artemether + lumefantrine Tablets 40 mg + 240 mg, 80 mg + 480 mg

Dossier type
CTD
Dossier status
Ready to file
Country of origin
Pakistan
GMP approvals
WHO, PICS
Manufacturer #21118

This CTD dossier owner and manufacturer is a pharmaceutical manufacturer with a strong commitment to quality and safety. Their products include solid dosage forms like tablets, capsules, sachets, and dry powder suspensions. They focus on research and development, utilizing cutting-edge technologies to meet international standards. The company holds cGMP certifications from the Pharmaceutical Inspection Convention (PIC/s) and has a dedicated team of researchers and regulatory experts. While they operate globally with a presence in diverse regions like the EU and North America, specific therapy areas and product patents are not mentioned.

Manufacturer usually replies in 26 days

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.