Sun Pharma gets South Africa approval for generic semaglutide, launch soon

Sun Pharma has secured South Africa's approval for its generic semaglutide injection and plans to launch the once-weekly diabetes treatment in the coming days

Sun Pharmaceutical on Wednesday said it has received regulatory approval from South African Health Products Regulatory Authority to manufacture and market a generic version of semaglutide injection in South Africa, marking the second market after India to clear the diabetes drug.

 

The approval covers use in adults with inadequately controlled type 2 diabetes mellitus as an adjunct to diet and exercise.

 

The company said it plans to launch the once- weekly injectable in South Africa in the coming days. It will be available as a pre-filled, multi-dose injectable pen in two strengths 2 mg/1.5 mL and 4 mg/3 mL.

 

 

“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," said Aalok Shanghvi, chief operating officer, Sun Pharma.

 

The company said South Africa’s rising type 2 diabetes burden, driven rapid urbanisation and lifestyles changes, underscores the need for greater to effective treatment options.