Last updated: April 24, 2026
What is ISOVUE-200 in the supply chain?
ISOVUE-200 is a brand of iodinated contrast media. In the US, it is supplied and marketed by Baxter Healthcare Corporation and manufactured by Baxter’s manufacturing network for injectable use. The product is distributed as a finished, regulated sterile drug product under a US NDA.
Key product identifiers used in sourcing and regulatory due diligence:
- Drug name: ISOVUE-200 (iopamidol injection)
- Strength: typically 200 mg iodine/mL
- Form: injectable contrast media (sterile)
- US marketing authorization holder (labeling): Baxter Healthcare Corporation
Who are the named suppliers/manufacturers on the label?
For procurement and downstream IP diligence, the “supplier” question maps to: (1) the US label holder and (2) the actual manufacturing site(s) named on regulatory labeling or listings.
Named US label holder
- Baxter Healthcare Corporation (US labeling/market supply)
Manufacturing
- Baxter-manufactured finished drug product is supplied through Baxter’s manufacturing sites (the sites can vary by package configuration and distribution region, but the manufacturer remains within Baxter’s manufacturing system for ISOVUE-200).
Because the label-holder and manufacturer identity are the actionable inputs for vendor qualification, ISOVUE-200 supply chains are characterized by Baxter-controlled manufacturing and release rather than third-party tolling that results in a different NDA holder.
What procurement-ready supplier entities matter most for ISOVUE-200?
For R&D sourcing, regulatory submissions, and commercial vendor screening, the entities that drive compliance and traceability are:
-
NDA/label holder (commercial supplier interface)
- Baxter Healthcare Corporation
-
Finished sterile drug manufacturer (GMP release interface)
- Baxter manufacturing network (named on product documentation and labeling under US regulatory framework)
-
Importer/distributor (logistics interface, if applicable)
- In US distribution, Baxter is the primary commercial supplier; import roles are typically secondary and depend on packaging and distribution lane.
How do you map ISOVUE-200 sourcing to patent/IP diligence?
From a drug patent perspective, supplier identification matters because different actors appear in different document types:
- Labeling and regulatory filings identify the NDA holder and often manufacturer sites.
- GMP manufacturing is where process IP and device/manufacturing improvements typically anchor.
- Component suppliers (iodinated intermediates, sterile filling, packaging components) are usually not named in the finished-label public information; IP diligence therefore focuses on the NDA holder and manufacturing platform.
For ISOVUE-200, the actionable supplier set is dominated by Baxter-controlled entities (label holder and Baxter manufacturing sites), which concentrates the most relevant compliance and process execution risk.
ISOVUE-200 supplier map (actionable for vendor qualification)
| Supply-chain role |
Entity |
What this role controls for ISOVUE-200 |
| US label holder / marketing supplier |
Baxter Healthcare Corporation |
Label content, product release framework, US commercial supply responsibility |
| Finished sterile drug manufacturer |
Baxter manufacturing sites (Baxter network) |
GMP manufacturing and batch release for ISOVUE-200 |
| Primary commercial procurement channel |
Baxter |
Sales, distribution, and distribution documentation |
What is the most reliable evidence trail for ISOVUE-200 supplier identification?
For procurement and compliance workflows, supplier identification should be anchored to:
- US product labeling for ISOVUE-200 (lists the manufacturer and/or label holder)
- US FDA product listing (Drugs@FDA / Orange Book entries where applicable) for the application holder and product authorization context
- GMP facility references as captured in labeling, FDA inspection records, or supplier master documentation used by distributors and hospitals
Key Takeaways
- Baxter Healthcare Corporation is the US label holder and primary commercial supplier interface for ISOVUE-200.
- ISOVUE-200 is a Baxter-manufactured finished sterile drug product supplied through Baxter’s manufacturing network.
- For vendor qualification and patent/IP diligence, the supplier set that matters is Baxter as label holder plus Baxter GMP manufacturing sites; component-level suppliers are typically not identified in finished-label public documentation.
FAQs
1) Who supplies ISOVUE-200 in the US?
Baxter Healthcare Corporation supplies ISOVUE-200 as the US label holder and primary commercial supplier interface.
2) Is ISOVUE-200 manufactured by a third party?
ISOVUE-200 is manufactured within Baxter’s controlled manufacturing network for the finished sterile drug product.
3) Where is ISOVUE-200 sourced for hospital procurement?
Through Baxter distribution channels under Baxter labeling and product release documentation.
4) Does supplier identity affect patent and IP diligence for ISOVUE-200?
Yes. The NDA/label holder and Baxter manufacturing sites are the core actors appearing across regulatory and manufacturing documentation that anchor IP risk reviews.
5) Are iodinated raw material or intermediate suppliers publicly listed for ISOVUE-200?
Finished-label public sources generally do not name intermediate/component suppliers; the actionable publicly anchored entities are typically the label holder and manufacturer.
References
[1] Drugs@FDA. “ISOVUE-200 (iopamidol) label information and application details.” US Food and Drug Administration.
[2] DailyMed. “ISOVUE-200 (iopamidol injection) prescribing information.” US National Library of Medicine.
