Contract drug manufacturer OneSource Specialty Pharma has received approval for its generic version of Ozempic in Saudi Arabia, marking a significant milestone for the company's expansion into the Middle East market. According to reports from Mint, the approval from the Saudi Food and Drug Authority (SFDA) enables the company to enter Saudi Arabia, which represents one of the largest markets for Ozempic and other weight management/loss drugs in the region.
Under the exclusive partnership agreement, OneSource will manufacture and supply semaglutide from its facility in Bengaluru, while Hikma Pharmaceuticals PLC will handle commercialization in the Middle East and North Africa (MENA) region. As reported by Mint, Hikma serves as OneSource's exclusive commercialization partner for the MENA region, leveraging its position as the largest pharmaceutical company in the MENA region by sales to expand drug availability across both private and institutional customers.
The partnership positions both companies to capitalize on rising demand for generic semaglutide products, with OneSource CEO and Managing Director Neeraj Sharma expressing confidence that collaborating with Hikma will provide a strong platform to scale access to this important therapy. According to Mint, OneSource is fast-tracking a $100 million capacity expansion to tap into the global boom in weight-loss drugs, as innovator Novo Nordisk is set to lose patent exclusivity in over 80 countries this year for the drug known by brands Ozempic and Wegovy.
The company's revenue performance has been impacted by regulatory delays, with Q3 revenue dropping 26% year-over-year to ₹290.3 crore ($33.1 million) after semaglutide approvals were delayed in Canada. As reported by Mint, EBITDA dropped 88% and the EBITDA margin contracted to 6% from 36% a year earlier. Despite these challenges, OneSource is targeting $500 million in revenue by FY28, with the company prepared for market expansion in terms of manufacturing and regulatory approvals for its facilities.
