Biocon unit gets USFDA approval for diabetes drug Sitagliptin

28 Aug 2025 , 11:08 AM

Biocon Ltd announced that its wholly-owned unit Biocon Pharma secured a tentative approval from the United States Food and Drug Administration (US FDA) for Sitagliptin tablets. These tablets are available in 25 mg, 50 mg and 100 mg strengths.

The drug will expand the drugmaker’s portfolio of vertically integrated products, Biocon said in its filing with the exchanges. The drug shall be used to treat diet and exercise for improvement of glycemic control in adults with type 2 diabetes. 

This regulatory achievement comes after the pharma business struggles with profit pressures. Earlier this month, the business announced its results for the quarter. 

The business reported a sharp decline of 95% on a year-on-year basis in its consolidated net profit at ₹31.40 Crore. The business logged a consolidated net profit of ₹659.70 Crore in the previous corresponding quarter.

The business also said that its revenue from operations registered a 14.80% year-on-year growth in the quarter under review. The business posted revenue from operations of ₹3,942 Crore. EBITDA for the quarter increased by 20.70% to ₹749 Crore. Margins improved to 19% as compared to 18% in the previous comparable quarter.

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