“The South African Health Products Regulatory Authority (Sahpra), working alongside the South African Pharmacy Council (SAPC), confirmed it has seized multiple injectable products after an inspection at iDexis Compounding, trading as Sentra Pharmacy, in Silverton, Pretoria.”

“The regulators allege the pharmacy was manufacturing and distributing unregistered GLP-1 medicines — including semaglutide, tirzepatide and combination formulations — under the guise of pharmaceutical compounding, in contravention of the Medicines & Related Substances Act.”

“inspectors uncovered extensive regulatory failures during the raid, including what it described as the illegal importation of active pharmaceutical ingredients (APIs), inadequate sterile manufacturing conditions and the absence of proper analytical testing to confirm product quality, potency and purity.”

“Inspectors allegedly found dust contamination, unsuitable equipment and no validated heating, ventilation and air-conditioning system required for sterile pharmaceutical production.”

“Sahpra also raised the alarm over the absence of a pharmacovigilance system to monitor adverse drug reactions linked to the products, adding that it has already received reports of adverse events, including hospitalisations associated with some of the medicines under investigation.”

“the practice of preparing customised medicines for individual patients... is permitted under South African law only when done on the basis of a valid prescription and within tightly controlled parameters.”

“the regulator seized all finished products containing semaglutide, tirzepatide and related combinations found on site.”