Last updated: May 25, 2026
INFeD (iron dextran) suppliers: who manufactures, supplies, and distributes INFeD in the US
Executive summary: INFeD (iron dextran injection) is supplied through a small set of manufacturer-supplier relationships because iron dextran products are tightly constrained by injectable manufacturing capacity and regulatory approval history. For “suppliers,” the operational sources that matter for procurement and substitution are (1) the current FDA-listed label holder and (2) the firms that distribute/market the product under that label for US availability. Without the specific label-holder and distributor entries for the current INFeD package, no complete, accurate supplier list can be produced.
Who supplies INFeD (iron dextran injection) in the US?
Featured snippet answer: The only defensible “supplier” list for INFeD is the FDA-label manufacturer/holder plus the listed US distributor(s). Those entries must be verified against the latest product listing/label for the marketed strengths and presentations.
Which INFeD strengths and presentations determine supplier mapping?
- INFeD is marketed as iron dextran injection with specific concentration(s) and pack sizes that can vary by NDC and presentation.
- Supplier and distributor lists can differ by NDC, so a complete procurement view must be NDC-specific.
What counts as a “supplier” for procurement and substitution?
- Manufacturing/labeling entity (the firm responsible for the approved drug product)
- US distributor/marketed-by entity tied to the NDC listing
- Contract manufacturers are sometimes involved but are not reliably visible without full licensing and facility data
What companies manufacture INFeD (iron dextran) drug substance and drug product?
Featured snippet answer: Manufacturer identification requires the current FDA drug listing (label holder and manufacturing sites) for the exact INFeD NDC.
Drug product vs. drug substance split
- Iron dextran injection is produced as a complex iron-carbohydrate colloidal formulation.
- Contract manufacturing can apply to sterile fill-finish even when the label holder is the brand owner.
How to interpret “made by” vs “distributed by”
- “Manufactured for” language on packaging often differs from “distributed by” marketing information.
- Regulatory responsibility sits with the approved label holder; supply-chain procurement should map to the NDC-linked distributor.
What is the Orange Book status of INFeD, and does that affect supplier availability?
Featured snippet answer: If INFeD is listed as an approved drug and is not subject to an exclusivity barrier, multiple suppliers might exist. If supply is concentrated in one label holder and one distribution channel, availability remains concentrated even without patent barriers.
Why Orange Book entries matter for supplier counts
- Orange Book listings can indicate whether there are approved generics or pharmaceutically equivalent products.
- For injectables, approved equivalents often still face manufacturing and sterility constraints that limit the number of active suppliers.
Are there INFeD generic or authorized alternatives, and who supplies them?
Featured snippet answer: Supplier diversification depends on whether approved iron dextran equivalents exist for the same route, concentration, and dosing regimen.
What to check for alternatives
- Same active ingredient (iron dextran)
- Pharmaceutically equivalent presentation (NDC matching by strength/pack)
- Approved substitution feasibility in formularies
Which distributors supply INFeD to hospitals and group purchasing organizations (GPOs)?
Featured snippet answer: Hospital supply usually flows through GPOs and national distributors that carry the NDC. Exact distributors vary by contract and can change by shortage status.
Procurement implications
- INFeD availability can shift during supply interruptions even when the label holder remains constant.
- In practice, “supplier” for purchasing is often the distributor that can fulfill contracted allocation.
What patent estate and litigation risks affect INFeD supply or generic entry?
Featured snippet answer: Patent status can constrain generic entry, but supply can still be limited by manufacturing capacity and sterile injectable controls. Without verified INFeD patent and regulatory listings, a complete risk map cannot be stated.
When did INFeD supply change, and which suppliers gained or lost availability?
Featured snippet answer: Supply changes depend on label holder production interruptions, distributor allocations, and shortage designations. A timeline requires sourcing from FDA drug shortage communications tied to the specific INFeD NDC.
Key Takeaways
- A complete, accurate INFeD supplier list requires FDA-linked label holder and NDC-linked distributor entries for the currently marketed INFeD presentation.
- “Supplier” in procurement terms means the approved label manufacturer/holder and the US distributor tied to the INFeD NDC.
- Generic/alternative availability and supply stability depend on approved equivalents and manufacturing capacity, not only patent status.
FAQs
- How do I find the correct INFeD supplier for my hospital purchase order? Use the NDC on the order and map to the FDA drug listing distributor/manufacturer for that NDC.
- Can INFeD suppliers differ by strength or vial size? Yes, distributor and sometimes manufacturing coverage can vary by NDC/presentation.
- Are there approved iron dextran alternatives that can substitute for INFeD? Only if they are pharmaceutically equivalent to the same active ingredient and presentation and are accepted for formulary substitution.
- Do INFeD shortages affect all distributors equally? Allocation can concentrate through specific distribution channels during production constraints.
- Does patent status determine INFeD availability? Patent barriers influence generic entry, but shortages are more directly driven by manufacturing and regulatory production capacity.
References
No sources were cited because the necessary, current FDA/Orange Book/label-linked INFeD supplier facts were not provided in the prompt.
