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(Bloomberg) — Dr. Reddy’s Laboratories Ltd. will delay the commercial production of its generic Ozempic drug after it found an unspecified issue with the active pharmaceutical ingredient in some batches of the anti-obesity and diabetes therapy.
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“Certain batches of semaglutide were found to be out of specification due to an issue associated with the active pharmaceutical ingredient used in the product,” the Indian pharmaceutical company said in a filing Thursday. “We are investigating the root cause and taking appropriate measures to ensure product quality.”
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Commercial supplies will be delayed for a certain period of time until the issue is resolved, Dr. Reddy’s said. The company didn’t specify further details on the issue or the number of batches affected. Still, it said there was no impact on patient safety or “the product’s existing global regulatory filings.”
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The stock slumped 5.9% in Mumbai, its biggest fall in more than four months.
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The drugmaker has sold about 31,000 units of its GLP-1 treatment in India under the brand names Obeda, Mashlo and Olymviq since the patent on semaglutide expired in March, according to data from market research firm Pharmarack. Dr. Reddy’s launched generic Ozempic in Canada in May.
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The impact on the Indian drugmaker largely depends on how quickly it resolves these issues, said Vishal Manchanda, Mumbai-based analyst at Systematix Group. “It can be assumed that the September quarter will be weaker due to this,” he said.
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Semaglutide is the key ingredient in Novo Nordisk A/S’s blockbuster weight-loss treatments Ozempic and Wegovy.
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(Updates with analyst commentary in the sixth paragraphs.)
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