Ranbaxy files data for three new antiretrovirals with WHO
Ranbaxy Laboratories, India's largest pharmaceutical company, has made three fresh filings of its Anti-Retrovirals (ARVs) agents to the WHO for its approvals. Earlier, Ranbaxy said that it had begun filing data for its range of ARVs with the US FDA under its expedited review process for the US President's Emergency Programme For Aids Relief (PEPFAR).
Ranbaxy Laboratories, India's largest pharmaceutical company, has made three fresh filings of its Anti-Retrovirals (ARVs) agents to the WHO for its approvals. Earlier, Ranbaxy said that it had begun filing data for its range of ARVs with the US FDA under its expedited review process for the US President's Emergency Programme For Aids Relief (PEPFAR).
'Ranbaxy fully supports WHO's prequalification project, and we are working speedily to provide adequate fresh data to the WHO on our generic ARV's, including fixed dose combinations, so that they can study it and provide their expeditious approvals,' said Dr Brian 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.'
Ranbaxy is committed to making affordable, bio-equivalent ARV's accessible to HIV/AIDS patients throughout the world, particularly to those who might not otherwise be able to access therapy, and has been exporting pharmaceuticals to US and Europe for several years.
Work on the new bio-equivalence studies for all ARV's is being carried out at recognised Contract Research Organisations (CROs) around the world, including in North America. Ranbaxy expects to complete a majority of the filings by March 2005 and is moving to complete a majority of these submissions to the US FDA by the same date.