Sun Pharma Wins SAHPRA Nod to Manufacture, Market Generic Semaglutide Injection in South Africa
New Delhi: Sun Pharmaceutical Industries Limited has received approval from the South African Health Products Regulatory Authority (SAHPRA) to manufacture and market a generic version of semaglutide injection in South Africa for the treatment of adults with inadequately controlled type 2 diabetes mellitus as an adjunct to diet and exercise.
The company said it plans to launch the product in the South African market in the coming days.
The generic semaglutide injection will be available as a pre-filled, multi-dose injectable pen in two strengths—2 mg/1.5 mL and 4 mg/3 mL—designed to support flexible once-weekly dosing.
Commenting on the approval, Aalok Shanghvi, Chief Operating Officer, Sun Pharma, said, "South Africa is the second market after India where Sun Pharma has received approval for generic semaglutide. This reflects our ability to develop complex generic medicines that meet the stringent quality standards across different markets. We remain committed to improving access to generics and making evidence-based treatment options available to patients and healthcare professionals."
According to the company, South Africa is witnessing a growing burden of type 2 diabetes, driven by rapid urbanisation and changing lifestyles. It noted that expanding access to effective treatment options is essential to addressing the country's increasing diabetes burden and reducing pressure on the healthcare system.
Sun Pharma is among the world's top pharmaceutical companies with businesses spanning innovative medicines, generics and consumer healthcare products. The company has operations in more than 100 countries and maintains a portfolio across multiple therapeutic areas, including dermatology, ophthalmology and onco-dermatology.
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