Durban - Listed pharmaceutical producer Aspen Pharmacare has received approval from the Food and Drug Administration (FDA) in the US for its multimillion-rand Port Elizabeth plant.
Group chief executive Steven Saad said the factory would start producing a generic combination antiretroviral (ARV) pack as soon as the product had been registered with the FDA.
This registration would qualify the product for use under George W Bush's President's Emergency Plan for Aids Relief.
This initiative, which has been granted a budget of $15 billion (R87.39 billion) over five years, is intended to provide generic Aids drugs in developing countries.
Provision was made when the emergency plan was announced for firms to obtain expedited FDA reviews and approval of their products. Aspen is the first African manufacturer to win FDA approval for a production facility.
Saad said the company was in the process of registering with the FDA Lamivudine 150mg, Zidovudine 300mg and Nevirapine 200mg as co-packaged tablets or a combination ARV pack.
Aspen has six generic ARVs registered in South Africa - Aspen Stavudine, Aspen Didanosine, Aspen Nevirapine, Aspen Lamivudine (tablets and solution), Aspen Zidovudine (tablets and solution) and Aspen Lamzid (a combination of Lamivudine and Zidovudine).
The FDA made a pre-operational review of the Port Elizabeth facility in September, after which Aspen was able to submit a new drug application for registration of its three drugs.
There were a further six days of good manufacturing practice inspections at the facility.
The SA Medicines Control Council recently inspected the plant and granted approval for full-scale production.
Aspen has been a keen contender for the state ARV tender to supply antiretrovirals in South Africa for the next three years.
The chief director of pharmaceutical policy and planning, Humphrey Zokufa, said yesterday that the names of companies that had been successful in the ARV tender would probably be announced in January.
Aspen's share price rose 40c to R18.15 on the JSE Securities Exchange yesterday. The pharmaceuticals and biotechnology sector climbed 0.83 percent.