Dr Reddy’s Laboratories on Thursday said commercial supplies of its semaglutide product will be delayed after certain batches were found to be out of specification due to an issue with the active pharmaceutical ingredient (API) used in the drug.
In an exchange filing, the Hyderabad-based drugmaker said it is investigating the root cause of the issue and taking appropriate measures to ensure product quality.
“Certain batches of semaglutide were found to be out of specification due to an issue associated with the active pharmaceutical ingredient (API) used in the product,” the company said.
The company said commercial supplies will remain delayed until the issue is resolved. However, it clarified that there is no impact on patient safety or on the product’s existing global regulatory filings.
“We remain committed to ensuring reliable global supplies of this important metabolic therapy,” it added.
The disclosure comes less than two months after Dr Reddy’s commercially launched its oral semaglutide tablet under the brand name Obeda in India for the treatment of type-2 diabetes. The once-daily oral drug is available in 3 mg, 7 mg and 14 mg strengths, priced at Rs 99, Rs 135 and Rs 225 per tablet, respectively.
The company had positioned the launch as a key milestone in building its GLP-1 portfolio after also becoming one of the first companies to launch a generic once-weekly injectable semaglutide in India following the expiry of the relevant patent earlier this year.
Dr Reddy’s said its management will host a conference call later on Thursday to discuss the development and answer investor queries.
