Hyderabad, India, Apr 11th: Orbicular Pharmaceutical Technologies Pvt. Ltd., a Hyderabad–based leading developer of complex peptide-based generics, announced today that a generic version of Ozempic® (semaglutide injection), developed in partnership with Apotex, has received Tentative Approval from the U.S. Food and Drug Administration (FDA). The product will be marketed and commercialized in the United States by Apotex Corp., the ANDA applicant.
The Tentative Approval represents a significant milestone in advancing access to complex peptide therapies, an area where scientific, analytical, and regulatory challenges are among the most demanding in generic drug development.
Commenting on the development, 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.”
Apotex also acknowledged the strength of the collaboration and Orbicular’s scientific contribution.
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, which combines advanced analytical capabilities, deep process understanding, and technical problem solving to support partners in accelerating the development of complex generics.
