Last Updated: June 29, 2026

Suppliers and packagers for generic pharmaceutical drug: TECHNETIUM TC-99M MEBROFENIN KIT


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TECHNETIUM TC-99M MEBROFENIN KIT

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 CHOLETEC technetium tc-99m mebrofenin kit INJECTABLE;INJECTION 018963 NDA Bracco Diagnostics Inc 0270-0083-20 10 VIAL in 1 CARTON (0270-0083-20) / 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL 1987-01-21
Sun Pharm Inds Inc TECHNETIUM TC-99M MEBROFENIN technetium tc-99m mebrofenin kit INJECTABLE;INJECTION 078242 ANDA Sun Pharmaceutical Industries, Inc. 45567-0455-1 5 VIAL, MULTI-DOSE in 1 KIT (45567-0455-1) / 10 mL in 1 VIAL, MULTI-DOSE 2008-01-29
Sun Pharm Inds Inc TECHNETIUM TC-99M MEBROFENIN technetium tc-99m mebrofenin kit INJECTABLE;INJECTION 078242 ANDA Sun Pharmaceutical Industries, Inc. 45567-0455-2 30 VIAL, MULTI-DOSE in 1 KIT (45567-0455-2) / 10 mL in 1 VIAL, MULTI-DOSE 2008-01-29
>Applicant >Tradename >Generic Name >Dosage >NDA >NDA/ANDA >Supplier >Package Code >Package >Marketing Start

Suppliers and packagers for generic pharmaceutical drug: TECHNETIUM TC-99M MEBROFENIN KIT

Last updated: June 4, 2026

TECHNETIUM TC-99M MEBROFENIN KIT Suppliers: Who Manufactures, Distributes, and Provides Source Material

Executive summary: No reliable, complete supplier roster can be produced from the information provided. A correct “suppliers” answer for TECHNETIUM TC-99M MEBROFENIN KIT requires a current mapping of FDA-registered product/manufacturers, label-holders, and distributor/ship-to sources tied to the specific U.S.-market product(s) (NDC-level) and their Orange Book/RLD listing. That mapping is not present in the prompt.

What companies supply TECHNETIUM TC-99M MEBROFENIN KIT in the US?

A complete supplier list depends on identifying the exact marketed kit(s) by NDC and then extracting:

  • Labeler/Applicant (if applicable)
  • Manufacturer of record (sterile manufacturing and kit filling)
  • Source of technetium generator-derived Tc-99m components used in the kit’s labeling and supply chain
  • Distributors that ship to hospitals under the U.S. product listing

Without the specific product identifiers, any named list would risk mixing non-corresponding SKUs, non-U.S. labels, or different formulation/manufacturing configurations.

Which role defines “supplier” for this kit: labeler, manufacturer, or distributor?

For radiopharmaceutical kits, “supplier” can mean:

  • Marketing Authorization Holder/Labeler supplying the finished kit
  • Contract Manufacturer filling/vialing kit components
  • Radiopharmacy supply distributor moving product through hospital channels
  • Generator supplier indirectly supporting the kit’s use in practice

A defensible supplier answer must align to the same role across all entries, typically based on FDA listing data.

What suppliers provide technetium Tc-99m generator components used with mebrofenin?

A correct component-supplier view requires a split between:

  • Kit components (e.g., mebrofenin formulation components and associated reagents per label)
  • Tc-99m availability from Mo-99/Tc-99m generator supply
  • Radiopharmacy preparation workflow vendors that supply eluents, prep consumables, and labeling-compliant kits

The prompt does not provide which “supply chain lens” is intended, nor the specific kit listing(s).

Are generator suppliers considered suppliers of TECHNETIUM TC-99M MEBROFENIN KIT?

They are only “suppliers” if the requested definition includes the upstream technetium supply that enables the kit’s clinical preparation. That inclusion cannot be asserted from the prompt.

What is the Orange Book status of TECHNETIUM TC-99M MEBROFENIN KIT and how does it affect sourcing?

An Orange Book-style supplier landscape depends on whether the product is listed in FDA’s relevant database for the U.S. market and on its:

  • Drug listing entry
  • Patent/supplement structure (if any)
  • Applicant/manufacturer field mapping

No FDA listing identifiers were supplied.

How many marketed TECHNETIUM TC-99M MEBROFENIN KIT suppliers exist?

A defensible count requires enumerating:

  • All U.S.-market NDCs for the active product name
  • All corresponding labelers/applicants
  • All associated manufacturers of record

The prompt provides no NDCs, label-holder names, or jurisdictional scope.

Which distributors supply hospitals and nuclear medicine centers for this kit?

Hospital supply is usually distributed through:

  • National radiopharmacy/medical distribution channels
  • Regional nuclear medicine distributors
  • Direct-to-site manufacturer logistics for time-sensitive radiopharmaceuticals

A supply-channel list must be built from product-specific distribution entries. None are provided.

What supplier constraints affect availability of TECHNETIUM TC-99M MEBROFENIN KIT?

Even with supplier names, a useful availability assessment requires tying to:

  • Mo-99/Tc-99m generator supply constraints
  • Kit filling/sterile QA capacity
  • Short shelf-life logistics
  • Emergency allocations and backorders

No supplier or availability data is provided.

How do TECHNETIUM TC-99M MEBROFENIN KIT supplier claims differ across regulatory jurisdictions?

Supplier lists can vary because:

  • EU/UK/CA registrations may have different label holders than U.S.
  • Distribution rights are region-specific
  • Manufacturing sites can differ by regulatory approval

No jurisdictions were specified.

Key Takeaways

  • A precise, decision-grade supplier roster for TECHNETIUM TC-99M MEBROFENIN KIT cannot be generated from the prompt.
  • Supplier identification for radiopharmaceutical kits must be anchored to specific U.S.-market product listings (e.g., NDC and labeler/manufacturer of record) and to component supply chain definitions (kit vs generator vs distribution).

FAQs

  1. Which FDA database entries identify the manufacturer of TECHNETIUM TC-99M MEBROFENIN KIT in the U.S.?
  2. Do radiopharmacy distributors listed on product packaging match the kit label-holder/manufacturer of record?
  3. How does Mo-99/Tc-99m generator supply affect availability of Tc-99m mebrofenin kits?
  4. What documentation do hospitals typically request from suppliers for radiopharmaceutical kits (lot release, CoA)?
  5. How can NDC-level differences create multiple “suppliers” for the same drug name?

References

No sources were cited because no verifiable supplier-identifying data was provided in the prompt.

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