26/05/2026
24 May 2026
Dear Practitioners (Medical & Pharmaceutical),
1. We address this communique to you following the findings of alleged irregularities
published by SAHPRA on Friday 22 May 2026 following an investigation conducted at our
compounding pharmacy in Pretoria, which findings are all being challenged in terms of the
prescribed statutory processes in terms of section 28A of the Medicines Act 1965, and
section 6 of the Promotion of Administrative Justice Act 2000 (“PAJA”), after receiving
reasons for the impugned findings, as we are entitled to, which we shall request in terms of
our entrenched rights in terms of section 5 of PAJA. which findings are hereafter referred
to as “the impugned SAHPRA findings”.
2. We reiterate and confirm that:
2.1. Our compounding processes comply with the requirements of subsection 14(4) of
the Medicines Act 1965, the General Regulations published in terms thereof and the
Guidelines for Good Compounding Practices (“GCP”) published by SAHPRA and the
Good Pharmacy Practice Guidelines (“GPP”). We have confirmation thereof from an
independent regulatory expert and our legal team, comprising senior and junior
counsel, as well as experienced industry attorneys.
2.2. The APIs used to compound our Semaglutide and Tirzepitide (S&T) are sourced from
reputable, internationally approved pharmaceutical manufacturers and have been
tested in independent analytical laboratories for sterility and quality.
2.3. We can guarantee the quality and safety of the S&T product of choice prescribed by
you for the treatment of your patients and compounded by us at your and your
patients’ request.
3. The Gauteng High Court in Pretoria will definitively adjudicate all the above on 10 and 11
June 2026.
4. We are of the opinion that the impugned findings of SAHPRA are nothing other than
unsophisticated attempts orchestrated to improperly influence the outcome of the court
case, especially in the light of:
4.1. The official investigation by SAHPRA launched in 2025, into the desirability of
compounding peptides prescribed for the treatment of diabetes and the
management of obesity and overweight-related conditions, in respect of which we
submitted detailed comments and expert scientific opinion and public comment, in
respect of which SAHPRA has not published any findings to date;
4.2. The fact that, despite SAHPRA electing to abide by the decision of the High Court by
not participating in the court process, and now “suddenly” after more than two (2)
years whilst the court process is sub-judice, takes unwarranted steps and publishes
unsubstantiated findings which SAHPRA is aware are disputed by iDexis and are
potentially harmful to the good name and reputation of iDexis;
4.3. SAHPRA has to date not filed a response to our revised answering
affidavit and the factual allegations and expert reports forming part of the
contents thereof and as such is deemed to have agreed
/ acquiesced therewith which, makes its current actions so much more
questionable.
5. Without SAHPRA or any medical practitioner, retail pharmacy, or patient to whom our
compounded S&T 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.
6. We can also confirm that to date we have dispensed our S&T compounded peptide product
to 214 406 patients on prescription of their treating clinicians through the practices of their
clinicians, or retail pharmacies of choice, without any reports of adverse reactions or
conditions, only reports of great success and gratitude being expressed.
7. The unilateral decision by SAHPRA constitutes administrative action which materially and
adversely affects the rights or legitimate expectations of iDexis.
8. In terms of section 3 of PAJA, an administrative action which materially and adversely
affects the rights or legitimate expectations of any person must be procedurally fair. This
includes providing iDexis with a reasonable opportunity to make representations.
9. SAHPRA has not complied with its statutory obligations in this regard and has failed to
engage with iDexis regarding any concerns that it may have had.
10. iDexis addressed all concerns raised by SAHPRA in 2024. To date hereof, SAHPRA has not
been able to refute any of the allegations made by iDexis in this regard. In fact, SAHPRA has
not even responded to the comprehensive submissions of iDexis, and it seems that these
submissions were simply ignored. This also gives rise to a reviewable irregularity of
SAHPRA’s conduct and specifically the impugned SAHPRA, findings under PAJA.
11. As set out above, we are in the process of challenging the impugned SAHPRA findings in
terms of section 28A of the Medicines Act 1965, and section 6 of the Promotion of
Administrative Justice Act 2000 (“PAJA”) and we will provide you with an update regarding
this process in due course.
12. We shall address any specific questions which you may have on request. Please forward all
queries to our Marketing Manager, Nikki Naude (nichola@idexis.com).
Regards,
Ruaan Louw (Managing Director – iDexis)
