Compounding pharmacy iDexis says it is taking legal advice after the high court ordered it to stop producing weight-loss medicines containing the GLP-1 semaglutide. The Pretoria high court on Monday granted Danish pharmaceutical manufacturer Novo Nordisk an interim interdict against iDexis, preventing it from compounding and supplying semaglutide shots, pending the outcome of regulatory investigations. Semaglutide is the active ingredient in Novo Nordisk’s blockbuster shots Ozempic and Wegovy, which are approved for diabetes and weight loss. The ruling dealt a further blow to iDexis, which was last month directed by the South African Health Products Regulatory Authority (Sahpra) to recall its compounded products containing semaglutide and tirzepatide over safety concerns. Compounding pharmacies prepare customised formulations of medicines that meet the specific needs of individual patients. In a joint statement issued with the South African Pharmacy Council in late May, Sahpra said its investigation of iDexis’ facility had found deficiencies in its quality, safety and regulatory compliance. iDexis has not issued a product recall notice, but sent a notice to pharmacies earlier this week stating that its semaglutide is out of stock. It declined to answer Business Day’s questions about why it had not complied with Sahpra’s instruction to issue a product recall. “The notice issued to pharmacies regarding semaglutide was an operational communication which was necessitated by the court order. It should not be construed as an admission of any defect, illegality or wrongdoing,” said iDexis marketing manager Nikki Naude. “iDexis remains committed to patient safety, regulatory compliance and the proper ventilation of the issues before the court and the relevant regulatory bodies,’ she said. Patients who had used any iDexis products should seek advice specific to their circumstances from their prescribing medical practitioner or pharmacist, she said.The high court found iDexis had been manufacturing large quantities of weight loss shots containing a version of semaglutide that had not been registered with Sahpra, obtained from an undisclosed source. It ruled that only registered active pharmaceutical ingredients (API) may be used in compounded medicines, and that these products may only be made up for a specific patient on receipt of a prescription from a healthcare professional. iDexis was therefore illegally compounding semaglutide, ruled judge Petrus van Niekerk.The court had heard iDexis was producing 84,500 doses of semaglutide a month, more than Novo Nordisk’s South African sales of Ozempic and Wegovy combined.Novo Nordisk welcomed the ruling, saying it provided important legal clarity on compounding that applied to products across the board.“This is a very clear judgment on what is and what isn’t allowed [and] really [solidifies] the rules around compounding in South Africa,” said Novo Nordisk South Africa GM Sara Norcross.A pharmacy could only compound medicines that contained registered APIs for a specific patient and must be in receipt of a prescription, she said. Novo Nordisk’s patent on semaglutide in South Africa expired in March. It is currently the only pharmaceutical manufacturer that has obtained Sahpra approval to sell medicines containing semaglutide.