NEW DELHI, Apr 29: Dr Reddy’s Laboratories on Wednesday said it has received a notice of compliance (NOC) from Health Canada for its generic semaglutide injection indicated for the management of type-2 diabetes.
Dr Reddy’s becomes the first company to receive the market authorisation for generic Semaglutide Injection in Canada, ahead of Health Canada’s review target date, the company said in a regulatory filing.
The market authorisation covers the 2 mg/pen (1.34 mg/ml) and 4 mg/pen (1.34 mg / m), it added.
With the launch preparations underway, Dr Reddy’s said it is “well-positioned to bring this important treatment option available to Canadian patients”.
“The approval of our generic semaglutide Injection by Health Canada represents a significant milestone in our GLP-1 journey and underscores our expertise in complex product development, peptide science, and our ability to meet stringent global regulatory standards. Canada remains a priority market for us,” Dr Reddy’s CEO Erez Israeli said.
As the first company to receive market authorisation for generic semaglutide injection in Canada, Israeli said, “We remain dedicated to expanding access to innovative, high-quality, affordable GLP-1 treatments for patients with diabetes in the country.”
This approval further fortifies the company’s long-standing presence in Canada and enhances its diabetes management portfolio for regulated markets, he added. (PTI)
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