About artemisinin
Artemisinin manufacturers are mainly extractors in China and Vietnam, plus smaller producers in East Africa, which supply artemisinin to makers of artemisinin-based antimalarial drugs. Artemisinin is a natural compound extracted from sweet wormwood (Artemisia annua). It is the starting material for artesunate, artemether and dihydroartemisinin, which are the core of WHO-recommended malaria treatments. Its discovery earned Tu Youyou the 2015 Nobel Prize. Pharmaceutical companies can source artemisinin and its derivatives through supply or technology transfer.
Artemisinin key facts
|
Property |
Artemisinin |
|---|---|
|
INN |
Artemisinin (qinghaosu) |
|
Chemical description |
Sesquiterpene lactone with an endoperoxide bridge |
|
Molecular formula / weight |
C15H22O5 / 282.3 g/mol |
|
CAS number |
63968-64-9 |
|
ATC code |
P01BE01 |
|
Drug class |
Antimalarial (artemisinin and derivatives) |
|
Source |
Extraction from Artemisia annua leaves; semi-synthetic routes also developed |
|
Discovery |
Chinese Project 523 team led by Tu Youyou, 1972; Nobel Prize in Physiology or Medicine 2015 |
|
Main derivatives |
Artesunate, artemether, dihydroartemisinin (artenimol), arteether |
|
Main use |
Starting material for artemisinin-based combination therapies (ACTs) and injectable artesunate |
|
WHO position |
Oral artemisinin monotherapy should not be used; use ACTs |
|
Resistance |
Partial resistance (kelch13 mutations) in Southeast Asia and now in parts of East Africa |
|
Main producing countries |
China, Vietnam; smaller production in Kenya, Tanzania, Uganda, Madagascar |
|
Patent status |
Off-patent |
Artemisinin manufacturers and licensing history
Artemisinin was discovered in 1972 by a Chinese research team led by Tu Youyou, who received the 2015 Nobel Prize for this work. Chinese companies developed the first derivatives, artemether and artesunate, which became the basis of modern malaria treatment.
Most artemisinin is extracted from A. annua grown in China and Vietnam, with smaller supply from East Africa and Madagascar. Supply and prices have swung widely with harvests. To stabilise supply, a semi-synthetic route using engineered yeast was developed and scaled up by Sanofi from 2013.
Artemisinin is mainly sold to makers of artesunate, artemether and dihydroartemisinin, many of which hold WHO prequalification. Buyers should confirm artemisinin content, impurity profile, GMP status and supply security before choosing a supplier.
Artemisinin dosage forms and dossier types
Artemisinin is supplied mainly as an API starting material. Finished medicines use its derivatives in combinations or injections.
|
Form |
Strengths |
Typical dossier |
Notes |
|---|---|---|---|
|
Artemisinin (API / starting material) |
Bulk |
DMF; WHO prequalification supply chain |
Main form traded |
|
Artemisinin derivatives (artesunate, artemether, dihydroartemisinin) |
Bulk |
DMF; WHO PQ API |
For ACTs and injections |
|
Artemisinin-based combination tablets |
Per WHO list |
WHO PQ; national CTD |
E.g. artemether-lumefantrine |
|
Target market |
Dossier format |
Key requirement |
|---|---|---|
|
WHO / Global Fund tenders |
WHO prequalification |
GMP inspection; prequalified API source |
|
Africa, Asia |
National CTD |
ACTs only; no oral monotherapy |
|
Other markets |
CTD |
Reference to WHO PQ or stringent approval |
Artemisinin regulatory and patent status
Artemisinin is off-patent and is used mainly as a starting material. The WHO recommends artemisinin-based combination therapies for uncomplicated malaria and injectable artesunate for severe malaria. It has called for oral artemisinin monotherapies to be removed from the market to slow resistance. Partial artemisinin resistance, linked to kelch13 gene mutations, is established in Southeast Asia and has now been confirmed in parts of East Africa.
Artemisinin mechanism of action and therapeutic use
Artemisinin and its derivatives contain an endoperoxide bridge that reacts with iron inside the malaria parasite, producing free radicals that kill it. They clear parasites very quickly but are short-acting, so they are combined with a longer-acting partner drug. Artemisinin derivatives are used in ACTs for uncomplicated malaria and as injectable artesunate for severe malaria.
Artemisinin licensing and sourcing
Artemisinin suppliers typically offer API supply, derivative manufacturing or technology transfer. Buyers usually compare GMP status, WHO prequalification of downstream products, supply security and territory availability. Current offers and supplier contacts are listed among the artemisinin manufacturers on Pipelinepharma.
Frequently asked questions about artemisinin
Who are the main artemisinin manufacturers? Artemisinin is produced mainly by extractors in China and Vietnam, with smaller producers in East Africa and Madagascar.
What is artemisinin used for? Artemisinin is the starting material for artesunate, artemether and dihydroartemisinin, which are used in WHO-recommended malaria treatments.
Why is artemisinin not used alone? The WHO advises against oral artemisinin monotherapy, because using it alone speeds the development of resistance. It should be combined with a longer-acting partner drug.
Is there artemisinin resistance? Yes. Partial resistance, linked to kelch13 mutations, is established in Southeast Asia and has now been confirmed in parts of East Africa.
What forms of artemisinin are available? Artemisinin is mainly sold as a bulk starting material. Finished medicines use its derivatives in combination tablets and injections.
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