Dr. Reddy’s Gets Non-Compliance Notice from Canada for Semaglutide Generic

Dr. Reddy’s Laboratories Ltd. said it has received a Notice of Non-Compliance (NoN) from Health Canada’s Pharmaceutical Drugs Directorate for its Abbreviated New Drug Submission (ANDS) for semaglutide injection, used to treat diabetes and obesity.

The notice comes as the company was preparing to launch the drug in Canada once it goes off-patent on January 4, aiming to capture early market share. The Canadian semaglutide market is valued at about $1.6 billion annually, and Dr. Reddy’s had projected $300 million in initial revenue from the launch. At least three other generic firms are also seeking approval for the drug.

Health Canada issues a NoN when a company’s drug submission does not meet approval standards. The letter seeks additional information and clarifications on parts of the submission, Dr. Reddy’s said.

“We will submit a response at the earliest and well within the stipulated time,” the company said, adding it remains confident in the quality, safety, and comparability of its product.

Dr. Reddy’s is also preparing to launch semaglutide in Brazil and India by March, followed by entry into around 87 other international markets in phases.