artemether + lumefantrine Tablets 80 mg+480 mg

Dossier type
CTD
Dossier status
Ready to file
Country of origin
India
GMP approvals
WHO
Manufacturer #19508
This company is a manufacturer and exporter of pharmaceuticals, operating for over two decades in the South Asian market. They specialize in prescription drugs for cardiovascular and central nervous system (CNS) conditions, along with over-the-counter medications for respiratory illnesses. They produce a variety of dosage forms, including tablets, capsules, inhalers, and liquid suspensions, and have obtained EU and US GMP approvals for several production lines. Their core therapeutic areas include cardiology, neurology, and respiratory health. While specific product patents weren't mentioned, their wide product range suggests a focus on generic pharmaceuticals, aiming to compete through cost-effectiveness.
Artemether is a medication used to treat malaria. Although manufacturers of artemether produce drugs with it as the standalone ingredient, it is almost always marketed in combination with lumefantrine. Artemether suppliers market it in the form of oral tablets as well as injectable solutions. The developer and earliest manufacturer of artemether/lumefantrine medications is Novartis, who markets it under the trade name Coartem. The standalone formulation was first introduced into medical use in 1987, whereas the artemether/lumefantrine combination formulation was first approved in 1992. Both drugs have since gained approvals in over 80 countries worldwide, including the U.S., China, numerous African countries and across Europe. What is more, the drug has become included in the World Health Organization’s list of Essential Medicines that contains the most important medications recommended for a basic health system. Alternatives to artemether are other artemisinin class malaria drugs such as dihydroartemisinin and artesunate. The prices of artemether medications are not particularly high. Its wholesale cost in the developing world typically falls into a range of 0,10 EUR to 1,00 EUR per daily treatment dose.