HYDERABAD, India — Dr. Reddy’s announced that it has received a Notice of Compliance (NOC) from Health Canada for its generic Semaglutide Injection. Dr. Reddy’s becomes the first company to receive the market authorization for generic Semaglutide Injection* in Canada, ahead of Health Canada’s review target date. The market authorization covers the 2 mg / pen (1.34 mg / mL) and 4 mg / pen (1.34 mg / mL). With launch preparations underway, Dr. Reddy’s is well-positioned to bring this important treatment option available to Canadian patients.
As per Public Health Agency of Canada, around 3.9 million people (9.7% of the population) in Canada over a year old live with diagnosed diabetes. In addition, over 6% of adults in Canada live with prediabetes, which gives them a higher chance of developing type 2 diabetes. The number of people living with diabetes is expected to continue to increase as Canada's population ages and grows 1. GLP‑1 receptor agonist therapies, including Semaglutide, are supported by a substantial global clinical evidence base demonstrating improvements in glycemic control, as measured by HbA1c, in adults with type 2 diabetes when used as part of a comprehensive diabetes management strategy. Canada is recognized as the world's second-largest market for Semaglutide2.
Health Canada’s approval demonstrates Dr. Reddy’s expertise in complex generics and peptide-based therapeutics, supported by in-house API as well as formulation development capabilities. The API is entirely produced in‑house, with finished product manufacturing currently carried out by the company’s manufacturing partner, OneSource Specialty Pharma Limited.
Erez Israeli, Chief Executive Officer, Dr. Reddy’s, said: “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. As the first company to receive market authorization for generic Semaglutide Injection in Canada, we remain dedicated to expanding access to innovative, high‑quality, affordable GLP‑1 treatments for patients with diabetes in the country. Additionally, with our in-house development capabilities, we are committed to ensuring a reliable and consistent supply of this important therapy for Canadian patients. This approval further fortifies our long-standing presence in Canada and enhances our diabetes management portfolio for regulated markets.”
* Semaglutide Injection (semaglutide) is indicated for the once-weekly treatment of adult patients with type 2 diabetes to improve glycemic control, in combination with
- diet and exercise in patients for whom metformin is inappropriate due to contraindication or intolerance
- metformin, when diet and exercise plus maximal tolerated dose of metformin do not achieve adequate glycemic control
- metformin and a sulfonylurea, when diet and exercise plus dual therapy with metformin and a sulfonylurea do not achieve adequate glycemic control
- metformin or a sulfonylurea and a sodium-glucose cotransporter 2 inhibitor (SGLT2i), when diet and exercise plus metformin or a sulfonylurea, in addition to an SGLT2i, do not achieve adequate glycemic control
- basal insulin with metformin, when diet and exercise plus basal insulin with metformin do not achieve adequate glycemic control
Semaglutide has not been studied in combination with prandial insulin (short acting). Semaglutide Injection is not a substitute for insulin. Semaglutide Injection should not be used in patients with type 1 diabetes mellitus (formerly known as insulin-dependent diabetes mellitus or IDDM) or for the treatment of diabetic ketoacidosis.
Please consult the product monograph for complete prescribing information, warnings and precautions, adverse reactions, and contraindications.
