Ranbaxy seeks WHO nod for anti-retroviral filings

Ranbaxy Laboratories Ltd announced today that the company has made three fresh filings of its anti-retroviral (ARV) agents to the World Health Organisation (WHO) for its approval.

Earlier this month, Ranbaxy had announced that it had begun filing data for its range of ARVs with the US FDA under it's expedited review process for the US President's Emergency Programme For Aids Relief (PEPFAR).

Brian W. Tempest, CEO and MD, said, "Ranbaxy fully supports WHO's prequalification project and we are working speedily to provide adequate fresh data to the World Health Organisation on our generic anti-retrovirals, including fixed dose combinations so that they can study it and provide their expeditious approvals. This will pave the way for the early availability of these quality medicines, in areas where they are most urgently needed."

Ranbaxy will be making submissions of its complete range of ARV's for pre-qualification, to the WHO and expects to complete a majority of the filings by March 2005.

Ranbaxy's facilities at Paonta Sahib in Himachal Pradesh, which will also manufacture these ARVs, were inspected recently by the USFDA. Ranbaxy has been exporting pharmaceuticals to the US and Europe, among other countries, from the plant for several years.

Work on the new bio-equivalence studies for all ARVs is being carried out at recognized contract research organisations (CROs) around the world, including in North America.

These (CROs) have extensive experience and history of working with numerous generic and innovator companies towards their regulatory filings across the globe.