Last updated: April 23, 2026
What are the key suppliers of pharmaceutical-grade cytarabine?
Cytarabine (commonly marketed as cytosine arabinoside) is supplied globally in both sterile injection and lyophilized formats, with upstream access dominated by specialized API manufacturers and downstream by sterile-filling and packaging vendors. Supplier landscapes shift by region and registration status, but the base set of active suppliers that repeatedly appears in regulatory filings and product catalogs includes the following.
Who supplies cytarabine active pharmaceutical ingredient (API)?
The cytarabine API supply chain is typically concentrated in manufacturers that also support controlled substance-like handling of sterile oncology products through robust GMP systems.
| Manufacturer |
Common role in the chain |
Notes for diligence |
| Fujifilm Wako Chemicals (Japan) |
Cytarabine ingredient supply |
Frequently appears as a chemistry/biochemical supplier for lab and preclinical use; track whether the offering is API vs research grade. |
| Mitsubishi Chemical / API ecosystem (Japan) |
Cytarabine ingredient ecosystem |
Regional presence in cytidine analog supply chain; confirm GMP status for injectables. |
| Bharat Serums and Vaccines (India) / Bharat Biotech ecosystem (India) |
API/biotech ingredient supply |
Indian specialty supply channels often support sterile oncology intermediates; confirm cytarabine API classification and DMF/CEP availability. |
| Teva active pharma ingredient network (Israel/Global) |
API and/or contract supply to finished products |
Teva frequently supplies oncology intermediates through its global manufacturing and distribution network; confirm exact product form (API vs finished). |
| Sandoz / Novartis group supply network (Switzerland/Global) |
API and contract supply |
Large oncology generic networks typically have API-to-finished integration or supplier contracts; confirm cytarabine-specific sourcing. |
| Hospira/Pfizer legacy supply ecosystem (US/Europe) |
Finished product supply via manufacturing network |
Often relevant where brand/generic finished-dose products are manufactured under legacy contracts; confirm current manufacturer-of-record. |
Critical diligence target: for any supplier short-listed for clinical or commercial manufacture, require proof of GMP manufacture of cytarabine API, including audit-ready documentation for:
- DMF/CEP status (if applicable)
- Sterility and pyrogen controls only if the supplier is providing sterile drug product (API suppliers do not provide sterility)
- Residual solvents, elemental impurities, assay and water specs that match your intended dosage form
Who supplies cytarabine finished injectable drug product (sterile fill)?
Finished cytarabine supply tends to concentrate among companies with established sterile manufacturing in oncology injectables.
| Company |
Typical supply role |
Product form to verify |
| Pfizer (legacy brand and sterile manufacturing network) |
Brand and/or supply to channel |
Verify whether the current SKU is made by Pfizer sites or contract manufacturers. |
| Sandoz |
Generic oncology injectable supplier |
Often distributes multiple strengths; confirm concentration (mg/mL) and vial format. |
| Teva |
Generic injectable supplier |
Verify fill volume, vial size, and labeler. |
| Hospira (Pfizer legacy brand in many markets) |
Sterile manufacturing and supply |
Relevant for historical channels; confirm whether Hospira still manufactures for your target market. |
| Fresenius Kabi |
Sterile injectable manufacturing supplier |
Strong presence in sterile oncology; verify cytarabine concentration and lyophilized vs solution. |
| Baxter / Baxter affiliates |
Sterile injectable supply |
Confirm whether they supply cytarabine in your region and the manufacturer-of-record for the NDC/MA. |
| Mylan / Viatris |
Generic injectable supplier |
Verify current commercialization entity and manufacturing site. |
What product specifications should you force suppliers to match?
Cytarabine is dosed by mg/m² and delivered as intravenous or subcutaneous therapy, and the product must match the intended regimen and route. When comparing supplier offers, normalize around the following:
- Drug product form
- Injection solution (typical) versus lyophilized powder reconstitution (varies by market and SKU)
- Strength
- Common commercial strengths include 50 mg/mL, 100 mg/mL, and low-concentration vial formats, depending on jurisdiction and labeling
- Container/closure
- Vial size, stopper material compatibility, and whether the product uses plastic syringes or glass vials
- Stability profile
- Storage temperature, in-use stability, and freeze-thaw tolerance if relevant to your supply chain
- Sterility and endotoxin
- Sterility assurance and endotoxin acceptance criteria
- USP/NF or pharmacopeial compliance
- The supplier should map to your target compendial requirements
How to map “supplier” to what you actually need
For procurement or development, “supplier” splits into three practical categories:
- API manufacturer (GMP API supply only)
- Sterile drug product manufacturer (sterile fill-finish, labeling, packaging)
- Commercial distributor / marketer (labeler of record, logistics, regulatory owner)
A supplier you select for development should match your manufacturing plan:
- If you build a sterile drug product: you need sterile fill-finish capacity and validated sterile process controls.
- If you buy finished product: you need regulatory status and site-specific manufacturing authorization for your target market.
Supplier vetting checklist for cytarabine (actionable)
Use these screens to eliminate non-viable suppliers quickly:
- Confirm API or sterile scope in writing (API suppliers do not supply sterility testing and vice versa).
- Require CoA and batch manufacturing records aligned to your target strength.
- Demand change-control traceability for:
- synthesis route changes
- crystallization/form changes (if applicable)
- container/closure changes
- sterilization method or fill-finish changes
- Inspect whether the supplier has cytarabine-specific batch experience (oncology sterile injectables have distinct operational requirements).
- Check regulatory listing coverage in your target region (US FDA, EMA, local health authorities).
Key takeaways
- Cytarabine supply is split between API manufacturers and sterile injectable fill-finish producers; “supplier” must be mapped to scope.
- Short-listed suppliers typically come from established oncology sterile networks (e.g., Pfizer legacy, Sandoz, Teva, Fresenius Kabi, Baxter, and other generic oncology manufacturers) plus specialized API ingredient suppliers.
- The decisive procurement filters are GMP scope, drug product form, strength, container-closure, sterile/endotoxin specs, and regulatory listing for your target market.
FAQs
1) What counts as a “cytarabine supplier” for procurement purposes?
A cytarabine supplier can be an API manufacturer (ingredient only) or a sterile finished-dose manufacturer (injection product). Selection depends on whether you need to fill-finish or buy ready-to-use drug product.
2) Do API suppliers provide sterile guarantees?
No. API suppliers provide GMP controls for the substance; sterility and endotoxin requirements apply to the sterile drug product manufacturer.
3) Which cytarabine formats are commonly supplied?
Market offerings commonly include sterile injection solution formats and, in some regions, lyophilized formats for reconstitution.
4) What’s the fastest way to reduce supplier mismatch risk?
Normalize specs up front: strength (mg/mL), vial size, drug product form, storage conditions, sterility/endotoxin criteria, and labeled manufacturer-of-record for your jurisdiction.
5) Why do supplier lists differ by region?
Because regulatory status, manufacturing site authorization, labeling, and commercial distribution vary by country, and multiple companies may hold equivalent SKUs with different manufacturer-of-records.
References
[1] FDA Orange Book. Cytarabine drug products (various listed sponsors/manufacturers). U.S. Food and Drug Administration. https://www.accessdata.fda.gov/scripts/cder/daf/
[2] EMA European Public Assessment Reports (EPAR) for cytarabine-containing medicinal products. European Medicines Agency. https://www.ema.europa.eu/ema/
[3] WHO Global Drug Information. Antineoplastic and cytotoxic medicines procurement and availability references (cytarabine listings). World Health Organization. https://www.who.int/publications/journals/global-drug-information
