Pretoria pharmacy iDexis has said it will be taking legal advice after the High Court order to stop producing weight-loss medicines containing semaglutide – a decision that was welcomed by Novo Nordisk, reports Business Day.
Meanwhile, it has issued a notice to pharmacies saying its semaglutide is out of stock.
The ruling had dealt another blow to iDexis, coming on the heels of an order last month from the South African Health Products Regulatory Authority (SAHPRA) to recall its compounded products containing semaglutide and tirzepatide over safety concerns.
In a joint statement issued with the South African Pharmacy Council in late May, SAHPRA said its investigation of the iDexis facility had found deficiencies in its quality, safety and regulatory compliance.
“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 added.
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 (APIs) 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, Judge Petrus van Niekerk ruled.
The court had heard iDexis was producing a rather staggering 84 500 doses of semaglutide a month, more than Novo Nordisk’s South African sales of Ozempic and Wegovy combined.
Novo Nordisk said the ruling 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.
Novo Nordisk’s patent on semaglutide in South Africa expired in March. It is the only pharmaceutical manufacturer that has obtained SAHPRA approval to sell medicines containing semaglutide.
See more from MedicalBrief archives:
Novo wins round one to block compounded Ozempic by local pharmacy
Novo Nordisk sues local pharmacy over alleged ‘knock-off’ weight-loss jabs