Aspen Pharmacare wins Canada approval for generic Ozempic

Aspen Pharmacare Holdings, the South Africa–based multinational drugmaker led by billionaire Stephen Saad, has received approval from Health Canada for Aspen-Semaglutide, a generic version of Novo Nordisk’s blockbuster diabetes medicine Ozempic. 

The Africa’s largest pharmaceutical company said the approval allows Aspen-Semaglutide to be used for the treatment of adults with Type 2 diabetes, marking a key step in the company’s expansion in North America’s growing market for GLP-1 medicines. 

The approval follows the expiry of Novo Nordisk’s Canadian patent covering semaglutide, the active ingredient in Ozempic for diabetes and Wegovy for weight management. The patent expiry has created an opportunity for generic drugmakers to introduce lower-cost alternatives to the market. 

Aspen said the timing of its commercial launch in Canada will depend on the availability of semaglutide active pharmaceutical ingredient (API) supplied by India’s Dr. Reddy’s Laboratories. 

An API is the ingredient responsible for a medicine’s therapeutic effect. Earlier this month, Dr. Reddy’s said supplies of its generic semaglutide would remain unavailable in India and continue to face disruptions in Canada until at least late October after an impurity was detected in the drug’s active ingredient, forcing the company to suspend production of new batches.

Manufacturing plans remain in place 

Speaking in March, Chief Executive Stephen Saad said Aspen plans to manufacture its generic semaglutide at facilities in South Africa and France. Higher-volume multi-dose injection pens will be produced at the company’s South African plant, while its French facility will manufacture single-dose autoinjectors.

Balance sheet strengthened after asset sale 

Aspen reported unaudited interim results for the six months ended Dec. 31, 2025, with revenue easing to R21.08 billion ($1.28 billion) from R21.96 billion ($1.3 billion) a year earlier. Gross profit declined to R9.58 billion ($583.7 million) from R10.45 billion ($636.7 million), while normalized EBITDA fell to R5.05 billion ($307.7 million) from R5.82 billion ($354.6 million), largely due to the absence of prior-period mRNA contract contributions and currency translation. 

In May, the company completed the sale of its Asia-Pacific business for about R27 billion ($1.6 billion), a transaction that strengthened its balance sheet and allowed it to focus more closely on its core pharmaceutical operations. 

Founded in 1997 and headquartered in Durban, Aspen has become Africa’s largest pharmaceutical manufacturer and one of the world’s leading specialty drugmakers. Saad, who has led the company since 1999, owns about 13.2% of Aspen, or roughly 58.8 million shares, making him the company’s largest shareholder.