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Unichem Laboratories receives ANDA approval from USFDA for Valsartan Tablets

07 May 2018 Evaluate

Unichem Laboratories has received Abbreviated New Drug Application (ANDA) approval from United States Food and Drug Administration (USFDA) for Valsartan Tablets USP, 40 mg, 80 mg, 160 mg and 320 mg, which are therapeutically equivalent to DIOVAN (Valsartan) tablets, 40 mg, 80mg, 160 mg and 320 mg of Novartis Pharmaceuticals Corporation. Valsartan is a non-peptide, orally active, and specific angiotensin II receptor blocker acting on the AT1 receptor subtype.

This drug product is indicated for treatment for hypertension, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions. This product will be commercialized from Unichem’s Ghaziabad plant.

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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