- Receives regulatory approval to manufacture and market once-weekly injectable for Type 2 diabetes
- South Africa becomes second market after India to clear generic semaglutide
- Move reinforces company’s leadership in complex generics and wider access to affordable diabetes care
NE BUSINESS BUREAU
MUMBAI, JULY 16
Strengthening its global diabetes portfolio, Sun Pharmaceutical Industries Ltd has secured regulatory approval to manufacture and commercialise a generic version of semaglutide injection in South Africa, marking another milestone in its strategy to expand access to advanced yet affordable diabetes therapies across international markets.
The approval, granted by the South African Health Products Regulatory Authority (SAHPRA), covers the use of the once-weekly injectable for adults with inadequately controlled Type 2 diabetes mellitus as an adjunct to diet and exercise.
Sun Pharma said it plans to introduce the product in South Africa in the coming days. The medicine will be marketed as a pre-filled, multi-dose injectable pen in two strengths—2 mg/1.5 mL and 4 mg/3 mL—offering patients flexible, once-weekly dosing.
The approval makes South Africa the second country after India where Sun Pharma has obtained regulatory clearance for its generic semaglutide, underlining the company’s growing capabilities in developing and manufacturing complex generic medicines for global markets.
“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 the launch assumes significance as South Africa continues to grapple with a rising incidence of Type 2 diabetes, fuelled by rapid urbanisation and changing lifestyles. The increasing disease burden has placed growing pressure on patients as well as the country’s healthcare system, making wider access to effective and affordable treatment options increasingly important.
With the latest approval, Sun Pharma further strengthens its presence in the global diabetes therapeutics market while reinforcing its commitment to expanding access to high-quality, evidence-based medicines in emerging healthcare markets.
