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 attach 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.(Source: Adele Shevel, Sunday Times, 12 December 2004)
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