India\u2019s Sun Pharmaceutical Industries has received approval from South Africa\u2019s health regulator to manufacture and sell a generic version of semaglutide, the active ingredient used in Novo Nordisk\u2019s blockbuster diabetes and obesity drugs Ozempic and Wegovy.<\/p>\n
The approval by the South African Health Products Regulatory Authority (SAHPRA) makes South Africa the second market after India where Sun Pharma has secured regulatory clearance for its generic semaglutide injection, the company said in a statement.<\/p>\n
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Sun Pharma said the approval is for adults with inadequately controlled type 2 diabetes and that it plans to launch the product in South Africa in the coming days.<\/p>\n
The drug will be sold as a pre-filled, multi-dose injectable pen in two strengths \u2014 2 mg and 4 mg \u2014 and will be administered once a week.<\/p>\n
The development comes after Novo Nordisk\u2019s patent on semaglutide expired in South Africa in March, paving the way for generic drugmakers to enter the market with more affordable alternatives.<\/p>\n
Semaglutide belongs to a class of medicines known as GLP-1 receptor agonists, which help regulate blood sugar levels and have also gained global popularity for their weight-loss benefits.<\/p>\n
Novo Nordisk\u2019s Ozempic, originally developed for diabetes treatment, and Wegovy, approved for obesity management, have become some of the world\u2019s biggest-selling medicines. The patent expiry has triggered expectations of increased competition from generic manufacturers.<\/p>\n
\u201cWe remain committed to improving access to generics and making evidence-based treatment options available to patients and healthcare professionals,\u201d said Sun Pharma Chief Operating Officer Aalok Shanghvi.<\/p>\n
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Sun Pharma\u2019s entry into the South African market is expected to increase competition for Novo Nordisk as well as US pharmaceutical major Eli Lilly, which has launched its own diabetes and obesity drug Mounjaro in the country.<\/p>\n
South Africa\u2019s weight-loss drug market is currently dominated by Ozempic, Wegovy and Mounjaro, but the high demand for these treatments has also led to the rise of compounded versions of the medicines.<\/p>\n
Regulators globally have been tightening oversight of compounded drugs due to concerns around safety, quality control and manufacturing standards as demand for lower-cost versions of GLP-1 medicines rises.<\/p>\n
The global market for diabetes and obesity treatments has expanded rapidly in recent years, driven by rising obesity rates and growing adoption of GLP-1 therapies.<\/p>\n
For Indian pharmaceutical companies, the entry into the semaglutide market represents an opportunity to expand beyond traditional generic medicines into high-growth therapies.<\/p>\n
Sun Pharma, India\u2019s largest drugmaker by market capitalisation, has been increasing its presence in specialty medicines and complex therapies, including products targeting chronic diseases.<\/p>\n
The company\u2019s South Africa approval follows its earlier regulatory clearance in India for generic semaglutide, strengthening its position in the global race to provide cheaper alternatives to some of the world\u2019s most expensive medicines.<\/p>\n
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