OneSource Partner Wins USFDA Nod for Generic Semaglutide Drug

OneSource Speciality Pharma has said that its partner, Orbicular Pharmaceutical Technologies, along with a US-based front-end partner, has received tentative approval from the U.S. Food and Drug Administration for a generic version of semaglutide injection, a widely used treatment for diabetes.

The approval relates to an Abbreviated New Drug Application (ANDA) for a generic version of Ozempic, a leading drug used to manage type 2 diabetes and, increasingly, for weight loss. A tentative approval means the product has met the regulator’s standards for drug safety, quality, and effectiveness, but cannot yet be launched commercially due to existing patent protection barriers.

OneSource acted as the contract development and manufacturing organization (CDMO) partner for the product. The company supported the process with its manufacturing capabilities, including work carried out at its USFDA-approved facility in Bengaluru. This highlights its growing role in handling complex injectable drugs for global markets.

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The partnership followed a collaborative model. While Orbicular led the development and technical work for the drug, OneSource contributed to manufacturing and regulatory approval support required for filing in the US. This combined effort helped move the product forward through the approval process.

Commenting on the development, Managing Director and CEO Neeraj Sharma said the approval reflects the strong scientific and technical capabilities of both companies. He noted that such partnerships demonstrate OneSource’s ability to support advanced pharmaceutical products for international markets.

Semaglutide, part of a class of drugs known as GLP-1 receptor agonists, has seen strong global pharmaceutical demand due to its effectiveness in controlling blood sugar levels and supporting weight management. However, high prices and limited supply have restricted access in several regions.

While this approval marks an important step, the actual launch of the generic drug will depend on when intellectual property rights and exclusivity barriers are cleared. Until then, the product will remain on hold for commercial sale.

The development further strengthens OneSource Speciality Pharma’s position as a growing player in the global CDMO space, especially in the segment of specialty pharmaceuticals.