Dr. Reddy's Labs Secures Health Canada Approval for Generic Semaglutide Injection
Dr. Reddy's Laboratories Ltd. announced on April 29, 2026, that it has received a Notice of Compliance (NOC) from the Pharmaceutical Drugs Directorate, Canada (Health Canada), for its generic Semaglutide Injection. This achievement positions Dr. Reddy's as the first company to obtain market authorization for generic Semaglutide Injection in Canada, coming ahead of Health Canada's review target date.The market authorization covers the specific formulations of Semaglutide Injection: 2 mg / pen (1.34 mg / mL) and 4 mg / pen (1.34 mg / mL). The issuance of the NOC from Health Canada authorizes the commercialization, sale, and distribution of Semaglutide Injection throughout Canada.
In Canada, the need for such treatments is significant, with an estimated 3.9 million people, or 9.7% of the population over one year old, living with diagnosed diabetes. Additionally, over 6% of adults in Canada report living with prediabetes. GLP-1 receptor agonist therapies, including Semaglutide, are clinically supported for improving glycemic control in adults with Type 2 diabetes when used as part of a comprehensive management strategy.
Health Canada's approval highlights Dr. Reddy's expertise in complex generics and peptide-based therapeutics. The company noted that its API is produced entirely in-house, while the finished product manufacturing is currently managed by its manufacturing partner, OneSource Specialty Pharma Limited.
Erez Israeli, Chief Executive Officer of Dr. Reddy's, stated that the approval of the generic Semaglutide Injection by Health Canada represents a major milestone in the company's GLP-1 journey. He emphasized that the achievement underscores Dr. Reddy's proficiency in complex product development, peptide science, and meeting stringent global regulatory standards.
"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," Israeli said. He added that this approval further solidifies Dr. Reddy's long-standing presence in Canada and enhances the company's diabetes management portfolio for regulated markets.
The treatment options for Semaglutide Injection include management for adult patients with Type 2 diabetes, in combination with diet and exercise, and in various combinations with metformin, sulfonylurea, or SGLT2 inhibitors, depending on the patient's specific glycemic control needs.
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