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Artesunate | CAS No: 88495-63-0 | GMP-certified suppliers
A medication that provides rapid initial treatment for severe malaria in adults and children, supporting reliable supply needs across key US and EU markets.
Therapeutic categories
Acids, AcyclicAnionsAnthelminticsAnti-Infective AgentsAntimalarialsAntineoplastic Agents
Generic name
Artesunate
Molecule type
small molecule
CAS number
88495-63-0
DrugBank ID
DB09274
Approval status
Approved drug, Investigational drug
ATC code
P01BE03
Primary indications
- Artesunate is indicated for the initial treatment of severe malaria in adult and pediatric patients
Product Snapshot
- Artesunate is available as injectable and oral small‑molecule formulations across multiple parenteral and solid‑dose presentations
- It is used for the initial management of severe malaria in adult and pediatric populations
- It is approved in the US and EU, with additional investigational status in some markets
Clinical Overview
Artesunate (CAS 88495-63-0) is an artemisinin derivative indicated for the initial treatment of severe malaria in adults and children. Global guidelines, including those from the World Health Organization, recommend intravenous artesunate as the preferred therapy for severe disease due to its rapid parasiticidal activity. The compound was approved by the US FDA in 2020 for this indication.
Structurally, artesunate belongs to the artemisinin class of sesquiterpenoid lactones derived from Artemisia annua. Its pharmacological activity requires conversion to dihydroartemisinin, an active metabolite that retains the characteristic endoperoxide bridge essential to the class. This structural feature facilitates interactions with heme within infected erythrocytes.
The primary mechanism of action involves cleavage of the endoperoxide bridge of dihydroartemisinin by intraparasitic ferrous iron, generating reactive free radicals. These reactive species inhibit nucleic acid and protein synthesis across multiple erythrocytic stages of Plasmodium parasites. Protein alkylation targets include parasite calcium ATPases and glutathione S-transferase–related proteins, disrupting essential cellular processes.
Artesunate exhibits rapid onset and short duration of action, driven by fast hydrolysis to dihydroartemisinin and a short plasma half-life. Absorption and distribution characteristics vary by route of administration, and both artesunate and its metabolite undergo hepatic biotransformation involving UGT pathways and cytochrome P450 interactions. Elimination is primarily through metabolic clearance.
Safety considerations include risk of post-treatment hemolytic anemia, hypersensitivity reactions, and potential drug interactions linked to its status as a substrate or inhibitor of several transporter and metabolic pathways. Monitoring for delayed hemolysis is recommended, particularly after parenteral therapy.
Artesunate is used globally in hospital settings, often supplied as sterile injectable formulations. When procuring the API, quality assessment should emphasize control of peroxide-containing impurities, confirmation of stereochemistry, and compliance with pharmacopeial or regulatory specifications to ensure consistent clinical performance.
Structurally, artesunate belongs to the artemisinin class of sesquiterpenoid lactones derived from Artemisia annua. Its pharmacological activity requires conversion to dihydroartemisinin, an active metabolite that retains the characteristic endoperoxide bridge essential to the class. This structural feature facilitates interactions with heme within infected erythrocytes.
The primary mechanism of action involves cleavage of the endoperoxide bridge of dihydroartemisinin by intraparasitic ferrous iron, generating reactive free radicals. These reactive species inhibit nucleic acid and protein synthesis across multiple erythrocytic stages of Plasmodium parasites. Protein alkylation targets include parasite calcium ATPases and glutathione S-transferase–related proteins, disrupting essential cellular processes.
Artesunate exhibits rapid onset and short duration of action, driven by fast hydrolysis to dihydroartemisinin and a short plasma half-life. Absorption and distribution characteristics vary by route of administration, and both artesunate and its metabolite undergo hepatic biotransformation involving UGT pathways and cytochrome P450 interactions. Elimination is primarily through metabolic clearance.
Safety considerations include risk of post-treatment hemolytic anemia, hypersensitivity reactions, and potential drug interactions linked to its status as a substrate or inhibitor of several transporter and metabolic pathways. Monitoring for delayed hemolysis is recommended, particularly after parenteral therapy.
Artesunate is used globally in hospital settings, often supplied as sterile injectable formulations. When procuring the API, quality assessment should emphasize control of peroxide-containing impurities, confirmation of stereochemistry, and compliance with pharmacopeial or regulatory specifications to ensure consistent clinical performance.
Identification & chemistry
| Generic name | Artesunate |
|---|---|
| Molecule type | Small molecule |
| CAS | 88495-63-0 |
| UNII | 60W3249T9M |
| DrugBank ID | DB09274 |
Pharmacology
| Summary | Artesunate is rapidly converted to dihydroartemisinin, which reacts with heme to generate free radicals that damage *Plasmodium* proteins and nucleic acids across erythrocytic stages. These radicals can alkylate key parasitic targets, including the calcium ATPase and the glutathione S‑transferase EXP‑1. Its pharmacologic activity is characterized by rapid parasite clearance and a short duration of action due to rapid metabolic turnover. |
|---|---|
| Mechanism of action | Artesunate is metabolized to the active DHA.the endoperoxide bridge of DHA reacts with heme, generating free radicals which inhibit protein and nucleic acid synthesis of the _Plasmodium_ parasites during all erythrocytic stages.Reactions with these free radicals can also lead to alkylation of parasitic proteins such as a calcium adenosine triphosphatase and EXP1, a glutathione S-transferase. |
| Pharmacodynamics | Artesunate is an artemisinin derivative that is metabolized to DHA, which generates free radicals to inhibit normal function of _Plasmodium_ parasites.It has a short duration of action due to its short half life, and a moderate therapeutic index.Patients should be counselled regarding the risk of post treatment hemolytic anemia and hypersenstivity. |
Targets
| Target | Organism | Actions |
|---|---|---|
| Malaria protein EXP-1 | Plasmodium falciparum | inhibitor |
ADME / PK
| Absorption | The C<sub>max</sub> of artesunate is 3.3µg/mL while the C<sub>max</sub> of the active metabolite DHA is 3.1µg/mL.The AUC of artesunate is 0.7µg\*h/mL while the AUC of DHA is 3.5µg\*h/mL.After intravenous artesunate, DHA has a T<sub>max</sub> of 0.5-15 minutes in adult patients and 21-64 minutes in pediatric patients.Intramuscular artesunate has a T<sub>max</sub> of 8-12 minutes.Infants less than 6 months old will have a higher AUC due to an undeveloped UGT metabolic pathway. |
|---|---|
| Half-life | The elimination half life of artesunate is 0.3h with a range of 0.1-1.8h.The elimination half life of DHA is 1.3h with a range of 0.9-2.9h.Half life after intramuscular administration is 48 min in children and 41 min in adults. |
| Protein binding | Artesunate and its metabolite DHA are approximately 93% protein bound in plasma.Artesunate can bind to serum albumin. |
| Metabolism | Artesunate is rapidly metabolized to dihydroartemisinin (DHA) by plasma esterases.DHA is glucuronidated by UGT1A9 and UGT2B7 to DHA-glucuronide.DHA-glucuronide can undergo a minor metabolic pathway to for a furano acetate derivative of DHA-glucuronide.CYP2A6 may minorly contribute to the metabolism of artesunate. |
| Route of elimination | The main route of elimination in humans is unknown.In rats, a dose of artesunate is 56.1% eliminated in the urine and 38.5% in the feces. |
| Volume of distribution | The volume of distribution of artesunate is 68.5L while the volume of distribution of DHA is 59.7L. |
| Clearance | The clearance of artesunate is 180L/h while the clearance of DHA is 32.3L/h. |
Formulation & handling
- Artesunate is a small‑molecule artemisinin derivative used in both injectable and oral formats, requiring reconstitution for IV use due to limited aqueous solubility.
- The endoperoxide bridge is chemically sensitive, so formulations should minimize exposure to heat and prolonged acidic or basic conditions to maintain stability.
- Solid oral forms may require solubility‑enhancing approaches to improve dispersion and absorption given its moderate lipophilicity and low water solubility.
Regulatory status
| Lifecycle | The API is in a mature phase, with key patent protections in the US and EU either expired or nearing expiry. Both markets reflect established generic competition and stable post‑patent market dynamics. |
|---|
| Markets | US, EU |
|---|
Supply Chain
| Supply chain summary | Artesunate is supplied by a limited number of originator or primary developers, with branded products such as those marketed by Amivas supporting distribution in the US and EU. The active ingredient is widely established globally, and its long-standing use means patents have expired. As a result, generic manufacturing is already feasible and present in many markets. |
|---|
Safety
| Toxicity | Data regarding overdoses of artesunate are rare.Patients experiencing an overdose may present with pancytopenia, melena, seizures, multiorgan failure, and death.Treat overdose with symptomatic and supportive measures. |
|---|
High Level Warnings:
- Overexposure may result in severe hematologic and neurologic toxicity, including pancytopenia, seizures, and evidence of gastrointestinal bleeding such as melena
- Reported overdose scenarios have progressed to multiorgan failure and can be fatal, underscoring the need for controlled handling and accurate dosing in manufacturing and research settings
Artesunate is a type of Antimalarial
The Antimalarial category of pharmaceutical APIs encompasses a range of active ingredients used in the development of drugs to treat and prevent malaria, a life-threatening infectious disease caused by the Plasmodium parasite. These APIs are crucial in formulating effective antimalarial medications.
One widely used API in this category is Artemisinin, derived from the Artemisia annua plant. It exhibits potent antimalarial properties and is a key component in various combination therapies. Another prominent API is Chloroquine, an aminoquinoline compound that has been historically used as a primary treatment for malaria. However, due to emerging drug resistance, alternative APIs like Mefloquine and Quinine have gained prominence.
These APIs work by interfering with the life cycle of the Plasmodium parasite. They inhibit various stages of parasite development, such as preventing the replication of the parasite's DNA and disrupting its metabolic processes. By targeting the parasite, antimalarial APIs help to control and eliminate the infection, reducing the severity of symptoms and preventing complications.
The development and production of high-quality antimalarial APIs require stringent quality control measures to ensure their safety and efficacy. Pharmaceutical companies adhere to strict regulations and guidelines to guarantee the purity, stability, and bioavailability of these APIs. Additionally, ongoing research aims to discover new antimalarial APIs and formulations to combat drug resistance and improve treatment outcomes.
In conclusion, the Antimalarial category of pharmaceutical APIs plays a vital role in the formulation of drugs used to treat and prevent malaria. These APIs, such as Artemisinin, Chloroquine, Mefloquine, and Quinine, effectively target the Plasmodium parasite, aiding in the management and eradication of malaria infections.
Artesunate API manufacturers & distributors
Compare qualified Artesunate API suppliers worldwide. We currently have 7 companies offering Artesunate API, with manufacturing taking place in 2 different countries. Use the table below to review supplier type, countries of origin, certifications, product portfolio and GMP audit availability.
| Supplier | Type | Country | Product origin | Certifications | Portfolio |
|---|---|---|---|---|---|
| Cipla | Producer | India | India | CoA, GMP, USDMF, WC | 164 products |
| Gonane Pharma | Producer | India | India | BSE/TSE, CoA, GMP, MSDS | 166 products |
| Ipca Labs. | Producer | India | India | CoA, GMP, WC | 69 products |
| Mangalam Drugs & Organics... | Producer | India | India | CoA, GMP, WC | 10 products |
| Pharma Links India | Distributor | India | India | CoA, GMP | 7 products |
| Shin Poong Pharm | Producer | South Korea | South Korea | CoA, GMP | 11 products |
| Vital Laboratories Pvt. L... | Producer | India | India | CoA, WC | 22 products |
When sending a request, specify which Artesunate API quality you need: for example EP (Ph. Eur.), USP, JP, BP, or another pharmacopoeial standard, as well as the required grade (base, salt, micronised, specific purity, etc.).
Use the list above to find high-quality Artesunate API suppliers. For example, you can select GMP, FDA or ISO certified suppliers. Visit our help page to learn more about sourcing APIs via Pharmaoffer.
Frequently asked questions about Artesunate API
Sourcing
What matters most when sourcing GMP-grade Artesunate?
When sourcing GMP‑grade Artesunate, the key considerations are compliance with US and EU regulatory standards and verification that the manufacturer operates under validated GMP systems. It is important to confirm that the supplier has a reliable production history, especially given the limited number of originator developers and branded products supporting these markets. Because patents have expired and generics are established, ensuring consistent quality and traceability across different manufacturing sources is essential.
Which documents are typically required when sourcing Artesunate API?
Request the core API documentation set: CoA (7 companies), GMP (5 companies), WC (4 companies), MSDS (2 companies), USDMF (1 company). Confirm versions and validity dates match the destination market to avoid delays in qualification.
Which manufacturers are known to produce Artesunate API?
Known or reported manufacturers for Artesunate: Xi'an Tian Guangyuan Biotech Co.,Ltd, Gonane Pharma. Evaluate their GMP history, scale, and regional coverage before requesting dossiers or allocating demand.
How can I request quotes for Artesunate API from GMP suppliers?
Submit quote requests through the supplier listings with your specs and required documents (specifications, target volume, delivery timeline, and destination). Providing consistent details upfront speeds comparable offers and clarifies technical feasibility.
Is a GMP audit report available for Artesunate manufacturers?
Audit reports may be requested for Artesunate: 2 GMP audit reports available. Confirm the scope and recency of any audit before relying on it for qualification decisions.
How many suppliers offer Artesunate API on Pharmaoffer?
Reported supplier count for Artesunate: 7 verified suppliers. Filter listings by certifications, regions, and delivery options to match your qualification plan.
Which countries are known to manufacture Artesunate API?
Production countries reported for Artesunate: India (5 producers), China (1 producer), South Korea (1 producer). Knowing the manufacturing geography helps anticipate logistics lead times and import compliance needs.
Which certifications do suppliers of Artesunate usually hold?
Common certifications for Artesunate suppliers: CoA (7 companies), GMP (5 companies), WC (4 companies), MSDS (2 companies), USDMF (1 company). Always verify issuing authorities and expiry dates when reviewing audit packages.
Technical
What is Artesunate (CAS 88495-63-0) used for?
Artesunate is used for the initial treatment of severe malaria in adults and children. It acts rapidly after conversion to dihydroartemisinin, which generates free radicals that inhibit nucleic‑acid and protein synthesis in *Plasmodium* parasites. Intravenous Artesunate is recommended in global guidelines, including those of the World Health Organization, for severe malaria.
Which therapeutic class does Artesunate fall into?
Artesunate belongs to the following therapeutic categories: Acids, Acyclic, Anions, Anthelmintics, Anti-Infective Agents, Antimalarials. This positioning helps teams compare alternative APIs, anticipate pharmacology expectations, and align early research priorities.
What conditions is Artesunate mainly prescribed for?
The primary indications for Artesunate: Artesunate is indicated for the initial treatment of severe malaria in adult and pediatric patients. These use cases frame the target patient populations and help prioritize formulation and safety evaluations.
How does Artesunate work?
Artesunate is metabolized to the active DHA.the endoperoxide bridge of DHA reacts with heme, generating free radicals which inhibit protein and nucleic acid synthesis of the _Plasmodium_ parasites during all erythrocytic stages.Reactions with these free radicals can also lead to alkylation of parasitic proteins such as a calcium adenosine triphosphatase and EXP1, a glutathione S-transferase.
What should someone know about the safety or toxicity profile of Artesunate?
Artesunate can cause post‑treatment hemolytic anemia, hypersensitivity reactions, and drug interactions related to its metabolic and transporter pathways. Overexposure is associated with severe hematologic and neurologic toxicity, including pancytopenia, seizures, gastrointestinal bleeding, and progression to multiorgan failure. These risks highlight the importance of accurate dosing, controlled handling, and monitoring for delayed hemolysis after parenteral use.
What are important formulation and handling considerations for Artesunate as an API?
Formulation of Artesunate should account for its low aqueous solubility, which often necessitates reconstitution for injectable use and may require solubility‑enhancing strategies in oral solid forms. The endoperoxide bridge is chemically sensitive, so exposure to heat and prolonged acidic or basic conditions should be minimized during processing and storage. Handling should maintain protection from degrading conditions to preserve potency and ensure consistent conversion to its active metabolite.
Is Artesunate a small molecule?
Artesunate is classified as a small molecule. That classification shapes process design, impurity profiling, and analytical control strategies.
Are there special stability concerns for oral Artesunate?
Oral Artesunate contains an endoperoxide bridge that is chemically sensitive, so it should be protected from heat and prolonged exposure to acidic or basic conditions. Its low aqueous solubility also means solid oral forms may need strategies that maintain adequate dispersion without compromising stability. Proper storage conditions that limit thermal and chemical stress help preserve potency.
Regulatory
Where is Artesunate approved or in use globally?
Artesunate is reported as approved in the following major regions: US, EU. Understanding geographic coverage informs regulatory filings, supply planning, and risk assessments before escalating procurement.
What’s the regulatory and patent landscape for Artesunate right now?
Artesunate is described under a regulatory framework that includes the United States and the European Union, indicating attention to compliance within these jurisdictions. The context does not address any patent considerations, so only regulatory aspects in these regions are characterized.
Pharmaoffer
How does Pharmaoffer’s Smart Sourcing Service help with Artesunate procurement?
Pharmaoffer's Smart Sourcing Service coordinates compliant suppliers, documentation, and competitive quotes for Artesunate. It centralizes outreach, follow-ups, and document validation to shorten procurement timelines.
Is Artesunate included in the PRO Data Insights coverage?
PRO Data Insights coverage for Artesunate: 567 verified transactions across 126 suppliers and 85 buyers worldwide. Use the dataset to benchmark suppliers and monitor regulatory activity where available.
Where can I access the API market report for Artesunate?
Market report availability for Artesunate: Report Available. The report highlights demand trends, pricing drivers, and supplier landscape insights for procurement planning.
