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The US health regulator has provided its final approval to Unichem Laboratories to market generic Irbesartan tablets that are used in treating hypertension, in the American market.
Unichem Laboratories said in a BSE filing that the company has received final abbreviated new drug application (ANDA) approval from the US Food and Drug Administration (USFDA) for Irbesartan tablets.
It said that “The product would be commercialized from Unichem’s Ghaziabad plant. Active Pharmaceutical Ingredient (API) for the product would also made in-house at Pithampur plant”.
