IRIN PlusNews HIV/AIDS News and information service | Southern Africa | SOUTH AFRICA: Generic AIDS drug maker gets US approval | Care Treatment, Prevention Research, Other | News Items
Tuesday 15 November 2005
Home About PlusNews Country Profiles News Briefs Special Reports Subscribe Archive IRINnews
 

Regions

Africa
East Africa
Great Lakes
Horn of Africa
Southern Africa
·Angola
·Botswana
·Comoros
·Lesotho
·Madagascar
·Malawi
·Mauritus
·Mozambique
·Namibia
·South Africa
·Swaziland
·Zambia
·Zimbabwe
West Africa
RSSyndication
RSS - News Briefs

Features

PlusNews E-mail Subscription
 

SOUTH AFRICA: Generic AIDS drug maker gets US approval


[This report does not necessarily reflect the views of the United Nations]


JOHANNESBURG, 25 January (PLUSNEWS) - 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.

[ENDS]




 
Recent SOUTH AFRICA Reports
Poor governance blamed for US $10 million unspent in HIV/AIDS budget,  1/Nov/05
NAPWA partners with controversial Rath Foundation,  20/Oct/05
Trials test efficacy of diaphragms in preventing HIV/AIDS,  26/Sep/05
Churchmen move towards disclosing their HIV-positive status,  23/Sep/05
New effort to ease community's HIV/AIDS woes,  16/Sep/05
Links
Le portail d'informations générales de la Côte d’Ivoire
Sida Info Services
Le Fonds mondial de lutte contre le SIDA, la tuberculose et le paludisme
Le Réseau Afrique 2000
The Global Fund to fight AIDS, Tuberculosis & Malaria

PlusNews does not take responsibility for info in links supplied.


[Back] [Home Page]

Click here to send any feedback, comments or questions you have about PlusNews Website or if you prefer you can send an Email to Webmaster

Copyright © IRIN 2005
The material contained on www.PlusNews.org comes to you via IRIN, a UN humanitarian news and information service, but may not necessarily reflect the views of the United Nations or its agencies.
All PlusNews material may be reposted or reprinted free-of-charge; refer to the IRIN copyright page for conditions of use. IRIN is a project of the UN Office for the Coordination of Humanitarian Affairs.