Last Updated: May 10, 2026

Suppliers and packagers for IRON SUCROSE


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IRON SUCROSE

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

Applicant Tradename Generic Name Dosage NDA NDA/ANDA Supplier Package Code Package Marketing Start
Intl Medication Sys IRON SUCROSE iron sucrose INJECTABLE;INTRAVENOUS 208977 ANDA International Medication Systems, Limited 76329-9200-1 10 VIAL, SINGLE-DOSE in 1 PACKAGE (76329-9200-1) / 2.5 mL in 1 VIAL, SINGLE-DOSE 2025-08-12
Intl Medication Sys IRON SUCROSE iron sucrose INJECTABLE;INTRAVENOUS 208977 ANDA International Medication Systems, Limited 76329-9201-1 10 VIAL, SINGLE-DOSE in 1 PACKAGE (76329-9201-1) / 5 mL in 1 VIAL, SINGLE-DOSE 2025-08-12
Intl Medication Sys IRON SUCROSE iron sucrose INJECTABLE;INTRAVENOUS 208977 ANDA International Medication Systems, Limited 76329-9202-5 5 VIAL, SINGLE-DOSE in 1 PACKAGE (76329-9202-5) / 10 mL in 1 VIAL, SINGLE-DOSE 2025-09-12
Mylan Labs Ltd IRON SUCROSE iron sucrose INJECTABLE;INTRAVENOUS 212559 ANDA Mylan Institutional LLC 67457-638-10 10 VIAL, SINGLE-DOSE in 1 CARTON (67457-638-10) / 5 mL in 1 VIAL, SINGLE-DOSE 2025-08-11
Mylan Labs Ltd IRON SUCROSE iron sucrose INJECTABLE;INTRAVENOUS 212559 ANDA Mylan Institutional LLC 67457-638-25 25 VIAL, SINGLE-DOSE in 1 CARTON (67457-638-25) / 5 mL in 1 VIAL, SINGLE-DOSE 2025-08-11
Mylan Labs Ltd IRON SUCROSE iron sucrose INJECTABLE;INTRAVENOUS 212559 ANDA Mylan Institutional LLC 67457-639-10 5 VIAL, SINGLE-DOSE in 1 CARTON (67457-639-10) / 10 mL in 1 VIAL, SINGLE-DOSE 2025-08-11
Mylan Labs Ltd IRON SUCROSE iron sucrose INJECTABLE;INTRAVENOUS 212559 ANDA Mylan Institutional LLC 67457-957-99 10 VIAL, SINGLE-DOSE in 1 CARTON (67457-957-99) / 2.5 mL in 1 VIAL, SINGLE-DOSE 2025-08-11
>Applicant >Tradename >Generic Name >Dosage >NDA >NDA/ANDA >Supplier >Package Code >Package >Marketing Start

Suppliers and packagers for IRON SUCROSE

Last updated: April 24, 2026

Who Supplies Iron Sucrose for Pharmaceutical Use?

Iron sucrose is an established parenteral iron formulation used to treat iron deficiency where oral therapy is inappropriate or ineffective. The supply base is largely driven by injectable drug manufacturers and, for many regions, by branded and authorized generic product lines under national marketing authorizations.

Which companies supply iron sucrose injections?

Iron sucrose products are sold globally under multiple brand names and strengths, commonly as iron(III) hydroxide sucrose complex in an aqueous injection. The most consistently referenced supplier set includes the following manufacturers of iron sucrose injection products (by marketing authorizations and major market availability):

Supplier / Manufacturer Common marketed strength (typical) Product type
Vifor Pharma 20 mg/mL Branded iron sucrose injection; widely distributed internationally
Hikma Pharmaceuticals 20 mg/mL Generic/authorized-brand distribution (region-dependent)
Apotex 20 mg/mL Generic/authorized-brand distribution (region-dependent)
Sandoz 20 mg/mL Generic/authorized-brand distribution (region-dependent)
Amneal Pharmaceuticals 20 mg/mL Generic/authorized-brand distribution (region-dependent)
Fresenius Kabi 20 mg/mL Distribution via local authorizations (region-dependent)
Sun Pharma 20 mg/mL Generic/authorized-brand distribution (region-dependent)
Teva 20 mg/mL Generic/authorized-brand distribution (region-dependent)
Accord Healthcare 20 mg/mL Generic/authorized-brand distribution (region-dependent)
Mylan (now Viatris) 20 mg/mL Generic/authorized-brand distribution (region-dependent)

Note on reading the table: “Supplier” here means the company that markets and supplies iron sucrose injection products through drug approvals in target countries; regional authorization determines the exact legal seller of record. Strength is presented as the market-standard presentation most commonly used for iron sucrose injections.

What suppliers appear in US market references?

In the US, iron sucrose injection is marketed as Venofer by Vifor Pharma (brand ownership and commercialization). This brand serves as the anchor reference point for the molecule’s US commercial supply, with additional generic entrants varying over time by ANDA approvals and label holders.

US anchor product Seller/Marketing authorization holder
Venofer (iron sucrose injection) Vifor Pharma

What suppliers appear internationally (EU/UK and other large markets)?

European and other markets typically show multiple authorized suppliers due to broad generic availability after earlier product and process exclusivities. Common supplier names in these markets include the firms listed above (Hikma, Sandoz, Teva, Amneal, Fresenius Kabi, Sun Pharma, Accord, Viatris), with exact availability by country and tender cycles.

What are the typical sourcing and supply channels?

Iron sucrose injection supply typically uses these commercial channels:

  1. Original brand commercialization
    • Example anchor: Vifor Pharma (Venofer).
  2. Authorized generics
    • Company brand names vary; same active substance and strength are typically marketed under national approvals.
  3. Tender-driven hospital procurement
    • Hospitals purchase through national tender systems; the “supplier” on the purchase order is the locally authorized marketing company and distributor.

What product specifications govern supplier qualification?

Supplier qualification for iron sucrose injections is driven by pharmacopoeial and regulatory requirements that remain consistent across brands:

  • Dosage form: injectable solution
  • Active ingredient: iron(III) hydroxide sucrose complex
  • Clinical target: iron deficiency states requiring parenteral iron
  • Regulatory basis: marketing authorization in the destination country, plus labeling that specifies dosing and administration requirements
  • Quality controls: sterility assurance, particulate matter controls, iron content assay, and stability testing per applicable pharmacopeia and regulatory guidance

How to map suppliers for procurement or partnering

From a business standpoint, supplier mapping for iron sucrose should be organized around:

  • Regulatory standing in the buyer’s jurisdiction
    • Identify which companies have currently authorized iron sucrose injection products in that country.
  • Label presentation and strength
    • Most commonly 20 mg/mL, but packaging formats (number of mL per vial) can differ.
  • Contracting model
    • Brand manufacturer supply, generic tender supply, or distributor-led procurement.

Supplier short-list (actionable)

For market engagement, the supplier short-list most frequently encountered across jurisdictions is:

  • Vifor Pharma
  • Hikma Pharmaceuticals
  • Sandoz
  • Teva
  • Amneal Pharmaceuticals
  • Fresenius Kabi
  • Sun Pharma
  • Accord Healthcare
  • Viatris (Mylan)
  • Apotex

Key Takeaways

  • Iron sucrose injection is supplied by a mix of the original branded commercial holder and multiple generics with country-specific authorization.
  • Vifor Pharma is the primary anchored supplier for Venofer in the US.
  • The most common global generic and authorized-brand suppliers include Hikma, Sandoz, Teva, Amneal, Fresenius Kabi, Sun Pharma, Accord, Viatris, Apotex.
  • Procurement decisions hinge on jurisdictional authorization, presentation (commonly 20 mg/mL), and tender/distributor structure.

FAQs

1) Is iron sucrose supplied only by one company globally?

No. The market supports both branded supply and multiple authorized generic products, with availability dependent on the buyer’s country.

2) What strength is most commonly marketed for iron sucrose injection?

20 mg/mL is the most common marketed strength for iron sucrose injections, though packaging and vial size can vary.

3) Who supplies the branded iron sucrose product in the US?

Vifor Pharma supplies Venofer in the US.

4) What determines which supplier can be purchased in a given hospital system?

National regulatory authorization and tender/distributor contracting in that country, which determines the legal marketing entity and the contracted supplier.

5) Are generics interchangeable for procurement planning?

For procurement, generics generally use the same active ingredient (iron(III) hydroxide sucrose complex) and labeled strength, but hospital formulary decisions depend on local authorization, packaging, and tender terms.


References

[1] FDA. (n.d.). Venofer (iron sucrose injection) product information. U.S. Food and Drug Administration. https://www.accessdata.fda.gov/ (accessed via FDA product databases)
[2] EMA. (n.d.). Iron sucrose medicinal products and EPAR/SmPC information across Member States. European Medicines Agency. https://www.ema.europa.eu/
[3] European Pharmacopoeia. (current edition). Iron (III) hydroxide sucrose complex monographs and quality requirements. European Directorate for the Quality of Medicines & HealthCare (EDQM). https://www.edqm.eu/
[4] Drugs@FDA. (n.d.). Approved Drug Products search for iron sucrose injection (ANDA and label holders). U.S. FDA. https://www.accessdata.fda.gov/scripts/cder/daf/
[5] NHS / UK medicines listings. (n.d.). Iron sucrose injection brand/generic listings by manufacturer where available. National Health Service. https://www.nhs.uk/ (accessed via medicine pages)

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