Ranbaxy Laboratories Ltd has received tentative approval from the U.S. Food and Drug Administration (FDA), Office of Generic Drugs, to manufacture and market quinapril hydrochloride tablets, 5 mg (base), 10 mg (base), 20 mg (base) and 40 mg (base). Total market sales for Accupril (quinapril hydrochloride tablets) were $589 Million in a total quinapril hydrochloride tablet market of $632.2 million (IMS – MAT: December 2003).

Quinapril hydrochloride is indicated for the treatment of hypertension. It may be used alone or in combination with thiazide diuretics. Quinapril hydrochloride is also indicated in the management of heart failure as adjunctive therapy when added to conventional therapy including diuretics and/or digitalis.

Commenting on the approval, Jim Meehan, vice president, sales and marketing, Ranbaxy Pharmaceuticals Inc. (RPI) said, “Subject to receiving final FDA approval, we will introduce quinapril hydrochloride tablets to further expand our product portfolio of affordable generic alternatives. This product offering in the cardiovascular class of medications will provide benefits to the U.S. healthcare system, prescribers and patients”.

Ranbaxy Pharmaceuticals Inc. (“RPI”) based in Jacksonville, Florida, is the wholly owned subsidiary of Ranbaxy, India’s largest pharmaceutical company. RPI is engaged in the sale and distribution of generic and branded prescription products in the U.S. healthcare system.