RANBAXY ISSUES UPDATE ON US ANTIRETROVIRALS FILINGS

Indian generics producer Ranbaxy has issued a progress report on filings with the US FDA for its generic HIV/AIDS products. The company has filed applications for three prospective antiretrovirals to date, under the expedited review process of the US government's PEPFAR initiative. Ranbaxy first announced plans to submit its HIV/AIDS treatments for approval in July 2004, with the first application submitted to the US FDA in October.

Ranbaxy's facility in Paonta Sahib, India, which is to manufacture the drugs, has already received approval after a US FDA inspection. Meanwhile, reports suggest the company will also submit its entire portfolio of HIV/AIDS drugs to the World Health Organisation (WHO), for inclusion to its essential drugs list. Ranbaxy hopes to complete the majority of both US FDA and WHO filings by March 2005.