Dr Reddy's Delays Semaglutide Supply After API Quality Issue
Hyderabad: Dr. Reddy's Laboratories has announced a temporary delay in the commercial supply of certain batches of its semaglutide product after identifying an out-of-specification issue associated with the active pharmaceutical ingredient (API) used in the product.
The company stated that it is investigating the root cause of the issue and implementing appropriate corrective measures to ensure product quality.
The company disclosed the development through a regulatory filing dated July 9, 2026, submitted to the National Stock Exchange of India (NSE), BSE Limited, New York Stock Exchange (NYSE), and NSE IFSC under Regulation 30 of the SEBI (Listing Obligations and Disclosure Requirements) Regulations, 2015.
According to the filing, certain batches of semaglutide were found to be out of specification due to an issue related to the API used in the product. Dr. Reddy's said it has initiated an investigation to determine the root cause of the quality deviation and is taking suitable measures to maintain the quality standards of the product. Until the issue is resolved, commercial supplies of semaglutide will remain delayed for a certain period.
The company clarified that the identified issue does not have any impact on patient safety. It further stated that there is no effect on the product's existing global regulatory filings. Dr. Reddy's reiterated its commitment to ensuring reliable global supplies of the important metabolic therapy while addressing the quality concern.
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