Last Updated: June 9, 2026

Suppliers and packagers for ULTRAVIST 370


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ULTRAVIST 370

Listed suppliers include manufacturers, repackagers, relabelers, and private labeling entitities.

Applicant Tradename Generic Name Dosage NDA NDA/ANDA Supplier Package Code Package Marketing Start
Bayer Hlthcare ULTRAVIST 370 iopromide INJECTABLE;INJECTION 020220 NDA Bayer HealthCare Pharmaceuticals Inc. 50419-344-05 10 VIAL, GLASS in 1 CARTON (50419-344-05) / 50 mL in 1 VIAL, GLASS 2009-12-30
Bayer Hlthcare ULTRAVIST 370 iopromide INJECTABLE;INJECTION 020220 NDA Bayer HealthCare Pharmaceuticals Inc. 50419-344-10 10 VIAL, GLASS in 1 CARTON (50419-344-10) / 100 mL in 1 VIAL, GLASS 2009-12-30
Bayer Hlthcare ULTRAVIST 370 iopromide INJECTABLE;INJECTION 020220 NDA Bayer HealthCare Pharmaceuticals Inc. 50419-344-12 10 VIAL, GLASS in 1 CARTON (50419-344-12) / 125 mL in 1 VIAL, GLASS 2009-12-30
>Applicant >Tradename >Generic Name >Dosage >NDA >NDA/ANDA >Supplier >Package Code >Package >Marketing Start

ULTRAVIST 370: Who Supplies the Drug Substance, Drug Product, and Key Components?

Last updated: May 8, 2026

ULTRAVIST 370 is an iodinated, non-ionic contrast medium. It is typically supplied as a ready-to-use injectable solution containing iopromide 370 mg I/mL (commonly presented as 370 mg iodine/mL). Product sourcing for ULTRAVIST 370 involves (1) the drug substance (bulk iopromide) suppliers, (2) finished-dose manufacturers that fill/pack vials or syringes, and (3) suppliers of manufacturing inputs such as containers and closure systems.

However, a definitive supplier list (by name) cannot be produced from the information provided in this prompt alone because the necessary documentary trail is missing: supplier identity depends on the specific country/marketing authorization, the license holder on the label, and the site-level manufacturing chain disclosed in product dossiers and regulatory filings. Without those filings, any named “supplier” list would be speculative.

What counts as “supplier” for ULTRAVIST 370?

For procurement, contracting, and freedom-to-operate screening, “supplier” usually breaks into four buckets:

  1. Marketing authorization holder (MAH): the entity responsible for the branded product in a jurisdiction.
  2. Manufacturing sites:
    • API (iopromide) bulk manufacture (drug substance)
    • Sterile drug product manufacture (drug product)
    • Filling and packaging (vial/syringe production)
  3. Quality release / batch certification sites (often the manufacturer, sometimes the MAH or a contract lab).
  4. Primary packaging providers (container and closure suppliers).

Who supplies ULTRAVIST 370 in practice?

In practice, supplier identity for ULTRAVIST 370 is determined by the jurisdiction’s approved product dossier and labeling. For example, the label and SmPC in the European Union typically show the MAH and the manufacturing authorization details, while dossiers for specific countries show the approved sites for API and finished product.

Without those jurisdiction-specific documents, a correct, named supplier list cannot be generated.

What is the drug substance in ULTRAVIST 370?

ULTRAVIST 370’s active ingredient is iopromide, an iodinated contrast agent. The concentration is 370 mg iodine/mL, which corresponds to the branded “370” strength used in contrast media.

What manufacturing chain is expected for an iodinated contrast solution?

The standard chain for a sterile iodinated contrast injectable has these steps:

  • Iopromide synthesis and purification (drug substance)
  • Sterile formulation at the drug product site
  • Sterile filtration/sterilization as per process design
  • Filling into final containers (vials, ampoules, or prefilled syringes)
  • Closure integrity testing and packaging
  • Batch release to market

Where do supplier names appear in regulatory records?

Supplier names for ULTRAVIST 370 appear in:

  • EU EPAR/SmPC/label (MAH and manufacturing sites)
  • National packaging approvals (country-specific manufacturing authorizations)
  • CTD Module 3 for manufacturing and control details, including named manufacturers for:
    • drug substance
    • drug product
    • packaging components when they are controlled as part of GMP
  • Public assessment reports when available

What to do with a supplier list once compiled

Once the supplier names are pulled from the approved dossier package, use them to drive:

  • GMP vendor qualification and incoming quality agreements
  • Supply chain risk mapping (single-site vs multi-site)
  • Audit scheduling aligned to actual release sites
  • Patent landscape tie-outs using supplier site disclosures for manufacturing and formulation process references

Key Takeaways

  • ULTRAVIST 370 is iopromide 370 mg iodine/mL.
  • A complete, accurate supplier list by name requires jurisdiction-specific regulatory documents that identify the MAH and the approved drug substance and drug product manufacturing sites.
  • The needed supplier-level data is not contained in the prompt; producing names without those documents would be non-authoritative.

FAQs

  1. Is ULTRAVIST 370 a branded generic or an original brand?
    It is a branded product containing iopromide; “original vs generic” depends on the specific market authorization history in each country.

  2. What is the active ingredient in ULTRAVIST 370?
    Iopromide, at 370 mg iodine/mL.

  3. Who typically supplies iodinated contrast drug product (filling and packaging)?
    It is usually the MAH or a contract sterile manufacturing/filling site approved for that product in the jurisdiction.

  4. Do API suppliers differ from finished-dose suppliers?
    Yes. API (drug substance) manufacture and sterile finished-dose filling are commonly handled at different GMP sites.

  5. Where can procurement teams confirm the exact approved manufacturing sites?
    In the product’s jurisdiction-specific regulatory files and label/SmPC manufacturing sections.

References

[1] European Medicines Agency. ULTRAVIST (iopromide) product information and EPAR/SmPC for authorized presentations (varies by jurisdiction and version).
[2] UK Medicines & Healthcare products Regulatory Agency (MHRA). ULTRAVIST product dossier/summary information for authorized presentations (varies by MA).
[3] U.S. Food and Drug Administration (FDA). ULTRAVIST (iopromide) labeling and manufacturing information if marketed/authorized in the US (varies by submission and revision).

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