Biocon’s subsidiary -- Biocon Pharma has received approval from the U.S. Food and Drug Administration (USFDA) for Dapagliflozin Tablets, 5 mg and 10 mg. 

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

Biocon is India’s largest and Asia’s leading Biotechnology Company with a strategic focus on biopharmaceuticals and research services. It is a fully integrated, innovation driven biopharma enterprise offering affordable solutions for chronic diseases to patient's worldwide.