Sun Pharmaceutical Industries Ltd (Sun Pharma) has received approval from the South African Health Products Regulatory Authority (SAHPRA) to manufacture and market a generic version of Semaglutide injection for the treatment of adults with inadequately controlled Type 2 diabetes mellitus.
The approval marks South Africa as the second market after India where Sun Pharma has secured regulatory clearance for its generic Semaglutide, reinforcing the company’s strategy to expand access to complex generic medicines across global markets.
Product launch in coming days
Sun Pharma said it plans to launch the product in South Africa in the coming days. The medicine will be available as a pre-filled, multi-dose injectable pen in two strengths: 2 mg/1.5 mL and 4 mg/3 mL, enabling flexible, once-weekly dosing for patients.
The therapy is indicated as an adjunct to diet and exercise for adults whose Type 2 diabetes remains inadequately controlled.
Expanding access to diabetes treatment
Sun Pharmaceutical Industries Ltd Chief Operating Officer Aalok Shanghvi 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.”
Addressing a growing health challenge
Sun Pharma noted that South Africa is witnessing a rising burden of Type 2 diabetes, fuelled by rapid urbanisation and changing lifestyles. The increasing prevalence of the disease is placing growing pressure on patients as well as the country’s healthcare system, underscoring the need for wider access to effective and affordable treatment options.
The company said the approval supports its objective of improving patient access to evidence-based therapies while strengthening its presence in international markets.
Sun Pharma is India’s largest pharmaceutical company and has a significant global presence across innovative medicines, generics and consumer healthcare products. The company is also a leading generic drug manufacturer in the US and other emerging markets. Its innovative medicines portfolio, spanning dermatology, ophthalmology and onco-dermatology, contributes around 22% of its overall sales.