OneSource Specialty Pharma’s partner Orbicular Pharmaceutical Technologies (Orbicular), together with its U.S.-based front-end partner (the ANDA holder), has secured tentative U.S. Food and Drug Administration (FDA) approval for an Abbreviated New Drug Application (ANDA) for a generic version of Ozempic (Semaglutide Injection). The company is the contract development and manufacturing organization (CDMO) partner for this product.

This step highlights a closely integrated development-to-submission model: Orbicular led the product development and technical program for this complex peptide, while the company supported the program as the CDMO partner, providing end-to-end manufacturing capabilities for the U.S. market filing. The collaboration is designed to ensure reliable commercial supply from the company’s US-FDA approved flagship site in Bangalore.

OneSource Specialty Pharma is a multimodal specialty pharma CDMO with end-to-end capabilities across technology platforms and therapeutic modalities.