Important note: Information in this article was accurate in 2004. The state of the art may have changed since the publication date.
Sunday Times (Johannesburg) - December 12, 2004
Adele Shevel
Late on Friday it was announced that Aspen's new R157-million plant in Port Elizabeth had received approval from the US's Federal Drug Administration (FDA).
Aspen is the first African manufacturer, and the first from a developing nation, to receive FDA approval to supply generic antiretroviral drugs.
FDA approval is a prerequisite to gain access to the US President's Emergency Plan for Aids Relief (Pepfar).
The plan has pledged $15-billion to assist developing countries address the HIV/Aids crisis over the next five years.
The money will be spent on drugs, training of physicians and nurses, testing, counselling, prevention and orphan care.
Gray Handley, the health attache for the US embassy in SA, says Pepfar will purchase the approved drugs from Aspen for use all over the world.
Aspen expects to extend its supply of generic antiretroviral drugs offshore through among others the Clinton Foundation, which has selected Aspen as one of only three manufacturers worldwide.
Lynn Margherio, executive vice-president of the Clinton Foundation, says "the FDA approval Aspen received is a clear demonstration that Aspen products are of the highest quality".
She says that on the basis of the FDA approval, funds will be made available from the World Bank and other global funds to purchase drugs from Aspen.
The SA government is expected to announce the outcome of the tender for antiretrovirals in January. Aspen, whose biggest client is the state, is among the front-runners.
In sub-Saharan Africa, about 50000 people are on antiretrovirals, while about four-million people are HIV-positive.
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