MUMBAI: Dr Reddy’s Laboratories’ plans to capitalize on the early generic semaglutide market have hit a setback after manufacturing issues delayed supplies of the blockbuster diabetes and weight-loss drug, forcing the company to cut its expected volumes for the year.
The drugmaker said in an exchange filing on Thursday that supplies of its generic semaglutide would be delayed, with shipments now expected to resume by November, after certain batches were found to be out of specification.
The issue stems from the active pharmaceutical ingredient (API) used in the product. Commercial supplies will remain on hold until the problem is resolved, the company said, adding that there was no impact on patient safety or its existing global regulatory filings.
The disclosure rattled investors, sending the Hyderabad-based company’s shares down more than 6% intraday before they closed 5.77% lower at ₹1,271.20 apiece on the National Stock Exchange.
Speaking on an investor call later on Thursday, the company’s management said supplies were likely to resume by November. It also cut its expected supply for the .current fiscal to 6-7 million pens from an earlier estimate of 12 million. Existing inventory in India and Canada, where the drugmaker received approval in May, has not been impacted, the company said.
While the company’s leadership maintained its broader FY27 financial outlook, analysts said a prolonged disruption could erode its competitive advantage in the generic semaglutide market. Dr Reddy’s was among the first companies to launch a generic version of the diabetes and weight-loss drug in Canada.
The company said it detected an impurity during API testing in pre-validation batches while scaling up production.
Beyond selling its own brand, Dr Reddy’s also manufactures semaglutide for other drugmakers.
Ahmedabad-based Torrent Pharma said on Thursday that it was recalling select batches of its Semalix injection (2mg and 4mg), manufactured by Dr Reddy’s, as a “precautionary measure”. Its oral semaglutide tablets, as well as other dosages of the injections, remain unaffected, it said.
Dr Reddy’s manufacturing partner, contract manufacturer OneSource Specialty Pharma, said in a separate exchange filing that the development would have no material impact on its operations.
“While we stay committed to our long-standing valuable partnership with DRL, we have enough demand for the product from other customers, including for Canada, and our capacities are fully committed,” it said.
