Ranbaxy makes three fresh ARV filings to WHO

By This comes shortly after | 25 Jan 2005

New Delhi: Ranbaxy Laboratories Ltd has made three fresh filings of its anti-retrovirals (ARVs) agents to the WHO for approval.

This comes shortly after the company announced 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.

Ranbaxy's anti-AIDS drugs were dropped from the WHO list last year.

In a statement, Brian W. Tempest, chief executive officer and managing director, Ranbaxy, said, "Ranbaxy fully supports WHO's pre-qualification project and we are working speedily to provide adequate fresh data to the WHO on our generic ARVs, 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's facilities at Paonta Sahib in Himachal Pradesh that will also manufacture these ARVs were inspected recently by the USFDA.