Ranbaxy files three anti-Retoviral patents

Ranbaxy Laboratories Ltd announced today that the company has so far made three filings of its anti-Retrovirals (ARVs) to the USFDA (Food & Drug Administration) for its approval under the expedited review process of the US Presidents Emergency Plan for AIDS Relief (PEPFAR).

The company had in July 2004 said that the company would make its first ARV filing with the US FDA under the PEPFAR by the end of 2004.

Ranbaxy has met this expectation and has till date filed three ARVs with the USFDA after the first ARV filing in October 2004.

Brian W Tempest, CEO and MD, Ranbaxy, said, We are working speedily to provide all the data required by the USFDA, so our generic ARV's can be approved.

Ranbaxy is committed to making affordable, bio-equivalent ARVs accessible to HIV/AIDS patients throughout the world, particularly to those, who might not otherwise be able to access therapy.

Towards this end, the company will be filing its complete range of ARVs including fixed dose combinations with the USFDA.

Ranbaxy's facilities in India at Paonta Sahib (Himachal Pradesh) that will manufacture these ARVs were inspected recently by the USFDA authorities and found to be compliant.

Work on new bio-equivalence studies for all ARVs is being carried out at recognised CRO's around the world, including in North America.

These CRO's have extensive experience and history in working with numerous generic companies and the USFDA to provide relevant and acceptable data that is required to support the PEPFAR initiative.

Alongside, but separately from the USFDA filings, Ranbaxy will also be making submissions of its complete range of ARV's for pre-qualification to the World Health Organisation (WHO). The company expects to complete a majority of the filings to the USFDA and to the WHO by March 2005.

HIV/AIDS is a serious pandemic that now infects some 40 million people around the globe. More than 20 million individuals have so far succumbed to this disease.