Sun Pharma Secures South African Approval for Generic Diabetes Drug Semaglutide
Sun Pharmaceutical Industries Ltd. 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 approval, announced on Wednesday, is for the treatment of adults with type 2 diabetes mellitus whose blood sugar levels are not adequately controlled through diet and exercise alone.
The company stated in a regulatory filing that the generic semaglutide will be available as a pre-filled, multi-dose injectable pen in two strengths: 2 mg per 1.5 mL and 4 mg per 3 mL. These doses allow for flexible, once-weekly administration.
South Africa is the second market, after India, where Sun Pharma has received approval for a generic version of this drug. Aalok Shanghvi, Chief Operating Officer of Sun Pharma, said, 'This reflects our ability to develop complex generic medicines that meet 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.'
The company highlighted that South Africa faces a growing burden of type 2 diabetes, driven in part by rapid urbanisation and changing lifestyles. This rising prevalence places significant strain on patients and healthcare services. Improving access to effective therapies is therefore an important component of addressing this national health challenge.
Semaglutide belongs to a class of drugs known as GLP-1 receptor agonists, which help lower blood sugar levels by stimulating insulin secretion and reducing glucagon release. The generic version is expected to provide a more affordable treatment option for patients in South Africa.
