We are pleased to announce that we have now completed our Pivotal BE program for Dapagliflozin 10mg film-coated tablets. This product has been developed in collaboration with one of our strategic partners.
Our product has been developed based on the reference brand Forxiga 10mg film-coated tablets, which is indicated in the treatment of type 2 diabetes, heart failure and chronic (long-term) kidney disease.
The brand sold approximately $5bn globally in 2021, having a significant growth potential with Global 3Y CAGR at +44%, according to IQVIA.
Based on our positive progress, we believe that we will be ready for launch on Day-1. This development further showcases our ability to bring differentiated products to our partners.
Adalvo is able to offer a number of dossiers within this domain, as depicted below.