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Adalvo Submits DCP for Dapagliflozin + Metformin IR Fixed-Dose Combination, Expanding Diabetes Portfolio

Business
05 September 2025

Adalvo announces the successful DCP submission for Dapagliflozin + Metformin IR fixed-dose combination tablets, strengthening its commitment to improving access to advanced oral therapies for type 2 diabetes mellitus in adults requiring dual therapy. 

This combination brings together Dapagliflozin, a sodium-glucose cotransporter 2 (SGLT2) inhibitor, and Metformin, a first-line biguanide, offering complementary mechanisms of action to improve glycemic control when used alongside diet and exercise. The immediate-release formulation, administered twice daily, provides an effective, film-coated oral dosing option. 

According to IQVIA, the global market for Dapagliflozin + Metformin IR reached $528 million in 2024, with a 3Y CAGR of 22%, highlighting its strong growth trajectory and relevance in the diabetes segment. 

The submission builds on Adalvo’s expanding diabetes portfolio, which already includes a DCP-approved Dapagliflozin monotherapy and a ready-to-file Dapagliflozin + Metformin XR formulation, providing partners with a complementary suite of differentiated products to address diverse patient needs across treatment pathways. 

For licensing opportunities or further information about Adalvo’s diabetes portfolio, contact the team today.