The approved product is indicated for the treatment of adults with type-2 diabetes mellitus as an adjunct to diet and exercise to improve glycemic control, and reduce the risk of hospitalization for heart failure in adults with type-2 diabetes mellitus and either established cardiovascular disease or multiple cardiovascular risk factors.

Dapagliflozin Tablets will be manufactured at Biocon’s FDA-approved facilities, in compliance with global quality and regulatory standards.

'This approval further strengthens Biocon’s expanding diabetes portfolio, which spans oral solid dosage formulations, biosimilar insulin, and complex GLP-1 peptides, reinforcing the company’s integrated approach to addressing the evolving needs of people living with diabetes globally,” the Bengaluru-based company said in a statement.

Biocon is a global biopharma company dedicated to improving affordable access to therapies for chronic conditions such as diabetes, cancer, and autoimmune diseases.

The company's consolidated net profit surged to Rs 143.80 crore in the quarter ended December 2025 as against Rs 25.10 crore during the previous quarter ended December 2024. Sales rose 9.28% to Rs 4,123 crore in Q3 FY26 as compared with Q3 FY25.