OneSource Specialty Pharma has helped unlock a key milestone in the global obesity and diabetes drug race.
The pharma powerhouse has announced that its partner Orbicular, together with a Canadian front-end collaborator, has secured Health Canada approval for a generic version of Ozempic (semaglutide injection).
The approval marks the second generic semaglutide authorization in Canada, positioning OneSource-linked partners among the first wave of entrants into one of the world’s largest and fastest-growing markets for the blockbuster drug class.
The development highlights a tightly coordinated global manufacturing and development chain. Orbicular led formulation and technical development of the complex peptide-based therapy, while OneSource provided end-to-end manufacturing support for the Canadian regulatory filing.
Commercial supply will be produced from OneSource’s US FDA-approved flagship facility in Bengaluru, strengthening its role as a cross-border production hub for regulated markets.
The Canadian green light comes on the heels of a recent tentative approval in the United States supported by OneSource, reinforcing its expanding footprint in complex peptide injectables and drug-device combination programs across highly regulated jurisdictions.
Neeraj Sharma, CEO & MD of OneSource Specialty Pharma Limited, said: “We are pleased with these back-to-back approvals from two of our global customers in one of the most important semaglutide markets globally.
"This milestone reflects the strength of our CDMO platform, our compliance standards, technical expertise, and ability to scale complex drug-device-combination programs for highly regulated markets. Our partnership with Orbicular highlights our role in enabling global commercialization through strong, collaborative ecosystems.”
The Canadian approval also builds on momentum in India, where OneSource has been supplying multiple branded products through partner launches since March.
With semaglutide becoming one of the most closely watched therapeutic franchises worldwide, OneSource is positioning itself deeper into high-value CDMO segments spanning biologics, oral technologies, and complex injectable systems—aiming to accelerate global commercialization for its partners.
