Dr. Reddy's Laboratories Flags Semaglutide Supply Delay, Says No Recall Risk

Dr. Reddy's Laboratories said a scale-up issue involving the API for its semaglutide injection will delay commercial supply, after an impurity was found out of specification during validation testing.

The company said the problem is tied to new validation batches, not previously shipped material.

Management stressed there is no recall or patient safety concern, because products already sold to the market were not affected and remain safe.

The issue also does not affect the company’s existing global regulatory filings or its oral semaglutide tablets.

Dr. Reddy’s expects validation work could be completed around September, with commercial supply potentially restarting in late October or early November if successful.

The delay means the company will miss some expected sales in the July-to-October period, though demand for semaglutide remains strong.

Dr. Reddy's Laboratories NYSE: RDY said a scale-up issue tied to the active pharmaceutical ingredient for its semaglutide injection will temporarily delay commercial supplies, though management emphasized that products already supplied to the market are not affected and do not raise patient safety concerns.

Chief Executive Officer Erez Israeli said on a company call that Dr. Reddy's identified an out-of-specification impurity during testing connected to the validation of a scaled-up synthetic API manufacturing process.

The API itself met specifications, he said, but an impurity degraded during formulation testing of the finished drug product.