Sun Pharma receives South Africa approval for generic semaglutide

Sun Pharmaceutical Industries (Sun Pharma), including its subsidiaries and associate companies, 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.

The approval covers the use of generic semaglutide injection for the treatment of adults with inadequately controlled type 2 diabetes mellitus as an adjunct to diet and exercise. Sun Pharma said it plans to launch the product in the South African market in the coming days.

The product will be available as a pre-filled, multi-dose injectable pen in two strengths—2 mg/1.5 mL and 4 mg/3 mL—allowing 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 experiencing a growing burden of type 2 diabetes, driven in part by urbanisation and changing lifestyles. It added that the increasing prevalence of the disease is placing pressure on patients and healthcare services, making access to treatment an important part of addressing the country’s healthcare needs.