Dr. Reddy’s Laboratories has received a Notice of Compliance (NOC) from Health Canada for its generic semaglutide injection. The Hyderabad-based pharma major becomes the first company to receive the market authorisation for generic semaglutide injection in Canada, ahead of Health Canada’s review target date. The market authorisation covers the 2 mg/pen (1.34 mg/mL) and 4 mg/pen (1.34 mg/mL).

As per Public Health Agency of Canada, around 3.9 million people (9.7 percent of the population) in Canada over a year old live with diagnosed diabetes. In addition, over six percent of adults in Canada live with prediabetes, which gives them a higher chance of developing type 2 diabetes (T2D). The number of people living with diabetes is expected to continue to increase as Canada's population ages and grows. GLP 1 receptor agonist therapies, including semaglutide, are supported by a substantial global clinical evidence base demonstrating improvements in glycaemic control, as measured by HbA1c, in adults with T2D when used as part of a comprehensive diabetes management strategy.

Canada is recognised as the world's second-largest market for semaglutide.

Health Canada’s approval demonstrates Dr Reddy’s expertise in complex generics and peptide-based therapeutics, supported by in-house Active Pharmaceutical Ingredient (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.

Erez Israeli, Chief Executive Officer (CEO), 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 authorisation 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.”