India Pharma Outlook Team | Thursday, 28 August 2025
Biocon has announced that its wholly owned subsidiary, Biocon Pharma Limited has received Tentative Approval from the United States Food and Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) for Sitagliptin Tablets USP, in strengths of 25 mg, 50 mg, and 100 mg.
Sitagliptin is indicated, usually in conjunction with diet and exercise, to improve glycemic control in adults with type 2 diabetes mellitus.
The approval is another meaningful addition to Biocon's vertically integrated drug portfolio. In a filing made by Biocon with the Bombay Stock Exchange (BSE), it said this approval further strengthens its presence in the global diabetes space.
This would be another milestone reached after a number of regulatory approvals recently initiated by Biocon and its subsidiaries. In July, Biocon Biologics Ltd received USFDA approval for Kirsty (Insulin Aspart-xjhx), the first and only interchangeable biosimilar of NovoLog (Insulin Aspart).
Kirsty and rapid-acting insulin analog, has been approved for the purpose of improving glycemic control in adults and pediatric patients with diabetes mellitus. Biocon's Liraglutide, drug substance and product (Liraglutide 6 mg/ml solution for injection in prefilled pens and cartridges) was cleared in India.
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The Central Drugs Standard Control Organisation (CDSCO) issued the approval under the recently established 101 route for regulatory approval, which accepts approvals from global regulatory authorities acknowledged by the CDSCO. Liraglutide is a synthetic GLP-1 analog that is injected once daily.
Biocon Limited, founded in 2004 and publicly listed, is one of the largest biopharmaceutical companies in the world, specializing in the development and commercialization of novel biologics, biosimilars, and complex small molecule APIs. The company was incorporated in India, but serves customers in the U.S., Europe, and other markets, providing excellence in complex and technically challenging generics, and has a growing pipeline of biologics.
