Dr Reddy’s Laboratories has received a Notice of Compliance (NOC) from Health Canada for its generic Semaglutide Injection.

The company is first to secure market authorization for a generic version of the therapy in Canada ahead of the regulator’s review target date.

The approval covers the 2 mg/pen (1.34 mg/mL) and 4 mg/pen (1.34 mg/mL) strengths. The company said launch preparations are currently underway to make the treatment available to patients across Canada.

According to the Public Health Agency of Canada, nearly 3.9 million Canadians live with diagnosed diabetes, while more than 6% of adults are estimated to have prediabetes, increasing their risk of developing type 2 diabetes.

The company noted that Canada is the world’s second-largest market for Semaglutide, citing IQVIA MAT Q3 2025 data.

Erez Israeli, Chief Executive Officer, Dr. Reddy’s, said: “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."

He added further: "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.”

Dr. Reddy’s said the approval highlights its capabilities in complex generics and peptide-based therapeutics, backed by in-house API and formulation development expertise. The active pharmaceutical ingredient for the product is manufactured internally, while the finished dosage form is currently being produced through its manufacturing partner OneSource Specialty Pharma.