E-DRUG: First ARV prequalified from Varichem, Zimbabwe (2)
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Dear E-drug,
Regarding your posting of 15 October 2010 on the prequalification of an ARV
manufactured by Varichem Pharmaceuticals (Pvt), of Zimbabwe.
Please note that Varichem is the* third* and not the fourth company in
sub-Saharan Africa to have had a product prequalified by WHO. The other two
companies are Aspen Pharmacare and Sandoz Pty Ltd, both in South Africa.
Quality Chemical Industries Ltd (QCIL) in Uganda has *not* had any products
prequalified by WHO. As indicated by the posting of the relevant WHO Public
Inspection Report, QCIL was inspected in January 2010 and found to comply
with WHO good manufacturing practice (GMP). But this does not constitute
prequalification by WHO of the products manufactured by QCIL. A
clarification to this effect was posted on the WHO Prequalification of
Medicines web site (http://apps.who.int/prequal/info_press/pq_news_12March2010_UGA_Manufacturer.pdf
on 12 March 2010.
Best wishes.
Dr Lembit Rägo
*Lembit Rägo MD, PhD *
*Coordinator,*
*Quality Assurance and Safety: Medicines*
*Essential Medicines and Pharmaceutical Polices*
*World Health Organization*
*Geneva*
*Switzerland*
*Tel. +41 22 791 44 20*
*Fax: +41 22 791 47 30*
ragol@who.int