iDexis, a fully licensed compounding pharmacy, is aware of recent media reports concerning the alleged seizure and recall of products compounded by the company, as well as related public health concerns.
A number of these reports are inaccurate and require clarification.
These publications have appeared more than a month after the matter was argued before the Gauteng High Court and following the granting of an interim interdict against iDexis.
The company has instructed its legal representatives to apply for leave to appeal the judgment. iDexis has been advised that several of the findings have final effect and are therefore appealable. An application for leave to appeal has accordingly been lodged.
Products Handed to Inspectors
During an inspection conducted at iDexis's fully licensed Pretoria premises on 11 May 2026, a number of compounded products were voluntarily handed to inspectors representing the South African Health Products Regulatory Authority (SAHPRA) and/or the South African Pharmacy Council (SAPC) following requests that the products be made available for inspection.
To the company's knowledge, neither SAHPRA nor the SAPC has, to date, conducted or disclosed the results of any testing performed on those products.
By contrast, independent testing commissioned by iDexis found no evidence of any breach of sterility. The company therefore maintains that the products were safe for use and that appropriate compounding procedures were followed. This position is supported by an independent expert report that has already been provided to both SAHPRA and the SAPC.
Regulatory History
iDexis is concerned by what appears to be a developing public narrative suggesting that SAHPRA and the SAPC only recently became aware that the company was compounding the GLP-1 and GIP products that later became the subject of litigation involving Novo Nordisk.
That narrative is inconsistent with the regulatory history.
The company's legal representatives informed SAHPRA of iDexis's specific compounding activities several years ago. Thereafter, both SAHPRA and the SAPC conducted inspections at the company's premises.
Those inspections resulted in favourable grading by the SAPC, and neither regulator raised material objections regarding the company's compounding activities prior to the inspections conducted in May 2026.
The compounding of GLP-1 and GIP products was taking place at the premises during those earlier inspections and was capable of being observed by inspectors. Accordingly, any suggestion that these activities were concealed from, or only recently discovered by, the regulatory authorities is rejected.
As previously indicated, we respect the court and we have ceased compounding GLP-1 and GIP products after the judgment was handed down. We remain committed to conducting our business lawfully and with due regard for public health and safety.
Ongoing Legal Processes
Appeals have also been lodged against the relevant findings and decisions of SAHPRA and the SAPC.
iDexis remains committed to exhausting the internal remedies prescribed by law. Should those processes fail to resolve the disputes fairly and lawfully, the company intends to pursue the appropriate relief before courts of competent jurisdiction.
The company remains of the view that certain public statements and publications attributed tovSAHPRA and the SAPC are inaccurate, materially prejudicial, and have caused significant harm to its business and reputation.
Concerns Regarding Regulatory Consistency
iDexis is also concerned that it appears to have been singled out, notwithstanding that a number of compounding pharmacies throughout South Africa are understood to be compounding similar products.
The company is further aware of information suggesting that one such pharmacy may be associated with an individual who performs inspection functions for SAHPRA. This raises legitimate concerns regarding consistency, transparency and potential conflicts of interest. iDexis reserves all of its rights in this regard.
Commitment to Patients and Healthcare Professionals
iDexis does not intend to litigate these matters through the media. However, continued media enquiries and the repetition of inaccurate allegations have made it necessary to place the company's position on record.
No further statements will be made at this stage.
iDexis remains committed to the quality and safety of its compounded medicines and to serving the interests of patients, healthcare practitioners and retail pharmacies.
The company will continue to apply the highest appropriate quality standards, pursue available legal remedies through the prescribed processes, and take all necessary steps to vindicate its position and restore its reputation within the South African compounding pharmacy sector.
Kind regards,
Ruaan Louw (Managing Director - iDexis)