Dr. Reddy's Laboratories announced today that the U.S. Food and Drug Administration (FDA) has approved the Company's NDA for AmVaz (Amlodipine Maleate).

Commenting on the development, GV Prasad, CEO, Dr. Reddy's Laboratories, said, "the final approval, the first for an Indian Pharmaceutical Company, marks a significant milestone for Dr. Reddy's, setting the stage for the launch of our first specialty branded product in the United States. We have not made a final decision on the launch date. But we are making all necessary preparations for the launch and are in the process of finalizing a co-promotion partner for AmVaz (Amlodipine Maleate) in the United States."

The Company has active development programs on a number of differentiated compounds in major therapeutic categories and expects additional NDA filings during the current fiscal year.

The Company is also preparing to launch Amlodipine Maleate in Europe upon expiration of the Supplementary Protection Certificate in March 2004.

Dr. Reddy's US product pipeline currently comprises 27 ANDAs, 2 NDAs (including Amlodipine Maleate) and 44 DMFs. Of these ANDAs, 20 were submitted under Paragraph IV. During the current fiscal, the Company expects to file 15-18 ANDAs, 15 DMFs and additional NDAs.