Dr Reddy’s wins Canada approval for generic semaglutide injection

Dr. Reddy’s Laboratories Ltd. on Wednesday said it has received marketing approval from Health Canada for its generic semaglutide injection, becoming the first company to secure such authorisation in Canada.

The Hyderabad-based drug major said it has been granted a Notice of Compliance (NOC) by Health Canada for its abbreviated new drug submission (ANDS) of semaglutide injection.

The approval allows the company to commercialise, sell and distribute the product in Canada, it added in a regulatory filing.

Dr. Reddy’s noted that the approval covers two dosage strengths of the injection and does not have a fixed expiry period.

The company said it received the clearance ahead of the regulator’s target review date.

Semaglutide belongs to a class of GLP-1 receptor agonists used to improve blood sugar control in adults with type 2 diabetes, a market that has seen surging global demand in recent years.

According to the company, Canada is among the largest markets for semaglutide therapies, with a growing patient pool driven by rising incidence of diabetes and prediabetes.

“Canada remains a priority market for us,” Dr. Reddy’s CEO Erez Israeli said in a statement. “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.”

The active pharmaceutical ingredient (API) for the product is manufactured in-house, while the finished formulation is currently produced through a manufacturing partner.

Indian drugmakers are rushing to tap the lucrative market with significantly cheaper versions.

Companies including Sun Pharma, Dr Reddy’s Laboratories, Glenmark Pharmaceuticals, Zydus Lifesciences, Eris Lifesciences and Natco Pharma have launched or announced semaglutide injections in India.

Semaglutide mimics the GLP-1 hormone, boosting insulin release, lowering glucose production and suppressing appetite, making it effective for both diabetes management and weight loss.