IGMPI India



USFDA approves Unichemís generic hypertension tablets

Unichem Laboratories announced the receipt of approval for its generic drug amlodipine besylate tablets by the United States Food and Drug Administration (USFDA). These amlodipine tablets are used in the treatment of hypertension and coronary artery disease. The company announced of having received ANDA approval for amplodipine besylate tablets from the USFDA. The Goa facility of the company would be in charge of commercializing the product.

The tablets amlodipine besylate are antihypertensive drugs, basically calcium channel blockers. These are helpful in reducing blood pressure and are used in treating hypertension. As hypertension is a major risk factor for heart diseases and stroke, it is used in treatment of cardiovascular disorders.

The amlodipine tablets are in the strengths of 2.5mg, 5 mg and 10 mg. These tablets correspond to Norvasc tablets of Pfizer Inc in the same strengths. While there are six to seven companies predominantly dealing with the US market, the company has a huge potential to perform as the current market size is around USD 45-50 million.