Last updated: May 28, 2026
Omnipaque 140 is the brand of iohexol 140 mg I/mL (nonionic, iodinated X-ray contrast media). In the US, GE Healthcare markets Omnipaque and supplies through its distribution channels, while manufacturing is split among contract/affiliate sites depending on batch and packaging configuration. Omnipaque’s supply chain is built around sterile drug product manufacturing (aseptic fill-finish) and iodinated active ingredient (iohexol) sourcing, with regulatory release tied to FDA-approved processes and facilities.
Who supplies Omnipaque 140 (iohexol) in the US market?
Primary commercial supplier (US): GE Healthcare (marketing authorization holder and the brand supplier listed in US distribution).
Distribution and channel structure
Omnipaque 140 is supplied to wholesalers and health systems through standard US pharmaceutical distribution:
- Brand marketing/distribution: GE Healthcare
- GPO and hospital supply: contracted distribution via the same wholesalers that carry GE Healthcare sterile injectables
- Direct-to-institution fulfillment: through GE Healthcare distribution contracts and fulfillment programs tied to wholesaler inventory
Regulatory link: FDA-labeled manufacturer vs. brand supplier
For sterile injectable contrast agents, the “supplier” that the market experiences is often the brand/distributor (GE Healthcare), while the FDA-approved drug product manufacturing site can be a different legal entity and physical plant. Omnipaque 140’s supply chain therefore has two layers:
- Brand supply (GE Healthcare)
- Manufacturing release (FDA-approved sterile manufacturing and packaging sites)
Which companies manufacture Omnipaque 140 (iohexol) drug product and fill-finish?
Answer format: Omnipaque 140 manufacturing is tied to FDA-approved facilities for sterile iodinated contrast media and can include GE Healthcare manufacturing sites and/or contract manufacturers. Without facility-level labels, batch records, or the specific FDA facility names for Omnipaque 140’s current label, a complete and accurate list of every manufacturer and fill-finish site cannot be provided.
What manufacturing steps typically define “supplier” status for Omnipaque 140
- Aseptic preparation and filtration of iohexol-containing solution
- Sterile fill-finish into the labeled container system (syringes and/or vials depending on presentation)
- Sterile container integrity controls (leachables, particulates, container closure)
- Final release testing per NDA controls
What raw-material and active ingredient suppliers support iohexol contrast manufacturing?
Active ingredient: iohexol is produced via chemical synthesis and then supplied to drug product manufacturers. In the Omnipaque 140 supply chain, raw-material suppliers fall into two categories:
- iohexol API manufacturers (chemical synthesis and iodinated intermediate sourcing)
- Sterile injectable excipient/packaging suppliers (pharmaceutical-grade excipients and container systems)
Without the current Omnipaque 140 labeling that identifies the API sourcing chain or the NDA chemistry manufacturing controls supplier list, a complete supplier roster cannot be stated accurately.
How do package types (syringe vs vial) change the supplier footprint for Omnipaque 140?
Omnipaque 140 is sold in multiple presentations. Different presentations usually map to:
- Different fill volumes
- Different container closure systems
- Different aseptic filling lines and sometimes different manufacturing lots
As a result, the “supplier” you receive may be the same brand distributor (GE Healthcare) but from a different plant schedule and a different FDA lot release facility depending on the presentation.
What does the FDA Orange Book status imply for Omnipaque 140 sourcing and manufacturing control?
Omnipaque 140 is protected under an NDA/Orange Book listing framework that governs:
- Brand drug product manufacturing controls
- Patents on formulations, methods of use, and/or manufacturing
- Abbreviated approval and generic/therapeutic equivalent pathways (where applicable)
The Orange Book status influences who can lawfully market competing products but does not, by itself, enumerate supplier names for contract manufacturing or raw ingredient sources.
Which generic or biosimilar alternatives compete with Omnipaque 140 and how does that affect suppliers?
Omnipaque 140 is an iodinated contrast agent. Competitive pressure can shift procurement choices for hospitals and distributors. Generic manufacturers typically source and manufacture their own iodinated contrast products, changing:
- Wholesaler mix
- Purchasing contracts
- Short-term allocation behavior during manufacturing constraints
However, a “supplier map” that lists the competitive product manufacturers alongside Omnipaque supplier entities requires the exact product-NDC-level labeling and Orange Book and facility lists for each alternative. That level of mapping cannot be produced from the prompt alone.
Supply reliability: what causes Omnipaque 140 shortages and reallocation to alternate suppliers?
For sterile contrast products, shortages usually stem from:
- Aseptic fill-finish line constraints
- Sterile raw material/packaging bottlenecks (container closure and sterilization readiness)
- Quality hold events tied to particulates, sterility assurance, or container integrity
- API synthesis and iodinated intermediate supply constraints
Omnipaque’s reallocation typically keeps the brand constant (GE Healthcare supply) but can route inventory through different manufacturing lots and packaging runs. A definitive list of alternate manufacturing entities requires current label manufacturing site identification.
Who is the best-placed “supplier” for procurement: GE Healthcare distributors or specific manufacturing plants?
For procurement, the effective decision points are:
- Contractual supplier: GE Healthcare or its authorized distributors (what purchase orders name)
- Inventory source: wholesaler chain and lot-level manufacturing release site
- Documentation needs: lot numbers, expiration, COA, and FDA compliance documentation tied to the manufacturing site
A complete roster of “suppliers” including every legal manufacturer and facility is not available from the prompt.
Key Takeaways
- GE Healthcare is the US brand supplier/distributor for Omnipaque 140 (iohexol 140 mg I/mL).
- The supply chain has two layers: brand distribution and FDA-approved sterile manufacturing release, which can involve different affiliate or contract sites.
- A complete, accurate list of all drug product manufacturers, fill-finish sites, and iohexol API suppliers cannot be generated from the prompt without product-label facility identification and regulatory listings.
FAQs
- What NDC supplier names appear on Omnipaque 140 packaging in the US?
- Do GE Healthcare and the Omnipaque 140 manufacturer have the same legal entity and address on the label?
- Which facilities typically produce sterile iodinated contrast injectables like iohexol solutions?
- How do shortages of iodinated contrast media generally affect Omnipaque 140 availability?
- What procurement documents (COA/lot traceability) matter most for Omnipaque 140 sourcing?
References
- FDA Orange Book. (n.d.). Drug Products (Orange Book): Omnipaque 140 (iohexol). US Food and Drug Administration.
- FDA. (n.d.). Drug Approval Package and Labeling for Omnipaque 140 (iohexol). US Food and Drug Administration.
