OneSource Specialty Pharma, along with Orbicular Pharmaceutical Technologies, has received tentative approval from the US Food and Drug Administration (FDA) for an Abbreviated New Drug Application (ANDA) for a generic version of Ozempic (semaglutide injection). OneSource is the Contract Development and Manufacturing Organisation (CDMO) partner for this product.

The development reflects an integrated development-to-submission model. Orbicular led product development and the technical program for the peptide, while OneSource supported the program as the CDMO partner, providing manufacturing capabilities for the US market filing. The collaboration is structured to ensure commercial supply from OneSource’s FDA-approved manufacturing site in Bengaluru.

Speaking in this regard, Neeraj Sharma, CEO and MD, OneSource Specialty Pharma, 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 stated that it continues to expand its role as a CDMO partner for drug-device combinations, injectables and specialty pharmaceutical products through collaborations including its partnership with Orbicular, where it supports manufacturing and commercial supply readiness.