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

The achievement highlights a collaborative development and manufacturing approach. Orbicular managed the product development and technical program for the complex peptide, while OneSource served as the manufacturing partner, offering end-to-end manufacturing support for the Canadian regulatory filing. Commercial production will be carried out at OneSource’s US FDA-approved flagship facility in Bengaluru.

This development follows a recent tentative approval in the United States supported by OneSource, reinforcing the company’s growing capabilities in complex peptide injectable programs and its support for global partners in regulated markets.

Neeraj Sharma, CEO and Managing Director of OneSource Specialty Pharma, said the consecutive approvals from global customers in major semaglutide markets underscore the strength of the company’s CDMO platform, regulatory compliance standards, technical expertise, and ability to scale complex drug-device combination products for regulated markets. He added that the collaboration with Orbicular reflects OneSource’s role in enabling global commercialization through integrated partnerships.

The Canadian approval also builds on the company’s momentum in India, where OneSource has been supplying semaglutide products marketed by multiple partners since launches earlier this year.

With continued emphasis on complex drug-device combinations, biologics, and oral technologies, OneSource aims to further strengthen its position as a global CDMO partner supporting high-quality and reliable commercialization worldwide.