Suppliers and packagers for generic pharmaceutical drug: FERRIC CARBOXYMALTOSE

FERRIC CARBOXYMALTOSE

Listed suppliers include manufacturers, repackagers, relabelers, and private labeling entitities.

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Am Regent	INJECTAFER	ferric carboxymaltose	SOLUTION;INTRAVENOUS	203565	NDA	American Regent, Inc.	0517-0602-01	1 VIAL, SINGLE-DOSE in 1 BOX (0517-0602-01) / 2 mL in 1 VIAL, SINGLE-DOSE	2022-06-01
Am Regent	INJECTAFER	ferric carboxymaltose	SOLUTION;INTRAVENOUS	203565	NDA	American Regent, Inc.	0517-0620-01	1 VIAL, SINGLE-DOSE in 1 BOX (0517-0620-01) / 20 mL in 1 VIAL, SINGLE-DOSE	2021-06-01
Am Regent	INJECTAFER	ferric carboxymaltose	SOLUTION;INTRAVENOUS	203565	NDA	American Regent, Inc.	0517-0650-01	1 VIAL, SINGLE-DOSE in 1 BOX (0517-0650-01) / 15 mL in 1 VIAL, SINGLE-DOSE	2013-08-12

Suppliers and packagers for generic pharmaceutical drug: FERRIC CARBOXYMALTOSE

Last updated: April 24, 2026

Who Supplies Ferric Carboxymaltose for Pharmaceutical Markets?

Ferric carboxymaltose (FCM) suppliers typically fall into four tiers: (1) branded originators and their authorized manufacturers, (2) generic injectable entrants, (3) raw-material and intermediate suppliers used to make the API, and (4) contract manufacturing organizations (CMOs) that produce drug product under licensing. Contract and branded ecosystems change quickly by geography, but the supply-chain structure is consistent.

What is the market anchor for ferric carboxymaltose supply?

The commercial reference product is INJECTAFER (ferric carboxymaltose), which is marketed in multiple regions through regional marketing authorizations and manufacturing networks tied to the original development and manufacturing chain.

Who are the key branded and platform suppliers?

Which companies control major branded ferric carboxymaltose supply?

• Vifor Pharma: Original brand owner/marketer of INJECTAFER across multiple geographies.
• Luitpold / Nattermann manufacturing ecosystem under authorized arrangements: Historically linked to injectable iron product manufacturing networks used for branded ferric carboxymaltose supply in certain markets (varies by region and authorization).

The dominant practical takeaway for sourcing decisions is that for regulated markets, branded supply is usually stable but capacity and pricing flow through the regional marketing authorization holder and their release sites, not through “open” market API procurement.

Who supplies generic ferric carboxymaltose?

Which generic manufacturers supply ferric carboxymaltose injections?

Generic supply is typically provided by manufacturers that hold marketing authorizations for iron(III)-carboxymaltose products in specific jurisdictions. The supplier list is country-specific and changes with tender cycles, pricing controls, and substitution rules.

For investment and procurement, the correct approach is to map by: 1) Country (authorization and tender landscape), 2) Presentation (commonly 50 mg/mL in 2 mL or 10 mL vials depending on label), 3) Regulatory status (approved vs. import-only), 4) Local batch release and distribution model (direct, distributor, or tender supplier).

Because generic approvals are jurisdiction- and time-dependent, a fully accurate “global supplier roster” cannot be stated as a single fixed list without a jurisdiction filter.

Who supplies the API and critical intermediates?

How does API sourcing work for ferric carboxymaltose?

Ferric carboxymaltose API is not typically sourced like commodities. It is usually:

• manufactured by specialized iron-complex API makers,
• supplied under technical agreements with defined specifications,
• used by finished-dose manufacturers under GMP controls.

In practice, pharmaceutical suppliers who “sell” ferric carboxymaltose are usually either:

• marketing authorization holders (drug product suppliers), or
• API manufacturers operating through controlled sales channels.

What are the drug-substance and product specifications procurement teams match?

What spec targets matter when qualifying ferric carboxymaltose suppliers?

Procurement qualification typically matches on:

• Strength and concentration (FCM injection strength per label)
• Iron content per container (mg Fe per mL and per vial/ampoule)
• Complex stability profile (complexation and release behavior)
• Impurities profile (residuals and process impurities aligned to pharmacopeial/registration specs)
• Sterility assurance and container closure system
• Particle and appearance limits (injectable acceptance criteria)

These are the elements procurement and QA use to confirm interchangeability between suppliers and to pass exchange programs when tenders switch brands.

Where do suppliers sit in the value chain?

Which supplier categories are relevant to a sourcing plan?

Supplier category	What they sell	Typical customer	Sourcing outcome
Branded marketing authorization holder	Finished dose with local release and distribution	Hospitals, distributors, wholesalers	Fast availability, stable label compliance
Authorized contract manufacturer	Finished dose for brand or licensee	Regional marketing entity	Stable supply with defined release site
Generic marketing authorization holder	Finished dose with local authorization	Tender channels, hospital systems	Price-competitive supply with label-matched dosing
API/intermediate supplier	Ferric carboxymaltose substance for drug product	Finished-dose manufacturers	Lower direct purchasing, higher technical qualification load
CMO under license	GMP drug product manufacturing	Brand owner or generic holder	Enables capacity scaling without owning plants

How to decide which “supplier” matters for your use case

What supplier definition should you use for ferric carboxymaltose procurement?

• If you need tender-ready supply to hospitals, the relevant supplier is the drug product marketing authorization holder with local distribution and batch release.
• If you need manufacturing continuity for a branded or generic program, the relevant supplier is the CMO API-to-finished-dose chain (API + drug product) and the release site.
• If you need raw sourcing for internal manufacture, the relevant supplier is the API manufacturer, qualified to your registration route and specs.

Key constraints that limit supplier portability

What factors block easy switching between ferric carboxymaltose suppliers?

• Regulatory authorization: product name, strength, and formulation are tied to specific approvals in each jurisdiction.
• Batch release and distribution: supply timing is linked to release sites and logistics.
• Tender frameworks: hospital procurement often locks to prequalified bidders and substitution rules.
• QA comparability: manufacturers and distributors require analytical comparability and documentation completeness.

Key Takeaways

• Ferric carboxymaltose supply is anchored by branded INJECTAFER distribution networks under the Vifor Pharma ecosystem, with finished-dose manufacturing executed through authorized manufacturing partners.
• Generic supply exists but is jurisdiction-specific, and the actionable supplier list depends on the country’s marketing authorization and tender landscape.
• For procurement, the “supplier” that matters is the finished-dose marketing authorization holder with batch release and local distribution, not necessarily the API producer.
• Supplier switching is constrained by authorization, release logistics, and QA documentation tied to the specific registered presentation and specs.

FAQs

1) Who is the main branded supplier of ferric carboxymaltose?

Vifor Pharma is the main branded ecosystem supplier for INJECTAFER in multiple regions.

2) Do ferric carboxymaltose suppliers differ between countries?

Yes. Generic and even branded supply depends on local marketing authorizations, batch release sites, and tender prequalification.

3) Can hospitals buy ferric carboxymaltose from API manufacturers?

Typically no. Hospitals purchase finished-dose products released under local regulatory approvals, not API.

4) What matters most for supplier qualification?

Strength and iron content per vial, stability and impurities profile aligned to registration/pharmacopeia specs, sterility assurance, and container closure acceptance.

5) What is the practical procurement target for supply continuity?

The finished-dose supplier with confirmed local batch release and contractual supply continuity into the tender cycle.

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References

[1] Vifor Pharma. INJECTAFER (ferric carboxymaltose) product information and regulatory materials.
[2] European Medicines Agency (EMA). Public assessment and EPAR documents related to ferric carboxymaltose-containing products (INJECTAFER and authorized equivalents where applicable).