Unichem Laboratories has received ANDA approval from the United States Food and Drug Administration (USFDA) for Irbesartan and Hydrochlorothiazide Tablets USP, 150 mg/12.5 mg, and 300 mg/12.5 mg, which are therapeutically equivalent to Avalide Tablets 150 mg/12.5 mg, and 300 mg/ 12.5 mg of Sanofi-Aventis U.S. LLC.
Irbesartan and Hydrochlorothiazide is a combination of Irbesartan, an angiotensin II receptor antagonist and Hydrochlorothiazide, a thiazide diuretic. This product is indicated for hypertension in patients not adequately controlled with monotherapy and also as initial therapy in patients with hypertension likely to need multiple drugs to achieve their blood pressure goals. 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).
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.
