Health Canada Approves Generic Semaglutide Injection by OneSource and Orbicular
OneSources' CDMO client receives Health Canada approval for semaglutide injection
Business Standard
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OneSource Specialty Pharma and its partner Orbicular have received Health Canada approval for a generic version of Ozempic (semaglutide injection). This approval positions them as the first generic entrants in Canada, enhancing their presence in the significant semaglutide market.
- 01Health Canada approved a generic semaglutide injection by OneSource and Orbicular.
- 02This is the second generic semaglutide approval in Canada.
- 03OneSource's US FDA-approved facility in Bengaluru will support commercial supply.
- 04The approval follows a tentative approval in the United States.
- 05The partnership aims to enhance global commercialization of complex peptide-based injectables.
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OneSource Specialty Pharma announced that its partner, Orbicular, has received approval from Health Canada for a generic version of Ozempic (semaglutide injection). This marks the second approval for generic semaglutide in Canada, establishing OneSource and Orbicular as the first generic entrants in a significant market. The product development was led by Orbicular, while OneSource provided comprehensive manufacturing support, utilizing its US FDA-approved facility in Bengaluru for commercial supply. This approval follows a recent tentative approval in the United States, further solidifying OneSource's position in complex peptide-based injectable programs. Neeraj Sharma, CEO & MD of OneSource, expressed satisfaction with the back-to-back approvals, emphasizing the strength of their contract development and manufacturing organization (CDMO) platform and collaborative partnerships for global commercialization.
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The approval of the generic semaglutide injection may lead to increased accessibility and potentially lower prices for patients in Canada, enhancing treatment options for those managing type 2 diabetes.
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