The company expects validation to complete by September, pushing commercial supply to late October or November.
Dr. Reddy’s Laboratories announced a temporary delay in commercial supply of its semaglutide injection due to an out-of-specification impurity found during validation testing of a scaled-up API manufacturing process. The issue affects new validation batches but does not impact products already shipped to the market, which remain safe for use.
The company stated that validation work could be finalized by September, with potential resumption of commercial supply in late October or early November. This delay is expected to result in missed sales during the July-to-October period, though demand for semaglutide remains robust. Existing regulatory filings and oral semaglutide tablets are unaffected.
Management emphasized there is no recall risk or patient safety concern, as the problem is isolated to the validation phase of the API scale-up process.