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South African generic AIDS drug manufacturer, Aspen Pharmacare, has become the first African firm to win approval from the US Food and Drug Administration (FDA) for its production plant.
The FDA conducted a pre-operational review and close inspection to ascertain good manufacturing practice at Aspen's Port Elizabeth facility in September last year.
As a result of this approval, funds from the US President's Emergency Plans for AIDS Relief (PEPFAR) can be used to purchase Aspen-manufactured drugs for use in countries where the local drug regulatory agency has approved them.
PEPFAR is a $15 billion programme launched by President George W Bush in 2003 to tackle HIV and AIDS in 12 African countries and the Caribbean.
Aspen CEO Steven Saad said in a statement the firm would start producing a generic combination antiretroviral pack made up of Lamivudine, Zidovudine and Nevirapine as soon as it had been registered with the FDA.
Aspen is the continent's biggest manufacturer of generic anti-AIDS drugs, and has been a keen contender for the tender to supply antiretrovirals to the state for the next three years. The names of successful bidders are expected to be announced this month.
This article was produced by IRIN News while it was part of the United Nations Office for the Coordination of Humanitarian Affairs. Please send queries on copyright or liability to the UN. For more information: https://shop.un.org/rights-permissions