Last updated: June 3, 2026
Ifex (ifosfamide) suppliers: who manufactures and supplies the US market, and what’s the Orange Book status?
Ifex is the brand name for ifosfamide (an alkylating chemotherapy agent) used in oncology regimens. Market access and supply are driven by CDMO and active pharmaceutical ingredient (API) chains, but the specific “supplier” list depends on which product strength and presentation is being purchased (US injectables, package size, and whether it is listed under the FDA Orange Book for generic interchange).
Who supplies Ifex (ifosfamide) in the US market?
In the US, “suppliers” for a brand injectable typically split into:
- Marketing authorization holder / labeler (the company responsible for the marketed product)
- Manufacturer of record (site(s) that produce the drug product)
- API supplier(s) (sites that supply ifosfamide API used in finished dosage manufacture)
For Ifex, the supplier stack is defined by:
- FDA Orange Book listings (drug product and applicant)
- NDC directory entries (labeler and dosage form metadata)
- FDA labeling and facility listings (manufacturing site and, sometimes, packager details)
- Compounding and distribution channels that carry branded and generic ifosfamide injectables
What is the Orange Book status of Ifex (ifosfamide)?
Featured-snippet answer: Ifex’s Orange Book listing status determines whether approved generics exist for the same active ingredient, dosage form, and strength, which in turn dictates the intensity of supplier competition.
Orange Book status for an injectable is assessed by:
- Active ingredient: ifosfamide
- Dosage form: injectable solution (or lyophilized form if applicable)
- Applicant: brand NDA holder and any ANDA holders
- Exclusivity and patents: listed patent coverage (drug product, formulation, and method-of-use where relevant)
How many suppliers exist for ifosfamide injectables versus Ifex?
Featured-snippet answer: The supplier count for ifosfamide generally exceeds the branded “Ifex” footprint because:
- Multiple generic manufacturers can supply equivalent ifosfamide injectables under ANDAs.
- Contract manufacturing and labeler changes can occur while maintaining the same finished product specification.
The practical way to count suppliers is to enumerate:
- Distinct NDC labelers for ifosfamide injection strengths
- Distinct ANDA applicants with “same drug, same dosage form” entries
- Distinct manufacturing sites listed for those NDCs
Which companies manufacture ifosfamide (API) for finished injectables?
API supply for ifosfamide typically comes from:
- Specialty small-molecule API manufacturers
- Long-term partnerships with injectable-focused CDMOs
- Secondary suppliers who feed API lots into multiple finished product labelers
Key supplier signals for API sourcing come from:
- Finished product labels that name the manufacturer of drug substance (sometimes)
- Quality agreements and DMF-linked supplier networks (indirectly)
What finished-dose manufacturers supply Ifex and equivalents?
Finished-dose manufacturing “suppliers” can differ from the labeler, often including:
- Sterile injectable CDMOs with aseptic fill-finish
- Companies with lyophilization and reconstitution packaging (if applicable)
A complete supplier list requires mapping:
- Labeler (NDA holder)
- Manufacturer of record for drug product
- Sterile manufacturing facility and packaging site
- Any contract packager
What generic entry risks exist for Ifex (ifosfamide)?
Featured-snippet answer: Risk is driven by whether patents or exclusivities block ANDA filers, and by whether manufacturing constraints create supply bottlenecks.
Generic entry risks for an injectable like ifosfamide depend on:
- Orange Book patent status (if listed)
- ANDA approval timing and patent litigation history (if any)
- Sterile manufacturing capacity and inspection histories for the drug product class
What formulation or manufacturing patents could affect suppliers?
If multiple suppliers rely on different:
- manufacturing process steps
- crystallization/purification parameters
- container-closure systems and fill volumes
- stability profiles under storage and transport conditions
…then some competitors may face technical or regulatory hurdles even if the active ingredient is off-patent.
For an injectable brand, the most common supplier-impacting patent categories are:
- drug substance manufacturing process patents
- sterile drug product formulation/process patents
- container closure and stability patents
What manufacturing and quality constraints can limit ifosfamide supply?
Ifosfamide supply is sensitive to:
- sterile manufacturing capacity
- aseptic processing personnel and facilities
- contamination control and batch release testing throughput
- hazardous drug handling controls (HPAPI requirements)
- shipping constraints for cold chain or stability-limited products (if applicable to the specific product strength)
How does Ifex supply compare with other ifosfamide brands and generics?
Featured-snippet answer: Branded Ifex generally has fewer sources than generics, with:
- higher reliance on the labeler’s manufacturing network
- less redundancy if one sterile facility is offline
- more exposure to batch-specific quality/sterility release delays
Generic supplies typically expand redundancy through multiple ANDA manufacturers, but quality and inspection outcomes can still concentrate supply quickly.
Key takeaways
- “Suppliers for Ifex” is not a single list in practice; it is a chain spanning labeler, manufacturer of record, and potentially API sourcing.
- The fastest way to identify the authoritative supplier set is via FDA Orange Book and NDC mapping for the exact ifosfamide strength and presentation.
- Supplier count and availability depend heavily on whether multiple ANDA manufacturers are approved and operating, not just on the brand’s existence.
- For injectable ifosfamide, sterile manufacturing capacity and HPAPI handling constraints are recurring supply determinants.
FAQs
- How do I find the labeler and manufacturer of record for a specific Ifex NDC?
- Do Orange Book patents for ifosfamide affect which companies can supply generics?
- Which sterility/aseptic manufacturing certifications typically matter for ifosfamide injectables supply?
- What batch-release and inspection events most often disrupt ifosfamide injectable availability?
- How can I map API supplier sites to finished-dose suppliers for ifosfamide?
References (APA)
- U.S. Food and Drug Administration. Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations. https://www.accessdata.fda.gov/scripts/cder/daf/
- FDA. NDC Directory. https://www.fda.gov/drugs/drug-approvals-and-databases/national-drug-code-directory
