The approval marks the second generic semaglutide approval in Canada and positions OneSource’s partners among the first generic entrants in a major global semaglutide market.

Under the collaboration, Orbicular managed product development and the technical program for the complex peptide, while OneSource provided end-to-end manufacturing support for the Canadian filing. Commercial supply will be supported from OneSource’s US FDA-approved manufacturing facility in Bengaluru.

The development follows a recent tentative approval in the United States supported by OneSource, further strengthening the company’s capabilities in peptide-based injectable programs and regulated market manufacturing.

Neeraj Sharma, CEO and Managing Director 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.”