The Hindu Business Line : Ranbaxy makes 3 more filings for AIDS drugs

RANBAXY Laboratories Ltd said on Friday that it has made three filings of its anti-retroviral (ARV) formulations to the World Health Organisation for approval under the latter's pre-qualification project for HIV/AIDS drugs.

This takes the total number of filings submitted by the company to the WHO to 11, of which five are fixed-dose combinations, Ranbaxy said in a notice to the Bombay Stock Exchange.

All the ARVs filed are manufactured at a plant inspected and approved by the USFDA. The contract research organisation used by Ranbaxy to carry out these bio-equivalence studies are globally reputed. They conduct and file their studies routinely with some of the most stringent regulatory authorities around the world.

On the progress of the ARV filings, Dr Brian W. Tempest, CEO and MD said, "With these recent filings, we have already re-submitted the majority of our dossiers with WHO. We are working with speed and focus to submit almost all our ARVs with WHO and USFDA this year. We are committed to making these affordable, quality medicines available throughout the world, particularly to patients in those developing countries who might not otherwise be able to access this life-saving therapy."

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

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