Biocon Gets USFDA Clearance and EU Nod for Diabetes Drug

27 Dec 2024 , 03:28 PM

Biocon’s stock jumped on December 24 after the United States Food and Drug Administration (USFDA) and the European Union provided positive updates. The USFDA released an Establishment Inspection Report with a “Voluntary Action Indicated” status for Biocon’s Active Pharmaceutical Ingredients facility in Bengaluru.

On December 27, 2024, at 3:12 pm, shares of Biocon is currently trading at ₹352.40 which is a 1.72% gain than the previous close. Biocon shares has gained a total of 39% in the last one year, and 1.81% in the last six months.

This EIR, for the Bengaluru Unit 1 site, concludes the inspection by the USFDA between September 16 and September 20, 2024. Earlier today, Biocon and its European partner Zentiva received Decentralised Procedure (DCP) approval for their complex formulation, Liraglutide, in the European Union.

The approval encompasses generic versions of Victoza for Type-2 Diabetes treatment and Saxenda for weight management. Management expects strong growth in Biocon’s formulations business during the second half of the current financial year.

Liraglutide, Semaglutide and Tirzepatide generics were some of the major structural growth drivers in financial year 2026. The updates underscored the company’s commitment to expand the portfolio of complex generics, including meeting global regulatory milestones for innovations in the healthcare sector.