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25-Jul2017

Unichem receives ANDA approval for Losartan Potassium, Hydrochlorothiazide tablets

Unichem Laboratories has received ANDA approval from the United States Food and Drug Administration (USFDA) for Losartan Potassium and Hydrochlorothiazide tablets USP, 50mg/12.5 mg, 100mg/12.5mg, and 100 mg/25mg, which are therapeutically equivalent to Hyzaar Tablets 50mg/12.5 mg, 100mg/12.5mg, and 100 mg/25mg of Merck Sharp & Dohme Corporation. The product will be commercialized from Unichem's Ghaziabad plant. Active Pharmaceutical Ingredient will also be made in house at Pithampur/Roha API Plant(s).

Losartan Potassium and Hydrochlorothiazide is a combination of Losartan Potassium, an angiotensin II receptor blocker (ARB) and Hydrochlorothiazide, a diuretic indicated for treatment of hypertension (to lower blood pressure) and for reduction of the risk of stroke in patients with hypertension and left ventricular hypertrophy.

Unichem Laboratories is an international, integrated, specialty pharmaceutical company. It manufactures and markets a large basket of pharmaceutical formulations as branded generics as well as generics in India and several other markets across the world.


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