OneSource Specialty Pharma has announced today that it has received approval from the Saudi Food and Drug Authority (SFDA) for its generic Ozempic (semaglutide), clearing the way to commercialize the product in Saudi Arabia through an exclusive partnership with Hikma Pharmaceuticals PLC (Hikma).

 

The approval marks a major milestone for OneSource’s entry into Saudi Arabia, one of the largest markets for GLP-1 therapies, and positions the partnership to meet rising demand while offering high-quality, affordable generic alternatives to patients across the Middle East and North Africa (MENA).

 

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

 

Speaking on the approval, Neeraj Sharma, CEO & MD of OneSource, said: "We are extremely excited to secure SFDA approval for semaglutide in Saudi Arabia, one of the largest GLP-1 market globally with significant long-term potential. We are confident that collaborating with Hikma, the largest pharmaceutical company in the MENA region by sales, will give us a strong platform to scale access to this important therapy across both private and institutional customers."

 

This launch underscores the shared ambition of OneSource and Hikma to expand access to affordable, high-quality therapies across the region.