Last Updated: May 10, 2026

Suppliers and packagers for DEFEROXAMINE MESYLATE


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DEFEROXAMINE MESYLATE

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

Applicant Tradename Generic Name Dosage NDA NDA/ANDA Supplier Package Code Package Marketing Start
Fresenius Kabi Usa DEFEROXAMINE MESYLATE deferoxamine mesylate INJECTABLE;INJECTION 078718 ANDA Fresenius Kabi USA, LLC 63323-597-10 1 VIAL in 1 BOX (63323-597-10) / 5.3 mL in 1 VIAL 2009-12-15
Fresenius Kabi Usa DEFEROXAMINE MESYLATE deferoxamine mesylate INJECTABLE;INJECTION 078718 ANDA Fresenius Kabi USA, LLC 63323-599-30 1 VIAL in 1 BOX (63323-599-30) / 21.1 mL in 1 VIAL 2009-12-15
Gland DEFEROXAMINE MESYLATE deferoxamine mesylate INJECTABLE;INJECTION 207384 ANDA Apotex Corp. 60505-6236-6 4 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 CARTON (60505-6236-6) 2021-11-05
Gland DEFEROXAMINE MESYLATE deferoxamine mesylate INJECTABLE;INJECTION 207384 ANDA Apotex Corp. 60505-6237-6 4 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 CARTON (60505-6237-6) 2021-11-05
Gland DEFEROXAMINE MESYLATE deferoxamine mesylate INJECTABLE;INJECTION 207384 ANDA Gland Pharma Limited 68083-172-01 4 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 CARTON (68083-172-01) 2017-10-09
Gland DEFEROXAMINE MESYLATE deferoxamine mesylate INJECTABLE;INJECTION 207384 ANDA Gland Pharma Limited 68083-173-01 4 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 CARTON (68083-173-01) 2017-10-09
>Applicant >Tradename >Generic Name >Dosage >NDA >NDA/ANDA >Supplier >Package Code >Package >Marketing Start

Suppliers for Deferoxamine Mesylate (Drug Substance)

Last updated: April 26, 2026

Deferoxamine mesylate is the mesylate salt form of deferoxamine (deferoxamine). Supply is typically provided by (i) active pharmaceutical ingredient (API) manufacturers and (ii) intermediates and custom-synthesis vendors that produce deferoxamine or deferoxamine mesylate to pharmaceutical-grade specifications.

Who supplies deferoxamine mesylate API?

Which companies sell deferoxamine mesylate as an API?

Common global supply channels for deferoxamine mesylate API include:

  • Thermo Fisher Scientific (Gibco/now Life Sciences supply channels; chemical/pharma-grade distribution)
  • Bachem (API and specialty chemical production, including complex building blocks and salts)
  • CordenPharma (contract manufacturing and API/intermediate supply pathways)
  • Aenova / other CDMO networks (salt form preparation and API supply via contract programs)
  • Mainline chemical suppliers that list deferoxamine mesylate for laboratory use (not always GMP-compliant; pharma-grade supply depends on documentation)

Note: Pharmaceutical “supplier” in procurement terms usually means a GMP-manufactured API supplier with a Drug Master File (DMF) or equivalent regulatory package, not a general catalog chemical.

What evidence indicates pharma-grade availability?

In regulated procurement, suppliers typically provide one or more of the following:

  • GMP manufacturing confirmation (facility qualification)
  • DMF/CEP/registration references for the API or relevant salt form
  • CoA and impurity profiles tied to the release specification
  • Controlled specifications for identity (e.g., IR/LC methods), assay, water content, and residual solvents

How do suppliers typically source deferoxamine mesylate?

What are the usual upstream routes into deferoxamine mesylate?

Deferoxamine mesylate supply generally comes from two practical production models:

  1. API manufacturer path

    • Deferoxamine base synthesis (or procurement)
    • Salt formation with methanesulfonic acid (mesylate)
    • API purification and crystallization to meet specification
  2. CDMO/custom synthesis path

    • Synthesis of deferoxamine or late-stage intermediates
    • Salt formation and API finishing under GMP
    • Transfer of analytical methods and documentation packages

Supplier categories for procurement use

Which vendor types show up in real-world deferoxamine mesylate sourcing?

Procurement usually evaluates four categories:

  • GMP API manufacturers that sell under their own regulatory package (DMF/CEP)
  • CDMOs that produce the API for multiple markets under contract
  • Specialty chemical salt-formers that can convert deferoxamine base into mesylate under controlled conditions
  • Distributor channels that resell API produced by GMP manufacturers (CoA and chain-of-custody determine compliance)

What specifications do suppliers typically align to?

What specification elements matter for deferoxamine mesylate API?

A compliant supplier will offer routine documentation covering:

  • Assay (deferoxamine mesylate content)
  • Identity (chromatographic and/or spectroscopic confirmation)
  • Impurities (related substances; often specified with thresholds)
  • Residual solvents (ICH Q3C-aligned where applicable)
  • Water content (K-F method or equivalent)
  • Particle/crystal form control (if relevant to downstream formulation performance)

Supply landscape and practical sourcing patterns

How are deferoxamine mesylate supplies typically arranged by buyers?

Buyers typically request:

  • GMP lots with full batch release documentation
  • Regulatory support (DMF letter of access or standalone dossier support)
  • Long-term supply agreements for continuity due to niche API demand

Because deferoxamine is a specialty chelator and mesylate salt form is frequently used for dosing consistency, buyers often manage supply via:

  • Dual sourcing (primary + approved alternate)
  • Vendor qualification on impurity control rather than only assay

Key Takeaways

  • Deferoxamine mesylate is supplied through GMP API manufacturers and CDMO pathways, with salt formation (mesylate) as a key finishing step.
  • In regulated procurement, “supplier” must map to a GMP-capable manufacturer with CoA and regulatory documentation (DMF/CEP or dossier support), not only a catalog chemical listing.
  • The most dependable sourcing pattern is dual sourcing and qualification focused on impurity profile, residual solvents, and identity methods.

FAQs

1) Is deferoxamine mesylate typically sold as GMP API or as lab-grade chemical?

It is available in both channels; regulated procurement requires GMP API with batch release documentation and regulatory support.

2) What does the mesylate part of deferoxamine mesylate imply for suppliers?

It means suppliers must perform salt formation with methanesulfonic acid and control crystallization to meet identity and impurity specs.

3) Do distributors qualify as “suppliers” for regulatory filings?

Distributors usually resell product. Regulatory use typically depends on the manufacturer’s GMP and documentation package (DMF/CEP/CoA).

4) What documentation should procurement insist on for deferoxamine mesylate?

At minimum: CoA, GMP confirmation, impurity/assay specification, residual solvent and water data, and identity results; for filings, a DMF/dossier support mechanism.

5) How do buyers reduce supply risk for this niche API?

They use dual sourcing and qualify alternates based on impurity profiles and method equivalency, not only assay.

References

[1] Thermo Fisher Scientific. Deferoxamine mesylate product information and specifications (catalog and technical resources). APA: Thermo Fisher Scientific website.

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