Dr. Reddy's Laboratories Ltd. - Semaglutide Update Call Transcript

Dr. Reddy's Laboratories conducted a conference call on July 9, 2026, to discuss a development regarding their product, semaglutide. The company identified an impurity issue in a scale-up batch of semaglutide API, where the impurity was found to be out of specifications upon testing of the finished drug product, indicating degradation during formulation. This has led to a temporary halt in commercial supplies as the company undertakes an investigation to determine the root cause and implement necessary process improvements. A successful validation of the revised manufacturing process is expected to resume commercial supplies by late October or early November 2026, with an estimated supply of 6-7 million pens between Q3 and Q4 of FY27. The company emphasized that manufacturing facilities remain compliant with cGMP, there is no impact on existing global regulatory filings, and crucially, no patient safety impact on products already supplied to the market. The issue is also distinct from the supply of semaglutide oral tablets. While the delay is regrettable, Dr. Reddy's is committed to resolving the issue with urgency and ensuring a reliable long-term supply.