– Pretoria, South Africa
The Gauteng Division of the Pretoria High Court has granted Novo Nordisk a provisional injunction barring iDexis and its director from compounding, supplying, or marketing products containing semaglutide. The ruling, issued on Monday, requires immediate compliance and remains in effect until regulatory processes and any potential review are completed.
Novo Nordisk argued that iDexis was illegally manufacturing and distributing unregistered medicines containing semaglutide, the active ingredient in its Ozempic and Wegovy brands. The company maintained that these activities violated South Africa’s Medicines Act, which restricts the large-scale production and sale of unregistered medicines.
In South Africa, only Ozempic is registered for the treatment of type 2 diabetes. Compounded versions of semaglutide have emerged to meet the demand for weight-loss medications, but the court determined that iDexis's operations exceeded the legal limits for pharmacy compounding, which is intended for individual patient needs and not commercial distribution.
The interim order reflects the growing regulatory scrutiny of unapproved weight-loss drugs amid rising global demand for GLP-1 receptor agonists. It aims to ensure compliance with drug safety and registration standards while broader regulatory reviews continue.
This decision could influence the management of pharmacy-prepared semaglutide products in South Africa. It underscores the balance between patient access to affordable treatments and compliance with stringent pharmaceutical regulations designed to protect public health.