Dr. Reddy’s halts semaglutide supply on quality concerns, shares plunge, Torrent recalls product

Dr. Reddy’s Laboratories on Thursday said it has halted commercial supplies of its generic semaglutide after an issue associated with the active pharmaceutical ingredient (API) used in the drug and fresh despatches were likely to resume only towards late October or early November.

The decision saw the Hyderabad-based drugmaker’s shares plunge nearly 6% on BSE and Torrent Pharmaceuticals announcing a voluntary recall of select batches of Semalix injection disposable pens manufactured by Dr. Reddy’s on instructions from the latter.

“Certain batches of semaglutide were found to be out of specification due to an issue associated with the API used in the product. Until the issue is resolved, commercial supplies of the product will be delayed for a certain period of time,” Dr. Reddy’s said in a filing.

There is no impact on patient safety or on the product’s existing global regulatory filings, the company said.

Semaglutide is the active ingredient in Novo Nordisk’s blockbuster diabetes and weight loss drugs Wegovy and Ozempic. Dr. Reddy’s was among the clutch of drugmakers in India that rolled out generic versions almost immediately after the patent on Semaglutide expired in March.

On a call with analysts in the evening, CEO Erez Israeli said the decision to halt commercial supplies follows an unknown impurity noticed during a scale-up of the production. A thorough investigation to determine the root cause would be undertaken, and necessary process improvement made. Only after a complete validation of the revised manufacturing process will commercial supplies be resumed, something that is bound to impact availability for customers in India as well as Canada.

He sought to clarify that there is no patient safety impact associated with the product already available in the market. The off specification products, noticed during the scale up, were not despatched. Also, there is no impact on the supply of semaglutide oral tablets, which utilise different API sources, he said.

With commercial supplies unlikely for more than three months, Dr. Reddy’s is unlikely to achieve the 12 million pens target it was eyeing this year. It may sell 6-7 million pens in Q3-Q4 of FY27, he said. The company’s shares closed 5.85% lower at ₹1,269.80 apiece on the BSE.

Separately, Torrent Pharmaceuticals said announced a voluntary recall, as a precautionary measure, only for select batches of Semalix injection disposable pens. “This action follows a product recall notification issued by our manufacturer Dr. Reddy’s Laboratories, for a technical evaluation,” the company said.

Mr. Israeli said the recall pertains to one batch in India and it has got nothing to do with the “issue we are discussing.”