Dr Reddy's First to Get Generic Semaglutide Approval in Canada
Health Canada grants market authorization for generic semaglutide injection for type-2 diabetes management
Quick Look
- Dr Reddy's Laboratories has received notice of compliance from Health Canada for its generic semaglutide injection, becoming the first company to receive market authorization for this diabetes treatment in Canada.
- The approval covers 2 mg/pen and 4 mg/pen dosages.
- The company is preparing to launch the medication to provide Canadian patients with access to this therapy.
AI-generated summary
New Delhi: Dr Reddy's Laboratories on Wednesday said it has received a notice of compliance (NOC) from Health Canada for its generic semaglutide injection indicated for the management of type-2 diabetes. Dr Reddy's becomes the first company to receive the market authorisation for generic Semaglutide Injection in Canada, ahead of Health Canada's review target date, the company said in a regulatory filing. The market authorisation covers the 2 mg/pen (1.34 mg/ml) and 4 mg/pen (1.34 mg / m), it added. With the launch preparations underway, Dr Reddy's said it is "well-positioned to bring this important treatment option available to Canadian patients". "The approval of our generic semaglutide Injection by Health Canada represents a significant milestone in our GLP-1 journey and underscores our expertise in complex product development, peptide science, and our ability to meet stringent global regulatory standards. Canada remains a priority market for us," Dr Reddy's CEO Erez Israeli said. As the first company to receive market authorisation for generic semaglutide injection in Canada, Israeli said, "We remain dedicated to expanding access to innovative, high-quality, affordable GLP-1 treatments for patients with diabetes in the country." This approval further fortifies the company's long-standing presence in Canada and enhances its diabetes management portfolio for regulated markets, he added.
