Orbicular Pharmaceutical Technologies Pvt. Ltd. announced that a generic version of Ozempic® (semaglutide injection), developed in partnership with Apotex, has received Tentative Approval from the US Food and Drug Administration (FDA).

The product will be marketed and commercialised in the United States by Apotex Corp., the ANDA applicant.

The Tentative Approval represents a milestone in the development of complex peptide-based generics, which involve scientific, analytical, and regulatory challenges.

Dr. M. S. Mohan, Managing Director, Orbicular Pharmaceutical Technologies, said “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.”

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. We value this strong partnership, which has enabled us to reach this important milestone.”

The semaglutide injection program reflects Orbicular’s integrated development model, combining analytical capabilities, process understanding, and technical execution to support the development of complex generics.

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