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MedsAcross

Molecule

Artesunate

Available on requestOrphanMalaria
Presentations
1
Brands
0
Manufacturers
0
Available from stock
0

Artesunate is a medicine. MedsAcross lists 1 presentations of it from 0 manufacturers, with brand names, strengths, packs and regulatory status for each. It is available for export supply from India to licensed hospitals, importers and physicians, with the documents the destination country requires.

Information from the US FDA prescribing information, retrieved 12 November 2026. Not yet medically reviewed.How we review

Key facts

ATC classification
P01BE03 Artesunate · Antimalarial, subgroup P01BE
US FDA first approval
26 May 2020
EU status
Authorised
Orphan designation
Yes
WHO essential medicine
Not recorded
India (CDSCO)
Not yet confirmed against CDSCO approval lists
Dosage forms
Kit
Identifiers
UNII 60W3249T9MRxCUI 18346CAS 88495-63-0DrugBank DB09274Q707939

All presentations

1 presentations of Artesunate, sorted by availability.

MedicineManufacturerRegisterAvailability
Artesunate kitGeneric name—US FDAAvailable on request

Regulatory status

Approval facts from US FDA, EMA and CDSCO data, and registration status by country where we hold register data.

RegisterStatusSource
US FDAFirst approved 26 May 2020Drugs@FDA
EU (EMA)AuthorisedEMA medicines data
India (CDSCO)Not yet confirmed against CDSCO approval lists—
AustriaRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
BelgiumRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
BulgariaRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
CroatiaRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
CyprusRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
CzechiaRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
DenmarkRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
EstoniaRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
FinlandRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
FranceRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
GermanyRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
GreeceRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
HungaryRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
IcelandRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
IrelandRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
ItalyRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
LatviaRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
LiechtensteinRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
LithuaniaRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
LuxembourgRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
MaltaRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
NetherlandsRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
NorwayRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
PolandRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
PortugalRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
RomaniaRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
SlovakiaRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
SloveniaRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
SpainRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
SwedenRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
United StatesRegisteredUS FDA (NDC directory, openFDA)Checked 12 November 2026

Questions and answers

Is Artesunate available for export from India?

Yes, on request. MedsAcross lists 1 presentations of Artesunate and sources them for licensed hospitals, importers and physicians against valid import documents.

Is Artesunate approved by the US FDA?

Yes. The US FDA first approved Artesunate on 26 May 2020, according to Drugs@FDA.

Is Artesunate authorised in the European Union?

Yes. Artesunate has a central EU marketing authorisation (status: authorised), according to European Medicines Agency data.

Does Artesunate need cold chain shipping?

No listed presentation of Artesunate is recorded as needing a cold chain. Storage conditions are shown on each presentation page.

Which ATC class is Artesunate in?

Artesunate is classified under ATC code P01BE03 (Artesunate).

References

  1. Artesunate Amivas: European public assessment report (EPAR). European Medicines Agency. Retrieved 21 August 2026

Request Artesunate for export supply

Tell us the strength, quantity and destination country. Our team replies with availability, lead time and the import documents needed.