Last updated: May 30, 2026
Executive summary
- CLARISCAN is a gadoterate meglumine (gadoteric acid) MRI contrast product supplied through a defined brand supply chain dominated by the original gadoterate API technology owner and the current marketing authorization holder in each country.
- “Suppliers” in practice map to: (1) gadoterate meglumine API manufacturers, (2) finished-dose manufacturers who fill/pack CLARISCAN, and (3) distribution/marketing authorization holders that control batch release and labeling.
- To build a defensible supplier map for CLARISCAN (including which entities provide API vs. finished sterile solution), company-level and regulatory-level sources must be aligned. Without jurisdiction-specific labeling/MAH and the exact presentation strength (typically 0.5 mmol/mL), supplier identification cannot be completed to a litigation-grade standard.
Who are the main CLARISCAN suppliers (API and finished-dose manufacturing)?
Featured snippet answer: CLARISCAN’s supply chain divides into gadoterate meglumine API producers and finished-dose sterile-solution manufacturers. The most authoritative “suppliers” are the marketing authorization holder (MAH) who lists manufacturing sites on regulatory product dossiers and the batch-release manufacturing sites shown in country-level authority databases.
What counts as a “supplier” for procurement and IP risk?
- API supplier: entity manufacturing gadoterate meglumine (the active pharmaceutical ingredient).
- Finished-dose supplier: entity manufacturing the sterile filled product (bulk drug product preparation, sterile filtration/filling, vial/syringe assembly, labeling, packaging).
- Batch release authority/QA site: entity that signs off release specifications (sometimes same as manufacturer, sometimes not).
- Local MAH/distributor: entity that holds the authorization and supplies finished goods for a given country.
Which data sources identify CLARISCAN manufacturing sites?
- National drug regulator product listings (manufacturing site addresses and release sites).
- The product’s EU or national SmPC/label and the MAH’s submission documents.
- FDA/Orange Book is not applicable if CLARISCAN is not an FDA-approved listed drug (gadoterate-containing products are often authorized outside the US, and brand-specific listings vary).
What organizations manufacture gadoteric acid (gadoterate meglumine) used in CLARISCAN?
Featured snippet answer: Gadoterate meglumine is produced by a limited number of global API manufacturers with established MRI contrast chemistry know-how and ISO/sterile supply competence.
Common global API supply patterns for gadoterate-based agents
- API is typically manufactured in dedicated multi-purpose small-molecule plants that support high-purity chelator salts.
- Finished-dose production occurs in sterile injectable facilities with validated filling lines for vials and syringes.
Supply chain concentration and procurement leverage
- MRI contrast agents face periodic capacity constraints tied to sterile fill-finish throughput rather than only API chemistry.
- Contract manufacturing agreements often split responsibilities between bulk solution preparation and vial/syringe fill.
Which finished-dose manufacturers fill and package CLARISCAN sterile vials or syringes?
Featured snippet answer: Finished-dose manufacturers are identified by the manufacturing and batch release site(s listed on the SmPC/authorization for each jurisdiction.
Dosage form considerations that affect the supplier list
- CLARISCAN is marketed as an injectable MRI contrast solution (presentation differs by country).
- Supplier identity can differ by presentation:
- Vial strength and pack count
- Prefilled syringe variants (if offered)
- Packaging format (carton, blister, kit)
What procurement teams should verify in the CoA and labeling
- Manufacturing site name on CoA matches the regulator-listed site.
- Batch numbering system matches the stated manufacturer.
- Sterile filtration and fill line data align with the validated manufacturing process.
How do MAH/distributor entities change CLARISCAN suppliers by country?
Featured snippet answer: CLARISCAN supplier entities shift by country because the marketing authorization holder and contracted fill-finish sites differ across jurisdictions.
Why the same brand can have multiple “suppliers”
- The MAH appoints manufacturers per region for:
- GMP compliance
- logistics and cold-chain requirements
- local regulatory submission strategy
What this means for global procurement
- A single corporate group can supply API globally but appoint different sterile fill-finish partners by country.
- IP risk mapping also becomes jurisdiction-specific, because patent coverage and litigation are country-linked.
What patents protect CLARISCAN’s gadoterate meglumine product supply and formulations?
Featured snippet answer: Patents protecting gadoterate meglumine MRI contrast typically cover synthesis of the chelator, salt form specifications, formulations, and method-of-use indications. Supplier switching can be constrained by process and formulation IP, depending on jurisdiction.
Formulation and manufacturing patents that can constrain “generic-style” supply
- Sterile solution composition and stabilizer systems
- Particle control and specification windows
- Container-closure compatibility (glass, elastomer compatibility)
- Manufacturing process steps that reduce impurities
Method-of-use patents
- Indications for MRI contrast enhanced imaging of defined anatomical systems can have method-of-use claims in some jurisdictions, affecting launch strategies for competitors.
When does CLARISCAN lose exclusivity and enable generic or biosimilar-style entry?
Featured snippet answer: Exclusivity timelines for gadoterate-based agents depend on the jurisdiction and the specific authorization date, plus any data exclusivity or patent term extensions for the MAH’s earliest filings.
Practical exclusivity drivers
- Composition patent expiry for the chelator salt and synthesis routes
- Formulation and manufacturing process patent expiry
- Regulatory data exclusivity (where applicable)
- Residual market authorization terms for particular presentations
What generic entry risks exist for CLARISCAN in the US vs. EU?
Featured snippet answer: For gadoterate-based MRI contrasts, competitor entry usually follows generic (or locally authorized) pathways rather than biosimilar frameworks, because the products are small-molecule drugs.
US pathway logic
- If an FDA-listed reference exists for gadoterate meglumine products, abbreviated applications and reliance on reference product data can occur post-patent and exclusivity windows.
EU pathway logic
- Generic authorization depends on patent status in each member state and acceptance of bioequivalence/quality comparability, with sterile product-specific CMC scrutiny.
What supply chain risks can stop CLARISCAN deliveries even if API exists?
Featured snippet answer: Delivery risk is often tied to sterile fill-finish capacity, container-closure supply, and batch release bottlenecks more than to raw API chemistry.
Typical operational constraints
- Shortages of vials, stoppers, and syringe components
- Reduced sterile filling line availability due to maintenance or validation cycles
- Batch release delays tied to atypical impurity profiles
Key Takeaways
- CLARISCAN “suppliers” should be mapped as separate roles: gadoterate API producers, sterile finished-dose manufacturers, and the marketing authorization holder who controls batch release and labeling by country.
- Supplier identity is jurisdiction-specific. Without the specific country authorization and presentation, a complete supplier list cannot be constructed to a high-standard procurement and IP-risk standard.
- Supply constraints for MRI contrast agents usually concentrate at sterile fill-finish and container-closure compatibility steps.
FAQs
- How do I confirm the real CLARISCAN manufacturing site on the packaging and CoA?
- Are CLARISCAN vials and prefilled syringes made by the same contract manufacturer?
- Do gadoterate meglumine API suppliers differ from sterile fill-finish partners for CLARISCAN?
- What documents best show batch release and sterility manufacturing controls for CLARISCAN procurement?
- How does patent status differ across EU member states for gadoterate meglumine MRI contrast supply?
References
- (No sources cited)
