Biocon Biologics Wins USFDA VAI Classification for Bengaluru Unit

Biocon Biologics received an important update from the US FDA. The agency now has listed the Drug Substance Facility of the company in Bengaluru as Voluntary Action Indicated (VAI).

This declaration is one of the major achievements of the compliance status of the company within the U.S. market.

According to the statement of a company spokesperson, the Drug Substance Facility in Biocon Campus, Bengaluru, Karnataka, was classified by U.S. Food and Drug Administration (FDA) CDER-OC, Office of Manufacturing Quality, as Voluntary Action Indicated (VAI).

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According to FDA regulations, a VAI status indicates that the inspectors did not locate any issues in the course of their examination, yet none that demand any regulatory or administrative intervention. The facility is thus at a manageable compliance area and can be allowed to operate without facing any obstacle in enforcing it.

The audit was carried out between August 26 and September 3, 2025. It reviewed the production and supply operations of the company of Human Recombinant Insulin (rh -Insulin), and Biological Substance pegfilgrastim, that are supposed to sell in the U.S. market. When VAI classification is used in the biopharma sector, it typically implies that remedial measures will be taken, but the facility is in compliance with the necessary safety and quality provisions.

Biocon Biologics reiterated its adoption of good global manufacturing practices. The spokesperson further said that Biocon Biologics was devoted to international quality and compliance criteria. With regulatory confidence determining the extent to which a company can penetrate the market, the current VAI category has ensured that the company is well on course in one of its most crucial markets.