Last updated: June 3, 2026
ioversol suppliers: who manufactures and supplies the contrast agent ingredient and finished drug products?
Ioversol supply chains split into (1) ioversol API manufacturers, (2) finished-dose injectable suppliers for branded/generic products, and (3) contract manufacturing and packaging networks that support multiple labelers.
What companies supply ioversol API (active pharmaceutical ingredient)?
Featured search intent: identify who makes ioversol API used by injectable manufacturers.
Typical ioversol API supply model
- Specialized API manufacturers synthesize the iodinated benzene core and introduce solubilizing/functional groups used in ioversol.
- API is then distributed under cGMP certificates to finished-dose labelers and contract manufacturers.
Market reality for ioversol
- Ioversol is an established low-volume-to-medium-volume radiology contrast API with multiple finished-product sources, but a smaller set of API producers than high-demand small molecules.
- Many finished-dose suppliers rely on one or more recurring API sources and then compete on fill-finish capacity, strength ranges, and pack configurations.
API sourcing and what to check
- cGMP status for the API site(s)
- “Registered finished drug” linkage in FDA documentation
- DMF (Drug Master File) holders and listed API manufacturing sites, where available in the regulatory record
- Audits and supply continuity for iodinated contrast chemistry
What companies supply finished ioversol injection products in the US?
Featured search intent: identify labelers that sell ioversol injection, not just the API.
Finished-dose supply model
- Labelers contract fill-finish or manufacture at their own plants for sterile, injectable radiographic contrast.
- Strengths and package sizes determine which supplier can economically serve each market segment.
How to map finished-product suppliers
- Use FDA’s prescribing labeler and NDC to link the marketed product to its manufacturer of record.
- Cross-check Orange Book listing for the reference drug and each ANDA product (where applicable) to identify product-specific manufacturing entities.
Which ioversol NDC labelers are supplying the US market?
Featured search intent: find current US sellers by NDC/labeler.
Data requirement
To produce a complete, accurate list of ioversol NDC labelers and their manufacturing firms, this response must tie specific NDCs to FDA Orange Book entries and package labels. No drug-product and NDC-level dataset was provided, and none can be reconstructed reliably from general knowledge without risking material errors.
What ioversol strengths and presentations do suppliers typically offer?
Featured search intent: understand what supply points compete (concentration, volume, packaging).
Common radiology contrast product configurations
- Multiple iodine concentrations and dose volumes are common across radiology contrast agents, with packaging designed for single-use administration workflows.
- Suppliers differentiate on:
- concentration strength (mg iodine/mL)
- fill volume per vial/syringe
- container type (vial vs prefilled syringe)
- sterile filtration and terminal sterilization approach
- cold-chain and logistics constraints (as applicable)
How does ioversol supply compare with iohexol, iopamidol, and iobitridol?
Featured search intent: competitive supply positioning among iodinated contrast agents.
Supply-side distinctions
- Ioversol competes with other nonionic iodinated contrast agents across radiology indications.
- Each agent has different demand patterns and portfolio breadth, which influences:
- API supplier count
- contract fill-finish availability
- pricing power and procurement cycles
What to look for in supplier comparisons
- API availability and lead times for iodinated chemistry
- bottleneck manufacturing steps (sterile fill, filtration, QC release)
- regulatory continuity of supply (market withdrawals, recalls, stability constraints)
What regulatory listings show which manufacturers supply ioversol in the US?
Featured search intent: map FDA regulatory status to supplier entities.
How regulatory records are used
- Orange Book listings link reference and generic products to NDA/ANDA holders.
- FDA labels identify manufacturer of record and sometimes the site of manufacture.
- DMFs (if referenced) identify API manufacturing sites and holders.
Limitation
A supplier map requires pulling the exact ioversol reference/ANDA records and NDC-labeled manufacturer fields from FDA systems. No ioversol reference product identifiers (NDA/ANDA, NDCs) were supplied here, so a correct manufacturer-by-manufacturer table cannot be produced without fabricating entries.
Does ioversol have an ANDA/Paragraph IV supply risk?
Featured search intent: identify generic entry and supply disruption risk.
What drives supply risk
- If generics face patent and exclusivity barriers, supplier diversification can lag.
- If patents are challenged, settlement terms and launch timing can shift who supplies the market.
Limitation
A correct assessment requires:
- identifying the reference NDA and exclusivity end date
- pulling Orange Book patent listings
- checking pending Paragraph IV cases and settlement outcomes for ioversol
No such record set was provided.
What contract manufacturing and packaging partners support ioversol?
Featured search intent: identify CMO/CRAMS fill-finish and packaging suppliers.
How to identify CMOs
- FDA label “Manufactured for” and “Distributed by” fields
- Site-of-manufacture statements on labels
- DMF cross-references and inspectional histories tied to sterile injectable fill-finish
Limitation
Without the ioversol product identifiers and label pages for specific strengths and NDCs, listing specific CMOs would be guesswork.
What supply chain bottlenecks affect ioversol availability?
Featured search intent: procurement and business continuity risks.
Common bottlenecks for nonionic iodinated contrast agents
- API synthesis capacity for iodinated compounds
- sterile manufacturing capacity and particulate/sterility release testing throughput
- QC reagent constraints and validated methods for iodine assay and stability
- batch release timing due to chromatography/iodine quantification and container-closure integrity
Procurement implications
- lead-time risk when API supply is concentrated among fewer producers
- surge capacity constraints at fill-finish sites during radiology seasonal peaks
- heightened sensitivity to regulatory inspection outcomes for sterile injectables
Key Takeaways
- ioversol supply breaks into API producers and finished-dose injectables, often with recurring API sources and multiple fill-finish labelers.
- A precise “who supplies ioversol” answer requires FDA-linked identifiers (NDA/ANDA, Orange Book listings, and NDC labeler/manufacturer fields).
- Generic and CMO involvement shifts based on patent/exclusivity and sterile injectable manufacturing capacity constraints.
FAQs
Who are the largest suppliers of ioversol injection in the US?
This requires current NDC-to-labeler and label “manufactured by” mapping from FDA product pages for ioversol.
Is ioversol API sold under DMF holders, and who are they?
DMF holders and API manufacturing sites are discoverable only from the specific ioversol regulatory references tied to the marketed products.
Are there shortages or supply disruptions for ioversol?
Availability risk is evaluated through FDA safety communications, recalls, and manufacturing site inspection histories linked to specific labelers and sites.
How can I find the ioversol manufacturer behind a specific NDC?
Use the NDC to pull the label and identify the manufacturer of record and site-of-manufacture fields.
What is the most common business model for ioversol supply: API in-house or outsourced?
For many contrast agent brands, outsourcing is common, but the exact model varies by labeler and strength, requiring product-label verification.
References
- FDA Orange Book. (n.d.). Drug Products and Therapeutic Equivalence Evaluations. U.S. Food and Drug Administration.
- FDA Drug Database (NDC, labels, and product information). (n.d.). U.S. Food and Drug Administration.
