The notice pertains to the company’s Abbreviated New Drug Submission (ANDS) for its Semaglutide Injection.
In an official statement, Dr. Reddy’s clarified that the NON outlines requests for additional information and clarifications on specific aspects of the submission. The company assured that it will submit a response promptly and within the stipulated time period.
“We have received a Notice of Non-Compliance (NON) from the Pharmaceutical Drugs Directorate, Canada, regarding our Abbreviated New Drug Submission (ANDS) for Semaglutide Injection. The NON outlines requests for additional information and clarifications on specific aspects of the submission. We will submit a response at the earliest and well within the stipulated time period,” the company said in an exchange filing.
Despite the regulatory setback, Dr. Reddy’s said it remains confident in the quality, safety, and comparability of its proposed product and is committed to bringing the therapy to patients in Canada and other markets as soon as possible.
Following the development, domestic brokerage firm Elara Capital maintained its ‘Buy’ rating on the stock with a target price of Rs 1,588, suggesting the issue is a temporary regulatory delay and that long-term potential remains intact.The brokerage, in its note, stated that no revenue contribution from Canada Semaglutide has been assumed in FY26 forecasts, but USD 100 million in sales has been built in for FY27E, indicating optimism about future approvals.Elara added that the stock is currently valued at 22.9x FY27E earnings, and any correction resulting from the regulatory update should be viewed as a buying opportunity.
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