Sun Pharma Secures South African Approval for Generic Semaglutide

Sun Pharma
Image Courtesy: Sun Pharma

Sun Pharmal Industries Limited 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 once-weekly injectable treatment is indicated for adults with inadequately controlled type 2 diabetes mellitus, to be used alongside diet and exercise to improve blood sugar control.

The approval marks another milestone in Sun Pharma’s strategy to expand access to high-quality, affordable medicines in international markets. South Africa becomes the second country after India where the company has secured regulatory approval for its generic semaglutide product. Sun Pharma plans to introduce the medicine in the South African market in the coming days.The product will be offered as a pre-filled, multi-dose injectable pen in two strengths—2 mg/1.5 mL and 4 mg/3 mL—providing patients and healthcare professionals with flexible, once-weekly dosing options.

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 stringent quality standards across multiple markets. We remain committed to expanding access to affordable, evidence-based treatment options for patients while supporting healthcare professionals with reliable therapeutic choices.”

South Africa continues to witness a steady rise in the prevalence of type 2 diabetes, driven by rapid urbanisation, changing dietary patterns and increasingly sedentary lifestyles. The growing disease burden places considerable pressure on patients, healthcare providers and public health systems. Wider availability of effective treatment options is expected to play an important role in improving diabetes management and supporting better long-term health outcomes.

Sun Pharma is one of the world’s leading specialty generic pharmaceutical companies, with a strong presence across innovative medicines, generics and consumer healthcare products. The company is India’s largest pharmaceutical manufacturer and ranks among the leading generic drug companies in the United States and several emerging markets.

Its global innovative medicines portfolio includes products in dermatology, ophthalmology and onco-dermatology, while its vertically integrated manufacturing network spans five continents and supplies medicines to more than 100 countries. With a workforce representing over 50 nationalities, Sun Pharma continues to strengthen its global footprint by delivering quality medicines that address evolving healthcare needs across diverse markets.