Cytarabine, the pyrimidine antimetabolite at the core of AML induction and consolidation, and of intrathecal meningeal-leukaemia prophylaxis, is now supplied almost entirely as generic injection since the originator Cytosar-U was discontinued, and M Care sources FDA, MHRA and EMA-approved generic cytarabine injection from WHO-GMP manufacturer lines for hospital and tender-desk buyers outside India.
M Care Exports supplies cytarabine, the pyrimidine antimetabolite that anchors acute myeloid leukaemia induction regimens and intrathecal meningeal-leukaemia prophylaxis. Originally marketed as Cytosar-U, cytarabine is now supplied almost entirely as generic injection. As a merchant exporter, M Care sources FDA, MHRA and EMA-approved generic cytarabine solution for injection through licensed WHO-GMP manufacturing channels and dispatches on quote to hospital oncology pharmacies and tender desks outside India.
Cytarabine exporter and bulk supplier from India.
For hospital, wholesaler and tender-desk orders, M Care quotes cytarabine injection against buyer specification: vial size (100 mg, 500 mg, 1 g or 2 g, for intravenous and subcutaneous use), destination-market regulatory documentation and, where the protocol calls for intrathecal administration, the separate lower-concentration preservative-free presentation, available up to 1 g, drawn from licensed WHO-GMP manufacturer lines on the M Care roster. Because cytarabine's dosing spans standard induction and high-dose consolidation regimens with very different toxicity profiles, we confirm the buyer's intended protocol and route before dispatch, then align CTD/eCTD or country-specific dossier paperwork to the destination regulator's requirements.
Source
WHO-GMP-certified Indian manufacturing line, named on every quote.
Minimum order
No blanket MOQ. Set by the source manufacturer's minimum batch-release quantity for the strength and pack ordered.
Pricing
On request. Indicative FOB or CIF quote, formal proforma on confirmation.
Incoterms
EXW, FOB, CIF, CIP or DAP.
Payment
Letter of credit (sight or usance) and telegraphic transfer.
Documentation
WHO-GMP certificate of the source line, product-specific CoPP, batch CoA, method of analysis, Free Sale Certificate, Certificate of Origin, CTD or eCTD dossier. On request.
Shelf-life
Minimum remaining shelf-life agreed per order and confirmed on the proforma.
Response
Availability and CoPP status within two working days; pre-alert documents before dispatch.
Pyrimidine nucleoside analogue (deoxycytidine antimetabolite); DNA polymerase inhibitor, cell-cycle S-phase specific, sourced and documented for export.
Cytarabine (cytosine arabinoside) is a pyrimidine nucleoside analogue that is phosphorylated intracellularly to its active triphosphate, ara-CTP, which competes with deoxycytidine triphosphate for incorporation into DNA and inhibits DNA polymerase, making it S-phase specific and most active against rapidly dividing leukaemic blasts. It is given intravenously or subcutaneously, and, in a separate lower-concentration preservative-free presentation, intrathecally; it is never given orally, and standard-dose regimens need no special reconstitution beyond the manufacturer's diluent. The FDA label's flagship use is remission induction in acute myeloid leukaemia, usually the '7+3' regimen with an anthracycline, and cytarabine is also used in acute lymphoblastic leukaemia, the blast phase of chronic myeloid leukaemia, and by intrathecal route for prophylaxis and treatment of meningeal leukaemia. The higher-concentration presentation is supplied as a ready-to-use solution for injection at 100 mg/mL, in 100 mg, 500 mg, 1 g and 2 g vial sizes for intravenous and subcutaneous use, and as lyophilised powder for reconstitution from some manufacturers.
Active ingredient
Cytarabine. Pyrimidine nucleoside analogue (deoxycytidine antimetabolite); DNA polymerase inhibitor, cell-cycle S-phase specific.
Forms and strengths
100 mg/1 mL solution for injection vial; 500 mg/5 mL solution for injection vial; 1 g/10 mL solution for injection vial; 2 g/20 mL solution for injection vial.
Indications
Cytarabine, a pyrimidine antimetabolite indicated for remission induction and consolidation in acute myeloid leukaemia and, by intrathecal route (via a separate lower-concentration preservative-free presentation), for prophylaxis and treatment of meningeal leukaemia. Originally marketed as Cytosar-U, now discontinued, and supplied predominantly as licensed generic injection from Indian and international WHO-GMP facilities to regulated and semi-regulated markets outside India.
Administration
Intravenous, Subcutaneous, Intrathecal. Solution for injection/infusion (also supplied as lyophilised powder for reconstitution by some manufacturers).
Documentation
Batch-specific CoA, CoPP, manufacturing-site WHO-GMP certificate and stability data compiled per consignment, in the format the destination regulator expects.
Hospital pharmacies, licensed importers and tender desks across our export markets.
India is our origin. We do not sell into the Indian market.
Buyers for cytarabine are principally hospital haematology-oncology pharmacies running AML induction and consolidation protocols, national and regional MoH tender desks stocking core cytotoxic formularies, licensed pharmaceutical wholesalers and importers, and NGO or foundation procurement programmes supporting childhood and adult leukaemia treatment access where local registration is in place.
GCC registration routes
Supply against MoH registration held by your local licensed importer, or via the GCC central registration pathway.
UK unlicensed routes
Where no UK licence exists, the MHRA Specials and named-patient import routes cover clinically justified demand.
Tender desks
Bid-pack documentation assembled to the tender's specification, from CoPP to batch records.
Dossier support
CTD documentation from the sourcing manufacturer, compiled for your regulator's format.
What the dispensing pharmacist checks on cytarabine.
Cytarabine dosing varies sharply by regimen: standard induction combines cytarabine, typically 100 mg/m2/day by continuous infusion or 100 mg/m2 every 12 hours over 7 days, with an anthracycline, while high-dose consolidation (around 1-3 g/m2 per dose) carries a materially different toxicity profile, most notably cerebellar and other CNS toxicity that can become irreversible if therapy continues after early signs such as nystagmus, dysarthria or ataxia appear. Standard cytarabine solution for injection should not be refrigerated or frozen; refrigeration can cause crystal formation, so vials are stored below 25°C protected from light in the outer carton, the opposite convention from most parenteral oncology products. Prophylactic corticosteroid eye drops are standard practice during high-dose therapy to reduce chemical conjunctivitis. A self-limiting cytarabine syndrome, fever, myalgia, bone pain and a maculopapular rash appearing 6-12 hours after dosing, is managed with corticosteroids and does not usually require treatment discontinuation. Cytarabine is a potent bone-marrow suppressant, so full blood counts are checked before each dose and monitored closely through the nadir. No cold-chain handling is required for the standard injection.
The documentation pack a regulator actually asks for.
As a solution for injection, standard cytarabine travels on validated ambient or controlled-room-temperature logistics rather than the refrigerated cold-chain lanes M Care manages for biologics and insulins, and the label specifically warns against refrigeration. What buyers need instead is batch-level certificate of analysis, CDSCO export documentation and, where the destination market requires it, CTD or eCTD-format dossier support so the buyer's own regulator can register the product. Cytarabine is listed on the WHO Model List of Essential Medicines under cytotoxic medicines, as 100 mg powder for injection and 100 mg/mL solution presentations, reflecting its status as a first-line component of AML induction worldwide rather than a niche or newer agent. The originator Cytosar-U has been discontinued in the US (per FDA's Drugs@FDA record, not for safety or effectiveness reasons) and formularies now run almost entirely on FDA, MHRA and EMA-approved generic cytarabine injection from multiple manufacturers, so this is a generic-led molecule rather than a brand-versus-generic choice for most tenders. Buyers should also note that the higher-concentration 100 mg/mL presentation, available up to 2 g vials, is licensed for intravenous and subcutaneous use only; intrathecal orders require the separate lower-concentration preservative-free presentation, available up to 1 g.
How a licensed importer actually brings a consignment like this in is covered once, in the licensed import route guide, rather than repeated on every molecule page.
CoA and MoA, per batch
Batch-specific certificate and method of analysis from the sourcing manufacturer's QC release.
CoPP, WHO-GMP, MFG licence
Certificate of pharmaceutical product and site GMP certification issued via CDSCO channels, naming the actual manufacturing site.
CTD Module 3
Chemistry, manufacturing and controls documentation available from the sourcing manufacturer for registration filings.
Pack insert, labels, artwork
Destination-language patient information and labelling to the local regulator's standard, locked before shipment.
Pharmacovigilance
A named PV contact arranged in the destination market where the registration requires one.
Adjacent lines procurement desks order alongside cytarabine.
Molecule · strength · volume · destination. One working day to a quote.
- Send us the specifics. Form and strength, pack preference, destination market and indicative volume for cytarabine.
- We route to the right line. The enquiry goes to the WHO-GMP certified manufacturing partner whose certificates fit your regulator.
- Commercial and regulatory offer. FOB or CIF price with the documentation list, named manufacturing site and current certificate validity.
- Order, produce, release, ship. QC release on the Indian side, batch documents compiled, despatch on the agreed incoterm.
- After delivery. Batch records and certificates archived and retrievable for the life of the product on your shelf.
Cytarabine supply, the specific questions.
Is Cytosar-U still available, or is cytarabine only generic now?
The originator brand Cytosar-U has been discontinued, not for safety or effectiveness reasons, and the market now runs almost entirely on FDA, MHRA and EMA-approved generic cytarabine solution for injection from multiple manufacturers. M Care sources generic cytarabine injection and checks local registration status before quoting against a specific tender.
What vial sizes of cytarabine injection are available?
The higher-concentration presentation (100 mg/mL) is available in 100 mg, 500 mg, 1 g and 2 g vials for intravenous and subcutaneous use. Intrathecal orders use a separate, lower-concentration preservative-free presentation, available up to 1 g. Tell us your induction, consolidation or maintenance protocol and intended route and we quote the matching presentation.
Can cytarabine be stored in a refrigerator?
No. Standard cytarabine solution for injection should not be refrigerated or frozen; the label specifically warns that refrigeration can cause crystal formation in the vial. It is stored below 25°C, kept in its outer carton to protect it from light, which is the opposite storage convention from many other parenteral oncology products.
What is cytarabine syndrome and how is it managed?
Cytarabine syndrome is a self-limiting reaction of fever, myalgia, bone pain and a maculopapular rash appearing roughly 6-12 hours after dosing. It is managed with corticosteroids, given prophylactically in patients who have experienced it before, and does not usually require stopping treatment.
Why does high-dose cytarabine carry extra monitoring requirements?
High-dose consolidation regimens carry a meaningfully higher risk of cerebellar and other CNS toxicity than standard-dose regimens, which can become irreversible if treatment continues after early signs such as nystagmus, dysarthria or ataxia appear. Hospital protocols typically include neurological checks before each high-dose administration for this reason.
Is cytarabine on the WHO Essential Medicines List?
Yes. Cytarabine is listed on the WHO Model List of Essential Medicines under cytotoxic medicines for antineoplastic use, as 100 mg powder for injection and 100 mg/mL solution presentations, reflecting its role as a first-line component of acute myeloid leukaemia induction regimens worldwide.
What documentation does M Care provide with a cytarabine shipment?
Batch-level certificate of analysis, CDSCO export documentation from the Indian side, and CTD/eCTD-aligned dossier support where the destination regulator requires local registration. For intrathecal-use orders we confirm the preservative-free, lower-concentration specification with the sourcing partner before dispatch.
Who stands behind this page, and where its statements come from.
Reviewed by Dr. Rajat Bhatt, PharmD, Managing Director, M Care Exports. Last reviewed 2026-09-14.
This page is sourcing information for licensed importers, hospital procurement and tender desks. It is not medical, pharmaceutical or prescribing advice, and it is not a substitute for the approved product information of the line on your order. See our full disclaimer.
Send the specifics. You'll have a price inside one working day.
Form and strength, destination market and indicative volume. The Mumbai desk replies within one working day, including when the honest answer is that the route is not viable yet.