ONESOURCE's partner receives USFDA tentative approval for Semaglutide Injection

OneSource Speciality Pharma 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.

Neeraj Sharma, CEO & MD, OneSource Speciality Pharma, 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 CDMO capabilities, supported by our US-FDA approved manufacturing site.?