Sun Pharmaceutical Industries, India’s largest drugmaker by market value, led by founder Dilip Shanghvi, has received approval from South Africa’s health regulator to manufacture and sell a generic version of semaglutide, the active ingredient in Novo Nordisk’s diabetes drug Ozempic and weight-loss treatment Wegovy.

The approval from the South African Health Products Regulatory Authority makes South Africa the second market, after India, where Sun Pharma has secured authorization for its generic semaglutide injection. The treatment is approved for adults with inadequately controlled Type 2 diabetes.

Launch follows patent expiry

The approval comes after Novo Nordisk’s semaglutide patent expired in March, opening the door for lower-cost generic versions from manufacturers in India and other markets. The arrival of generics is also expected to intensify competition for Eli Lilly, which sells its diabetes and obesity medicines, including Mounjaro, in South Africa.

Sun Pharma said it plans to launch the medicine in South Africa within days. It will be available as a once-weekly, pre-filled multi-dose injection pen in 2 mg and 4 mg strengths.

“We remain committed to improving access to generics and making evidence-based treatment options available to patients and healthcare professionals,” Chief Operating Officer Aalok Shanghvi said.

Competition in obesity treatment market

South Africa’s market for diabetes and weight-loss medicines has been led by Novo Nordisk’s Ozempic and Wegovy and Eli Lilly’s Mounjaro. The market has also seen growing competition from compounded versions of the medicines, prompting regulators to step up oversight as demand for lower-cost treatments continues to rise.

Expanding global footprint

Mumbai-based Sun Pharma is the world’s fourth-largest specialty generic drugmaker, with annual revenue of about $6.2 billion. The company operates 41 manufacturing facilities and supplies medicines to more than 100 countries, producing treatments across dermatology, oncology, ophthalmology and other therapeutic areas.

The company has an established presence across emerging markets, including South Africa, Brazil, Mexico, Russia and Romania, while also serving customers in Western Europe, Canada, Australia, New Zealand, Israel and Japan. In Nigeria, it operates a manufacturing facility in Ogun State through its subsidiary, Ranbaxy Nigeria Limited.

Sun Pharma has also been broadening its business beyond traditional generic medicines. In April, the company agreed to acquire Organon & Co. for $11.75 billion, one of the pharmaceutical industry’s biggest recent transactions, expanding its presence in women’s health and biosimilar medicines.