Date:24/03/2005 URL: http://www.thehindubusinessline.com/2005/03/24/stories/2005032402340200.htm

Back Ranbaxy makes 2 fresh filings for ARVs with WHO

Our Bureau

New Delhi , March 23

RANBAXY Laboratories Ltd has made two fresh filings of its anti-retrovirals (ARVs) agents, to the World Health Organisation (WHO) for its approval, taking the total number of filings submitted with the WHO to five.

Besides, Ranbaxy has also filed one more ARV with the US FDA under its expedited review process for the US President's Emergency Programme For AIDS Relief (PEPFAR), thus taking the total number of ARV filings with the FDA to four.

In a company statement, Dr Brian W. Tempest, CEO and MD, Ranbaxy, said, "Ranbaxy remains committed towards refiling of its ARVs with the WHO and the USFDA (under the PEPFAR programme). By this summer, we expect most of our range of HIV medicines to be filed with WHO and US FDA."

Last year, the WHO had dropped Ranbaxy's ARVs from its list after it had found the documentation to be inadequate.

The company then appointed a new Clinical Research Organisation (CRO) to conduct fresh bio-equivalence studies.