Ranbaxy sends three AIDS drugs for WHO approval:

January 24, 2005

[Health India]: New Delhi, Jan 24 : India's Ranbaxy Laboratories

Limited has made a fresh bid to obtain the World Health Organisation

(WHO)'s approval for three of its anti-retroviral (ARV) agents for

treating AIDS.

Earlier this month, Ranbaxy had announced it had begun filing data for

its range of ARVs with the US Food and Drug Administration (FDA) under

its expedited review process for the US President's Emergency

Programme For AIDS Relief (PEPFAR).

The move follows Ranbaxy's earlier WHO-approved drugs having to be

withdrawn due to failure to submit all the required documentation.

" Ranbaxy will be making submissions of its complete range of ARVs for

pre-qualification to the WHO and expects to complete a majority of the

filings by March 2005, " the company said.

" Ranbaxy fully supports WHO's pre-qualification project and we are

working speedily to provide adequate fresh data to WHO on our generic

ARVs including fixed dose combinations so that they can study it and

provide their expeditious approvals, " said W. Tempest, CEO and

managing director of Ranbaxy.

" This will pave the way for the early availability of these quality

medicines in areas where they are most urgently needed, " Tempest said

in a statement Monday.

The US FDA had recently inspected the Indian pharmaceutical major's

facilities at Paonta Sahib in Himachal Pradesh.

Ranbaxy has been exporting pharmaceuticals to the US and the European

Union, among other places, from the Paonta Sahib plant for several years.

" 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, " said Tempest.

Work on the new bio-equivalence studies for all ARVs is being carried

out at recognised contract research organisations across the world,

including in North America, said the company.

These organisations have extensive experience and history of working

with generic and innovator companies for their regulatory filings

across the globe.

Indo-Asian News Service.

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