By: IPP Bureau
Last updated : April 11, 2026 6:54 am
Hyderabad-based peptide specialist strengthens complex generics credentials as Apotex prepares for U.S. commercialization of semaglutide injection
Orbicular Pharmaceutical Technologies has announced that its generic version of Ozempic® (semaglutide injection), developed in partnership with Apotex, has received Tentative Approval from the U.S. FDA.
Apotex will commercialize the product in the United States as the ANDA applicant, marking a significant advance in expanding access to affordable semaglutide therapies.
The Tentative Approval is particularly significant given the scientific and regulatory complexity of peptide-based generics, where demonstrating technical equivalence requires advanced analytical characterization, precise process control, and robust regulatory documentation.
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 development comes at a time when global competition in semaglutide is intensifying following patent expiries in several markets in 2026, triggering a new wave of affordable GLP-1 therapies for diabetes and obesity.