Last updated: May 7, 2026
Who supplies OMNIPAQUE 350 in the market?
OMNIPAQUE 350 (iopamidol injection 350 mg iodine/mL) is marketed in the US by GE HealthCare and is produced through a commercial manufacturing network that includes both GE HealthCare manufacturing sites and contract manufacturing for dosage forms of iopamidol injection.
Market-facing supplier (brand owner / distributor)
- GE HealthCare (US marketing authorization holder and supply chain for OMNIPAQUE 350)
Upstream manufacturing suppliers (site network)
- GE HealthCare manufacturing sites (iopamidol injection production and packaging for commercial supply within GE’s network)
- Contract manufacturing partners are used for specific strengths, presentations, and packaging configurations within the iopamidol injection commercial pipeline, with batch release conducted under GE quality systems.
What does the documented supply chain look like (evidence base)?
Public product documentation ties supply to the brand owner and its distribution arrangements, while manufacturing attribution appears in:
- US labeling and product insert documentation (manufacturer/distributor entries)
- Regulatory filings and product listing records (NDC labeler relationships)
- Public records that map labeler and manufacturing site associations for injectable imaging agents
Where is OMNIPAQUE 350 manufactured and packaged?
OMNIPAQUE 350 is an injectable radiographic contrast agent. For this product family, manufacturing and packaging are performed under GE HealthCare’s quality systems across:
- Primary manufacturing locations producing iopamidol injection drug substance and/or drug product
- Packaging sites performing vial/fill-finish and labeling for final NDC presentations
The specific list of manufacturing and packaging sites varies by NDC (presentation, vial size, pack configuration). The US supply chain is organized so that:
- GE HealthCare remains the labeler/distributor across presentations
- Underlying manufacturing can shift between GE sites and contract manufacturers without changing the labeler in many jurisdictions
Which entities are the practical “suppliers” for procurement?
For procurement and sourcing decisions, there are three supplier categories that matter operationally:
1) Brand owner / authorized distributor
- GE HealthCare (primary supplier of OMNIPAQUE 350 to wholesalers and hospital channels)
2) Wholesalers
- Licensed pharmaceutical wholesalers distribute OMNIPAQUE 350 under GE HealthCare’s supply/contract terms (commonly multiple independent wholesalers per region).
3) Contract manufacturing support
- Contract manufacturing organizations support fill-finish and/or packaging for injectable radiographic contrast agents in the iopamidol portfolio under GE quality agreements.
How should suppliers be mapped for R&D and supply risk?
To map suppliers correctly at the batch and packaging level for OMNIPAQUE 350, use the following procurement-to-compliance mapping logic:
-
Step 1: Lock the exact NDC and presentation
- NDC differences reflect packaging configuration and sometimes labeler/manufacturing assignment.
-
Step 2: Confirm the “Manufactured for” / “Distributed by” identity on the label
- This identifies the legally responsible market-facing entity (GE HealthCare).
-
Step 3: Match NDC to manufacturing/labeler relationships in listing databases
- This reveals the likely manufacturing site network behind the labeled product.
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Step 4: Validate lot-level release documentation with your distributor
- For hospitals and distributors, CoA and lot-specific release documents confirm the actual batch origin used for that shipment.
Supplier table (procurement view)
| Supplier category |
Entity |
Role in supply |
| Brand owner / labeler |
GE HealthCare |
Market supply, distribution, and quality system responsibility |
| Distributor channel |
Licensed pharmaceutical wholesalers |
Regional procurement and hospital/hub distribution |
| Manufacturing network |
GE HealthCare sites and contract manufacturers |
Drug product production, fill-finish, and packaging under GE quality agreements |
Key takeaways
- GE HealthCare is the practical supplier for OMNIPAQUE 350 procurement (brand owner/labeler and distributor).
- Manufacturing and packaging come from a network that includes GE HealthCare sites and contract manufacturing, with site usage tied to NDC/presentation and lot assignment.
- For operational sourcing, procurement should anchor on exact NDC + lot-level CoA to confirm the true manufacturing origin for each shipment.
FAQs
-
Is GE HealthCare the supplier of OMNIPAQUE 350 in the US?
Yes. GE HealthCare is the market-facing labeler/distributor for OMNIPAQUE 350.
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Do different NDCs change the supplier for OMNIPAQUE 350?
They can. NDCs reflect presentation and packaging configuration, and underlying manufacturing/packaging sites may vary.
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Are contract manufacturers involved in OMNIPAQUE 350?
Yes. Injectable radiographic contrast agent supply networks for this portfolio include contract manufacturing for specific fill-finish/packaging needs under GE quality systems.
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How do hospitals confirm where a shipped OMNIPAQUE 350 lot was made?
Through lot-level documentation supplied by the distributor, including the CoA and labeling that corresponds to the specific NDC and lot.
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Who distributes OMNIPAQUE 350 after GE HealthCare releases product?
Licensed pharmaceutical wholesalers distribute through regional channels to hospitals, clinics, and group purchasing organizations.
References (APA)
[1] GE HealthCare. OMNIPAQUE 350 (iopamidol) injection prescribing information/US label.
[2] U.S. FDA. Drug Product Database (NDC labeler/manufacturer listing records) for OMNIPAQUE 350.
