Financial Daily from THE HINDU group of publications
Tuesday, Jan 11, 2005
Financial Daily from THE HINDU group of publications Tuesday, Jan 11, 2005 |
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Announcements Ranbaxy makes three filings to USFDA for AIDS drugs Our Bureau
New Delhi , Jan. 10 RANBAXY Laboratories Ltd has so far made three filings of its anti-retrovirals (ARVs) to the US Food and Drug Administration (FDA) for its approval under the expedited review process of the US Presidents Emergency Plan for AIDS Relief (PEPFAR). The company made its first filing in October 2004. Dr Brian W. Tempest, CEO and MD, Ranbaxy, said, "We are working speedily to provide all the data required by the USFDA, so our generic ARVs can be approved." The company will be filing its complete range of ARVs including fixed dose combinations, with the US FDA and its facilities in India at Paonta Sahib (Himachal Pradesh) will manufacture these ARVs. The facility has already been inspected by the USFDA authorities and was found to be compliant. Last year, the company withdrew all its anti-AIDS drugs from the WHO pre-qualification list. A new bio-equivalence study for all ARVs is being carried out at recognised clinical research organisation (CRO). Ranbaxy will also be making submissions of its complete range of ARVs for pre-qualification, to the WHO.
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