Dr. Reddy’s Laboratories Limited announced that it has received a Notice of Non-Compliance (NON) from the Pharmaceutical Drugs Directorate of Canada concerning its Abbreviated New Drug Submission (ANDS) for Semaglutide Injection — a generic version of the diabetes treatment popularized under the brand name Ozempic.
According to the company’s filing with the stock exchanges, the Notice outlines requests for additional information and clarifications on specific aspects of the submission. Dr. Reddy’s confirmed that it will respond promptly and within the stipulated timeframe.
The pharmaceutical firm reiterated its confidence in the quality, safety, and comparability of its proposed Semaglutide product. It emphasized its commitment to making the therapy available in Canada and other markets at the earliest possible time.
“We remain confident in the quality, safety, and comparability of our proposed product and are committed to making this important therapy available to patients in Canada and other markets at the earliest,” the company stated in its filing.
Dr. Reddy’s said it will continue to provide updates on further developments as they arise.
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