Last updated: June 5, 2026
OPTIRAY 160 is the U.S.-market brand of iopamidol injection 160 mg I/mL (radiographic contrast). Supply is typically organized around (1) upstream manufacture of the iodinated contrast API (iopamidol), (2) sterile fill-finish of the final injection, and (3) specialty sourcing of excipients, sterile filtration components, and packaging used for radiopharmaceutical-grade quality systems.
No complete, current “supplier list” by name for every upstream input cannot be produced from the information provided.
What companies supply OPTIRAY 160 in the U.S. market?
Answer (high level): OPTIRAY 160 supply chain normally breaks into:
- API iopamidol manufacturers (chemical synthesis, iodination, purification, API quality release).
- Finished-dose sterile injection manufacturers (sterile filtration, aseptic filling, terminal sterilization where applicable, vial/bottle filling).
- Distribution network (wholesale distributors and contract logistics supporting FDA-compliant storage and traceability).
Which manufacturers are linked to OPTIRAY 160 label ownership?
Answer (label-linked): OPTIRAY 160 is marketed in the U.S. under Mallinckrodt’s brand portfolio for iodinated contrast products.
What to map for “supplier” identification
To convert “supplier” into a defensible list for R&D, procurement, or litigation, the supplier map must be anchored to:
- Marketing authorization holder / NDA holder (label owner)
- Manufacturer of record for the commercial product (as listed on the U.S. label and/or FDA product listing)
- Filing-type manufacturing sites (NDA/BLA supplements may list additional sites)
- Private label or contract manufacturing relationships (if the label lists multiple manufacturers)
How does iopamidol injection (OPTIRAY 160) supply chain sourcing work?
Answer (structure): Iopamidol supply is constrained by:
- Batch synthesis complexity (iodination and purification steps)
- Control of residual solvents, heavy metal catalysts, and free iodine
- Sterile production capability (aseptic fill-finish or validated sterilization)
- Packaging compatibility with high-iodine solutions (materials compatibility and container-closure integrity)
What upstream API suppliers make iopamidol used in OPTIRAY 160?
Answer (category-level): The iopamidol API is sourced from a small set of specialized iodine-contrast API producers globally. Those API suppliers then sell to finished-dose manufacturers or label holders through contract or framework supply agreements.
Which sterile fill-finish sites produce iopamidol injection under OPTIRAY 160?
Answer (category-level): Finished-dose OPTIRAY 160 requires:
- Sterile production rooms with validated aseptic processing systems (or validated sterilization, depending on the specific process)
- Controlled bioburden and endotoxin specifications
- Process controls for viscosity, osmolality, and iodine concentration uniformity
- Container-closure integrity testing and stability programs
Are there alternative “generic” or AB-rated suppliers for OPTIRAY 160?
Answer: Radiographic iodinated contrast products often face AB-rating and switching dynamics based on:
- Concentration (160 mg I/mL)
- Osmolality and viscosity profile
- Container type and volume
- Shortages and temporary substitution rules
However, identifying which companies supply AB-rated alternatives requires mapping to the Orange Book listing(s) for iopamidol injection 160 mg I/mL and the associated manufacturers of record. That mapping is not available from the inputs provided.
What regulatory filings identify OPTIRAY 160 suppliers?
Answer (where suppliers are disclosed):
- U.S. FDA label “Manufactured for” / “Manufactured by” sections
- FDA NDC directory / SPL (Structured Product Labeling) records
- FDA Orange Book manufacturing site listings for the application and supplements
Key Takeaways
- OPTIRAY 160 is iopamidol injection 160 mg I/mL, with supply typically split between iopamidol API makers and sterile finished-dose manufacturers.
- A complete supplier list by company name requires anchor data from U.S. label/manufacturer-of-record disclosures and FDA product listings; those are not included in the provided information.
- For sourcing, shortages, or litigation readiness, the supplier map should be built from label and FDA records tied to the NDA holder/marketing authorization and manufacturing sites.
FAQs
- Who is the NDA holder or label owner for OPTIRAY 160?
- What does “manufacturer of record” mean for OPTIRAY 160 sourcing?
- Which FDA databases show OPTIRAY 160 manufacturing sites?
- How do iopamidol API quality specifications affect downstream sterile fill-finish?
- What drives OPTIRAY 160 supply constraints during iodinated contrast shortages?
References (APA)
No sources were provided in the prompt and no external citations are available to cite accurately.
