About artether
Artether manufacturers are concentrated in India, led by Themis Medicare, which has sold the original alpha/beta arteether injection as E-Mal since 1997, alongside many other Indian generic makers. Artether (arteether) is an artemisinin derivative given by intramuscular injection for severe Plasmodium falciparum malaria. Its beta-isomer, artemotil, was registered in the Netherlands in 2000 as Artecef. Pharmaceutical companies can source arteether injection and API through out-licensing, supply or technology transfer.
Artether key facts
|
Property |
Artether |
|---|---|
|
Names |
Arteether; alpha/beta arteether; artemotil (INN for beta-arteether) |
|
Chemical description |
Ethyl ether of dihydroartemisinin |
|
Molecular formula / weight |
C17H28O5 / 312.4 g/mol |
|
CAS number |
75887-54-6 |
|
ATC code |
P01BE04 (artemotil) |
|
Drug class |
Antimalarial (artemisinin derivative) |
|
Brand names |
E-Mal (Themis Medicare, India); Artecef (artemotil, Netherlands); many Indian generics |
|
Developer |
Central Drug Research Institute (CDRI), Lucknow, India, with CIMAP |
|
Dosage form and strength |
Intramuscular injection 150 mg/2 ml in arachis oil (India); Artecef 50 and 150 mg/ml in sesame oil |
|
Composition (India) |
Alpha-arteether 25–35% and beta-arteether 65–75% |
|
Dose |
3 mg/kg once daily for 3 days, deep intramuscular |
|
Indication (India) |
Severe P. falciparum malaria, including cerebral malaria, as second-line treatment for chloroquine-resistant cases |
|
First approval |
India, January 1997 (alpha/beta arteether); Netherlands, May 2000 (artemotil) |
|
Patent status |
Off-patent |
Artether manufacturers and licensing history
India's Central Drug Research Institute (CDRI) developed alpha/beta arteether from Artemisia annua, working with the Central Institute of Medicinal and Aromatic Plants. It was registered in India in January 1997, and CDRI licensed it to Themis, which has marketed it as E-Mal since April 1997. It has been used in India's national malaria programme since 1999.
In parallel, the WHO and the Dutch company ARTECEF BV developed the pure beta-isomer, artemotil. It was registered in the Netherlands in May 2000 as Artecef for severe malaria in children and adolescents.
Today, many Indian companies market arteether injections. Buyers should confirm the alpha-to-beta isomer ratio, GMP status, sterile manufacturing capability and compliance with Indian national programme specifications before choosing a supplier.
Artether dosage forms and dossier types
Artether is supplied as an oily solution for intramuscular injection. Indian products contain 150 mg in 2 ml of arachis oil.
|
Form |
Strengths |
Typical dossier |
Notes |
|---|---|---|---|
|
Alpha/beta arteether injection |
150 mg/2 ml; 75 mg/1 ml |
Indian national dossier |
Main form; reference E-Mal |
|
Artemotil injection |
50 and 150 mg/ml |
Dutch national dossier |
Artecef; beta-isomer only |
|
Arteether API |
Bulk |
DMF |
Isomer ratio is critical |
|
Target market |
Dossier format |
Key requirement |
|---|---|---|
|
India |
National dossier |
National programme technical specifications |
|
Other malaria-endemic markets |
National CTD |
Check WHO treatment guidelines and local approval |
|
WHO tenders |
Not applicable |
WHO recommends injectable artesunate for severe malaria |
Artether regulatory and patent status
Alpha/beta arteether was registered in India in January 1997, and artemotil in the Netherlands in May 2000. Arteether is off-patent. The WHO now recommends injectable artesunate as the first choice for severe malaria, so arteether's use is concentrated in India. A Cochrane review found that more trials are needed before firm conclusions can be drawn about arteether's efficacy and safety compared with other options.
Artether mechanism of action and therapeutic use
Artether, like other artemisinin derivatives, contains an endoperoxide bridge that reacts with iron in the malaria parasite and produces free radicals that kill it. It acts quickly on the blood stage of the parasite. In India, it is used by deep intramuscular injection for severe P. falciparum malaria, including cerebral malaria, usually at 3 mg/kg once daily for 3 days.
Artether licensing and sourcing
Artether suppliers and licensing partners typically offer finished-product supply, dossier out-licensing or technology transfer. Buyers usually compare GMP status, sterile manufacturing capability, isomer ratio and territory availability. Current offers and supplier contacts are listed among the artether manufacturers on Pipelinepharma.
Frequently asked questions about artether
Who are the main artether manufacturers? Themis Medicare has sold E-Mal in India since 1997, and many other Indian companies market arteether injections. Artecef (artemotil) was registered in the Netherlands.
What is the difference between arteether and artemotil? Arteether is a mixture of alpha and beta isomers. Artemotil is the INN for the pure beta-isomer.
What is artether used for? Artether is used for severe P. falciparum malaria, including cerebral malaria, mainly in India.
What forms and strengths of artether are available? Artether is available as an intramuscular injection, typically 150 mg/2 ml in arachis oil in India.
Does the WHO recommend artether? The WHO recommends injectable artesunate as the first choice for severe malaria. Arteether is used mainly in India.
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