Dr. Reddy’s Laboratories (DRL) has received approval from Health Canada for its generic Semaglutide injection, becoming the first company to secure marketing authorisation for this product in Canada. The authorisation was granted to DRL ahead of Health Canada’s review target date. Canada is recognised as the world’s second-largest market for Semaglutide, a generic version of Ozempic.
DRL received a Notice of Compliance (NOC) from Health Canada for two formulations: the 2 mg/pen (1.34 mg/mL) and the 4 mg/pen (1.34 mg/mL).
Strategic CDMO Partnership
The active pharmaceutical ingredient (API) is produced entirely in-house by DRL, while the manufacturing of the finished product is carried out by OneSource Specialty Pharma, DRL’s partner. OneSource serves as the Contract Development and Manufacturing Organisation (CDMO) for this program, providing scale-up and commercial manufacturing of the formulation. The partnership ensures a reliable, scalable supply from OneSource’s US-FDA-approved manufacturing facility in Bengaluru.
“Canada remains a priority market for us. This approval further strengthens our long-standing presence in Canada and enhances our diabetes management portfolio for regulated markets,” said Erez Israeli, CEO of DRL. The approval from Health Canada marked a significant milestone in their GLP-1 journey, showcasing their expertise in complex product development, peptide science, and the ability to meet stringent global regulatory standards.
Neeraj Sharma, CEO and Managing Director of OneSource Specialty Pharma, said that this approval strengthens their collaboration with DRL, aligning their CDMO capabilities with DRL’s expertise in peptide development.
Multi-Billion Dollar Market
The Canadian market for the generic Semaglutide is estimated to be worth $ 1.5-1.8 billion. Health Canada has received nine generic semaglutide applications for review.
According to the Public Health Agency of Canada, approximately 3.9 million people (9.7% of the population) over the age of one are living with diagnosed diabetes. Additionally, over 6% of adults in Canada have prediabetes, increasing their risk of developing type 2 diabetes. The number of individuals with diabetes is expected to rise as Canada’s population continues to age and grow.