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OneSource Specialty’s partner gets Health Canada nod for generic version of Ozempic

This marks the second generic semaglutide approval in Canada

OneSource Specialty Pharma’s partner Orbicular, along with its Canadian front-end partner, has received approval from Health Canada for a generic version of Ozempic (semaglutide injection). This marks the second generic semaglutide approval in Canada, positioning the company’s partners as the first generic entrants in one of the world’s most significant semaglutide markets.

The step reflects a closely integrated development and manufacturing model. Orbicular led the product development and technical program for the complex peptide, while the company supported the program as the manufacturing partner, providing end-to-end manufacturing capabilities for the Canadian filing. Commercial supply will be supported from the company’s US FDA-approved flagship facility in Bengaluru.

The approval follows a recent tentative approval in the United States supported by the company, further reinforcing the company’s growing presence in complex peptide-based injectable programs and its ability to support global partners across highly regulated markets.

OneSource Specialty Pharma is a multimodal specialty pharma CDMO with end-to-end capabilities across technology platforms and therapeutic modalities.