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[afro-nets] ArteSunate AmodiaQuine, a WHO-prequalified ACT, now has a 36-month shelf life

Impact Malaria
Wednesday, 29 September 2010

The World Health Organization (WHO) has just approved an extension of shelf 
life from 24 months to 36 months for Sanofi-Aventis' artesunate and amodiaquine 
fixed dose combination, ASAQ Winthrop®, indicated in the treatment of 
uncomplicated Plasmodium falciparum malaria. ASAQ Winthrop® is the first 
prequalified antimalarial treatment with such a long shelf life.

A 36-month shelf life thanks to  Sanofi-Aventis' quality
In collaboration with partner organization DNDi (Drugs for Neglected Diseases 
initiative, Switzerland), ASAQ Winthrop® has benefited from an innovative 
galenic development from raw materials and active ingredients selected 
according to demanding quality criteria. The WHO GMP certified manufacture and 
aluminium foil blister packaging ("alu-alu") process in the Sanofi-Aventis' 
Maphar plant in Morocco, guarantee the quality and stability of ASAQ Winthrop®.
36 months of shelf life, a major progress in the fight against malaria

The results allowing the extension come from stability studies, carried out in 
compliance with current international guidelines, and rely on performing 
analytical methods certifying their quality and reliability. In a context of 
difficult distribution, this shelf life extension to 36 months, in unchanged 
storage conditions (store below 30°C), offers many advantages for all ACT users.

It offers improved flexibility in inventory management, thus greatly reducing 
the risks of stock-outs, and also the destruction of expired products. 
Therefore, it allows optimal usage of the financing provided to countries, and 
international agencies.

Ms. Clarisse Morris, MSc
Consultant Supply Chain Management and M&E
i+solutions, the Netherlands

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