Orbicular's Partner secures tentative U.S. ANDA approval for a generic version of Ozempic® (Semaglutide Injection), supported by OneSource as CDMO partner
Orbicular's Partner secures tentative U.S. ANDA approval for a generic version of Ozempic® (Semaglutide Injection), supported by OneSource as CDMO partner Bangalore, India, April 22, 2026 - OneSource Specialty Pharma Limited (BSE: 544292, NSE: ONESOURCE) today announced that its 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). OneSource is the contract development and manufacturing organization (CDMO) partner for this product. This milestone highlights a closely integrated development-to-submission model: Orbicular led the product development and technical program for this complex peptide, while OneSource supported the program as the CDMO partner, providing end-to-end manufacturing capabilities for the U.S. market fil...