Last updated: June 4, 2026
Optiray 350 is the brand name for ioversol, a low-osmolality iodinated contrast medium. The supplier landscape is dominated by the marketing authorization holder (MAH) and the primary manufacturers supplying bulk drug substance and finished dosage form, plus US distribution partners for the branded product.
Who manufactures OPTIRAY 350 (ioversol) and supplies the finished product?
Direct answer: OPTIRAY 350 is manufactured and supplied by the brand’s MAH and contract manufacturing network for ready-to-use vials/syringes. The supplier set is anchored by the ioversol manufacturing site(s) used for the specific presentation sold under the OPTIRAY 350 brand.
What are the main supplier categories for OPTIRAY 350?
- Marketing authorization holder / brand owner
- Finished-dose manufacturer (FDF) for vials and/or prefilled syringes
- Bulk active ingredient and/or intermediate suppliers (for ioversol manufacture)
- Distributor / wholesaler network in each country (often multiple routes depending on tendering and hospital contracts)
Are there multiple OPTIRAY 350 presentations that change the supplier?
Yes. Supplier identification often differs by presentation (vial vs prefilled syringe) and by geography. In practice, the market’s “supplier list” aggregates by presentation and packaging configuration, because contracts for specific container closure systems can be awarded to different FDF sites.
What companies supply ioversol contrast media that compete with OPTIRAY 350?
Direct answer: The most relevant supplier set is the broader ioversol iodinated contrast market, which includes branded ioversol equivalents and multiple authorized generic/contract-manufactured equivalents, each with its own manufacturing and distribution chain.
Common ioversol supplier landscape (by functional role)
- Branded ioversol marketers: maintain manufacturing qualification and supply allocations to meet hospital and imaging center demand.
- Generic/ioversol equivalence manufacturers: supply finished product under their own label or via private label agreements.
- Contract manufacturers: supply the FDF line for specific packaging (vial/syringe) and concentration.
How does this affect “supplier” lists in procurement?
Procurement teams typically need three names per SKU:
- Product label (brand holder/MAH)
- Finished goods manufacturer (site-level)
- Distributor that handles tender/wholesale supply in the purchasing territory
What are the key US supplier paths for OPTIRAY 350?
Direct answer: For the US, the practical supplier view is MAH/labeler plus the US distributor/wholesaler chain. If OPTIRAY 350 is not directly marketed under that exact brand in the US, procurement still maps to the ioversol manufacturer and labeler for the available equivalent product(s).
Orange Book alignment for supply chain diligence
Iodinated contrast media products are often regulated under NDA/BLA structures for label and distribution, with supply chain diligence anchored to:
- FDA product listing
- NDC labeler/distributor
- Inspection history and manufacturing site
(If OPTIRAY 350 is marketed under an NDA in the US, the labeler and manufacturer appear in FDA product listings; otherwise, supplier identification should be mapped through the equivalent ioversol product(s) available in the US.)
What supplier information is available for procurement due diligence?
Direct answer: Procurement-grade supplier intelligence focuses on: labeler, NDC-level manufacturer/packager, distributor, and the manufacturing sites used for the specific strength and container closure.
Procurement checklist for OPTIRAY 350 suppliers
- NDC-level labeler (the legal “who supplies the product under the listing”)
- Packager/manufacturer (site-level manufacturing and packaging)
- Distributor/wholesaler (for order routing)
- Batch release / supply allocations (commercial continuity risk)
- Country-specific MAH and tender channel (hospital procurement)
Supplier risk: what can break OPTIRAY 350 supply continuity?
Direct answer: Supply interruptions usually come from manufacturing site constraints, packaging line outages, iodinated raw material availability, or distribution route changes.
Where supply risk concentrates in iodinated contrast media
- Single-site FDF dependency for a specific packaging configuration
- Prefilled syringe line constraints (if used for certain markets)
- Raw material and iodide supply volatility impacting iodinated intermediate production
- QA batch rejection risk during peak imaging demand
How do OPTIRAY 350 suppliers compare versus alternative iodinated contrast media?
Direct answer: The supplier set for ioversol tends to be narrower than the supplier set for some other contrast families (e.g., iohexol, iopamidol), because each contrast molecule has distinct manufacturing know-how and regulated manufacturing approvals.
What to compare in supplier contracting
- Regulatory listing continuity (no labeler discontinuation risk)
- Batch release reliability (low lead time variability)
- Packaging flexibility (vial vs syringe availability)
- Secondary sourcing options (qualified alternate FDF sites)
Key Takeaways
- OPTIRAY 350 supplier mapping is best done by labeler/MAH plus NDC-level manufacturer and distributor, then validated by presentation (vial vs prefilled syringe) and country tender route.
- In practice, supplier continuity risk for iodinated contrast media concentrates in FDF site capacity, packaging line availability, and iodinated raw material availability.
- For procurement and contracting, treat “supplier” as a three-name structure: MAH/labeler, finished-dose manufacturer, and distributor.
FAQs
- How do I identify the correct OPTIRAY 350 manufacturer for a specific vial or syringe NDC?
- What distributor names typically show up on purchase orders for OPTIRAY 350 in hospital tenders?
- Do OPTIRAY 350 supplier lists change by country or packaging presentation?
- What supply constraints are most common for ioversol contrast media (raw material vs packaging vs batch release)?
- How can I substitute OPTIRAY 350 with an alternative ioversol product without changing procurement eligibility requirements?
References
- FDA. “Drug Product Database (NDC Directory)”. U.S. Food and Drug Administration.
- FDA. “NDC Directory Data Elements and Labeler/Manufacturer Definitions”. U.S. Food and Drug Administration.
