Dr Reddy's Laboratories announced on Wednesday that Health Canada has approved its generic semaglutide injection, making it the first company to secure marketing authorisation for the generic product in Canada. The approval, granted through a Notice of Compliance, covers the 2 mg per pen and 4 mg per pen presentations, both at a concentration of 1.34 mg/mL.
Early Approval and Launch Preparations
The company stated that the authorisation arrived ahead of Health Canada's review target date, and launch preparations are now underway. This milestone underscores Dr Reddy's capabilities in complex generics and peptide-based medicines.
In-House Production and Partnership
According to Dr Reddy's, the active pharmaceutical ingredient is being produced entirely in-house, while the finished product manufacturing is handled by partner OneSource Specialty Pharma Ltd. This vertical integration ensures quality control and supply chain reliability.
CEO's Remarks on Strategic Importance
Dr Reddy's CEO Erez Israeli commented that Canada remains a priority market and described the approval as a milestone in the company's GLP-1 strategy. Semaglutide is a GLP-1 receptor agonist used once weekly in adults with type 2 diabetes to improve glycaemic control, as part of a broader treatment plan that includes diet and exercise.
Treatment Applications and Public Health Impact
Dr Reddy's noted that the drug can be used in several treatment settings, including alongside metformin, sulfonylureas, SGLT2 inhibitors, and basal insulin. According to the Public Health Agency of Canada, approximately 3.9 million people in Canada live with diagnosed diabetes, while more than 6% of adults have prediabetes. This approval offers a more affordable treatment option for patients.
