OneSource Secures SFDA Approval for Generic Ozempic in Saudi Arabia, Partners Hikma for Exclusive MENA Commercialisation

Bengaluru, February 11, 2026 (IST) – OneSource Specialty Pharma Limited (BSE: 544292 | NSE: ONESOURCE) has secured approval from the Saudi Food and Drug Authority to commercialise its generic version of Ozempic® (semaglutide) in Saudi Arabia, marking a strategic entry into one of the largest GLP-1 therapy markets globally.

The approval enables the company to launch the product in partnership with Hikma Pharmaceuticals PLC, which will serve as the exclusive commercialisation partner across the Middle East and North Africa region.

Strategic Entry into High-Growth GLP-1 Market​

Saudi Arabia represents a significant growth opportunity for GLP-1 therapies, given the rising prevalence of diabetes and obesity in the region. With regulatory clearance now in place, OneSource is positioned to leverage Hikma’s commercial infrastructure to scale access across both private and institutional channels.

Under the agreement:

• OneSource will manufacture and supply semaglutide from its integrated biologics and drug-device combination facility in Bengaluru.
• Hikma will lead commercialisation efforts across MENA through its established distribution network and institutional relationships.

This collaboration aligns with both companies’ shared objective to expand access to high-quality, affordable generic therapies in the region.

Management Commentary​

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

“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. 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.”

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Manufacturing Capabilities and Compliance Track Record​

OneSource will produce the drug from its state-of-the-art integrated biologics and drug-device combination facility in Bengaluru. The company operates five manufacturing facilities approved by global regulatory authorities and employs over 1,600 professionals.

The company positions itself as a pure-play specialty pharmaceutical CDMO, focusing on complex products including:

• Biologics
• Drug-device combinations
• Sterile injectables
• Oral technologies such as soft gelatine capsules

Its development capabilities and manufacturing scale have enabled partnerships with global pharmaceutical players seeking end-to-end CDMO solutions.

Partnership Strength: Hikma’s Regional Scale​

Hikma Pharmaceuticals PLC, headquartered in the United Kingdom, operates across North America, MENA, and Europe. The company maintains a strong commercial presence in the MENA region, positioning it as a strategic partner for scaling semaglutide distribution in Saudi Arabia and beyond.

Through this exclusive arrangement, the partnership aims to address rising demand for GLP-1 therapies while expanding patient access to generic alternatives.

About OneSource Specialty Pharma Limited​

OneSource Specialty Pharma Limited is listed on both BSE and NSE under the ticker ONESOURCE. Formerly known as Stelis Biopharma Limited, the company operates as a specialty pharmaceutical CDMO with integrated capabilities across development and manufacturing of complex pharmaceutical products.

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