One of India's Largest Pharma Companies Gets SAHPRA Nod for Generic Semaglutide
South Africa becomes the second market after India where Sun Pharma has received regulatory approval for generic semaglutide injection, intended for adults with inadequately controlled type 2 diabetes.
✨ Key Takeaways
On Wednesday, Indian equity benchmarks traded higher, with the benchmark Nifty 50 index gaining 0.60 per cent to 24,196.60. Amid the broader market strength, shares of Sun Pharmaceutical Industries Limited traded at Rs 1,951.40, up 0.45 per cent from the previous close, after the company announced that it had received approval from the South African Health Products Regulatory Authority (SAHPRA) to manufacture and market a generic version of semaglutide injection in South Africa.
SAHPRA Approval for Generic Semaglutide
According to the company's exchange filing, the approved product is indicated 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 formulation 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 enable flexible, once-weekly dosing.
South Africa Becomes Second Approved Market
With this approval, South Africa becomes the second market after India where Sun Pharma has secured regulatory clearance for generic semaglutide. The company said the development strengthens its presence in Global Emerging Markets while reflecting its focus on developing complex generic medicines that meet stringent quality standards across multiple regulatory jurisdictions.
Rising Diabetes Burden in South Africa
Sun Pharma noted that South Africa is witnessing a growing burden of type 2 diabetes, driven by rapid urbanisation and changing lifestyles. The increasing prevalence of the disease has put pressure on healthcare systems, highlighting the need for greater access to effective and affordable treatment options. The company said the launch of generic semaglutide is aimed at improving treatment accessibility in the country.
Management Commentary
Commenting on the approval, Aalok Shanghvi, Chief Operating Officer of Sun Pharma, said South Africa is the second market after India where the company has received approval for generic semaglutide. He added that the milestone demonstrates Sun Pharma's capability to develop complex generic medicines that meet stringent quality standards across different markets. Shanghvi further said the company remains committed to improving access to quality generics and making evidence-based treatment options available to patients and healthcare professionals.
About Sun Pharmaceutical Industries Limited
Sun Pharmaceutical Industries Limited is a leading global pharmaceutical company engaged in innovative medicines, generic medicines and consumer healthcare products. It is India's largest pharmaceutical company and has a significant presence in the United States and Global Emerging Markets.
The company's Global Innovative Medicines portfolio, spanning dermatology, ophthalmology and onco-dermatology, contributes around 22 per cent of its sales. Sun Pharma markets its products in more than 100 countries through a vertically integrated manufacturing and distribution network.
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Disclaimer: The article is for informational purposes only and not investment advice.
