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 filing. The collaboration is designed to ensure reliable commercial supply from OneSource's US-FDA approved flagship site in Bangalore.
Mr. 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.