OneSource gets Saudi nod for Ozempic generic, partner Hikma will commercialise

Ozempic generic

• OneSource gets Saudi approval to launch generic Ozempic for diabetes, weight loss
• Hikma to distribute semaglutide across MENA, boosting regional access
• Approval strengthens OneSource's global CDMO position in complex injectables

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OneSource Specialty Pharma Ltd. on Wednesday said it has received regulatory clearance from Saudi Arabia to launch generic version of Ozempic, the blockbuster semaglutide therapy used for diabetes and weight loss.

Saudi Arabia is one of the world’s fastest‑growing GLP‑1 markets.

The approval by the Saudi Food and Drug Authority paves the way for commercialization through its exclusive regional partner Hikma Pharmaceuticals Plc, the largest drugmaker in the Middle East and North Africa by sales.

The move marks a significant strategic expansion for Bengaluru‑based OneSource, which has been rapidly scaling its capabilities in biologics and drug‑device combination manufacturing.

“We are extremely excited to secure SFDA approval for semaglutide in Saudi Arabia, one of the largest GLP‑1 markets globally with significant long‑term potential,” said Neeraj Sharma, CEO and managing director of OneSource. He added that partnering with Hikma provides a “strong platform to scale access to this important therapy across both private and institutional customers.”

The partnership comes as GLP‑1 demand accelerates across global markets, with Saudi Arabia emerging as one of the most promising growth geographies due to increasing rates of obesity and Type‑2 diabetes. Semaglutide, originally developed by Novo Nordisk, has become one of the most sought‑after metabolic therapies worldwide, shaping procurement strategies and intensifying competition among generics suppliers.

OneSource will produce semaglutide at its integrated biologics and drug‑device facility in Bengaluru, while Hikma will deploy its extensive sales and distribution footprint across MENA to drive uptake. Hikma’s position as the region’s largest pharmaceutical company gives it a powerful institutional reach across both government and private channels, reinforcing the partnership’s commercial potential.

Industry analysts note that the approval strengthens OneSource’s position as a key global contract development and manufacturing (CDMO) player in complex injectables. The company already supplies semaglutide to other global pharmaceutical firms and is also a partner to Dr. Reddy’s Laboratories, which is pursuing its own semaglutide ambitions for multiple markets.

The Saudi approval also underscores OneSource’s broader push to deepen its global footprint. The company operates five advanced manufacturing facilities certified by major global regulators and employs more than 1,600 specialists across biologics, drug‑device combinations, sterile injectables and soft‑gel oral technologies.

The collaboration with UK-based Hikma, combined with OneSource’s partnership with Dr. Reddy’s on semaglutide, positions the Indian CDMO as a central supplier in one of the most competitive therapeutic categories globally.