Onesource Specialty Pharma announced a significant regulatory milestone as its partner Orbicular Pharmaceutical Technologies, together with its US-based front-end partner, secured tentative US Food and Drug Administration (FDA) approval for a generic version of Ozempic® (Semaglutide Injection). Onesource served as the contract development and manufacturing organization (CDMO) partner for this complex peptide product.

Strategic Partnership Model

The achievement highlights a closely integrated development-to-submission approach between the partners. Orbicular led the product development and technical program for the complex peptide, while Onesource supported the initiative as the CDMO partner, providing comprehensive manufacturing capabilities for the US market filing.

Management Commentary

Mr. Neeraj Sharma, CEO & MD of Onesource Specialty Pharma Limited, commented on the development: "We are pleased to announce that our partner Orbicular, along with its front-end partner (the ANDA holder), has received tentative approval for a generic version of Ozempic® (Semaglutide Injection). This milestone reflects Orbicular's scientific expertise and Onesource's CDMO capabilities, supported by our US-FDA approved manufacturing site."

Manufacturing and Supply Strategy

The collaboration is structured to ensure reliable commercial supply from Onesource's US-FDA approved flagship manufacturing site in Bangalore. This arrangement demonstrates the company's capability to support complex pharmaceutical products through its established manufacturing infrastructure and regulatory compliance framework.

Strategic Positioning

This partnership reinforces Onesource's position as a global CDMO partner specializing in:

• Drug-device combinations
• Complex injectables
• Specialty pharmaceutical products

The company continues to build strategic collaborations where it serves as the CDMO partner, supporting both manufacturing and commercial supply readiness for complex pharmaceutical products.

About the Companies

Onesource Specialty Pharma Limited operates as a pure-play specialty pharmaceutical CDMO, focusing on development and manufacturing of complex pharmaceutical products including biologics, drug-device combinations, sterile injectables, and oral technologies. The company maintains five state-of-the-art manufacturing facilities approved by global regulatory authorities and employs over 1,600 professionals.

Orbicular operates as a partnership-driven, B2B specialty pharmaceutical company focused on designing, developing, and delivering complex generics and specialty pharmaceutical products, with integrated capabilities spanning development, advanced analytical characterization, regulatory strategy, and technology transfer.

OneSource Specialty Pharma Limited has successfully secured the renewal of its European Union Good Manufacturing Practices (EU-GMP) certification for its flagship Unit II manufacturing facility in Bengaluru. The company announced this regulatory milestone on April 17, 2026, following a comprehensive inspection conducted by a European regulatory authority.

Facility Details and Capabilities

The certified Unit II facility represents a cornerstone of OneSource's manufacturing operations, functioning as an integrated biologics manufacturing site. The facility demonstrates advanced capabilities across multiple specialized areas of pharmaceutical production.

Regulatory Significance

The EU-GMP certification renewal underscores OneSource Specialty Pharma's commitment to maintaining the highest standards of pharmaceutical manufacturing quality and regulatory compliance. This certification enables the company to continue manufacturing products that meet stringent European regulatory requirements for biologics and sterile injectable products.

The successful renewal process involved a thorough inspection by European regulatory authorities, validating the facility's adherence to Good Manufacturing Practices standards. This regulatory approval is particularly significant for biologics manufacturing, where stringent quality controls and manufacturing protocols are essential.

Manufacturing Excellence

Unit II's designation as a flagship facility reflects its strategic importance within OneSource's manufacturing network. The facility's integrated approach to biologics production, combining both drug-substance and drug-product manufacturing capabilities, positions the company to serve diverse pharmaceutical market segments.

The facility's specialized focus on drug-device combinations and sterile injectable products demonstrates OneSource's commitment to advanced pharmaceutical manufacturing technologies. These capabilities are increasingly important in the evolving pharmaceutical landscape, where complex drug delivery systems and sterile manufacturing processes are in high demand.