OneSource Secures Saudi Nod for Generic Ozempic, Partners Hikma for MENA Rollout
New Delhi: OneSource Specialty Pharma Limited has received regulatory approval in Saudi Arabia to commercialise a generic version of Ozempic (semaglutide), marking a significant milestone for the company's expansion in the Middle East.
The approval has been granted by the Saudi Food and Drug Authority, enabling OneSource to enter one of the largest and fastest-growing markets for GLP-1 therapies through an exclusive partnership with Hikma Pharmaceuticals.
The approval clears the way for OneSource to manufacture and supply generic semaglutide for the Saudi market, with Hikma Pharmaceuticals PLC acting as the exclusive commercialisation partner across Saudi Arabia and the wider Middle East and North Africa (MENA) region. The collaboration is aimed at increasing access to high-quality, affordable generic alternatives amid rising demand for GLP-1 therapies used in the management of diabetes and obesity.
Under the terms of the exclusive agreement, OneSource will manufacture and supply semaglutide from its integrated biologics and drug-device combination manufacturing facility in Bengaluru. Hikma, which has a strong commercial presence and institutional reach across the MENA region, will be responsible for marketing and distribution through both private and institutional channels.
Commenting on the development, the company’s management said the approval represents an important entry into Saudi Arabia, which is among the largest global markets for GLP-1 products and offers significant long-term growth potential. The partnership is expected to leverage OneSource’s advanced manufacturing capabilities and Hikma’s established regional footprint to scale patient access to the therapy.
The company highlighted that the approval reinforces its strategy of expanding into complex and high-value specialty pharmaceutical products while partnering with leading regional players to accelerate market access. It also reflects the shared objective of both companies to broaden availability of cost-effective treatment options in regulated and high-demand markets.
OneSource Specialty Pharma Limited, formerly known as Stelis Biopharma, operates as a pure-play specialty pharmaceutical CDMO with capabilities spanning biologics, drug-device combinations, sterile injectables, and oral technologies. Hikma Pharmaceuticals PLC is a multinational pharmaceutical company headquartered in the UK, with a strong presence across North America, Europe, and the Middle East and North Africa.
