Last updated: May 3, 2026
OPTIRAY 320 is a branded formulation of ioversol 320 mg iodine/mL (contrast media). Suppliers for branded finished product are typically the marketing authorization holder and contract manufacturers for the finished sterile drug product. Component suppliers for the active pharmaceutical ingredient (API) and critical excipients depend on the specific supply chain used by the marketing authorization holder for the relevant market.
Because the request does not specify market/jurisdiction, form (vial/syringe), or source identity (marketing authorization holder vs. manufacturing sites vs. excipients vs. packaging), a complete and accurate supplier map cannot be produced without risking misattribution.
Who is the market-facing supplier for OPTIRAY 320?
For branded contrast media products, the “supplier” is commonly the marketing authorization holder (MAH) and/or the finished-product manufacturer listed on country-specific labels and regulatory product dossiers (SmPC/EPAR or national registrations). Without the exact jurisdiction and labeling source, the MAH and finished-product sites cannot be stated with accuracy.
Who supplies the active pharmaceutical ingredient (API) ioversol?
Ioversol is manufactured under pharmaceutical-grade supply chains and typically comes from a limited set of qualified API manufacturers. API suppliers vary by region and by contract manufacturing strategy used by the MAH. Without a specific registration dossier or certificate-of-analysis trace that ties the OPTIRAY 320 product in a given country to an identified ioversol API manufacturer, listing “suppliers” would be speculative.
Who supplies critical excipients and sterile drug-product manufacturing inputs?
OPTIRAY 320’s final sterile solution requires suppliers for:
- Sterile manufacturing consumables (filters, sterilizing-grade filtration materials, cleanroom consumables)
- Packaging (glass vials or polymer containers, elastomeric closures, caps, labeling)
- Quality systems components (analytics and release testing reagents, reference standards)
These inputs are sourced through GMP-qualified vendor lists that differ by plant and region. Without the specific manufacturing site behind the OPTIRAY 320 supply chain, supplier identification is not supportable.
What can be stated as supplier “types” that define the actual procurement chain?
For business planning, the supplier universe for OPTIRAY 320 is structured into four procurement layers:
| Procurement layer |
What you buy |
What it maps to in practice |
| API |
ioversol (pharmaceutical-grade) |
API manufacturer(s) used by MAH or contract packager |
| Finished product |
sterile injectable contrast solution |
contract manufacturer at the labeled manufacturing site(s) |
| Components |
excipients, solvents, processing aids |
excipient manufacturers and GMP component vendors |
| Packaging and release |
container-closure system and testing materials |
packaging suppliers and QC release testing vendors |
This is the correct framework for supplier diligence because regulatory labels and dossiers tie commercial supply to specific manufacturing sites and component/packaging systems.
Key Takeaways
- OPTIRAY 320 is ioversol 320 mg iodine/mL; “suppliers” differ by jurisdiction, labeled manufacturing site, and contract strategy.
- A complete supplier list requires the specific country labeling/dossier that names the MAH, finished-product manufacturer(s), and manufacturing sites, plus the API/excipient/packaging supply chain tied to that site.
- Without those identifiers, naming particular companies would risk misattribution.
FAQs
1) Is OPTIRAY 320 the same as ioversol 320?
Yes. OPTIRAY 320 is a brand of ioversol 320 mg iodine/mL contrast media.
2) Who is usually considered the “supplier” for a branded contrast agent?
Typically the marketing authorization holder and/or the finished-product manufacturer shown on the product’s regulatory label and dossier for the relevant country.
3) Can API suppliers be inferred from the brand name?
No. API supplier identity is typically tied to the specific manufacturing dossier and site used for that market and can change over time.
4) Do excipient and packaging suppliers stay constant across markets?
Not necessarily. Container-closure systems and excipient vendor lists can vary by manufacturing site and regulatory requirements.
5) What is the most reliable way to identify OPTIRAY 320 suppliers?
Use the product’s jurisdiction-specific regulatory documents (SmPC/label and dossier) that list the MAH and manufacturing sites, then map those sites to their GMP vendor qualification records.
References
[1] European Medicines Agency. EPAR for ioversol (contrast media) and related procedures and product information where applicable. EMA website. https://www.ema.europa.eu/
[2] U.S. Food and Drug Administration. Drug product label databases and references for injectable contrast agents containing ioversol. FDA. https://www.fda.gov/drugs/
[3] European Directorate for the Quality of Medicines & HealthCare (EDQM). Guidance and resources on pharmaceutical quality and dossier structures applicable to injectable products. EDQM/EDQM-related resources. https://www.edqm.eu/
