Dr. Reddy’s Laboratories Ltd.a leading global pharmaceutical company, is pleased to announce it has received a Notice of Compliance (NOC) from Health Canada for its generic Semaglutide Injection. This milestone makes Dr. Reddy’s the first company to secure approval for a generic version of this critical GLP-1 therapy in Canada, notably achieving this milestone ahead of Health Canada’s scheduled review target date. The approval encompasses both the 2 mg / pen and 4 mg / pen (1.34 mg/mL) formulations. Semaglutide Injection is indicated for once-weekly use to improve glycemic control in adults with type 2 diabetes when used alongside diet and exercise.
With approximately 3.9 million people nearly 10% of the Canadian population—living with diagnosed diabetes, Canada is recognized as the world’s second-largest market for Semaglutide. As the population ages, the prevalence of type 2 diabetes and prediabetes is expected to rise, increasing the demand for effective GLP-1 receptor agonist therapies.
The approval highlights Dr. Reddy’s technical expertise in peptide science and complex generics. The Active Pharmaceutical Ingredient (API) is produced entirely in-house, ensuring a secure and consistent supply for the Canadian market. Finished product manufacturing is conducted in partnership with OneSource Specialty Pharma Limited.
“This approval represents a significant milestone in our GLP-1 journey and underscores our ability to meet stringent global regulatory standards,” said Erez Israeli, CEO of Dr. Reddy’s. “Canada remains a priority market for us. We are dedicated to expanding access to affordable, high-quality treatments and ensuring a reliable supply of this essential therapy for Canadian patients”.
Dr. Reddy’s is currently finalizing launch preparations to make this treatment option available to patients across Canada.
