Biocon shares in focus after unit’s drug substance unit gets VAI status from USFDA

Biocon Ltd’s biosimilars arm, Biocon Biologics Ltd, said its drug substance facility in Bengaluru has been classified as VAI by the US Food and Drug Administration. VAI stands for Voluntary Action Indicated.The US FDA inspected the site between August 26 and September 3, 2025. The facility manufactures and supplies rh-Insulin and the biosimilar Pegfilgrastim drug substance to the US. rh-Insulin refers to human recombinant insulin.

In an exchange filing, Biocon Biologics said it remains committed to global standards of quality and compliance.

Meanwhile, Biocon is considering merging Biocon Biologics with the parent entity, according to reports. The potential deal, which could value the subsidiary at about $4.5 billion, signals a shift from an earlier plan to list the biologics unit.The company is said to be in advanced talks with minority shareholders over a possible share swap and has also evaluated a cash plus swap structure.

Chairperson Kiran Mazumdar Shaw confirmed that the group is exploring multiple options, including an IPO, merger, or share swap, and has appointed Morgan Stanley to assess the best value creation route.

Shares of Biocon Ltd closed 1.34% higher on Wednesday at ₹398.50. The stock is up 8% in 2025.