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