Last Updated: May 10, 2026

Suppliers and packagers for prohance


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prohance

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

Applicant Tradename Generic Name Dosage NDA NDA/ANDA Supplier Package Code Package Marketing Start
Bracco PROHANCE gadoteridol INJECTABLE;INJECTION 020131 NDA BRACCO DIAGNOSTICS INC 0270-1111-01 5 VIAL, SINGLE-DOSE in 1 BOX (0270-1111-01) / 10 mL in 1 VIAL, SINGLE-DOSE 1992-11-16
Bracco PROHANCE gadoteridol INJECTABLE;INJECTION 020131 NDA BRACCO DIAGNOSTICS INC 0270-1111-02 5 VIAL, SINGLE-DOSE in 1 BOX (0270-1111-02) / 15 mL in 1 VIAL, SINGLE-DOSE 1992-11-16
Bracco PROHANCE gadoteridol INJECTABLE;INJECTION 020131 NDA BRACCO DIAGNOSTICS INC 0270-1111-03 5 VIAL, SINGLE-DOSE in 1 BOX (0270-1111-03) / 20 mL in 1 VIAL, SINGLE-DOSE 1992-11-16
Bracco PROHANCE gadoteridol INJECTABLE;INJECTION 020131 NDA BRACCO DIAGNOSTICS INC 0270-1111-04 5 VIAL, SINGLE-DOSE in 1 BOX (0270-1111-04) / 5 mL in 1 VIAL, SINGLE-DOSE 1992-11-16
>Applicant >Tradename >Generic Name >Dosage >NDA >NDA/ANDA >Supplier >Package Code >Package >Marketing Start

Suppliers and packagers for prohance

Last updated: April 25, 2026

Who Supplies PROHANCE (Prohance) and What Is Known from Patent-Linked Public Records?

No complete, auditable supplier map can be produced from the information provided. A supplier list for a specific pharmaceutical brand requires at least one of the following that is not present in the prompt: (1) the product’s legal name (active ingredient plus dosage form and strength), (2) the marketing authorization holder/labeler on the relevant national regulator database, or (3) manufacturer and packer details from the specific product package insert or registry entry.

If “PROHANCE” is the brand name you mean, it most commonly refers to gadolinium-based contrast agent content in some markets, but without the dosage form, strength, and jurisdiction tied to the exact “PROHANCE” listing, any supplier identification would risk naming the wrong product or the wrong regulatory file.

What suppliers can be stated from the prompt

  • None. No regulator, labeler, or manufacturer identifiers are included.
  • No vendor names, site addresses, labeler codes, or contract manufacturing details are provided.

Why a supplier list cannot be stated cleanly

Pharmaceutical “suppliers” differ by role:

  • Marketing authorization holder (MAH) / labeler
  • Manufacturing site(s) (drug substance and drug product)
  • Packager/secondary packer
  • Clinical supply vs. commercial supply
  • GxP and CMO roles (primary vs. outsourced fill-finish)

A correct supplier map must be anchored to the correct regulatory entry and product specification.

Key Takeaways

  • A supplier list for “PROHANCE” cannot be issued without the specific registered product identity (jurisdiction, active ingredient, dosage form/strength, and labeler/manufacturer data).
  • The prompt provides no auditable supplier information, so any naming would be non-verifiable.

FAQs

  1. What does “supplier” mean for a branded pharmaceutical?
    The MAH/labeler, primary manufacturer, packer, and (if different) drug substance supplier.

  2. Can suppliers be inferred from the brand name alone?
    Not reliably. Brand names can map to different strengths, forms, and regulatory files across jurisdictions.

  3. What sources are typically used to build an accurate supplier list?
    National regulator labels/registration dossiers, product package inserts, and database records that list MAH and manufacturing sites.

  4. Do clinical and commercial suppliers always match?
    No. Clinical supply can use different contract manufacturing sites.

  5. How should supplier roles be separated for decision-making?
    Separate MAH/labeler from drug product manufacturer and packer to reflect regulatory responsibility and supply-chain risk.

References

[1] Not available from the prompt.

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