Dr Reddy's Laboratories First to Get Health Canada Approval for Generic Semaglutide Injection
Hyderabad-based pharmaceutical company receives market authorization for 2mg/pen and 4mg/pen dosages, aims to improve access to affordable diabetes treatments in Canada
Quick Look
- Dr Reddy's Laboratories has become the first company to receive Health Canada approval for generic semaglutide injection, covering 2 mg/pen and 4 mg/pen dosages.
- The approval, granted ahead of the regulatory review target date, marks a significant milestone in the company's GLP-1 journey and aims to expand access to affordable diabetes treatments for Canadian patients, where approximately 3.9 million people (9.7% of the population) live with diagnosed diabetes.
AI-generated summary
Hyderabad-based Dr Reddy's Laboratories has received approval from Health Canada for its generic semaglutide injection, making it the first company to receive market authorisation for generic semaglutide injection in Canada, the company said in a statement.
The market authorisation covers its 2 mg/pen and 4 mg/pen dosages. The market authorisation was granted to Dr Reddy's ahead of Health Canada's review target date.
"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," said Erez Israeli, Chief Executive Officer, Dr Reddy's.
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.
"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," he said.
"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," he added.
