OneSource supports second generic semaglutide approval in Canada

OneSource Specialty Pharma, a leading specialty pharmaceutical CDMO, announced that its 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 OneSource partners as the first generic entrants in one of the world’s most significant semaglutide markets.

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

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

Neeraj Sharma, CEO & MD, OneSource Specialty Pharma 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 builds on momentum from India, where OneSource has been supplying a number of brands marketed by multiple partners following product launches in March.

With a continued focus on complex drug-device combinations, biologics, and oral technology, OneSource is strengthening its position as a global CDMO partner, enabling faster, reliable, and high-quality commercialisation for partners worldwide.

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