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Ranbaxy Gains Tentative Approval to Market Glimepiride Tablets

PRINCETON, NJ -- July 21, 2005 -- Ranbaxy Pharmaceuticals Inc. (RPI), a wholly owned subsidiary of Ranbaxy Laboratories Limited (RLL), announced today that RLL has received tentative approval from the U.S. Food and Drug Administration to manufacture and market glimepiride tablets, 1 mg, 2 mg, 4 mg, and 8 mg.

Total annual market sales for Glimepiride were $336.6 million (+22.4%) (IMS -- MAT: March 2005).

Glimepiride is indicated as an adjunct to diet and exercise to lower the blood glucose in patients with noninsulin-dependent (Type II) diabetes mellitus (NIDDM) whose hyperglycemia cannot be controlled by diet and exercise alone. Glimepiride may be used concomitantly with metformin when diet, exercise, and Glimepiride or metformin alone do not result in adequate glycemic control. Glimepiride is also indicated for use in combination with insulin to lower blood glucose in patients whose hyperglycemia cannot be controlled by diet and exercise in conjunction with an oral hypoglycemic agent. Combined use of Glimepiride and insulin may increase the potential for hypoglycemia.

"We are pleased to receive this tentative approval for Glimepiride Tablets. This product represents an interesting opportunity for Ranbaxy in which we will offer four strengths of this oral hypoglycemic agent to support patient compliance. Product will be launched following final approval from the FDA on October 6, 2005," according to Jim Meehan, Vice President of Sales and Marketing for RPI.

Ranbaxy Pharmaceuticals Inc. ("RPI") based in Jacksonville, Florida, is a wholly owned subsidiary of Ranbaxy Laboratories Limited ("RLL"), 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.


SOURCE: Ranbaxy Pharmaceuticals Inc.

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