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Suppliers and packagers for CYTOXAN
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CYTOXAN
Listed suppliers include manufacturers, repackagers, relabelers, and private labeling entitities.
| Applicant | Tradename | Generic Name | Dosage | NDA | NDA/ANDA | Supplier | Package Code | Package | Marketing Start |
|---|---|---|---|---|---|---|---|---|---|
| Baxter Hlthcare | CYTOXAN | cyclophosphamide | TABLET;ORAL | 012141 | NDA AUTHORIZED GENERIC | Baxter Healthcare Corporation | 10019-982-01 | 1 BOTTLE in 1 CARTON (10019-982-01) / 100 TABLET in 1 BOTTLE (10019-982-09) | 2020-08-07 |
| Baxter Hlthcare | CYTOXAN | cyclophosphamide | TABLET;ORAL | 012141 | NDA | Baxter Healthcare Corporation | 10019-984-01 | 1 BOTTLE in 1 CARTON (10019-984-01) / 100 TABLET in 1 BOTTLE (10019-984-09) | 2020-08-07 |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >NDA/ANDA | >Supplier | >Package Code | >Package | >Marketing Start |
Suppliers and packagers for CYTOXAN
Who Supplies Cytoxan (Cyclophosphamide) Globally?
Cytoxan is a branded form of cyclophosphamide, a widely used alkylating chemotherapy. Supply is dominated by generic cyclophosphamide manufacturers under multiple dosage forms and strengths, with branded product availability driven by the specific market and current commercialization status.
What are the main supplier/manufacturer categories for Cytoxan?
- Originator brand holder / licensees (market-specific; varies by country and current brand status)
- Generic cyclophosphamide API and finished-dose manufacturers (most commercial supply in many jurisdictions)
- CMO/packing and distribution partners (commonly handle labeling, blistering, and batch release for local markets)
Which companies are consistently active in cyclophosphamide drug supply?
The cyclophosphamide supply chain is broad, but the manufacturers below are repeatedly cited across major regulatory and market channels for cyclophosphamide finished products or related manufacturing capability.
Finished-dose cyclophosphamide suppliers (brand and generic channels)
- Baxter Oncology (historically associated with branded cyclophosphamide supply; market presence can be region-specific)
- Teva Pharmaceuticals (generic supply for oncology injectables across multiple markets)
- Sandoz / Novartis (generic oncology injectable footprint, including cyclophosphamide listings in multiple jurisdictions)
- Fresenius Kabi (oncology injectables and sterile supply chain in key markets)
- Hospira (Pfizer) (legacy sterile manufacturing footprint; availability depends on region and current product lifecycle)
- Mylan / Viatris (generic injectables supply, including oncology agents in multiple markets)
Common API and chemical supply ecosystem for cyclophosphamide
- Global chemical and pharma-intermediate producers supply cyclophosphamide API, which is then finished by sterile-dose manufacturers. API procurement is typically contract-based and varies by tender cycle and regulatory status in each market.
What dosage forms and strengths drive supplier diversity?
Supplier participation changes by formulation, because cyclophosphamide supply typically spans:
- Injection (powder for reconstitution or sterile injectable solutions) used in oncology protocols
- Oral tablets in some regions (brand and generic)
- Compounding and hospital pharmacy channels in hospitals, which can source from different labeled strengths
Sterile injection supply is more likely to be concentrated among fewer qualified sterile manufacturers, while oral supply can have broader generic competition.
How procurement typically works for Cytoxan-equivalent cyclophosphamide
What procurement patterns affect supplier selection?
- Regulatory approval status in the target country
- Sterile manufacturing license and inspection history
- Availability by tender cycle
- Formulation compatibility with hospital reconstitution and administration workflows
What pricing and contract structures usually govern supply?
- Global tenders often award to multiple suppliers to manage continuity.
- Single-source cycles occur when sterile capacity is constrained or when product is temporarily withdrawn and reintroduced.
Where to verify cytoxan-equivalent supplier listings (regulatory and market sources)
Which sources typically list cyclophosphamide manufacturers and labeled products?
- FDA “Drugs@FDA” and Orange Book for US approvals and exclusivity status by application and product
- EMA and national European medicine registers for EU authorizations
- MHRA (UK), Health Canada, TGA (Australia) product and manufacturer listings
- WHO and procurement databases used by hospitals and public health systems for tender qualification
- NDC labeler and listing datasets for US market identification of the company responsible for labeling
These sources are the fastest route to identify the current labeled supplier for a specific strength and dosage form, because cyclophosphamide supply changes with manufacturing transfers and market withdrawals.
Cytoxan supply reality check: what changes month-to-month
What signals indicate supplier churn?
- Product interruptions or substitutions during shortage periods
- Labeler/manufacturer changes at the NDC or EU marketing authorization level
- Sterile facility inspection outcomes impacting batch release
- Reformulations or packaging changes tied to local compliance
In practical procurement, the “supplier” you buy from depends on market-specific labeling more than on the chemical API producer.
Key Takeaways
- Cytoxan is cyclophosphamide; supply is largely executed by generic manufacturers plus market-specific branded channels.
- The most reliable supplier identification is strength-and-formulation specific, using regulatory listing systems (FDA/EMA/national registers).
- Sterile injection availability concentrates among fewer qualified manufacturers; oral can have broader competition.
- Expect supplier churn driven by packaging, batch release, and market authorization changes.
FAQs
-
Is Cytoxan supplied by one global company?
No. Cytoxan-equivalent cyclophosphamide is supplied by multiple manufacturers depending on country, dosage form, and current market authorization status. -
Who manufactures the cyclophosphamide API?
Cyclophosphamide API is produced by chemical/pharma-intermediate suppliers, then finished into sterile or oral drug products by qualified pharma manufacturers. API sourcing is contract-specific. -
Why do suppliers differ for injection versus tablets?
Sterile injection requires dedicated validated sterile manufacturing capacity, while oral tablets can be made by a wider set of generic manufacturers. -
How can procurement teams confirm the actual supplier?
Use the labeled product records in the target market’s regulatory databases (for example, FDA Drugs@FDA and NDC labeler listings in the US). -
Do shortages change who sells cyclophosphamide?
Yes. Availability can shift quickly based on batch release, manufacturing interruptions, and tender re-awards, especially for sterile injectables.
References (APA)
[1] U.S. Food and Drug Administration. (n.d.). Drugs@FDA. https://www.accessdata.fda.gov/scripts/cder/daf/
[2] U.S. Food and Drug Administration. (n.d.). Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations. https://www.accessdata.fda.gov/scripts/cder/ob/
[3] European Medicines Agency. (n.d.). Medicine Information. https://www.ema.europa.eu/en/medicines
[4] UK Medicines and Healthcare products Regulatory Agency. (n.d.). Medicines. https://www.gov.uk/government/organisations/medicines-and-healthcare-products-regulatory-agency
[5] Government of Canada. (n.d.). Drug Product Database. https://health-products.canada.ca/dpd-bdpp/index-eng.jsp
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