Artemisinin manufacturers

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Country of origin : India
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artemisinin + piperaquine

Tablets 62.5 mg + 375 mg

Dossier type
CTD
Dossier status
Ready to file
Country of origin
India
GMP approvals
WHO
Manufacturer #37379

CTD dossier owner and Manufacturer established in 1969. As a CTD dossier owner and Manufacturer, they operate with GMP approvals, ensuring high-quality pharmaceutical products. With production lines designed for tablets, capsules, oral liquids, and dry syrups, this GMP manufacturer reaches numerous countries and regions worldwide. The organization employs over 1000 individuals and is a trusted CTD dossier owner and Manufacturer in the pharmaceutical industry, adhering to GMP standards.

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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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