Mumbai, April 8 -- 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 tenta...