Ipca Laboratories has received approval for its anti-malarial finished fixed dose combination formulation of ‘Artemether + Lumefantrine’, under WHO’s Pre-qualification Programme. The product is now listed in the WHO Pre-qualification product list dated 15th December 2009.
Reportedly, Ipca is the 4th company in the world to have pre qualification for this product.
Ipca’s active pharmaceutical ingredients (APIs) – Arthemether and Lumefantrine are already approved by WHO. Ipca currently manufacturers and supplies Arternether and Lumefantrine APIs to many customers in several countries across the globe.
The pre-qulaification 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 prinicipally by the UN agencies including UNAIDS and UNICEF, to guide their procurement decisions.