Earlier in January, Ranbaxy announced that it had begun filing data for its range of anti-retrovirals (ARVs) with the FDA under its expedited review process for the US President’s emergency program for AIDS relief (PEPFAR).
Work on new bio-equivalence studies for all ARVs is being carried out at recognized contract research organizations (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.
Ranbaxy will be making submissions of its complete range of ARVs for pre- qualification to the World Health Organization (WHO) and expects to complete the majority of the filings by March 2005.
The company is also currently working to complete the majority of these submissions to the FDA, also by March 2005.