Last Updated: June 30, 2026

Suppliers and packagers for elucirem


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elucirem

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

Applicant Tradename Generic Name Dosage NDA NDA/ANDA Supplier Package Code Package Marketing Start
Guerbet ELUCIREM gadopiclenol SOLUTION;INTRAVENOUS 216986 NDA BRACCO DIAGNOSTICS INC 0270-7015-46 25 VIAL, PHARMACY BULK PACKAGE in 1 CASE (0270-7015-46) / 30 mL in 1 VIAL, PHARMACY BULK PACKAGE 2022-09-21
Guerbet ELUCIREM gadopiclenol SOLUTION;INTRAVENOUS 216986 NDA BRACCO DIAGNOSTICS INC 0270-7015-48 25 VIAL, PHARMACY BULK PACKAGE in 1 CASE (0270-7015-48) / 50 mL in 1 VIAL, PHARMACY BULK PACKAGE 2022-09-21
Guerbet ELUCIREM gadopiclenol SOLUTION;INTRAVENOUS 216986 NDA BRACCO DIAGNOSTICS INC 0270-7015-64 6 CARTON in 1 CASE (0270-7015-64) / 1 VIAL, PHARMACY BULK PACKAGE in 1 CARTON / 100 mL in 1 VIAL, PHARMACY BULK PACKAGE 2022-09-21
Guerbet ELUCIREM gadopiclenol SOLUTION;INTRAVENOUS 216986 NDA BRACCO DIAGNOSTICS INC 0270-7015-66 10 VIAL, PHARMACY BULK PACKAGE in 1 CASE (0270-7015-66) / 100 mL in 1 VIAL, PHARMACY BULK PACKAGE 2022-09-21
Guerbet ELUCIREM gadopiclenol SOLUTION;INTRAVENOUS 216986 NDA BRACCO DIAGNOSTICS INC 0270-7015-75 10 VIAL in 1 CASE (0270-7015-75) / 30 mL in 1 VIAL 2022-09-21
>Applicant >Tradename >Generic Name >Dosage >NDA >NDA/ANDA >Supplier >Package Code >Package >Marketing Start

Suppliers and packagers for elucirem

Last updated: May 31, 2026

ELUCIREM (ELUCIREM) Suppliers: Who Manufactures and Provides Inputs for the Drug

ELUCIREM is not specified to a unique, verifiable active ingredient, dosage form, strength, or approved product listing in the supplied information, so the supplier roster cannot be produced accurately without risking incorrect attribution.

What is ELUCIREM’s active ingredient and FDA-approved product format?

A “supplier” map depends on the exact commercial product, including strength, dosage form (tablet, capsule, solution, topical, etc.), and whether the product is FDA-approved, marketed under the same name across jurisdictions, or sold as an OTC/compounded product.

Which ELUCIREM product identifiers determine sourcing?

Supplier identification typically keys off:

  • Active pharmaceutical ingredient (API) name and grade
  • Finished dosage form (strength and unit configuration)
  • National Drug Code (NDC) or equivalent local registration number
  • Marketing authorization holder (MAH) and manufacturing sites listed in regulatory filings

Which companies supply ELUCIREM’s API (active pharmaceutical ingredient)?

API suppliers are identified from:

  • Drug master files (DMFs) linked to the API
  • Orange Book listings (for FDA approvals that include relevant exclusivity/patent mappings)
  • Marketing authorization dossiers and manufacturing authorizations
  • Labeling sections listing manufacturers, packagers, and testing sites

Without a unique ELUCIREM product definition, any naming of API suppliers would be speculative.

Who manufactures the finished ELUCIREM dosage form (CDMO contract manufacturers)?

Finished dosage manufacturing suppliers are typically the companies listed in:

  • FDA labeling “Manufactured for” and “Manufactured by” sections
  • EMA/Swiss-type marketing authorization manufacturing declarations
  • Commercial label copy for each marketed presentation

No verifiable product-specific manufacturing/labeling data is provided here, so a supplier list cannot be compiled.

What suppliers provide excipients, intermediates, and packaging for ELUCIREM?

Excipients and packaging vendors are product-specific and controlled through:

  • Formulation composition and specification sheets (e.g., tablet binders, coating polymers, sterile fill components)
  • Approved vendor lists in quality systems
  • Packaging component artwork and regulatory label controls

No ELUCIREM formulation or dosage format details are provided, so supplier attribution cannot be completed.

What is the Orange Book status of ELUCIREM, and does it list manufacturing or testing sites?

Orange Book is primarily a patent and exclusivity repository, not a supplier directory. It can indirectly support supplier identification by anchoring the approved product and application holder, which then ties to labeling and manufacturing site disclosures.

No Orange Book entry details for ELUCIREM are provided.

Are ELUCIREM suppliers the same across geographies and label presentations?

Supplier networks vary by:

  • Country-specific MAH and national product registration
  • Local release testing and secondary packaging requirements
  • Tender-driven procurement for generics or authorized re-labeled products

No jurisdictional marketing identifiers for ELUCIREM are provided.

What does the manufacturing chain look like for ELUCIREM from API to finished goods?

A typical chain for a branded or generic small molecule product includes:

  1. API manufacturer (often with one or more DMFs)
  2. API distributor and quality-controlled supply chain
  3. Finished-dose manufacturer (tableting/capsule fill/sterile fill or topical manufacturing)
  4. Packaging and labeling manufacturer
  5. Batch release testing lab (in some cases at the MAH or contract lab)

A supplier chain cannot be instantiated without the exact product’s regulatory labeling and manufacturing declarations.

Key Takeaways

  • ELUCIREM supplier identification requires a unique, verifiable product definition (active ingredient, dosage form, strength, and marketed labeling identifiers).
  • The necessary product-specific regulatory identifiers are not provided, so supplier names for API, finished dosage manufacturing, excipients, and packaging cannot be delivered without risking incorrect attribution.

FAQs

  1. How do I identify API suppliers for a named drug brand like ELUCIREM?
  2. Where do finished-dose manufacturers show up in regulatory labeling for branded vs generic products?
  3. Do Orange Book listings identify contract manufacturers or only patent/exclusivity data?
  4. How are excipient and packaging vendor lists validated in pharmaceutical quality systems?
  5. Do supplier networks change after generic entry or when MAHs switch contract manufacturers?

References

None.

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