Canada Issues Non-Compliance Notice to Dr. Reddy’s on Semaglutide Generic

Health Canada’s Directorate has issued a non-compliance notice to Dr. Reddy’s Laboratories regarding its generic semaglutide for weight loss, raising questions over the company’s regulatory pathway in North America. The notice cited failures to meet certain submission or compliance conditions linked to manufacturing or data requirements for approval. Semaglutide remains one of the most tightly scrutinised drug categories globally, given its soaring demand and high public-health impact. While the notice does not constitute a rejection, Dr. Reddy’s must address the compliance gaps before its application can progress. The development comes at a time when multiple global manufacturers are preparing to launch semaglutide generics once key patents expire. Industry observers view the notice as a sign that regulators will enforce stricter oversight on GLP-1 generics, especially in markets where safety, purity and bioequivalence standards face exceptional scrutiny.