Dr. Reddy’s Laboratories announced Thursday it has stopped commercial supplies of its generic semaglutide following a problem with the active pharmaceutical ingredient. Fresh shipments are expected only by late October or early November. The Hyderabad firm’s shares dropped nearly 6 percent on the BSE after the disclosure. Torrent Pharmaceuticals then initiated a voluntary recall of selected batches of Semalix injection pens made by Dr. Reddy’s. The company stated that certain batches failed specifications because of an issue with the ingredient. It added that patient safety and existing regulatory filings remain unaffected. Semaglutide is the key component in Novo Nordisk’s Wegovy and Ozempic. Dr. Reddy’s launched its generic version shortly after the patent expired in March. During an analyst call, chief executive Erez Israeli explained that an unknown impurity appeared during production scale-up. A full investigation and process improvements will follow before supplies resume, affecting availability in India and Canada. He confirmed no safety risk to products already distributed and noted that oral tablets use different sources. The firm now expects to sell only 6-7 million pens in the final two quarters instead of its 12 million target. Torrent described its recall as a precautionary step limited to specific batches following the manufacturer’s notification.

Credit:
https://www.thehindu.com/business/Industry/dr-reddys-to-delay-semaglutide-supplies-due-to-quality-isssue-shares-hit/article71201291.ece
BCN