Orbicular, Apotex Secure US FDA Tentative Approval for Generic Ozempic

Hyderabad firm strengthens position in complex peptide generics; Apotex to commercialise in US

Hyderabad: Orbicular Pharmaceutical Technologies has received tentative approval from the US Food and Drug Administration (FDA) for a generic version of Ozempic (semaglutide injection), developed in partnership with Apotex.

The product will be marketed and commercialised in the United States by Apotex Corp., the abbreviated new drug application (ANDA) applicant, marking a key milestone in expanding access to complex peptide-based therapies.

The approval highlights progress in one of the most challenging segments of generic drug development, where achieving technical equivalence requires high levels of scientific precision and regulatory compliance.

MS Mohan, Managing Director of Orbicular Pharmaceutical Technologies, said the development reflects strong scientific capabilities and execution. “Achieving technical equivalence for complex peptide products requires deep scientific rigour and advanced analytical precision. We are proud to have supported Apotex in this important program,” he said.

Barry Fishman, Chief Corporate Development Officer at Apotex, acknowledged Orbicular’s contribution, stating that its scientific expertise and quality standards were instrumental in achieving the milestone.

The semaglutide program underscores Orbicular’s integrated development model, combining advanced analytics, process expertise and regulatory strategy to support global pharmaceutical partners in bringing complex generics to market.

Orbicular operates as a B2B specialty pharmaceutical company focused on complex generics, while Apotex, headquartered in Canada with global operations, is a major player in generic and specialty pharmaceuticals, serving markets across the Americas and beyond.

The tentative approval positions both companies to capitalise on growing global demand for affordable diabetes and metabolic disorder treatments.