Artesunate Injection Exporter and Supplier in India
If you are sourcing for severe malaria case management, artesunate injection is the line item that cannot go out of stock. M Care Exports has traded pharmaceuticals since 2003 and supplies artesunate 60mg and 120mg powder for injection, sourced from WHO-PQ-listed manufacturing lines in India and shipped as the manufacturer packs it, solvent set intact. We are a merchant-exporter, not the manufacturer, so what you buy from us is sourcing, documentation and shipment discipline against the manufacturer's own batch release.
Sourcing artesunate injection for the severe-malaria lane
This page covers the parenteral product only. Artesunate injection is what a referral facility reaches for once malaria has already turned severe, and it is a different procurement problem from oral ACT: a multi-part vial that is worthless without its own solvent, hospital and programme end-users rather than retail pharmacy, and tender cycles set by national malaria programmes rather than by rolling demand. Worth correcting one common assumption: this is not a cold-chain product. The vials ship and store at ambient conditions below 30°C, protected from light, per the source line's approved product information. M Care Exports buys from Indian lines that hold WHO prequalification for this presentation, then handles consolidation, documentation and freight to your port. M Care does not hold WHO-PQ, WHO-GMP or EU-GMP itself: those attach to the manufacturer, and we name the specific line and its PQ reference on the quotation so your regulatory team can verify it directly in the WHO PQ database. Our own credential is ISO 9001:2015 for the trading operation. Quantities follow the source manufacturer's batch-release minimum rather than any figure we invent, and injectable pricing moves with API and vial input costs, so it is quoted on request against your volume, destination and Incoterm.
Supplied from WHO-PQ-listed lines
Indian manufacturers including Ipca Laboratories (artesunate 120mg, WHO PQ reference MA186) and Macleods Pharmaceuticals (artesunate 120mg, MA194, with a 60mg presentation also listed) hold WHO prequalification for artesunate injection. We source from listed lines and name the manufacturer and PQ reference on the offer so you can check it yourself.
Vial plus solvent, kept together
Artesunate powder is unusable without its accompanying solvent, and the prequalified Indian presentations ship with sodium bicarbonate and, in some packs, a sodium chloride diluent. We move the presentation exactly as the manufacturer assembles it, so the reconstitution chain is never broken by a splitting error at consolidation.
Built for tender and programme cycles
National malaria programmes, Global Fund grant lines and comparable donor-supported channels buy in scheduled waves, not on rolling demand. We supply the source-line documents technical evaluation asks for and work to your award dates and shipment windows rather than pushing stock at you.
Volumes set by batch release
There is no M Care-invented MOQ on this product. The quantity floor is the source manufacturer's batch-release minimum for the strength and pack you want, and we give you that number before you commit.
Artesunate injection at a glance
Active ingredient
Artesunate, a water-soluble semi-synthetic hemisuccinate derivative of dihydroartemisinin. ATC code P01BE03. Listed on the WHO Model List of Essential Medicines among antimalarial medicines for curative treatment. Note that WHO AWaRe classification covers antibacterials and does not apply to this molecule.
Strengths supplied
60mg and 120mg vials of sterile powder for injection, each supplied with the source manufacturer's solvent set. Pack configuration varies by line, so the exact presentation is confirmed on the offer rather than assumed.
Formulation and handling
The powder is dissolved in the supplied 5% sodium bicarbonate to form sodium artesunate, then diluted (commonly with the supplied 0.9% sodium chloride) before IV or IM administration. Unopened vials are stored below 30°C and protected from light; no cold chain is required. The reconstituted solution is short-lived and is not a hold-and-store product.
Regulatory class
Prescription-only parenteral antimalarial for hospital and programme use. Import licensing and product registration are destination-specific and sit with the importer of record.
Reference brands
Reference brands include Artesun (Guilin) internationally and Indian brands such as Artekill. Brand names appear here as buyer reference only; every offer is written against molecule, strength, presentation and named source line.
Not the oral ACT
This is the severe/parenteral product. Uncomplicated malaria is treated with a full oral ACT course such as artemether-lumefantrine, which is a separate line item and a separate page.
Which buyers we quote artesunate injection to
Demand for injectable artesunate is unusually structured. It is concentrated in endemic Africa and parts of South East Asia, and most of it flows through public and donor channels rather than private wholesale. These are the buyer profiles we actually deal with.
National malaria programme suppliers
Local agents and importers bidding into central medical stores in Nigeria, DRC, Tanzania, Mozambique, Uganda, Kenya and comparable markets. You need a source line that survives technical evaluation and paperwork that arrives before the shipment does.
Donor-funded and grant channel buyers
Buyers serving Global Fund grant lines or comparable donor-financed procurement, where WHO prequalification of the manufacturing line is a pass/fail criterion rather than a preference.
Hospital and tertiary-care distributors
Distributors serving referral and district hospitals that must hold artesunate injection for paediatric cerebral malaria and adult severe cases. Small, steady, non-negotiable stock rather than large campaign volumes.
Regional wholesalers and re-exporters
Importers in GCC and LatAm markets covering imported and traveller-acquired severe malaria, where annual volumes are modest but continuity of an approved source matters more than price.
Private hospital groups and mining or field operations
Buyers running clinics in endemic zones who need a defensible severe-malaria protocol on site, typically ordering the injection alongside an oral ACT and a diagnostic line.
Safety and handling notes for your technical file
The evidence base. Parenteral artesunate displaced quinine as the WHO-recommended first-line treatment for severe malaria on the strength of two large randomised trials: SEAQUAMAT in mainly adult patients in Asia and AQUAMAT in African children. SEAQUAMAT reported mortality of about 15% with artesunate against about 22% with quinine, a relative reduction near 35%, and AQUAMAT reported 8.5% against 11.0%, a relative reduction near 22.5%, without an increase in neurological sequelae. WHO guidance is that IV or IM artesunate is given for at least 24 hours and until the patient can tolerate oral medication, at which point a complete oral ACT course must follow. The parenteral phase alone is not a cure, and an incomplete handover to oral therapy is a recognised programme failure point. Dosing figures published in WHO guidance and manufacturer product information (for example 2.4 mg/kg body weight at 0, 12 and 24 hours then once daily, with WHO recommending a higher 3 mg/kg per dose in children under 20kg, a weight-band uplift that some national labels such as the US and EU marketing authorisations did not adopt) appear here purely as reference context for procurement, tender specification and training planning. This page is written for professional buyers. It is not medical advice, not a treatment instruction, and not a substitute for the approved product information of the line on your order.
Post-artesunate delayed haemolysis (PADH). This is the warning your clinical stakeholders will ask about, and it should be answered honestly rather than minimised. A proportion of patients develop delayed haemolytic anaemia in the weeks after treatment, occasionally severe enough to require transfusion, and it is carried as a special warning in the approved product information. Published guidance and case-series reviews support monitoring haemoglobin for around four weeks after treatment (commonly with checks near days 7, 14 and 21, alongside reticulocytes, LDH and haptoglobin where laboratory capacity allows), with some authors extending follow-up to six weeks. Hypersensitivity reactions are also reported, and hypersensitivity to artesunate or other artemisinin derivatives is a contraindication. WHO's position is unchanged: the therapeutic benefit of injectable artesunate far outweighs these risks and it remains first-line, including for pregnant women in all trimesters with severe malaria. Buyers supplying facilities with no post-discharge haematology follow-up pathway should factor that gap into their programme discussions, because PADH that is never looked for is never found.
Handling. The multi-part vial exists for a reason. The powder is dissolved in the supplied sodium bicarbonate solvent first and then diluted, typically with sodium chloride; the reconstituted solution is intended for prompt use rather than storage, so it is prepared at the bedside and not batched in a pharmacy. Unopened stock is an ambient product stored below 30°C and protected from light, so no cold chain is involved, but any consolidation or repacking that separates vial from solvent renders the consignment clinically useless. That is why we do not break the manufacturer's presentation. Always work from the approved product information of the specific source line on your order, not from a generic monograph, because reconstitution volumes and pack contents differ between prequalified presentations.
Written for professional buyers and importers, not as medical advice. Prescribing decisions sit with the treating clinician and the approved label in your market.
Documentation we put behind the shipment
On a PQ-sensitive injectable, the file matters as much as the goods. Here is what M Care genuinely provides, and where the line sits between our work and the manufacturer's.
Manufacturer identity and PQ reference
We name the source line and its WHO prequalification reference on the offer, so your regulatory or tender team can verify it independently in the WHO PQ database before you commit. We do not ask you to take the claim on trust.
CoA and batch release paperwork
Certificate of Analysis per batch, issued by the manufacturer's QC, with manufacturing and expiry dates. For a product with a defined shelf life and hospital end-use, remaining-shelf-life requirements are agreed in writing before dispatch.
CoPP and CTD dossier support
We compile the CTD dossier and the Certificate of Pharmaceutical Product alongside you and the manufacturer for your registration filing. The dossier is the manufacturer's; our role is coordination, completeness and turnaround.
Export and shipping set
Invoice, packing list, certificate of origin, export documentation and free sale certificate where the destination requires it, plus GMP certificate copies from the source line. Legalisation and attestation arranged where your market demands it.
Tender annexes on request
Where you are bidding into a programme or donor-funded tender, we supply the source-line documents that technical evaluation asks for, and our own ISO 9001:2015 certificate for the trading entity. We do not present WHO-GMP, WHO-PQ or EU-GMP as M Care credentials, because they are not ours.
Molecules buyers source alongside Artesunate (Injection).
Artemether-Lumefantrine
The oral ACT for uncomplicated malaria, and the course that must follow the parenteral artesunate phase. Usually bought on the same programme line.
Doxycycline
Tetracycline used in malaria chemoprophylaxis for travellers and expatriate staff, so it often sits alongside artesunate in field and mining-clinic supply lists.
Azithromycin
Macrolide antibiotic. Not an antimalarial, but a standard anti-infectives line item for the same hospital and distributor buyers.
How ordering works.
- Send the specification, not just the molecule. Tell us strength (60mg, 120mg or both), quantity, destination country, whether the end buyer is a programme, hospital or private channel, and any tender or registration reference. Whether the source line must be WHO-prequalified is the single question that shapes everything else, so answer it first.
- We come back with source options and a real quote. You get the named manufacturer, its PQ status and reference, the batch-release minimum quantity, the exact pack and solvent configuration, available shelf life and a price against your destination and Incoterm. Price on request is not evasion: injectable pricing moves with API and vial cost, and we would rather quote accurately than post a stale number.
- Documentation is agreed before the PO, not after. We settle the document set, shelf-life requirement, labelling and any legalisation your market needs in writing while the order is still being priced. This is where injectable shipments usually go wrong, so we front-load it.
- Production, release and despatch. Order placed against the manufacturer's batch schedule, CoA and release documents issued, consignment consolidated with the solvent presentation intact, then shipped with the agreed paperwork travelling ahead of the goods.
Artesunate (Injection) supply, the specific questions.
Is artesunate injection really the WHO first-line for severe malaria?
Yes. WHO recommends intravenous or intramuscular artesunate in preference to quinine for severe malaria in adults and children, with IV the preferred route and IM an accepted alternative. The change was driven by the SEAQUAMAT trial in Asia (1,461 patients) and AQUAMAT in African children (5,425 patients), which showed mortality reductions against quinine of roughly 35% and 22.5% respectively. Published reviews aligned with the WHO World Malaria Report put adoption at about 93% of African countries (42 of 45) recommending injectable artesunate as first-line for severe malaria, which is why programme demand for it is so structured.
How is this different from artemether-lumefantrine? Can I substitute one for the other?
No, and this is the most important distinction on the page. Artesunate injection treats severe malaria in a hospital setting, parenterally, when the patient cannot reliably take or absorb oral medication. Artemether-lumefantrine is an oral ACT for uncomplicated malaria. They are not alternatives, they are sequential: WHO guidance is that the parenteral artesunate phase runs for at least 24 hours and until oral therapy is tolerated, and is then followed by a complete oral ACT course. A procurement plan that buys one without the other has a gap in it.
Does M Care hold WHO prequalification for artesunate injection?
No, and we will not let a tender document imply otherwise. WHO prequalification attaches to a manufacturing line and its specific presentation, and M Care Exports is a merchant-exporter, not a manufacturer. What we can say honestly is that we supply from WHO-PQ-listed lines in India, and we name the manufacturer and PQ reference on the offer so your team can verify it in the WHO database. M Care's own credential is ISO 9001:2015 for the trading operation. If your tender requires the PQ certificate or the GMP certificate, those come from the manufacturer and we help you obtain them.
Why does the vial come with separate solvent ampoules?
Because artesunate powder is not directly injectable. It must first be dissolved in the supplied 5% sodium bicarbonate to form sodium artesunate, and then diluted, commonly with 0.9% sodium chloride, before IV or IM administration. The prequalified Indian presentations supply those solvents in the pack, and the 60mg and 120mg vials take proportionally different volumes, so the reconstitution table in the approved product information is the one to follow rather than a generic figure. The reconstituted solution is prepared for prompt use rather than storage. Practically, this means vial and solvent are one unit: we do not split the manufacturer's presentation at consolidation, because powder without solvent has no clinical value at the receiving facility.
Does artesunate injection need a cold chain?
No, and it is worth being clear about because buyers routinely budget for one. Unopened artesunate vials are an ambient product, stored below 30°C and protected from light per the source line's approved product information, so ordinary controlled-ambient warehousing and freight apply. What is time-critical is after reconstitution, not before: the prepared solution is for prompt use and cannot be batched ahead or stored, which is a bedside practice matter rather than a logistics one. The real supply-chain risks on this product are remaining shelf life on arrival and keeping the vial and its solvent together, and both are settled in writing before the PO.
What is post-artesunate delayed haemolysis and should it affect my procurement decision?
PADH is a delayed haemolytic anaemia that can appear in the weeks after treatment, occasionally severe enough to require transfusion, and it is carried as a special warning in the approved product information. Published guidance supports monitoring haemoglobin for around four weeks after treatment, commonly with checks near days 7, 14 and 21, alongside reticulocytes, LDH and haptoglobin where laboratory capacity allows. It should not change your decision to stock artesunate: WHO's assessment is that the therapeutic benefit far outweighs the risk and the product remains first-line. It should, however, inform what you discuss with receiving facilities, because a hospital with no post-discharge follow-up pathway will not detect PADH.
What is the minimum order quantity, and can you supply against a Global Fund or national programme tender?
There is no M Care-set MOQ. The floor is the source manufacturer's batch-release minimum for the strength and pack you want, and we give you that number in the quotation rather than inventing a threshold. Injectable artesunate is quoted on request: API and vial input costs move, PQ-listed lines price differently from non-listed ones, and destination and Incoterm change the landed number materially. On tenders, yes, and that is most of what this product does. We supply the source-line documentation technical evaluation asks for, work to your award and shipment dates, and are explicit about which certificates are the manufacturer's and which are ours. Bring us the tender reference and the specification, and we will tell you honestly whether we can meet it before you build a bid around us.
Request an artesunate injection quotation
Send the strength (60mg, 120mg or both), quantity, destination country and whether the source line must be WHO-prequalified. We will come back with the named manufacturer, its PQ reference, the batch-release minimum, the pack and solvent configuration, available shelf life and a price against your Incoterm. If we cannot meet your specification, we will tell you that instead of quoting anyway.