OneSource CDMO partner secures tentative US FDA approval for generic Ozempic

OneSource Specialty Pharma Ltd announced that its partner, Orbicular Pharmaceutical Technologies, along with its U.S.-based front-end partner, 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 served as the contract development and manufacturing organization (CDMO) partner for this product, providing end-to-end manufacturing capabilities for the U.S. market filing. This milestone reflects Orbicular's scientific expertise and OneSource's CDMO capabilities, supported by its US-FDA approved flagship site in Bangalore. The collaboration is designed to ensure reliable commercial supply. This development strengthens OneSource's position as a global CDMO partner for drug-device combinations, complex injectables, and specialty pharmaceutical products.