OneSource Specialty Pharma secures SFDA approval for generic Ozempic

11 Feb 2026 Evaluate

OneSource Specialty Pharma has received Saudi Food and Drug Authority (SFDA) approval for its generic Ozempic (semaglutide) in Saudi Arabia, clearing the path for commercialsing the product with Hikma Pharmaceuticals PLC (Hikma) as their exclusive commercialisation partner for the Middle East and North Africa (MENA).

The approval represents an important entry for OneSource Specialty Pharma into the Kingdom of Saudi Arabia, one of the largest markets for GLP-1 therapies, positioning the exclusive partnership to capitalise on rising demand for this product and underscoring the shared ambition of both companies to increase access to high-quality affordable generic alternatives to patients across the region.

Under the exclusive agreement, the company will manufacture and supply semaglutide from its state-of-the-art integrated Biologics and Drug-Device Combination facility in Bengaluru and Hikma, the largest pharmaceutical company in MENA based on sales, will use its extensive commercial reach and institutional relationships in the region to scale access across both private and institutional channels.

OneSource Specialty Pharma is a multimodal specialty pharma CDMO with end-to-end capabilities across technology platforms and therapeutic modalities.


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