Pretoria compounding pharmacy iDexis, trading as Sentra Pharmacy, has applied for leave to appeal the High Court order that stopped it from manufacturing and selling compounded medicines containing semaglutide. The application, lodged in mid-July 2026, is the latest turn in a legal and regulatory dispute that has run since May 2026 and has directly affected patients who were using iDexis-compounded semaglutide and tirzepatide products for diabetes and weight management.
How the dispute started
In May 2026, the South African Health Products Regulatory Authority (SAHPRA) and the South African Pharmacy Council (SAPC) carried out a joint inspection of iDexis’s Pretoria facility. The regulators said the inspection uncovered serious deficiencies in quality, safety and regulatory compliance, including the importation of unregistered active pharmaceutical ingredients and inadequate sterile manufacturing conditions. They ordered iDexis to recall its compounded semaglutide, tirzepatide and combination products, classifying the action as a Class I, Type A recall — the most serious category, reserved for products that pose a serious risk to health.
iDexis rejected the findings, saying its own independent testing showed the products were safe and compliant, and that it had been compounding medicines lawfully to meet demand that registered suppliers could not.
The High Court ruling
Novo Nordisk South Africa, which holds the registered patent for semaglutide in South Africa (sold locally as Ozempic and Wegovy), applied to the Pretoria High Court for an interdict against iDexis. On 22 June 2026, Judge Van Niekerk granted an interim interdict barring iDexis from manufacturing, marketing or supplying compounded medicines containing semaglutide. The court found that iDexis had used an unregistered, synthetically produced active ingredient sourced outside the approved supply chain, and that compounding is legally limited to individual patient prescriptions rather than broader commercial distribution.
Regulators widen the warning to healthcare professionals
On 8 July 2026, SAHPRA, the SAPC and the Health Professions Council of South Africa (HPCSA) issued a joint statement warning that any healthcare professional who continues to prescribe, dispense, or hold stock of the recalled iDexis products faces disciplinary action under the Medicines and Related Substances Act, 101 of 1965. This was the first time all three regulators had jointly warned practitioners directly, extending the consequences of the recall beyond the manufacturer itself.
What’s happening now
iDexis confirmed in mid-July 2026 that it has instructed legal representatives to apply for leave to appeal the interim interdict, and has separately lodged appeals against SAHPRA’s and the SAPC’s inspection findings. The company says it stopped compounding GLP-1 and GIP products once the judgment was handed down and maintains it is complying with the law while it contests the findings. It has also argued that it was singled out while other compounding pharmacies allegedly produce similar products.
What this means for patients
- Anyone using an iDEXIS-branded compounded semaglutide, tirzepatide, or combination product should stop and speak to their prescriber or pharmacist, per SAHPRA’s recall notice.
- The underlying legal question — how far a compounding pharmacy may go in producing GLP-1-based products under South African law — remains open while the appeal is pending, so the interim interdict stays in force for now.
- The case does not affect registered, SAHPRA-approved GLP-1 medicines such as Ozempic, Wegovy or Mounjaro, which remain available through normal prescription channels.
This article is for information purposes only and does not constitute medical advice. Patients affected by the recall should consult their healthcare provider.
Sources
- Business Day, 14 July 2026 — “iDexis seeks leave to appeal interim order on GLP-1 production”
- Eyewitness News, 14 July 2026 — “iDexis to appeal weight-loss meds ruling, as regulators warn against use of the compounded drugs”
- Mail & Guardian, 9 July 2026 — “Regulators tighten noose on recalled GLP-1 medicines”
- SAHPRA official press release, 8 July 2026 — “Health regulators warn against the use or dispensing of recalled Semaglutide and Tirzepatide”
- Adams & Adams (Novo Nordisk’s attorneys), 23 June 2026 — “High Court rules in favour of Novo Nordisk South Africa”
- SAHPRA official press release, 23 May 2026 — “SAHPRA and the SAPC Crack Down on Unlawful Manufacturing of Unregistered GLP-1/GIP Medicines”