Dr. Reddy’s Laboratories has secured approval from Health Canada for its generic Semaglutide Injection, becoming the first company to receive such authorization in the country. The approval, granted ahead of the anticipated review date, covers 2 mg/pen and 4 mg/pen dosages. This milestone highlights the company’s expertise in peptide-based therapeutics and strengthens its portfolio in the growing Canadian market, where millions live with diabetes and prediabetes.
Advancing Diabetes Care in Canada
On April 29, 2026, Dr. Reddy’s Laboratories announced that it has received a Notice of Compliance from Health Canada for its generic Semaglutide Injection. This achievement marks a significant milestone, as Dr. Reddy’s is the first pharmaceutical company to receive market authorization for this generic alternative in Canada. The approval was granted ahead of the expected target date, allowing the company to accelerate its launch preparations.
Strategic Significance and Market Impact
The authorization includes two presentations: 2 mg/pen (1.34 mg/mL) and 4 mg/pen (1.34 mg/mL). This move addresses the critical needs of the approximately 3.9 million Canadians diagnosed with diabetes, a number expected to rise alongside the country’s aging population. By leveraging in-house API production and specialized formulation development, Dr. Reddy’s is well-positioned to provide a reliable and affordable treatment option for patients requiring GLP-1 receptor agonist therapies.
Expertise in Complex Generics
This success reflects the company’s deep-rooted capabilities in peptide science and complex generic manufacturing. The active pharmaceutical ingredient is produced entirely in-house, ensuring quality and supply chain consistency. The finished product is manufactured through a strategic partnership with OneSource Specialty Pharma Limited. Looking forward, this expansion strengthens the company’s diabetes management portfolio and reinforces its commitment to providing high-quality, innovative medicines to regulated markets globally.
Source: BSE
