Last updated: May 25, 2026
Suppliers for OPTIRAY 240 (iohexol) Across Manufacturing, Packaging, and Regulatory Work
Executive summary: OPTIRAY 240 is a branded iohexol (non-ionic iodinated contrast) product. Supplies in the US market typically trace to generic “iohexol injection” manufacturers and labeler/manufacturer-of-record entities tied to the product’s FDA-registered drug establishment and Orange Book/RLD-labeling chain. To enumerate the current, authoritative supplier set, the controlling dataset is the FDA’s SPL/drug listing labeler, Drug Establishment Registration and Listing (DERL) records, and the product’s specific NDC labeler/manufacturer-of-record.
If sufficient source detail is not provided (specific country market, NDC(s), dosage form pack size), an exact supplier list cannot be produced from the available information.
Who supplies OPTIRAY 240 iohexol injection?
Short answer: OPTIRAY 240 supply comes from the labeler/manufacturer-of-record shown on the product’s FDA drug listing (NDC label), plus the underlying iohexol injection manufacturing sites registered in DERL.
What is OPTIRAY 240’s active ingredient and implication for supplier mapping?
OPTIRAY 240 is iohexol 240 mg I/mL (contrast media). Supplier ecosystems for iohexol injection generally split into:
- API or API-formulated contrast manufacturing (iohexol solution manufacturing, sterile filling)
- Sterile product filling and packaging (vial/bottle filling, stoppering, labeling)
- Labeling and distribution (labeler) (NDC assignment and product release chain)
Which regulatory data points determine “supplier” status?
For business and IP due diligence, “supplier” usually maps to:
- Labeler (NDC holder)
- Manufacturer of record (site releasing product)
- Packager/Distributor (where the SPL indicates separate roles)
- DERL registered manufacturing/processing sites for the exact dosage form
What are the OPTIRAY 240 NDC labeler and manufacturer-of-record?
Short answer: The NDC’s labeler and manufacturer-of-record are the definitive suppliers for that exact marketed product presentation.
Why NDC-level mapping matters
Different pack sizes, bottle types, and presentation formats can involve:
- Different manufacturing sites
- Different packaging lines
- Different distributors under the same brand name
What does the Orange Book and FDA labeling show for OPTIRAY 240?
Short answer: OPTIRAY 240 is not typically an Orange Book “reference listed” product for small-molecule exclusivity like innovator branded drugs; iodinated contrast products are more often tracked via FDA drug listings, labeling, and DERL than via Orange Book exclusivity. Supplier identification still relies on FDA SPL for the specific NDC.
Are there listing differences between branded OPTIRAY 240 and generic iohexol injection?
Supplier identity can diverge even for the same strength because:
- Sterile manufacturing and filling partners can change
- Distribution channels differ by country and importer
- Quality systems and lot release can be split across sites
Which pharma suppliers manufacture iohexol 240 mg I/mL injection?
Short answer: Multiple contract manufacturing and sterile filling networks produce iohexol 240 mg I/mL globally. However, the exact list for OPTIRAY 240 depends on the country-specific marketing authorization and NDC.
Typical iohexol sterile supply chain roles
- Iohexol solution production (sterile, isotonic formulation)
- Aseptic filling into vials or bottles
- Secondary packaging and carton labeling
- Regulatory release and distribution through the marketing authorization holder
How can suppliers change over time for OPTIRAY 240?
Short answer: Supplier substitution happens through site change notifications, packaging line swaps, and labeler/manufacturer updates in FDA listings and foreign marketing authorizations.
Signals that supplier sites changed
- NDC manufacturer-of-record changes
- DERL site additions or deletions for the same dosage form
- SPL labeling update with different establishment registration identifiers
- Lot release source changes in quality agreements (commercially)
What supplier constraints affect OPTIRAY 240 availability?
Short answer: Availability is usually constrained by sterile filling capacity, iodinated contrast sterile filtration/aseptic capability, and regulatory lot release capacity, not by generic API scarcity alone.
Manufacturing and compliance bottlenecks for contrast media
- Aseptic processing throughput
- Container closure integrity testing capacity
- Iodinated contrast-specific quality testing bandwidth
- Temperature excursion and shipping qualification
Key Takeaways
- “Supplier for OPTIRAY 240” is best defined by the FDA SPL NDC labeler and manufacturer-of-record tied to the exact presentation.
- Confirming supplier identity requires NDC-specific FDA listing records and DERL site registrations for the same dosage form.
- Without the exact NDC(s) or marketed presentation/country, an authoritative supplier list cannot be stated.
FAQs
- How do I identify the manufacturer-of-record for OPTIRAY 240 by NDC?
- Do different OPTIRAY 240 pack sizes use different manufacturing sites?
- Where in FDA data is OPTIRAY 240 listed for labeling and establishment details?
- What does DERL tell you about OPTIRAY 240 manufacturing sites?
- What typically causes OPTIRAY 240 supply shortages: API, sterile fill, or release?
References
No sources were provided in the prompt, and no FDA/NDC/DERL records were supplied for citation.
