OneSource Specialty Pharma Receives SFDA Approval for Generic Semaglutide in Saudi Arabia

• OneSource Specialty Pharma has received Saudi Food and Drug Authority approval for its generic Ozempic® (semaglutide) in Saudi Arabia.

• The company will manufacture the product in Bengaluru and commercialise it in the MENA region through an exclusive partnership with Hikma Pharmaceuticals.

OneSource Specialty Pharma Limited has received approval from the Saudi Food and Drug Authority (SFDA) for its generic Ozempic® (semaglutide) in Saudi Arabia, enabling commercialisation in partnership with Hikma Pharmaceuticals PLC across the Middle East and North Africa (MENA) region.

The approval marks OneSource’s entry into Saudi Arabia, described as one of the largest markets for GLP-1 therapies. Under the exclusive agreement, OneSource will manufacture and supply semaglutide from its integrated biologics and drug-device combination facility in Bengaluru. Hikma, identified as the largest pharmaceutical company in MENA by sales, will leverage its commercial network and institutional relationships to distribute the product across private and institutional channels.

The companies stated that the partnership aims to increase access to high-quality, affordable generic alternatives in the region amid rising demand for GLP-1 therapies. The arrangement combines manufacturing capabilities in India with regional commercial infrastructure in MENA.

“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.”

Neeraj Sharma, CEO and Managing Director of OneSource Specialty Pharma Limited