South African pharmacy iDexis has been temporarily barred from distributing and marketing its compounded weight loss injectable pens, with the Gauteng High Court issuing a scathing ruling on Monday as Novo Nordisk won an interdict and costs against the pharmacy, reports News24.
Pending ongoing regulatory reviews, iDexis, trading as Sentra in Pretoria, is now prohibited from making and selling its weight-loss products, which were also allegedly manufactured under unsafe conditions.
Judge Petrus van Niekerk ordered the respondents, iDexis and pharmacist Ruaan Louw – the only director and shareholder of iDexis – to pay punitive costs, saying the company showed “callous disregard” for clients’ health by failing to halt its compounding despite evidence of potential danger.
iDexis, which has consistently said its products are safe, is considering its legal options. However, it refuses to disclose the source of its compounding ingredients.
Novo Nordisk, which holds SA patents for Ozempic and Wegovy, both of which use semaglutide as their active ingredient, had argued that iDexis was producing compounded medicine at scale, treating as many as 84 500 patients per month, but Dexis argued it could compound on behalf of patients because semaglutide is registered.
However, Novo said its active ingredient is bioengineered in a process using yeast, and registered with the South African Health Products Regulatory Authority (SAHPRA) as a biological product. It argued there was no chance that iDexis would be able to obtain its active pharmaceutical ingredient (API), which is registered and approved in SA.
This would be different from a “synthetically derived” semaglutide, which is essentially built block by block on a tiny scaffolding – often polystyrene beads.
Pharmacies are allowed to compound medicines, but in May 2026, iDexis was raided by regulators who seized various medications and alleged that the pharmacy was compounding outside the law.
The pharmacy has denied wrongdoing and says the APIs it uses for its compounds are “sourced from reputable, internationally approved pharmaceutical manufacturers and have been tested in independent analytical laboratories for sterility and quality”.
Two-year battle
The matter dates back to early 2024, when Novo Nordisk lodged a complaint about iDexis with SAHPRA, which asked Novo not to proceed with legal action pending the finalisation of its probe.
But Novo went to court on an urgent basis in December 2024, after various requests for feedback from the regulator did not yield satisfactory responses, the judgment reads. Various procedural issues raised by iDexis delayed the enrolment of the matter until early 2026.
According to the judgment, iDexis had faced an application to place it in business rescue in May 2025, with the South African Revenue Service (SARS) intervening in October that year as it sought R32m. The court noted iDexis did not disclose this in its legal papers during proceedings.
The Novo Nordisk interdict hearing took place from 10 to 12 June, with a key issue being the comparison of the underlying products.
SAHPRA has different pathways for the registration of “orthodox medicines” (generally chemically derived) and “biological medicines”, which are derived from or contain components of biological organisms.
Amid expert testimony on the differences between biologically and chemically derived APIs, the court concluded that a similarity does not allow iDexis to compound a medicine containing a synthetically produced semaglutide that has not been approved by SAHPRA.
The court also took into account the recent raid on iDexis, when SAHPRA, in collaboration with the South African Pharmacy Council (SAPC), conducted a joint inspection at iDexis, and allegedly discovered “critical regulatory non-compliance”. They seized all unregistered injectable products and unverified APIs found onsite.
Authorities said they would recommend that the SAPC review iDexis’ compounding licence based on the scale of compounding at the site, which they said crosses into “manufacturing”.
“The investigation revealed that the company was producing and supplying medicines under the pretext of compounding, but outside the legal framework permitted under SA law,” SAHPRA said then.
“Further inspection findings revealed serious deficiencies in quality, safety and regulatory compliance,” it said, including the illegal importation of semaglutide and tirzepatide APIs; the absence of analytical testing to confirm identity, potency and purity of ingredients; inadequate sterile manufacturing conditions; high risk of contamination; inadequate equipment for aseptic medical preparations; and no temperature and ventilation regulation system.
The court was also scathing of iDexis regarding response to the May raid. It ordered punitive costs against the first and second respondents for several reasons, including that many arguments seemingly sought to “cloud the issues”, while Louw further refused to disclose the source of the semaglutide used.
Novo Nordisk welcomed the judgment, said the company’s general manager for South Africa, Sara Norcross.
“Medicines registration is an important safeguard for patients; it means a medicine has been reviewed against recognised standards for quality, safety and efficacy, and remains subject to ongoing monitoring once it is in use.”
iDexis said the ruling was “being studied and considered, and we will obtain advice from our legal representatives on the way forward”.
In response to the enforcement announcement in May, iDexis accused SAHPRA of potentially impugning its name, and challenged those findings.
It claimed its products were safe.
“Without SAHPRA or any medical practitioner, retail pharmacy, or patient to whom our compounded (semaglutide and tirzepatide) peptide was dispensed, reporting any material adverse reaction as a result of the use thereof to iDexis, it must also be accepted that the compounded product is safe, of good quality, and effective for the purpose of its intended purpose,” it said.
See more from MedicalBrief archives:
Pretoria pharmacy denies infringing Novo Nordisk patent rights
Novo Nordisk sues local pharmacy over alleged ‘knock-off’ weight-loss jabs