Hyderabad: Dr Reddy’s Labs said 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 1.34 mg/mL.The company said the authorisation arrived ahead of Health Canada’s review target date and that launch preparations are now underway.The company said the approval highlights its capabilities in complex generics and peptide-based medicines.According to Dr Reddy’s, the active pharmaceutical ingredient is being produced entirely in-house, while the finished product manufacturing is being handled by partner OneSource Specialty Pharma Ltd.Dr Reddy’s CEO Erez Israeli said 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.Dr Reddy’s said 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, about 3.9 million people in Canada live with diagnosed diabetes, while more than 6% of adults have prediabetes.
