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SAHPRA vs iDexis: the semaglutide compounding case

Published · RetaRadar

In 2026 a Pretoria compounding pharmacy called iDexis became the centre of South Africa's biggest fight over copied weight-loss medicines. The regulator, SAHPRA, ordered a recall of its semaglutide and tirzepatide products. The High Court then barred it from making semaglutide medicines. iDexis disputes both.

This article sets out what each side has said, what the court decided, and where things stand on 25 September 2026.

Who is iDexis?

iDexis Compounding Specialists (Pty) Ltd trades as Sentra Pharmacy. It is based in Silverton, Pretoria. According to the High Court judgment, it holds a retail pharmacy licence and specialises in compounding. Its sole shareholder and director is pharmacist Ruaan Louw.

Compounding means a pharmacist prepares a medicine for a specific patient. South African law allows this only within narrow limits.

iDexis made injectable products containing semaglutide (the active ingredient in Novo Nordisk's Ozempic and Wegovy), tirzepatide, and a combination of both. The judgment records that its semaglutide product was dispensed to about 84,500 patients a month. In a May 2026 letter to practitioners, iDexis said it had dispensed its semaglutide and tirzepatide products to 214,406 patients in total.

Two tracks: the regulator and the court

The dispute runs on two tracks.

The first is regulatory. SAHPRA and the South African Pharmacy Council (SAPC) inspected iDexis and took enforcement action.

The second is a court case. It was brought by Novo Nordisk, not SAHPRA. SAHPRA and the SAPC were cited as respondents. The judgment says they filed no papers and did not oppose.

What SAHPRA found

SAHPRA and the SAPC inspected the Silverton premises on 11 May 2026. On 21 May SAHPRA sent iDexis a written notice of enforcement action (ENF/2026/0008). The court quoted it in full.

According to the notice, inspectors found "critical" deficiencies. SAHPRA said, among other things, that:

SAHPRA said this contravened section 14 of the Medicines and Related Substances Act 101 of 1965, read with the compounding regulations, and section 18 on advertising. It seized stock. It ordered a recall and a stop to sterile compounding. It said it would ask the SAPC to review iDexis's compounding licence.

SAHPRA and the SAPC announced the action in a joint media release on 23 May 2026. The products appear on SAHPRA's recall list.

What iDexis says

iDexis rejects the findings. In a letter to practitioners, Mr Louw said its processes comply with section 14(4) of the Medicines Act and SAHPRA's compounding guidelines. He said its ingredients come from "reputable, internationally approved pharmaceutical manufacturers" and are tested by independent laboratories.

The company said it would challenge the findings under section 28A of the Medicines Act and the Promotion of Administrative Justice Act. It argued SAHPRA had not given it a fair chance to make representations. It also said it had received no reports of adverse reactions.

In a later statement, iDexis said products were handed to inspectors voluntarily. It said earlier SAHPRA and SAPC inspections raised no material objections. It said independent testing found no sterility breach. It has also said it was singled out while other pharmacies make similar products.

The court case

Novo Nordisk launched an urgent application in December 2024 (case 2024-130119, Gauteng Division, Pretoria). It said iDexis was competing unlawfully by selling an unregistered medicine. The judgment records that Novo Nordisk had complained to SAHPRA in early 2024 and that SAHPRA asked it to hold off while it investigated.

The core legal question was section 14(4). This section lets pharmacists compound unregistered medicines in limited cases. But there is a proviso: the active components must "appear in another medicine which has been registered."

iDexis argued that semaglutide appears in Ozempic and Wegovy, so the proviso is met. Novo Nordisk argued that its semaglutide is a biological product made from yeast, while iDexis used a synthetic peptide from an undisclosed source. So, it said, the two are not the same active component.

Judge PA van Niekerk heard the matter on 10 June 2026. He gave judgment on 22 June 2026 ([2026] ZAGPPHC 612). He held that section 14(4) must be read restrictively. The active component must be the same as in the registered medicine, not merely similar. He found the synthetic semaglutide used by iDexis was not registered.

The court interdicted iDexis and Mr Louw from making, supplying or marketing any semaglutide medicine. The order is interim. It lasts until the SAHPRA and SAPC processes, including appeals and reviews, are finished. The court rejected iDexis's argument that the case was moot. It ordered costs on the punitive attorney-and-client scale.

iDexis said on 14 July that it had stopped compounding GLP-1 and GIP products after the order. It applied for leave to appeal. The same judge dismissed that application, Business Day reported on 11 September, calling it an abuse of process. iDexis's lawyers said they would approach the Supreme Court of Appeal.

Timeline

Where things stand

As of 25 September 2026, the interim interdict remains in force. The SAHPRA recall stands. According to Business Day, the SAPC registrar said iDexis may operate only as a community pharmacy while its registration is reviewed. iDexis's internal appeals against SAHPRA and SAPC, and any petition to the Supreme Court of Appeal, have no public outcome yet. No court has made a final ruling on the merits.

Why it matters for buyers of research peptides

The court read the compounding exception narrowly. Under this judgment, a pharmacy can compound only with an active ingredient that is the same as one in a registered medicine. A similar molecule from another source does not qualify.

SAHPRA's notice also treated importing active ingredients without its approval as a serious breach. The July joint statement warned that professionals who prescribe or dispense recalled products face disciplinary action.

Retatrutide is an investigational medicine. We found no retatrutide product on SAHPRA's register. On SAHPRA's stated position, a product that is not registered, and whose active ingredient is not in a registered medicine, has no route to lawful sale as a medicine in South Africa. Labels such as "for research use only" do not change how SAHPRA classifies a product.

This article is for information only and is not legal or medical advice.

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