Biocon Biologics Bengaluru Facility Receives VAI Classification from USFDA

27 Nov 2025 , 02:43 PM

Biocon Biologics has confirmed that its Drug Substance Facility in Bengaluru has been placed under the Voluntary Action Indicated category by the US Food and Drug Administration.

The classification follows a routine FDA inspection that took place at the Biocon Campus between August 26 and September 3, 2025.

During the review, the agency examined the facility’s production systems for Human Recombinant Insulin and the drug substance used in Biocon’s biosimilar Pegfilgrastim, both of which are supplied to the United States.

With a VAI status, the regulator has acknowledged certain observations but has not recommended any immediate corrective or enforcement actions. This means the site continues to be cleared for manufacturing and exports to the US market.

The company said the outcome reinforces its efforts to maintain a strong compliance culture and ensure its processes are aligned with international quality expectations.

A company spokesperson noted that Biocon Biologics will keep strengthening its systems to support a steady and high quality supply of insulin and biosimilar products to partners and patients globally.

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