Biocon Ltd. announced that its wholly owned subsidiary Biocon Pharma Limited has received tentative approval from thlets USP. The drug will be available in 25 mg, 50 mg, and 100 mg strengths.
Sitagliptin is prescribed as an adjunct to diet and exe U.S. Food and Drug Administration (USFDA) for its abbreviated new drug application (ANDA) of Sitagliptin Tabercise to help improve glycemic control in adults with type 2 diabetes mellitus. With this latest approval, Biocon strengthens its portfolio of vertically integrated drug products, the company stated in a regulatory filing to the BSE.
Expanding Global Diabetes Portfolio
This milestone comes as Biocon continues to expand its presence in the global diabetes care market. In July 2025, Biocon Biologics Ltd., another group company, received USFDA approval for Kirsty (Insulin Aspart-xjhz, 100 units/ml), the first and only interchangeable biosimilar to NovoLog (Insulin Aspart). Kirsty is a rapid-acting human insulin analog indicated for glycemic control in both adults and pediatric patients with diabetes mellitus.
Earlier, in June 2025, Biocon also secured approvals in India for its Liraglutide drug substance as well as its Liraglutide drug product (6 mg/ml solution for injection in pre-filled pen and cartridge) through its subsidiary Biocon Pharma Limited. The approvals were granted by the Central Drugs Standard Control Organisation (CDSCO) under the recently introduced 101 route, which recognizes approvals from established global regulatory authorities.
Strengthening Biocon’s US & India Presence
With diabetes emerging as one of the most significant global health challenges, Biocon’s series of recent approvals underlines its strategy of expanding both in the U.S. and Indian pharmaceutical markets. The company has built a diverse diabetes care portfolio, ranging from oral formulations like Sitagliptin to biologics such as insulin and GLP-1 analogs.
By securing regulatory clearances across geographies, Biocon aims to position itself as a key player in providing accessible and affordable treatments for diabetes patients worldwide.
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