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Country of origin : India
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artemether + lumefantrine

Tablets 20 mg + 120 mg

Dossier type
EU CTD
Dossier status
Under development
Country of origin
India
GMP approvals
EU GMP
Manufacturer #29381

This pharmaceutical company, operating for several decades, is a vertically integrated entity, encompassing research and development, manufacturing, distribution, marketing, and exports. Their headquarters are in South Asia. The company is a major player in the contract development and manufacturing organization (CDMO) sector, providing services and products to numerous pharmaceutical companies across the region. They have built a strong reputation by delivering high-quality, generic formulations for the domestic and international markets. Their manufacturing facilities are recognized for their adherence to strict quality standards and are equipped with a DSIR-accredited research and development lab, ensuring innovative product development and regulatory compliance. The company boasts a diverse product portfolio that includes oral solids, liquids, and injectables. Their key focus areas include generics, and they have secured GMP approvals from major regulatory bodies including the EU and the USA.

artemether + lumefantrine

Tablets 20 mg + 120 mg, 40 mg + 240 mg, 80 mg + 480 mg

Dossier type
CTD
Dossier status
Ready to file
Country of origin
India
GMP approvals
EU GMP
Manufacturer #2303
A pharmaceutical manufacturer with over 25 years of experience that develops and produces fixed-dose and single-entity generic and specialty pharmaceutical products. The company offers an extensive range of injectable dosage forms, including parenterals, and also manufactures oral solids. Its facilities operate under recognised international quality certifications such as EU-GMP, ANVISA, PIC/S and TGA approvals, supporting reliable large-scale production of pharmaceutical products for global export while emphasizing efficacy, affordability and consistent quality.

artemether + lumefantrine

Oral suspension 20 mg + 120 mg

Dossier type
CTD
Dossier status
Ready to file
Country of origin
India
GMP approvals
EU GMP, TGA
Manufacturer #18120
This globally competitive organization specializes in formulating a wide range of medications and exports to over 40 countries. Their state-of-the-art manufacturing facilities are strategically located across three cities, adhering to stringent regulatory standards like those set by the EU, UK, and UNICEF. They produce diverse dosage forms including tablets, capsules, creams, ointments, gels, and sterile formulations such as lyophilized products and prefilled syringes. Key therapy areas include complex generics, orphan drugs, and treatments for neglected tropical diseases. The company holds GMP certifications and possesses product patents, emphasizing their commitment to quality and innovation. They actively participate in global initiatives, providing emergency stockpiles for coronavirus treatments and partnering with organizations to address the healthcare needs of Palestinian refugees.

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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.

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