Pretoria Court Calls iDexis Appeal an ‘Abuse of Process’, Keeps Semaglutide Compounding Ban

South Africa’s High Court in Pretoria has dismissed iDexis Compounding Specialists’ bid to appeal an interim order that bars the pharmacy from making medicines containing semaglutide, the active ingredient in Novo Nordisk’s Ozempic and Wegovy. Judge Petrus van Niekerk called the application an “abuse of process”, keeping the semaglutide compounding ban in force while two regulators finish their investigations.

The ruling, reported by Tamar Kahn in Business Day on 11 September 2026, turns on the character of the June order. That order was not a final judgment but an interim measure, tied to probes by the South African Health Products Regulatory Authority (SAHPRA) and the South African Pharmacy Council (SAPC). Van Niekerk said the appeal papers were a “lengthy diatribe” that restated arguments the court had already rejected, without showing why another court would reach a different result.

iDexis has stopped compounding semaglutide and tirzepatide (Mounjaro and Zepbound) products in line with the June order. Its legal team says it will now ask the Supreme Court of Appeal for leave to appeal.

Ad

How the semaglutide compounding ban took shape

The case, Novo Nordisk (Pty) Ltd v iDexis Compounding Specialists (Pty) Ltd t/a Sentra Pharmacy and Others (2024/130119) [2026] ZAGPPHC 612, began when Novo Nordisk complained to SAHPRA about iDexis in early 2024. After a joint SAHPRA and SAPC inspection of Sentra Pharmacy in May 2026, the regulators seized GLP-1 and GIP injectables and ordered a recall over safety and quality concerns. Their findings cited unlicensed large-scale production, imported unregistered API, no identity, potency or purity testing, inadequate sterile conditions, and no pharmacovigilance system. Adverse events, including hospitalisations, were also reported.

In June the court granted an interim interdict: no manufacture or supply of any medicine containing semaglutide, whether by compounding or otherwise, and no marketing of compounded semaglutide or claim of SAHPRA approval. It also imposed punitive attorney-and-client costs against iDexis and its sole director, Ruaan Louw.

The compounding argument rested on section 14(4) of the Medicines and Related Substances Act, 101 of 1965. Van Niekerk read that provision narrowly: the active component used in a compound must be the same as in a registered medicine, not merely similar. Synthetic peptide copies of a registered biological API do not qualify. The court also recorded that iDexis would not disclose its API source and that the product it used was not the registered biological semaglutide.

The scale of the grey market

The June court record put iDexis production at about 84,500 semaglutide doses a month, roughly 1,200 doses a day. That is more than Novo Nordisk’s combined South African sales of Ozempic and Wegovy at the time. The channel is now closed pending regulator decisions.

Industry reaction

The Pharmaceutical Task Group (PTG), which represents manufacturers supplying more than 80% of medicines used in South Africa, welcomed the dismissal. Chair Stavros Nicolaou said the decision “reinforces the importance of allowing regulatory authorities to carry out their statutory responsibilities and investigations”, and that professionals and patients “must be able to trust that medicines are manufactured, supplied and distributed in accordance with the standards established to protect public health.”

SAPC registrar Vincent Tlala said SAHPRA, the SAPC and the Health Professions Council of South Africa have reminded pharmacists and medical practitioners not to order or hold recalled stock. Recent inspections, he said, confirmed pharmacies are not carrying the recalled items.

What happens next

The June order stays in force until SAHPRA and the SAPC decide, including exhaustion of internal remedies. If neither regulator has prohibited the activity within six months of 22 June 2026, a window that runs to late December, Novo Nordisk may institute further proceedings within eight months of the June order.

iDexis registration status is under review by the SAPC and the national Department of Health. While that process runs, the group may operate only as a community pharmacy, not a manufacturing pharmacy.

Novo Nordisk has paired the litigation with an authorised lower-cost offering. In July it launched Extensior in South Africa with Acino, a semaglutide for type 2 diabetes that uses the same API, process and device as the originator, alongside earlier list-price cuts on weight-management presentations. Private-sector monthly costs for semaglutide have been reported in the R1,500 to R2,800 per-dose range. Limited medical-aid cover for obesity indications is what pushed a large share of weight-loss users toward unregulated copies.

Implications for access

Demand did not disappear when the compounder closed. The 84,500-dose monthly figure is a measure of unmet, price-sensitive demand, and payers should treat it as such. Budget-impact work that ignores the grey channel will misstate both originator volume and the case for authorised lower-cost presentations.

The May findings also give health economics and medical affairs teams a concrete safety differential to place next to price: no identity or potency testing, a non-functional HVAC system, no pharmacovigilance, and hospitalisations. That differential is local and documented, and the court has already relied on it.

Enforcement is still incomplete. iDexis argued it was singled out while non-pharmacist sellers continue on social platforms. A single-firm interdict does not clean the channel, and affiliates should assume residual leakage until SAHPRA and the SAPC publish a class-wide position.

Patent expiry in 2027 will reopen the same fight on different ground, as generic and authorised-generic semaglutide compete on registered quality and price rather than a compounding exception.

Source: Tamar Kahn, “Judge calls iDexis appeal application an ‘abuse of process'”, Business Day, 11 September 2026. Judgment: Novo Nordisk (Pty) Ltd v iDexis Compounding Specialists (Pty) Ltd t/a Sentra Pharmacy and Others [2026] ZAGPPHC 612 (SAFLII).