Sun Pharmaceutical Industries Ltd on Wednesday said it has received approval from South African regulator to manufacture and market a generic version of semaglutide injection in the country for treatment of adults with type 2 diabetes mellitus.
The approval by the South African Health Products Regulatory Authority (SAHPRA) is to manufacture and market the 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, Sun Pharmaceutical Industries said in a regulatory filing.
The company plans to launch the product in the market 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) that allow flexible, once-weekly dosing, it added.
“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,” Sun Pharma Chief Operating Officer Aalok Shanghvi.
South Africa faces a growing burden of type 2 diabetes, driven in part by rapid urbanisation and changing lifestyles, the company said.
This rising prevalence places significant pressure on patients and healthcare services. Improving access to effective therapies is therefore an important component of addressing this national health challenge, it added.
