Ranbaxy Laboratories Limited (Ranbaxy) has initiated a programme to file its Anti Retroviral (ARV) range of products for the treatment of HIV/AIDS with the US FDA under the expedited review process of the US FDA for the US President's Emergency Plan for AIDS Relief (PEPFAR).
The first filing is likely to take place before the end of 2004. The first study for bio-equivalence is being planned at a Contract Research Organisation (CRO) in North America, a release from company said.
The Company's ARVs, including the Fixed Dose Combinations, have demonstrated their safety and efficacy in the treatment of HIV/AIDS patients in many countries since 2001. The Company supplies ARVs to around 40 countries, release added.