Dr. Reddy's Receives FDA Letter on AmVaz -- Amlodipine Maleate.

Business Editors/Health/Medical Writers

HYDERABAD, India--(BUSINESS WIRE)--Feb. 7, 2004

Dr. Reddy's Laboratories (NYSE:RDY) announced that the Company has received a letter from the US Food and Drug Administration (FDA) on February 5, 2004, indicating that the FDA plans an expedited reevaluation of its review of the AmVaz(TM) NDA, which was granted final approval on October 31, 2003.

The FDA's letter indicated that the reevaluation was prompted by questions raised about the source of the data relied on by FDA in its review and that the agency would stay the approval for AmVaz(TM) pending the expedited reevaluation. The FDA further indicated in the letter that it believes that the approval of AmVaz(TM) did not rely on any proprietary data from Pfizer's NDA.

Commenting on the development, GV Prasad, CEO, Dr. Reddy's Laboratories, said, "We are confident that FDA's initial decision was correct and remain optimistic of a positive outcome of FDA's reevaluation."

AmVaz(TM) (Amlodipine Maleate) was approved for marketing by the US Food and Drug Administration (FDA) on October 31, 2003 and is indicated for the treatment of hypertension (high blood pressure) and angina.

About Dr. Reddy's

Established in 1984, Dr. Reddy's Laboratories (NYSE:RDY) is an emerging global pharmaceutical company with proven research capabilities. The Company is vertically integrated with a presence across the pharmaceutical value chain. It produces finished dosage forms, active pharmaceutical ingredients and biotechnology products and markets them globally, with focus on India, US, Europe and Russia. The Company conducts research in the areas of cancer, diabetes, cardiovascular, inflammation and bacterial infection.

This press release includes forward-looking statements, as defined in the U.S. Private Securities Litigation Reform Act of 1995. We have based these forward-looking statements on our current expectations and projections about future events. Such statements involve known and unknown risks, uncertainties and other factors that may cause actual results to differ materially. Such factors include, but are not limited to, changes in local and global economic conditions, our ability to successfully implement our strategy, the market acceptance of and demand for our products, our growth and expansion, technological change and our exposure to market risks. By their nature, these expectations and projections are only estimates and could be materially different from actual results in the future.