OneSource Specialty Pharma Limited announced it has received approval from the Saudi Food and Drug Authority (SFDA) for its generic version of Ozempic® (semaglutide). This approval clears the way for commercialization in Saudi Arabia through an exclusive partnership with Hikma Pharmaceuticals PLC across the Middle East and North Africa (MENA). The development marks a major entry for OneSource into the substantial GLP-1 therapy market in the Kingdom.
SFDA Approval Secured for Semaglutide
On February 11, 2026, OneSource Specialty Pharma Limited confirmed receiving approval from the Saudi Food and Drug Authority (SFDA) for its generic version of Ozempic® (semaglutide). This regulatory milestone positions the company to commercialize the product in Saudi Arabia, which is recognized as one of the largest markets globally for GLP-1 therapies, citing significant long-term potential.
Exclusive Commercialization with Hikma
The commercialization strategy hinges on an exclusive partnership with Hikma Pharmaceuticals PLC, identified as the largest pharmaceutical company in the MENA region based on sales¹. Under the agreement, OneSource will leverage its state-of-the-art integrated Biologics and Drug-Device Combination facility in Bengaluru to manufacture and supply the semaglutide. In contrast, Hikma will utilize its extensive commercial reach and institutional relationships across the MENA region to scale access across both private and institutional channels.
Mr. Neeraj Sharma, CEO & MD of OneSource, expressed excitement, stating the collaboration with Hikma provides a strong platform to scale access to this important therapy for both private and institutional customers.
Company Capabilities Highlighted
The announcement underscored OneSource Specialty Pharma’s role as a pure-play specialty pharmaceutical CDMO, focusing on complex products including biologics and drug-device combinations. The company currently operates five state-of-the-art manufacturing facilities approved by global regulatory authorities, supported by a dedicated team of over 1,600 professionals. Meanwhile, partner Hikma supports millions globally, leveraging over 45 years of experience in providing high-quality, accessible medicines across North America, MENA, and Europe.
Source: BSE
