"The company has received ANDA approval from the United States Food and Drug Administration (US FDA) for Losartan Potassium tablets USP," Unichem Laboratories said in a filing to BSE.
The product will be commercialised from the company's Ghaziabad plant, it added.
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The product is generic version of Merck Sharp & Dohme Corp's Cozaar tablets in the strength of 25 mg, 50 mg and 100 mg, Unichem said.
Losartan Potassium is used for treatment of hypertension, it added.
Shares of Unichem Laboratories were trading at Rs 307.50 per scrip, up 1.52%, on BSE.