Ranbaxy Laboratories Limited has made further three filings of its Anti-Retroviral (ARVs) formulations, to the World Health Organisation (WHO) for its approval under the latter's pre-qualification 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 US FDA. The Contract Research Organisations used by Ranbaxy to carry out these bio-equivalence studies are globally reputed and conduct and file their studies routinely with some of the most stringent regulatory authorities around the world, claims the company in a press release.
Commenting on the progress of the company's ARV filings, Dr. Brian W. Tempest, CEO & MD, Ranbaxy, said, "With these recent filings, we have already resubmitted the majority of our dossiers with WHO. We are working with speed and focus to submit almost all our ARVs with WHO and US FDA this year."