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HIV/AIDS Research

Pharma company makes three antiretroviral formulation filings to WHO

Published in Vaccine Weekly, June 29th, 2005

Ranbaxy Laboratories Limited (Ranbaxy) announced that the company has made three filings of its antiretroviral (ARVs) formulations, to the World Health Organization (WHO) for its approval under the latter's prequalification project for HIV/AIDS drugs.

This takes the total number of filings submitted by Ranbaxy to the WHO to eleven, of which, five are fixed dose combinations (FDCs). All the ARVs filed by the company to WHO are manufactured at a plant inspected and approved by the U.S. Food and Drug Administration (FDA). The contract research organizations used by Ranbaxy to carry out these bioequivalence studies are globally reputed and conduct and file their studies...

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