Orbicular Pharmaceutical Technologies has received tentative approval for a generic version of Ozempic (semaglutide injection), developed in partnership with Apotex.
The product will be marketed and commercialised in the United States by Apotex Corp., the ANDA applicant.
“Achieving technical equivalence for complex peptide products requires deep scientific rigor, advanced analytical precision and a highly disciplined development approach. We are proud to have supported Apotex in this important program. Their regulatory leadership, combined with Orbicular’s development and execution capabilities, has been central to securing this FDA Tentative Approval,’’ M. S. Mohan, Managing Director, Orbicular Pharmaceutical Technologies said in a release on Saturday.
Barry Fishman, Chief Corporate Development Officer, Apotex, said: “Orbicular’s scientific depth and commitment to quality were instrumental in supporting this complex program. As the ANDA applicant, Apotex remains focused on advancing high-quality, affordable peptide therapies for patients.’’