Ipca Laboratories Ltd has received approval for its anti-malarial finished product formulation; artesunate tablets 50mg under WHO's prequalification programme. The product is now listed in the WHO pre-qualification product list.
Artesunate 50 mg tablets is an artemisinin based formulation which is recommended by WHO to be used in combination with other anti-malarials, such as, amodiaquine; mefloquine; and sulfadoxine + pyrimethamine.
The prequalification programme was created by the World Health Organization in 2001. It aims to increase access to priority medicinal products that meet unified standards of acceptable quality, safety and efficacy, currently focusing on those medicines used, for treatment of diseases such as Malaria.
The list of prequalified medicinal products is used principally by United Nations agencies including UNAIDS and UNICEF to guide their procurement decisions. But, the list has become a vital tool for any agency or organization involved in bulk purchasing of medicines, be this at country level, or at international level, as demonstrated by the global fund, to fight diseases such as Malaria.
Ipca Laboratories Ltd is an integrated pharmaceutical company, leader in anti-malarial drugs in India, producing and exporting wide range of anti malarial compounds like chloroquine, amodiaquine, primaquine, artemether, arteether and artesunate and their formulations. Ipca has strong thrust on exports. Its exports to over 110 countries accounted for 53 per cent of its turnover.