OneSource Specialty Pharma Enables Second Generic Semaglutide Approval In Canada

Bengaluru: OneSource Specialty Pharma is strengthening its global footprint as its partners secure another regulatory win in a key pharmaceutical market.

Canada Approval Milestone

The company confirmed that its partner Orbicular, along with a Canadian front-end partner, received approval from Health Canada for a generic version of semaglutide injection. This marks the second generic approval in Canada, placing the collaboration among the earliest entrants in a high-value market. The development signals progress in expanding access to complex peptide-based therapies in regulated international markets.

Manufacturing Role Strengthens

OneSource played a critical role as the manufacturing partner, supporting the program with end-to-end production capabilities. The commercial supply for the Canadian market will be handled through its US FDA-approved flagship facility in Bengaluru. This highlights the company’s ability to manage large-scale production for global filings while maintaining compliance with stringent regulatory standards.

Back-To-Back Approvals

The Canadian approval follows a recent tentative approval in the United States supported by OneSource. According to CEO and Managing Director Neeraj Sharma, these consecutive approvals from global partners reflect the strength of the company’s integrated development and manufacturing model.

He indicated that the company’s technical expertise and compliance framework are enabling it to deliver complex drug-device programs efficiently across regulated markets.

Expanding Global Presence

The momentum builds on activity in India, where OneSource has already been supplying multiple brands following product launches in March. The company continues to focus on complex drug-device combinations, biologics, and oral technologies to strengthen its position as a global CDMO partner. This approach reflects a strategy centered on scalable manufacturing and collaborative partnerships.

The latest approval underscores OneSource’s growing role in enabling global pharmaceutical commercialization, supported by its integrated capabilities and expanding presence across key regulated markets.

Disclaimer: This article is based solely on the contents of the company filing provided and does not include external verification or additional sources.