OneSource Specialty Pharma Limited, in collaboration with its partner Orbicular Pharmaceutical Technologies, has received tentative U.S. Food and Drug Administration (FDA) approval for a generic version of Ozempic® (Semaglutide Injection). This milestone leverages OneSource’s specialized CDMO capabilities for complex injectables and reinforces its role in supporting the commercial manufacturing of the drug. The product is slated for supply from the company’s US-FDA approved flagship manufacturing site located in Bangalore.
Strategic Milestone in Peptide Manufacturing
On April 21, 2026, OneSource Specialty Pharma announced a significant advancement in its product portfolio through a strategic partnership with Orbicular. The achievement of tentative U.S. ANDA approval for the generic version of the high-demand Semaglutide Injection underscores the effectiveness of a closely integrated development-to-submission model.
Integrated Development and Supply Chain
The collaboration highlights a clear division of expertise: Orbicular spearheaded the complex product development and technical program, while OneSource served as the dedicated CDMO partner. By providing end-to-end manufacturing capabilities, OneSource ensures reliable commercial supply readiness for the U.S. market. This project utilizes the infrastructure at the company’s flagship manufacturing facility in Bangalore, which maintains US-FDA approval.
Expanding Global CDMO Capabilities
This development is part of a broader strategy by OneSource Specialty Pharma to solidify its position as a global leader in drug-device combinations and complex injectables. With a team of over 1,600 professionals and five state-of-the-art facilities, the company continues to win the trust of global pharmaceutical entities by offering efficient, end-to-end solutions for technically demanding and high-value drug products.
Source: BSE
