OneSource Speciality Pharma Limited has received approval from the Saudi Food and Drug Authority (SFDA) for its generic Ozempic® (semaglutide) in Saudi Arabia. The approval allows the company to proceed with commercialisation of the product in the Kingdom through an exclusive partnership with Hikma Pharmaceuticals PLC, covering the Middle East and North Africa (MENA) region.
OneSource Speciality Pharma Limited, listed on BSE and NSE under the symbol ONESOURCE, will manufacture and supply semaglutide from its integrated biologics and drug-device combination manufacturing facility in Bengaluru. Hikma will handle commercial distribution across private and institutional channels in Saudi Arabia and other MENA markets, using its existing regional network.
Saudi Arabia represents a significant market for GLP-1 therapies due to increasing demand for treatments related to diabetes and metabolic disorders. The SFDA approval enables OneSource to enter this regulated market through a local commercial partner, in line with applicable regulatory requirements. No launch timelines or revenue guidance have been disclosed.
Commenting on the development, Neeraj Sharma, CEO and Managing Director of OneSource Speciality Pharma Limited, stated that the approval allows the company to collaborate with Hikma to supply semaglutide to patients across the region through established healthcare channels.