OneSource Specialty Pharma Limited (BSE: 544292, NSE: ONESOURCE), a specialty pharmaceutical contract development and manufacturing organization (CDMO), has announced that its partner Orbicular, together with its Canadian commercialization partner, has secured approval from Health Canada for a generic version of semaglutide injection, referencing OzempicĀ®. This represents the second approval for a generic semaglutide product in Canada and establishes the collaboration as among the earliest generic entrants in a key global market.
The achievement reflects a coordinated development and manufacturing approach. Orbicular led the formulation development and technical execution for the complex peptide program, while OneSource contributed as the manufacturing partner, delivering integrated capabilities to support the regulatory submission and supply requirements for the Canadian market. Commercial production will be undertaken at OneSourceās US FDA-approved facility in Bengaluru.
This development follows a recent tentative approval in the United States, also supported by OneSource, highlighting the companyās expanding involvement in peptide-based injectable therapies and its ability to support partners navigating stringent regulatory pathways.
Commenting on the development, Neeraj Sharma, Chief Executive Officer and Managing Director of OneSource Specialty Pharma Limited, stated that the dual milestones underscore the companyās technical depth, regulatory compliance standards, and capacity to scale complex pharmaceutical programs. He noted that the collaboration with Orbicular demonstrates the importance of integrated partnerships in advancing global commercialization efforts.
The Canadian approval adds to the companyās ongoing progress in India, where it has been supplying semaglutide products under multiple partner brands following launches earlier this year. These developments reinforce OneSourceās focus on specialized segments such as drug-device combinations, biologics, sterile injectables, and oral dosage technologies.
OneSource Specialty Pharma Limited operates as a dedicated CDMO, concentrating on the development and manufacturing of complex pharmaceutical products. Its capabilities include biologics, peptide-based therapies, sterile injectables, and soft gelatin capsule technologies. The company maintains five advanced manufacturing facilities that meet global regulatory standards and employs a workforce of over 1,600 professionals.
With established development expertise, scalable manufacturing infrastructure, and a consistent compliance record, OneSource continues to support pharmaceutical companies seeking efficient, end-to-end solutions for product development and commercialization across international markets.
