Ranbaxy files anti-retrovirals (ARVs) to the U.S. FDA

Jan 10 2005

Ranbaxy Laboratories Limited (Ranbaxy) announced today that the Company has so far made three filings of its Anti-Retrovirals (ARVs) to the U.S. FDA for its approval under the expedited review process of the President's Emergency Plan for AIDS Relief (PEPFAR).

Earlier, in July 2004, Ranbaxy had said that the Company would make its first ARV filing with the U.S. FDA under the PEPFAR, by the end of 2004. Ranbaxy has met this expectation and has filed two additional ARVs with the U.S. FDA after its first ARV filing in October 2004.

Speaking on the occasion, Dr. Brian W. Tempest, CEO and Managing Director of Ranbaxy, said, "We are working speedily to provide all the data required by the U.S. FDA, so our generic ARVs can be approved."

Ranbaxy is committed to making affordable, bio-equivalent ARVs accessible to HIV/AIDS patients throughout the world, particularly to those who might not otherwise be able to access therapy. Towards this end, the Company will be filing its complete range of ARVs including Fixed Dose Combinations, with the U.S. FDA.

Ranbaxy's facilities in India at Paonta Sahib (Himachal Pradesh) that will manufacture these ARVs were inspected recently by the U.S. FDA authorities and found to be compliant.

Work on new bio-equivalence studies for all ARVs is being carried out at recognized CRO's around the world, including in North America. These CRO's have extensive experience and history in working with numerous generic companies and the U.S. FDA to provide relevant and acceptable data that is required to support the PEPFAR initiative.

Alongside, but separately from the U.S. FDA filings, Ranbaxy will also be making submissions of its complete range of ARVs for pre-qualification, to the WHO.

The Company expects to complete a majority of the filings to the U.S. FDA and to the WHO by March 2005.

HIV AIDS is a serious pandemic that now infects some 40 million people around the globe. More than 20 million individuals have so far succumbed to this devastating disease. Ranbaxy will periodically issue further updates on the subject.

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