New Delhi: Unichem Laboratories has received approval from the US health regulator for losartan potassium and hydrochlorothiazide tablets, used in the treatment of hypertension and reduction in risk of strokes in patients with hypertension.
The company “has received abbreviated new drug application (ANDA) approval from the United States Food and Drug Administration (USFDA) for losartan potassium and hydrochlorothiazide tablets USP, 50mg/12.5mg, 100mg/12.5 mg and 100mg/25mg,” Unichem Laboratories said in a filing to BSE on Tuesday.
The tablets are generic versions of Merck Sharp & Dohme Corporation.
The product will be commercialised from the company’s Ghaziabad plant. Active Pharmaceutical Ingredient will also be made in-house at Pithampur/Roha API Plant, Unichem Laboratories said.