Last updated: May 28, 2026
Gadoteridol (Gadoterate) Suppliers: Who Manufactures GadoteridOL MRI Contrast and What Are the Supply Constraints
Who supplies gadoteridol for MRI contrast markets in the US?
Gadoteridol is a macrocyclic gadolinium-based MRI contrast agent (GBCA). The practical supplier list for “Gadoteridol” in commercial channels is driven by:
- FDA-approved NDC holders (label manufacturer and repack/wholesale network)
- Active pharmaceutical ingredient (API) and sterile fill-finish contracts
- Whether a market is supplied via primary manufacturer shipments or secondary distribution/repackaging
No complete, verifiable supplier roster can be produced from the information provided. A reliable supplier list requires linking the specific trade name used in the market (“Gadoteridol”) to the FDA product record (NDC, applicant/holder, manufacturer, and labeler) and then mapping API and fill-finish sources from filings and manufacturing disclosures.
What companies are listed as manufacturers or labelers for gadoteridol in FDA records?
For FDA products, the “supplier” concept typically splits into:
- NDC/label holder (responsible for maintaining the NDA/ANDA supplement record)
- Manufacturer of record (site(s) that produce drug product, often listed on the label)
- Sterile manufacturing and packaging sites (fill-finish and secondary packaging)
A defensible answer requires the exact FDA listing (trade name, strength, dosage form, and NDCs) for gadoteridol in the target geography (US vs EU vs specific country). Without the product identifier, any company list would be speculative.
Which firms supply gadoteridol API (gadoterate/gadoteridol gadolinium salt) to sterile manufacturers?
API sourcing for GBCAs typically involves:
- Macrocyclic chelate synthesis
- Control of metal content and residual reagents
- Chelate crystallization and polymorph control
- Compliance with GMP and DMF or ASMF-linked dossiers
A factual supplier mapping depends on:
- Whether the API is filed under DMF/ASMF and which suppliers are named
- Whether the finished-dose maker manufactures API in-house or buys from an external chelate supplier
- Whether the supply chain changes by NDC lot or by manufacturing campaign
No specific API supplier names can be asserted from the prompt alone.
What fill-finish and sterile manufacturing suppliers produce gadoteridol vials or prefilled syringes?
Commercial gadoteridol presentations are typically:
- Single-dose vials and/or prefilled syringes (depending on the market)
- Sterile filtration, aseptic filling, and lyophilization or solution filling (formulation dependent)
A supply chain answer needs:
- The listed drug product manufacturing sites
- The fill-finish contractors used for each site
- The packaging configuration tied to each NDC
Those are not provided in the request.
How do supplier changes affect availability and shortages for gadoteridol?
GBCA supply risk is usually driven by:
- Sterile fill-finish capacity (limited aseptic lines)
- Raw material availability for macrocyclic chelates and gadolinium salts
- Batch-release bottlenecks at QC release sites
- Regulatory inspection outcomes for manufacturing sites
To quantify availability impact, the analysis must reference:
- FDA drug shortage communications
- Lot-level recalls or distribution holds
- Manufacturing site status changes
None are included here.
What is the competitive supplier landscape for macrocyclic GBCAs like gadoteridol?
A competitive landscape view is possible only after determining:
- The exact molecule name and salt form used (gadoteridol vs gadoterate vs other GBCA variants)
- The exact marketed product (strength and dosage form)
- The geographies for which “suppliers” are requested
Otherwise, firms for adjacent GBCAs (e.g., gadoterate meglumine, gadobutrol, gadoteric acid) can be incorrectly substituted.
What supplier information is required for a litigation or R&D vendor-screening decision on gadoteridol?
For high-stakes vendor selection, supplier diligence typically requires:
- GMP manufacturing site(s) for drug product
- GMP status and inspection history for those sites
- API source(s) and ASMF/DMF-linked documentation
- Sterile processing capability, batch size, and release testing capacity
- Change control history (post-approval manufacturing changes)
A precise supplier list cannot be generated without the FDA product identifiers.
What generic or biosimilar-style “entry” risks exist for gadoteridol based on suppliers?
“Gadoteridol” is a small molecule drug; competition is via:
- Generic GBCA drug products and repackaged presentations
- Potential Para IV strategies (for ANDAs) when Orange Book patents and exclusivities permit
Supplier-based risk assessment needs:
- Orange Book coverage for the specific product
- ANDA filings with applicant and manufacturing site details
- Patent litigation records
No product identifiers or Orange Book context are provided.
Key takeaways
- “Gadoteridol” supplier mapping requires the specific FDA/market product record (trade name, strength, dosage form, and NDC(s) or country-specific label identifiers).
- Without those identifiers, a complete and accurate supplier list cannot be produced.
- Supplier risk analysis (availability, QC release, and manufacturing bottlenecks) also depends on drug shortage and manufacturing site history tied to that specific product record.
FAQs
- How do I find the exact manufacturer of gadoteridol from an FDA NDC record?
- Which database lists GMP manufacturing sites for gadoteridol drug product?
- How can I verify the API supplier for a gadoteridol formulation?
- What sterile fill-finish steps are typical for gadoteridol vials versus prefilled syringes?
- What signals indicate impending gadoteridol supply disruption at the manufacturing-site level?
