Last Updated: July 17, 2026

Suppliers and packagers for ULTRAVIST 150


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ULTRAVIST 150

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 150 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 150 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 150 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
Bayer Hlthcare ULTRAVIST 150 iopromide INJECTABLE;INJECTION 020220 NDA Bayer HealthCare Pharmaceuticals Inc. 50419-344-15 10 VIAL, GLASS in 1 CARTON (50419-344-15) / 150 mL in 1 VIAL, GLASS 2009-12-30
Bayer Hlthcare ULTRAVIST 150 iopromide INJECTABLE;INJECTION 020220 NDA Bayer HealthCare Pharmaceuticals Inc. 50419-344-21 10 BOTTLE in 1 PACKAGE (50419-344-21) / 200 mL in 1 BOTTLE 2009-12-30
Bayer Hlthcare ULTRAVIST 150 iopromide INJECTABLE;INJECTION 020220 NDA Bayer HealthCare Pharmaceuticals Inc. 50419-344-23 10 BOTTLE in 1 PACKAGE (50419-344-23) / 200 mL in 1 BOTTLE 2009-12-30
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Suppliers and packagers for ULTRAVIST 150

Last updated: June 9, 2026

ULTRAVIST 150 Suppliers: Who Manufactures and Supplies Ultravist 150 (Iopromide) and What Feedstock/IP Risks Exist?

ULTRAVIST 150 is a brand of iopromide (non-ionic iodinated contrast medium). The commercial “supplier” map typically splits into (1) marketing authorization holder (MAH) and brand owner for each country/market, and (2) contract manufacturers that produce the vial/pack and sterile fill-finish. For Ultraviist 150, the MAH and supplying sites vary by geography because iopromide is supplied through centralized global manufacturing plus local secondary packaging.

Who supplies ULTRAVIST 150 by geography and MAH (marketing authorization holder)?

Featured snippet answer: ULTRAVIST 150 is marketed in many markets by Bayer (the brand owner for Ultravist). Country-specific MAHs and labeling may differ, and the manufacturing sites listed on local SmPC/labeling and in regulatory dossiers determine the actual “supplier” for each market.

What to treat as the “supplier” in practice

  • MAH/Label holder (controls regulatory submissions, labeling, pharmacovigilance).
  • Manufacturer / Release site (QA disposition and batch release).
  • Contract fill-finish site (sterile manufacturing steps, vial filling, lyophilization is not relevant, as iopromide is supplied as a ready-to-use solution).
  • Logistics distributor (often separate; does not produce drug substance).

Market-by-market supplier evidence

ULTRAVIST product catalogs and regulatory labeling are the primary evidence sources for MAH and manufacturing site. For iopromide, common industrial patterns are:

  • One or more global aseptic/drug-product plants under Bayer control.
  • Additional regional plants or contract partners for local packaging, labeling, and distribution.

Which companies manufacture iopromide contrast media used in ULTRAVIST 150?

Featured snippet answer: The key “upstream” supplier category for ULTRAVIST 150 is the iopromide drug product manufacturer (aseptic solution). For Ultravist, Bayer’s controlled manufacturing network is usually the manufacturing source in markets where Bayer is the MAH.

Typical manufacturing step suppliers

Even when Bayer is the MAH, the supply chain can include:

  1. Drug substance procurement (iodinated intermediate feedstocks).
  2. Drug product formulation (buffering, solubilization, viscosity tuning).
  3. Aseptic sterile fill-finish into vials/syringes.
  4. Batch release and quality testing.
  5. Packaging (secondary cartons, labels, barcoding).

Drug substance vs drug product

  • Many listings distinguish “manufacturer” (drug product) and “manufacturer of substance.”
  • For procurement decisions (and supplier qualification), the sterile fill-finish facility and batch release site matter more than upstream chemical suppliers.

What contract manufacturers supply aseptic vial fill-finish for iopromide contrast media?

Featured snippet answer: In iodinated contrast media, contract manufacturers are common for vial fill-finish, but for ULTRAVIST 150 specifically, the most defensible “supplier” identification comes from the manufacturer section of the local product label/SmPC (which lists the actual aseptic manufacturing sites). Without market-specific labeling text, contract partner names cannot be verified at the company level.

What to look for on ULTRAVIST 150 labels

  • “Manufactured by” and address blocks tied to specific plants.
  • “Batch release” or “Batch certification” language.
  • Country-of-origin and MAH distribution addresses.

What are the key packaging formats supplied for ULTRAVIST 150 (vials vs prefilled syringes)?

Featured snippet answer: ULTRAVIST 150 is commonly supplied as ready-to-use vials (and in some markets as prefilled formats). The exact format depends on national packaging authorizations.

Supply implications

  • Prefilled syringes tighten the aseptic fill and device-sterility controls and can require device supplier integration.
  • Vials shift supply risk toward vial cleanliness, stopper integrity, and crimp/closure verification.

Who are the ULTRAVIST 150 distributors in hospitals and tenders?

Featured snippet answer: Distributors are usually local wholesalers and national procurement channels rather than the drug product manufacturer. Tender “supplier” language usually identifies the distributor and tender reference, not the manufacturing plant.

How to map tender suppliers to real manufacturing risk

For R&D sourcing, licensing diligence, or litigation risk, map:

  • Distributor identity (service level, lead times).
  • MAH (regulatory authority interface).
  • Manufacturing site (GMP inspection history, data pack).
  • QA release site (batch disposition, sterility testing method, deviation controls).

What does FDA or Orange Book status imply about ULTRAVIST 150 supply sources?

Featured snippet answer: ULTRAVIST 150 is an established iodinated contrast product, and generic availability depends on FDA ANDA or 505(j) pathways (where applicable for locally marketed products). The “supplier list” in the US is grounded in FDA drug listings and approval holders.

Why US “approval holder” differs from “manufacturer”

  • FDA labels list the applicant/holder, and sometimes multiple facilities.
  • Procurement lists might identify an authorized distributor, not the approval holder.

Are there generic or biosimilar alternatives that impact ULTRAVIST 150 supplier leverage?

Featured snippet answer: Iopromide generics (or authorized generics where marketed) can change pricing power and supply options. For iodinated contrast media, the main competitive set is other iopromide concentration equivalents and alternative iodinated agents, not biosimilars.

Procurement leverage drivers

  • Number of FDA/EMA-approved suppliers in the same concentration.
  • Availability of sterile batches and short-dated inventory risk.
  • Cold-chain needs are typically lower for contrast media solutions, but viscosity and filtration validation can affect batch timing.

How strong is ULTRAVIST 150 supplier risk tied to manufacturing and quality controls?

Featured snippet answer: The primary supply risk for iodinated contrast media is sterile manufacturing throughput and batch release controls, not “IP” in the ordinary sense. However, technical transfer constraints can limit new entrants because formulation and aseptic controls must be replicated.

Quality controls that constrain new supply

  • Sterility assurance level (SAL) controls.
  • Particulate matter specifications.
  • Iodine concentration assay and viscosity targets.
  • Closure integrity and container-closure system qualification.

What patent or exclusivity issues affect supplier entry for ULTRAVIST 150?

Featured snippet answer: Supply competition for iopromide solutions depends on patent estate for formulation, container closure, manufacturing process, and method-of-use. For a mature contrast medium brand, core active ingredient patents have long since expired, but secondary patents can still shape time-to-generic in specific jurisdictions.

How to evaluate patent-driven supplier restrictions

  • Identify jurisdiction-specific patents in force around:
    • concentration-specific formulations (150 mg I/mL products)
    • stability and shelf-life
    • sterilization/filtration and hold-time processes
    • container closure systems for vials/syringes
  • Track any Paragraph IV-style challenges (US) if relevant for route-to-market approvals.

Key suppliers checklist for ULTRAVIST 150 procurement due diligence

Use this to qualify and compare “suppliers” beyond price:

  • MAH / label holder for the target country.
  • Primary manufacturer (sterile fill-finish plant).
  • Batch release site and QC testing laboratories.
  • GMP inspection history for the relevant facility.
  • Container closure system (vial vs prefilled syringe).
  • Shelf-life and stability dossier (expiry risk).
  • Regulatory approvals for the exact concentration and presentation.

Key Takeaways

  • ULTRAVIST 150 is iopromide, and supplier identification must be done by MAH plus label-listed manufacturing sites, which vary by country and presentation.
  • For practical procurement and risk assessment, the most meaningful “supplier” is the sterile fill-finish manufacturer and batch release site, not the distributor.
  • Competitive pressure comes from iopromide generics and alternative iodinated contrast media, which can improve sourcing optionality but does not create biosimilar dynamics.
  • Patent effects for supply are typically driven by secondary patents (formulation, container closure, manufacturing process) rather than active ingredient core IP.

FAQs

  1. How do I identify the actual manufacturer of ULTRAVIST 150 for a specific country label?
    Use the “manufacturer” and “batch release” entries on the local SmPC/label and match the address to GMP facility identifiers.

  2. What is the most important facility to qualify for ULTRAVIST 150 supply continuity?
    The sterile manufacturing and batch release site listed on the product label.

  3. Do ULTRAVIST 150 tenders typically name the manufacturer or the distributor?
    Most tender documents name the distributor; manufacturing must be confirmed via label/SmPC.

  4. Are there biosimilars for ULTRAVIST 150?
    No biosimilars for small-molecule iopromide; competition is typically from generics and other iodinated contrast agents.

  5. What technical differences matter most between ULTRAVIST 150 suppliers?
    Container-closure system, sterile fill-finish controls, viscosity/iodine concentration specs, and validated shelf-life.

References

No citable sources were provided in the prompt, and no ULTRAVIST 150 label/SmPC, FDA drug listing, or regulatory dossier identifiers were supplied to support a company-accurate supplier mapping.

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