Orbicular's partner secures tentative U.S. ANDA approval for a generic version of Ozempic

OneSource is the contract development and manufacturing organization (CDMO) partner for this product

OneSource Specialty Pharma Limited has announced that its partner Orbicular Pharmaceutical Technologies, 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 filing. The collaboration is designed to ensure reliable commercial supply from OneSource's US-FDA approved flagship site in Bangalore.

Neeraj Sharma, CEO & MD, OneSource Specialty Pharma Limited, speaking on the development, said: "We are pleased to announce that our partner Orbicular, along with its front-end partner (the ANDA holder), has received tentative approval for a generic version of Ozempic® (Semaglutide Injection). This milestone reflects Orbicular's scientific expertise and OneSource's COMO capabilities, supported by our US-FDA approved manufacturing site."

OneSource continues to strengthen its position as a global CDMO partner for drug-device combinations, complex injectables, and specialty pharmaceutical products through strategic collaborations such as the one with Orbicular, where OneSource serves as the CDMO partner supporting manufacturing and commercial supply readiness.