Dr. Reddy’s Laboratories has received a Notice of Non-Compliance (NON) from the Pharmaceutical Drugs Directorate in Canada regarding its Abbreviated New Drug Submission (ANDS) for Semaglutide Injection. The NON outlines requests for additional information and clarifications. Dr. Reddy’s is confident in its product and will provide a response at the earliest, remaining committed to making the therapy available to patients in Canada.
Notice of Non-Compliance
Dr. Reddy’s Laboratories has been notified of a Notice of Non-Compliance (NON) concerning its submission for Semaglutide Injection in Canada. The notice, received from the Pharmaceutical Drugs Directorate, requests further information regarding the Abbreviated New Drug Submission (ANDS).
Company Response
Dr. Reddy’s is currently addressing the concerns raised in the NON and is preparing to submit additional information and clarifications. The company is committed to responding quickly and comprehensively to meet the requirements outlined in the notice. The company assures that they will submit the response at the earliest and well within the stipulated time period.
Commitment to Patients
Dr. Reddy’s remains confident in the quality, safety, and comparability of its Semaglutide Injection. The company reaffirms its commitment to making this important therapy available to patients in Canada and other markets as soon as possible. Dr. Reddy’s will provide further updates as appropriate.
Source: BSE
