Suppliers and packagers for generic pharmaceutical drug: gadoxetate disodium

gadoxetate disodium

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

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Bayer Hlthcare	EOVIST	gadoxetate disodium	SOLUTION;INTRAVENOUS	022090	NDA	Bayer HealthCare Pharmaceuticals Inc.	50419-320-05	5 VIAL, SINGLE-DOSE in 1 BOX (50419-320-05) / 10 mL in 1 VIAL, SINGLE-DOSE	2008-07-03
Bayer Hlthcare	EOVIST	gadoxetate disodium	SOLUTION;INTRAVENOUS	022090	NDA	Bayer HealthCare Pharmaceuticals Inc.	50419-320-15	5 VIAL, SINGLE-DOSE in 1 BOX (50419-320-15) / 15 mL in 1 VIAL, SINGLE-DOSE	2008-07-03
Bayer Hlthcare	EOVIST	gadoxetate disodium	SOLUTION;INTRAVENOUS	022090	NDA	Bayer HealthCare Pharmaceuticals Inc.	50419-320-75	5 VIAL, SINGLE-DOSE in 1 BOX (50419-320-75) / 10 mL in 1 VIAL, SINGLE-DOSE	2008-07-03

Last updated: May 26, 2026

ecutive summary
Suppliers for gadoxetate disodium (Gd-EOB-DTPA) split into (1) active pharmaceutical ingredient (API) manufacturers of the chelate and (2) finished-dosage and sterile manufacturing for MRI contrast products in the EU/US market. The dominant commercial sourcing model is contract manufacture plus regional packaging for branded and generic presentations. A complete, defensible supplier list requires an Orange Book, EMA product dossier, and direct manufacturer/DMF holder mapping to specific strengths and dosage forms, which is not available in the provided prompt.

Suppliers for gadoxetate disodium (Gd-EOB-DTPA): who makes the API and the finished MRI contrast product?

The supply chain for gadoxetate disodium typically includes:

• API chelate producers (manufacture of Gd-EOB-DTPA as disodium salt, purification, and drying).
• Finished product sterile manufacturers (aseptic filling, sterilization validation, container closure system qualification).
• Regional packagers/labelers that hold the marketing authorization and importation rights.

Because gadoxetate disodium is a gadolinium-based contrast agent used for liver MRI, supply is also constrained by:

• Gadolinium-specific regulatory and environmental handling requirements.
• Strict control of impurities related to gadolinium chelation and ligand integrity.
• Sterility assurance and stability for prefilled syringes/vials (varies by market).

Which companies supply gadoxetate disodium API (Gd-EOB-DTPA disodium) to the market?

API supply routes and typical roles

• DMF-referenced API holders: Companies that hold Drug Master Files for the chelate and provide API under license or supply agreement.
• Contract API manufacturers: Private chemical manufacturers that produce under tolling for branded finished-product holders.
• Vertical integrators: Firms that also run chelation and purification steps in-house and supply both API and drug product.

What matters for supplier selection

• Impurity profile: Control of free gadolinium, transmetallation risk, and ligand-related impurities.
• Particle and moisture characteristics: Impacts downstream sterile filtration and shelf-life.
• Scale capability: Contrast agents are manufactured in batch processes with high QA release thresholds.

Which companies supply gadoxetate disodium sterile injection (vials and prefilled syringes) for MRI?

Finished-dose manufacturing categories

• Sterile aseptic filling: Aseptic processing for vials or prefilled syringes.
• Terminal sterilization (rare for some contrast formats): If used, it requires compatibility and validated container closure systems.
• Packaging and labeling: Regional supply chains repackage and label to meet local regulatory requirements.

Market-specific supply patterns

• Branded originators tend to control drug product release and quality agreements with multiple API sources.
• Generic and biosimilar-like competitors for contrast agents focus on:
  • Matching concentration and presentation (dose volume per unit)
  • Demonstrating comparable physicochemical properties
  • Meeting sterility and stability specifications

What is the Orange Book status of gadoxetate disodium and how does it affect supplier competition?

There is no Orange Book exclusivity framework for gadoxetate disodium that can be mapped from the prompt. The practical implication for supplier strategy is that:

• Patent barriers and regulatory exclusivity in the US can limit generic drug product entry and therefore reduce the pool of finished-dose suppliers.
• DMF/ANDA referenced manufacturing can still broaden API sources even when product-level competition is constrained.

How long until gadoxetate disodium loses exclusivity or faces generic entry risk?

No exclusivity timeline can be produced from the provided information. For MRI contrast agents, generic entry risk is usually driven by:

• Product-level patent expiration
• Formulation and method-of-manufacture patent barriers
• Data exclusivity and approval pathways
• Ongoing regulatory manufacturing approvals and inspection outcomes

What patents or manufacturing/IP barriers affect gadoxetate disodium API and drug product suppliers?

Common barrier categories in contrast-agent manufacturing include:

• Chelation and purification process patents for the gadolinium complex
• Impurity control and crystallization steps
• Sterile filling process and container closure system
• Formulation stabilizers and buffering systems

A specific patent landscape requires listing of assignees, application numbers, jurisdictions, and expiration dates, which is not available in the prompt.

Who are the leading licensors, contract manufacturers, and toll manufacturers for gadoxetate disodium?

A defensible “who supplies whom” map requires:

• Identifying the marketing authorization holders per country
• Linking to API DMF holders
• Mapping contract manufacturing sites through regulatory filings

This mapping cannot be completed from the provided prompt.

How does gadoxetate disodium compare on supply resilience with similar gadolinium MRI contrast agents?

Supply resilience for gadolinium chelates typically tracks:

• Number of qualified API sites
• Sterile filling capacity and local aseptic infrastructure
• Regulatory inspection outcomes
• Chemical precursor supply constraints

A quantitative comparison requires market data not included in the prompt.

What generic entry risks exist for gadoxetate disodium and how would that change the supplier pool?

Generic entry for contrast agents can expand:

• API-source count (through additional DMF-referenced suppliers)
• Finished-dose sourcing options (multiple filled strengths and presentations)

But the direction and timing depend on:

• Patent and exclusivity status
• Regulatory acceptance of reference product comparability
• Supply agreements and quality agreements with validated sites

No entry schedule or risk quantification is available from the prompt.

Key Takeaways

• Gadoxetate disodium supply splits into API producers and sterile finished-dose manufacturers, with regional packagers/labelers as downstream nodes.
• Supplier availability is constrained by gadolinium chelation controls, impurity specifications, and sterile injection manufacturing requirements.
• A complete supplier list tied to specific regulatory authorizations (API DMF holders, finished-dose marketing authorization holders, and manufacturing sites) cannot be produced from the provided prompt.

FAQs

1. How do I identify the true API supplier for gadoxetate disodium?
   Use regulatory dossier linkages (DMF/ASMF references) from the finished-dose marketing authorization and map the API holder to named manufacturing sites.

2. What concentration and presentation details matter when qualifying gadoxetate disodium suppliers?
   Strength (mg/mL), fill volume (vial vs prefilled syringe), container closure system, and labeled dosing instructions.

3. What quality attributes drive batch release for gadoxetate disodium API?
   Free gadolinium levels, chelate integrity/ligand purity, and impurity thresholds that correlate with stability and safety.

4. What regulatory pathway differences affect supplier qualification for gadoxetate disodium drug product?
   The approval pathway (reference vs abbreviated/route-specific) drives what data can be bridged versus what must be generated at the manufacturing site.

5. How can contract manufacturing change the supply risk profile for gadoxetate disodium?
   Multiple qualified sterile filling sites reduce single-site risk, but only if API sources and quality agreements are validated.

References

1. (No citable sources were provided in the prompt.)