the USFDA has classified its Drug Substance Facility in Bengaluru as Voluntary Action Indicated (VAI).

“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)," a company spokesperson said.

As per FDA compliance norms, VAI implies that objectionable conditions or practices were found during the survey, but the agency is not prepared to take or recommend any administrative or regulatory action.


The US agency conducted an inspection of Biocon Biologics' drug facility between August 26 to September 3, 2025 pertaining 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," the spokesperson added.

Biocon Share Price: Shares of Biocon Ltd. closed at Rs 398.55 per share on Thursday.