OneSource Specialty Pharma and Orbicular Pharmaceutical Technologies Receive Tentative FDA Approval for Generic Ozempic On April 21, 2026, OneSource Specialty Pharma announced that its partner Orbicular Pharmaceutical Technologies, together with its U.S.-based front-end partner acting as the ANDA holder, has received tentative approval from the U.S. Food and Drug Administration (FDA) for an Abbreviated New Drug Application (ANDA) for a generic version of Ozempic (semaglutide injection). This development marks a significant step toward expanding access to a widely used medication for type 2 diabetes and weight management. OneSource serves as the contract development and manufacturing organization (CDMO) for the product, providing critical manufacturing support from its U.S. FDA-approved facility in Bangalore. Orbicular led the product development and technical program for the peptide formulation, although OneSource managed the manufacturing and commercial supply readiness for the U.S. Market. The collaboration follows an integrated development-to-submission model, combining Orbicular’s scientific expertise with OneSource’s CDMO capabilities. Neeraj Sharma, CEO and Managing Director of OneSource Specialty Pharma Limited, highlighted the importance of the milestone, stating that it reflects the strengths of both partners in bringing complex injectable therapies to patients. The company emphasized its ongoing commitment to advancing its role as a CDMO partner for drug-device combinations, injectables, and specialty pharmaceutical products through strategic collaborations like this one. Tentative FDA approval indicates that the ANDA has met all necessary requirements for approval, though final approval may be delayed due to patent exclusivity or regulatory proceedings. Once fully approved, the generic version of Ozempic could offer a more affordable alternative to the branded medication, potentially increasing patient access to semaglutide therapy. This announcement aligns with broader trends in the pharmaceutical industry toward increasing the availability of high-quality generic biologics and complex generics, particularly in high-demand therapeutic areas such as diabetes and obesity treatment. OneSource’s involvement underscores its growing capabilities in supporting the development and manufacturing of sophisticated injectable formulations for global markets.
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