Closing the Peptide Gap: SAHPRA’s New Guideline on Synthetic Peptides

Weight-loss and diabetes medicines such as semaglutide have become some of the most sought-after medicines in the world. In South Africa, that demand has been met in part by large-scale compounding of unregistered copies. On 8 October 2026 the South African Health Products Regulatory Authority (SAHPRA) responded with its first Guideline on the Quality and Clinical Aspects of Synthetic Peptides. The guideline explains how chemically made peptide medicines can be brought lawfully to market.

The backdrop: Illicit Compounding and the iDexis matter

In June 2026, Adams & Adams represented Novo Nordisk South Africa, the maker of Ozempic and Wegovy, in a semi-urgent application against the compounding pharmacy group iDexis. The evidence before the court was that iDexis was supplying about 84,500 units of compounded semaglutide base a month, more than the combined local sales of the registered products.

The Pretoria High Court granted an interim interdict halting the practice. It held that compounding is permitted only with the same active ingredient as a registered medicine, not merely a similar one. Importantly, iDexis used a synthetic semaglutide base of unknown origin, quality and efficacy, while semaglutide used in the registered products is made by way of an approved and regulated biological process.

The gap the guideline closes

Peptides sit between conventional chemical medicines and biological medicines. Some  biological products made by recombinant biological technology which are originally registered as biological products can be made by chemical synthesis. SAHPRA’s biosimilar pathway is open only to biosimilar products made by way of a biological process, and as a result a synthetic copy of a biologically made peptide had no clear registration route.

The new guideline removes that stumbling block. Its main features are as follows:

• Synthetic peptides are confirmed as medicines that require registration. They are evaluated on their quality, safety and efficacy, with peptide-specific quality and impurity standards.
• A generic company may rely on an originator’s biological product as its reference medicine. However, it must show through head-to-head testing that its synthetic product is highly similar in structure, activity, impurities and immunogenicity risk. Any differences must be justified, and SAHPRA may require further studies.
• Entirely new synthetic peptides still require full non-clinical and clinical data.
• The guideline does not expressly deal with a generic manufacturer that relies on an already registered synthetic peptide. It does, however, confirm that the usual bioequivalence guidelines apply to synthetic peptides as they do to other medicines, and its peptide-specific quality and impurity standards apply to every synthetic peptide application. Applicants in this position would be well advised to seek early guidance from SAHPRA.

In short, there is now a defined registration route for synthetic peptides, and that route runs through rigorous registration. It does not run through compounding.

What this means in practice

For originators, the guideline reinforces the principle in iDexis: an unregistered synthetic copy is not a substitute for a registered medicine. For generic manufacturers, it offers a clearer, if demanding, path to market. For pharmacies and compounders, it narrows the scope to argue that synthetic peptides fall into a regulatory grey zone.

Adams & Adams’ pharmaceutical regulatory and litigation team advises a number of pharmaceutical stakeholders on medicine registration, SAHPRA engagement and the enforcement of regulatory and intellectual property rights. Our team would be happy to discuss how the guideline may affect your products or plans.

Download the Synthetic Peptide Guideline PDF

This article provides general information only and is not legal advice.

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Danie Dohmen | Ramon Pereira | Russel Bagnall