South Africa’s High Court on Monday granted an interim order to block a local pharmacy group from \u200cmanufacturing and selling weight-loss medicines containing semaglutide, the key ingredient in Novo Nordisk’s Ozempic and Wegovy drugs.<\/p>\n
Following an application from Novo, the court ruled that iDexis and its director must immediately stop compounding, supplying and marketing semaglutide-based products pending the outcome of further investigations. Novo Nordisk had argued that iDexis \u200cwas unlawfully selling unregistered semaglutide medicines and competing in the lucrative weight-loss market without complying with South African law.<\/p>\n
The Danish drugmaker’s blockbuster \u200cdiabetes drug Ozempic and weight-loss drug Wegovy both have semaglutide as an active ingredient. Novo said it will issue a statement shortly, while the legal team for iDexis did not immediately respond to a request for comment.<\/p>\n
COURT REJECTED SIMILARITY ARGUMENT FROM IDEXIS Novo told the Gauteng Division of the High Court in Pretoria that iDexis had been producing \u2060compounded \u200bsemaglutide medicines at scale, supplying about 84,500 \u2060units each month, more than sales of Ozempic and Wegovy combined, and marketing them for weight loss despite lacking regulatory approval.<\/p>\n
iDexis argued it could compound semaglutide because \u2060it used a similar ingredient to that found in Ozempic and Wegovy, which are registered. Compounding involves pharmacies mixing the active ingredients of a medicine to \u200baddress specific patient needs. Judge Petrus van Niekerk rejected that argument, ruling that a section of the Medicines and Related Substances Act \u2060that allows limited drug compounding applies only where the same active ingredient appears in a registered medicine, not one that is merely similar.<\/p>\n
iDexis used a chemical synthetic version of \u2060semaglutide, whereas \u200bNovo Nordisk’s product is biological. The court heard that the iDexis product had never been tested or approved by the South African Health Products Regulatory Authority (SAHPRA), and that its active ingredient was sourced from undisclosed suppliers.<\/p>\n
ORDER WILL REMAIN IN FORCE UNTIL INVESTIGATIONS FINALISED Van Niekerk \u2060also said the court could not ignore that a SAHPRA inspection had found serious deficiencies in quality, safety and compliance, in support of \u2060the illegality complaints of Novo Nordisk.<\/p>\n
He \u2060held that the interim interdict was necessary to prevent ongoing illegality and to safeguard public health. The order will remain in force until SAHPRA and the South African Pharmacy Council finalise their investigations and \u200cany internal appeals, or \u200cuntil further court proceedings determine the parties’ rights. <\/p>\n
(This story has not been edited by Devdiscourse staff and is auto-generated from a syndicated feed.)<\/p>\n","protected":false},"excerpt":{"rendered":"South Africa’s High Court on Monday granted an interim order to block a local pharmacy group from \u200cmanufacturing…\n","protected":false},"author":2,"featured_media":113885,"comment_status":"","ping_status":"","sticky":false,"template":"","format":"standard","meta":{"footnotes":"","_share_on_mastodon":"0"},"categories":[271],"tags":[15786,53308,428,272,3102,689,28835,1910,280],"class_list":["post-113884","post","type-post","status-publish","format-standard","has-post-thumbnail","category-novo-nordisk","tag-diabetes","tag-idexis","tag-law","tag-novo-nordisk","tag-ozempic","tag-semaglutide","tag-south-african","tag-wegovy","tag-weight-loss"],"share_on_mastodon":{"url":"https:\/\/pubeurope.com\/@dk\/116794518827985499","error":""},"_links":{"self":[{"href":"https:\/\/www.europesays.com\/dk\/wp-json\/wp\/v2\/posts\/113884","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/www.europesays.com\/dk\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/www.europesays.com\/dk\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/www.europesays.com\/dk\/wp-json\/wp\/v2\/users\/2"}],"replies":[{"embeddable":true,"href":"https:\/\/www.europesays.com\/dk\/wp-json\/wp\/v2\/comments?post=113884"}],"version-history":[{"count":0,"href":"https:\/\/www.europesays.com\/dk\/wp-json\/wp\/v2\/posts\/113884\/revisions"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/www.europesays.com\/dk\/wp-json\/wp\/v2\/media\/113885"}],"wp:attachment":[{"href":"https:\/\/www.europesays.com\/dk\/wp-json\/wp\/v2\/media?parent=113884"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/www.europesays.com\/dk\/wp-json\/wp\/v2\/categories?post=113884"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/www.europesays.com\/dk\/wp-json\/wp\/v2\/tags?post=113884"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}