CYCLOPHOSPHAMIDE: Pharmaceutical manufacturers, suppliers, and packagers

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Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Alembic	CYCLOPHOSPHAMIDE	cyclophosphamide	CAPSULE;ORAL	215892	ANDA	Alembic Pharmaceuticals Limited	46708-618-31	100 CAPSULE in 1 BOTTLE (46708-618-31)	2022-11-23
Alembic	CYCLOPHOSPHAMIDE	cyclophosphamide	CAPSULE;ORAL	215892	ANDA	Alembic Pharmaceuticals Limited	46708-619-31	100 CAPSULE in 1 BOTTLE (46708-619-31)	2022-11-23
Alembic	CYCLOPHOSPHAMIDE	cyclophosphamide	CAPSULE;ORAL	215892	ANDA	Alembic Pharmaceuticals Inc.	62332-618-31	100 CAPSULE in 1 BOTTLE (62332-618-31)	2022-11-23
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>NDA/ANDA	>Supplier	>Package Code	>Package	>Marketing Start

Last updated: April 24, 2026

Who supplies cyclophosphamide in finished-dose and bulk form?

Cyclophosphamide is supplied through three main channels: (1) branded originator lines, (2) generic finished-dose manufacturers (tablets and injectable), and (3) bulk/active pharmaceutical ingredient (API) suppliers used by formulators. The supplier set varies by country, dosage form, and regulatory supply status.

Which manufacturers hold a meaningful footprint in cyclophosphamide supply?

United States (finished-dose and injectables)

Cyclophosphamide is widely supplied in the U.S. by multiple generic manufacturers with ANDA approvals, with hospital and oncology channel distribution concentrated among large contract and wholesaler networks. Key named manufacturers historically include:

B. Braun Medical Inc. (distribution and oncology injectable supply presence in the U.S. market)
Fresenius Kabi USA (injectable oncology supply presence)
Hospira (Pfizer) (injectable oncology legacy and market presence through historical product lines)

These companies appear across oncology injectable sourcing and distribution channels in U.S. hospital procurement structures, including during periods of cyclophosphamide supply tightness (notably in the 2023-2024 window).

EU/UK (finished-dose and injectable footprint)

European supply often runs through a combination of local generic players and large European sterile product manufacturers. Named active suppliers and distributors that have shown cyclophosphamide market activity in the region include:

Accord Healthcare (EU generics manufacturer footprint)
Teva (EU generic footprint)
Sandoz (EU generic injectables footprint)

Who supplies cyclophosphamide as the API?

Cyclophosphamide API supply is narrower than finished-dose supply. API is produced by chemical manufacturing sites with capacity for cytotoxic intermediates and controlled handling. API supply is generally concentrated among specialized chemical manufacturers and API lines tied to DMF/CEP dossiers.

Common API manufacturing countries for cytotoxic oncology APIs include China and India, supplemented by Europe for certain dossiers. Contract manufacturers and API houses typically supply multiple finished-dose generic programs under supply agreements, which makes “true API supplier” identification dependent on dossier mapping rather than public product packaging.

How does supply get organized in procurement (who actually ships)?

Procurement typically occurs through one of two structures:

Finished-dose manufacturers shipping directly to distributors/wholesalers
Finished-dose manufacturers shipping through regional distributors to hospitals and oncology clinics

During supply disruptions, wholesalers and distributors re-route inventory and allocate by customer tier. In the U.S., the FDA drug shortage process drives formal visibility of “who has product” at the level of NDC supply status. In EU markets, national shortage lists provide similar visibility for pharmacies and hospitals.

What supplier sets matter during drug shortages?

When cyclophosphamide is short, suppliers that matter are those with:

Sufficient sterile injectable capacity (for cyclophosphamide injection strengths)
Validated cytotoxic handling lines (sterile and non-sterile, depending on form)
Stable regulatory dossier coverage (multiple NDCs and strengths to avoid single-point failures)
Distributor network reach (ability to access allocation rather than waiting for sporadic spot supply)

The 2023-2024 U.S. shortage cycle led to heightened reliance on distributors who can secure allocated supply from manufacturers with available production slots, which changes effective “usable supplier” lists week to week. The most actionable view for buyers is the current shortage and allocation status by NDC.

What public sources identify cyclophosphamide suppliers by market?

To map “supplier” accurately, buyers typically triangulate:

U.S. FDA Drug Shortages entries by NDC and dosage form
NDC labeler/manufacturer strings on packaging and drug databases
EMA shortage lists or national competent authority updates (EU)
DMF/CEP-linked API dossier holders (for API-level mapping)

For cyclophosphamide specifically, the most direct supplier identification in the U.S. comes from FDA shortage records and NDC-level labeling, which tie product availability to specific manufacturers/distributors.

Cyclophosphamide shortage-driven supplier visibility (U.S.)

FDA shortage reporting for cyclophosphamide injection links to the specific product(s) in shortage by dosage form and strength, which then points to the manufacturer(s) and marketing authorization holder(s) tied to those NDC(s). This is the fastest way to convert “supplier candidates” into “currently deliverable suppliers” for procurement planning (e.g., alternative NDCs, alternative labelers, substitution readiness).

Supplier shortlists by procurement scenario

If you buy cyclophosphamide injection (hospital/wholesaler procurement)

Priority goes to manufacturers that:

have injectable-ready supply,
hold multiple strengths and package formats to reduce substitution risk,
maintain continuity through allocation periods.

These are typically the larger sterile-focused generics players and established oncology injectable suppliers active in U.S. distribution networks.

If you buy cyclophosphamide tablets/capsules (outpatient/retail)

Priority goes to manufacturers with:

finished-dose tablet/capsule production continuity
established generic distribution through major wholesalers

If you buy API (chemical procurement)

Priority goes to API manufacturers that:

support cytotoxic handling and impurity control
have dossiers aligned to the regulatory jurisdictions of the finished-dose programs
can meet qualification timelines for incoming customer validation

API supplier “names” are best verified via DMF/CEP dossier holder mapping tied to specific finished-dose labeler programs rather than product marketing claims.

Key Takeaways

Cyclophosphamide supply splits into finished-dose manufacturers and a narrower set of specialized API producers.
The most operational supplier list in practice comes from NDC-level manufacturer visibility (especially during shortage cycles) using FDA shortage records.
During supply tightness, buyer outcomes depend on injectable sterile capacity and distributor allocation access, not just theoretical product approvals.

FAQs

Who is the main supplier for cyclophosphamide injection in the U.S.?
The usable supplier set is defined by current NDC availability during shortage periods and is best determined from FDA drug shortage records for cyclophosphamide injection.
Can the API supplier be determined from the product label?
Not reliably. The product label identifies the manufacturer/labeler and NDC, while API producers are usually connected through DMF/CEP dossier structures.
Why do cyclophosphamide suppliers change during shortages?
Allocation shifts to manufacturers with available sterile production capacity and qualified supply chains; distributors reroute inventory based on availability and contractual allocation.
Are API sources concentrated in certain countries?
Cytotoxic oncology API capacity is commonly concentrated in specialized chemical manufacturing hubs, often in China and India, with supplemental capacity in Europe for specific dossier lines.
What is the fastest method to build an actionable supplier shortlist?
Build the shortlist using NDC-level information tied to active supply status (shortage and discontinuation signals) from FDA drug shortage records.

References (APA)

[1] U.S. Food and Drug Administration. (n.d.). Drug Shortages. https://www.fda.gov/drugs/drug-shortages

Suppliers and packagers for CYCLOPHOSPHAMIDE