Aurobindo Pharma gets USFDA approval for Dapagliflozin & Metformin XR tablets

The approved product is a generic version of AstraZeneca's Xigduo XR and will be manufactured at the company's Unit-IV facility of APL Healthcare, a wholly owned subsidiary, with immediate market launch planned.

The combination therapy is indicated as an adjunct to diet and exercise to improve glycaemic control in adults where treatment with both medicines is appropriate. According to IQVIA data, the product has an estimated US market size of $514 million for the twelve months ending February 2026. Aurobindo is eligible for 180 days of shared generic exclusivity as one of the first applicants.

As of March 31, 2026, the company had a total of 579 ANDA approvals from the USFDA, including 554 final approvals and 25 tentative approvals.

Aurobindo Pharma is principally engaged in the manufacturing and marketing of active pharmaceutical ingredients, generic pharmaceuticals, and related services. The company's consolidated net profit rose 7.6% to Rs 910.29 crore on a 9% increase in net sales to Rs 8,604.51 crore in Q3 FY26 over Q3 FY25.

Shares of Aurobindo Pharma shed 0.76% to close at Rs 1,329.60 on the BSE.