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Ranbaxy's 7 AIDS drugs in WHO pre-qualification list

Our Bureau

New Delhi , Aug. 11

RANBAXY Laboratories Ltd today said seven of its anti-retrovirals (ARVs) had been included in the World Health Organisation (WHO) pre-qualification list.

The step should unlock the ARV supplies and make it easier for developing countries to access affordable generic ARVs, and scale up treatment rapidly, the country's largest pharmaceuticals company said in a statement here.

"This is a significant step forward in Ranbaxy' s endeavour to make high quality, cost-effective ARVs available to HIV patients around the world. This, along with our USFDA approvals, will ensure that HIV patients have access to quality generic ARVs, irrespective of the funding programme in their country," the CEO and Managing Director of Ranbaxy, Mr Brian Tempest, said.

Ranbaxy's ARVs, including the products recently approved by WHO, are manufactured at the company's manufacturing facilities that have been inspected and approved by agencies including USFDA and WHO.

The Contract Research Organisations (CROs) used by Ranbaxy to carry out bio-equivalence studies for its ARVs are globally reputed and conduct and file their studies routinely with some of the most stringent regulatory authorities around the world, the company release said.

Ranbaxy had, in November last year, taken off all its anti-AIDS drugs from the WHO approved list after citing `discrepancies' in tests. This followed a move by the Geneva-based agency in August to drop three generic HIV/AIDS drugs produced by the firm.

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