Dr. Reddy’s Gets Health Canada Nod for Generic Semaglutide Injection

Hyderabad, Apr 29 (TNT): Dr. Reddy’s Laboratories on Wednesday announced that it has received a Notice of Compliance (NOC) from Health Canada for its generic Semaglutide injection, becoming the first company to secure market authorisation for the product in Canada.

The approval covers the 2 mg/pen (1.34 mg/mL) and 4 mg/pen (1.34 mg/mL) strengths, Hyderabad based pharma giant said in a release here.

The company said it is preparing for launch and aims to make the treatment available to patients in Canada soon.

Semaglutide, a GLP-1 receptor agonist, is used as a once-weekly therapy for adults with Type 2 Diabetes to improve glycaemic control, alongside diet and exercise or in combination with other therapies.

According to the Public Health Agency of Canada, nearly 3.9 million people in Canada live with diagnosed diabetes, while over 6 per cent of adults have prediabetes, underlining the growing demand for effective treatment options.

The company said the approval highlights its capabilities in complex generics and peptide-based therapeutics, supported by in-house API development and formulation expertise.

The active pharmaceutical ingredient is produced internally, while the finished product is currently manufactured in partnership with OneSource Specialty Pharma Limited.

CEO Erez Israeli said the approval marks a key milestone in the company’s GLP-1 portfolio and reinforces its commitment to expanding access to affordable, high-quality diabetes treatments in global markets.

Canada is considered one of the largest markets globally for semaglutide-based therapies, and the approval is expected to strengthen Dr. Reddy’s presence in the region while enhancing its diabetes care portfolio.

TNT TS

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