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.
Shares of the company gained Rs 3.95, or 1.45%, to trade at Rs 275.65. The total volume of shares traded was 15,201 at the BSE (1.07 p.m., Tuesday).