Dr Reddy’s Delays Anti-Diabetic Semaglutide Commercial Supplies After Issues With Ingredient

New Delhi, Jul 9 (PTI) Dr Reddy’s Laboratories on Thursday said commercial supplies of its anti-diabetic semaglutide will be delayed for a certain period of time due to “out of specification issues” with an ingredient.

There is no impact on patient safety and the company is investigating the root cause and taking appropriate measures to ensure product quality, Dr Reddy’s Laboratories said in a regulatory filing.

“…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.

“We are investigating the root cause and taking appropriate measures to ensure product quality,” it said. The company further said,”Until the issue is resolved, commercial supplies of the product will be delayed for a certain period of time.” There is no impact on patient safety or on the product’s existing global regulatory filings, Dr Reddy’s said.

“We remain committed to ensuring reliable global supplies of this important metabolic therapy,” it noted.

In May this year, Dr Reddy’s Laboratories launched its oral semaglutide biosimilar, indicated for type 2 diabetes mellitus in India under the Obeda brand.

This followed the launch of generic semaglutide injection in India and Canada.

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