OneSource and Orbicular secure USFDA tentative approval for generic semaglutide injection

OneSource Specialty Pharma announced that its partner Orbicular Pharmaceutical Technologies, along with its U.S.-based front-end partner acting as the ANDA holder, has received tentative approval from the U.S. Food and Drug Administration 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 programme for the peptide, while OneSource supported the programme as the CDMO partner, providing manufacturing capabilities for the U.S. market filing. The collaboration is structured to ensure commercial supply from OneSource’s USFDA-approved manufacturing site in Bangalore.

Neeraj Sharma, CEO and MD, OneSource Specialty Pharma Limited, 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.

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