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Suppliers and packagers for ISOVUE-250
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ISOVUE-250
Listed suppliers include manufacturers, repackagers, relabelers, and private labeling entitities.
| Applicant | Tradename | Generic Name | Dosage | NDA | NDA/ANDA | Supplier | Package Code | Package | Marketing Start |
|---|---|---|---|---|---|---|---|---|---|
| Bracco | ISOVUE-250 | iopamidol | INJECTABLE;INJECTION | 018735 | NDA | BRACCO DIAGNOSTICS INC | 0270-1314-15 | 10 BOTTLE in 1 BOX (0270-1314-15) / 200 mL in 1 BOTTLE | 1985-12-31 |
| Bracco | ISOVUE-250 | iopamidol | INJECTABLE;INJECTION | 018735 | NDA | BRACCO DIAGNOSTICS INC | 0270-1315-25 | 10 VIAL, SINGLE-DOSE in 1 BOX (0270-1315-25) / 30 mL in 1 VIAL, SINGLE-DOSE | 1985-12-31 |
| Bracco | ISOVUE-250 | iopamidol | INJECTABLE;INJECTION | 018735 | NDA | BRACCO DIAGNOSTICS INC | 0270-1315-30 | 10 VIAL, SINGLE-DOSE in 1 BOX (0270-1315-30) / 50 mL in 1 VIAL, SINGLE-DOSE | 1985-12-31 |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >NDA/ANDA | >Supplier | >Package Code | >Package | >Marketing Start |
Suppliers and packagers for ISOVUE-250
ISOVUE-250 Suppliers: Who Manufactures, Who Supplies, and What’s the Contracting Footprint
Executive summary: ISOVUE-250 (iopamidol injection, 250 mg iodine/mL) is supplied in the US through FDA-licensed manufacturing sites listed under the product’s NDA in FDA records and typically distributed via direct-to-provider channels and wholesale drug distribution networks. The supplier set is defined by (1) the NDA holder’s branded supply chain and (2) contract manufacturing and packaging sites tied to FDA label/CMC support.
Key business takeaway: For contracting, procurement, or biosupply diligence, supplier risk is driven less by “brand supply” and more by manufacturing-site continuity, sterile fill-finish capacity, and iodinated contrast media regulatory and quality history for iopamidol injection.
Who are the manufacturers and contract suppliers for ISOVUE-250 (iopamidol injection) in the US?
Featured snippet answer: ISOVUE-250 is marketed under its NDA with iopamidol injection manufactured at one or more FDA-registered sterile manufacturing and fill-finish facilities shown in FDA product/labeling and registration records. The “supplier” for sourcing and distribution is the labeled manufacturer(s) plus the branded distribution entities used by the NDA holder.
How to identify ISOVUE-250 “suppliers” correctly
Procurement and diligence should distinguish four supplier roles:
- NDA holder / marketer (brand supply responsibility for labeling and distribution)
- Drug substance and drug product manufacturer (iopamidol API and sterile injection manufacturing)
- Sterile fill-finish and packaging supplier (aseptic processing, vial filling/sorting, carton labeling)
- Wholesaler / distribution channel (distribution to hospitals and group purchasing organizations)
ISOVUE-250 supply chain typically maps to two manufacturing nodes
For sterile contrast media injections, iopamidol supply chains usually consolidate into:
- API supply: iopamidol manufacture and purification, then conversion to injection-form intermediate or direct drug product intermediate depending on site
- Drug product node: sterile filtration, aseptic filling into vials, and secondary packaging
What FDA registrations and labeling files identify ISOVUE-250 suppliers?
Featured snippet answer: ISOVUE-250 supplier identification is anchored in FDA drug establishment registrations (and site-specific manufacturing/processing roles) and approved labeling that names the manufacturer responsible for the marketed product.
Which FDA systems drive supplier lists
- FDA drug establishment registration data (lists manufacturing/processing sites)
- NDC directory + labeler/manufacturer mappings
- FDA product labeling for “manufactured for” and site attribution
- Inspectional history associated with registered sites (quality and compliance risk lens)
Which companies supply iopamidol injection (contrast media) alongside ISOVUE-250?
Featured snippet answer: Multiple branded and generic iopamidol injection products exist in the US and share a core set of contract manufacturing and sterile fill-finish capabilities. ISOVUE-250 is one branded product line within that ecosystem.
Competitive supply context for iopamidol injection
When hospitals dual-source or switch within iodinated contrast media, procurement typically considers:
- brand substitution policies
- availability during manufacturing disruptions
- price and supply assurance from distribution networks
- product form: vial size, concentration, and labeling
Does ISOVUE-250 have multiple manufacturing sites or is it single-site supply?
Featured snippet answer: Most sterile injectable products have at least one primary manufacturing and one secondary packaging/fill-finish site, but the exact number for ISOVUE-250 depends on FDA labeling attribution and registered establishment listings for the product’s current NDCs.
What matters for supplier continuity
For iopamidol injection, supplier continuity is sensitive to:
- aseptic fill-finish line uptime
- qualified aseptic components (closures, vial types)
- raw material sourcing for iodinated intermediates
- sterility assurance controls and batch release timelines
Who distributes ISOVUE-250 to hospitals and wholesalers?
Featured snippet answer: Distribution is typically handled through the NDA holder’s distribution organization and standard wholesale drug distribution channels for institutional and retail fulfillment, with product movement tied to NDC-specific labeler mappings.
How distributor lists show up operationally
In practice, supplier procurement is operationalized via:
- GPO contracted distributor lines
- hospital pharmacy purchasing systems linked to NDC catalog entries
- case pack and vial presentations that map to specific warehouse stocking SKUs
What procurement risks exist if ISOVUE-250 suppliers change?
Featured snippet answer: Supplier changes risk manifests as NDC/labeler differences, manufacturing-site attribution changes, and periodic shortages caused by sterile fill-finish capacity or quality-related batch release delays.
Risk drivers unique to iodinated contrast media
- sterile manufacturing constraints
- tight batch release tolerances for pH, osmolality, viscosity, and particulate controls
- regulatory scrutiny of aseptic processing controls
- distribution chain sensitivity to sudden allocation
What documentation should a supplier provide for ISOVUE-250 sourcing?
Featured snippet answer: For serious procurement and QA release, supplier documentation should include the shipment-level quality package tied to the commercial lot, typically comprising:
- Certificate of Analysis (CoA)
- lot-specific release documentation (as applicable)
- chain-of-custody for storage and handling conditions
- compliance statements covering labeling and intended use
Key Takeaways
- ISOVUE-250 “suppliers” in a business sense are defined by NDA holder distribution plus FDA-registered manufacturing and sterile fill-finish sites.
- For iopamidol injection, supplier risk concentrates in sterile aseptic fill-finish capacity and batch release compliance, not in generic API commoditization.
- Correct supplier identification requires anchoring to FDA establishment registrations and approved labeling manufacturer attribution tied to the product’s specific NDCs.
FAQs
1) How can I confirm the ISOVUE-250 manufacturing site behind a specific NDC?
Use the NDC to map to labeler/manufacturer attribution, then cross-reference FDA drug establishment registrations and labeling manufacturer statements for that NDC.
2) Are there common contract manufacturing suppliers for iopamidol injection products in the US?
Yes. Sterile fill-finish and packaging capacity can be shared across branded and generic iopamidol products, so supplier overlap can exist, but it must be validated by site-level FDA listings.
3) Does ISOVUE-250 supply change during shortages?
It can. When availability tightens, product can be allocated across NDCs that may correspond to different manufacturing sites, distributors, or pack configurations, depending on FDA release timing.
4) What quality documents do hospitals require when sourcing ISOVUE-250?
Hospitals typically require lot-specific CoA and documentation confirming storage/handling conditions and alignment to label claims for the shipped lot.
5) Can ISOVUE-250 be substituted with other iopamidol concentrations or formats from different suppliers?
Substitution depends on formulary policy, concentration/form factor equivalence, and availability. Procurement should validate clinical interchangeability and product labeling.
References
- FDA. Drug Establishment Registration and Drug Listing. (Accessed 2026-06-14). https://www.accessdata.fda.gov/scripts/cder/drls/
- FDA. NDC Directory. (Accessed 2026-06-14). https://ndclist.com/ (via official FDA NDC Directory access)
- FDA. Drug Labeling (Drugs@FDA) search for iopamidol injection and ISOVUE-250. (Accessed 2026-06-14). https://www.accessdata.fda.gov/scripts/cder/daf/
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