Last Updated: August 9, 2026

Suppliers and packagers for TECHNETIUM TC 99M MERTIATIDE KIT


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TECHNETIUM TC 99M MERTIATIDE 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
Jubilant Draximage TECHNETIUM TC 99M MERTIATIDE KIT technetium tc-99m mertiatide kit POWDER;INTRAVENOUS 216820 NDA Jubilant DraxImage Inc., dba Jubilant Radiopharma 65174-261-05 5 VIAL in 1 CARTON (65174-261-05) / 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL (65174-261-01) 2023-03-31
>Applicant >Tradename >Generic Name >Dosage >NDA >NDA/ANDA >Supplier >Package Code >Package >Marketing Start

Suppliers and packagers for TECHNETIUM TC 99M MERTIATIDE KIT

Last updated: June 1, 2026

Suppliers for TECHNETIUM TC 99M MERTIATIDE KIT (mertiatide)

TECHNETIUM TC 99M MERTIATIDE KIT is supplied as a radiopharmaceutical kit used to prepare Tc-99m mertiatide injectable after labeling and aseptic processing. Competitive supply in the US is driven by kit availability, generator/processing compatibility, and distribution licensing. Market access is constrained by radiopharmacy GMP capability and regulatory distribution requirements for radioactive drugs.

Who manufactures and supplies TECHNETIUM TC 99M MERTIATIDE KIT in the US?

No complete, citable supplier roster is available from the provided information. A supplier list must be sourced from FDA Orange Book, SPL/labeling, drug establishment registration listings, or reputable distribution catalogs. With those inputs missing, any named supplier set risks being incomplete or inaccurate.

What supplier categories exist for Tc-99m mertiatide kits

  • Kit manufacturers: Produce the lyophilized kit components and labeling.
  • Radiopharmacy distributors: Supply hospitals and imaging centers through licensed radioactive drug distribution networks.
  • Contract kit packagers/repackagers: Often operate under distribution or compounding frameworks, not as original kit originators.

What to check to confirm a supplier

  • FDA SPL/labeling “Manufacturer” and “Distributed by” fields
  • Drug Establishment Registration and radioactive drug distribution authorizations
  • Direct-to-radiopharmacy distribution channels (state-licensed)
  • Compatibility with common Tc-99m generator systems and aseptic workflow

What are the main distribution suppliers for TECHNETIUM TC 99M MERTIATIDE KIT?

No complete, citable distribution supplier list is available from the provided information. Distribution suppliers change with licensing, contract scope, and geographic coverage. A defensible list requires current label/distribution data and radioactive drug distribution authorization sources.

Geographic coverage patterns

  • National distributors typically handle multi-state accounts but route radioactive shipments through licensed nodes.
  • Regional distributors are common where radiopharmacy customers are concentrated.

Which companies supply TECHNETIUM TC 99M MERTIATIDE KIT to hospitals and imaging centers?

No complete, citable supplier mapping is available from the provided information. Hospital and imaging-center procurement is driven by local contracting, formulary status, and radiopharmacy pharmacy network purchasing.

Procurement drivers

  • Kit lead time and fill-rate performance
  • Radiopharmacy processing compatibility
  • Service support for tech transfer and labeling compliance

What patents or exclusivity affect TECHNETIUM TC 99M MERTIATIDE KIT suppliers?

No patent or exclusivity dataset is provided. Supplier availability for radiopharmaceutical kits can be influenced by specific manufacturing-process patents, labeling exclusivity, and regulatory data protection, but a precise assessment requires Orange Book and patent term data for this exact kit.

What is the FDA status and Orange Book listing for TECHNETIUM TC 99M MERTIATIDE KIT?

No FDA Orange Book/SPL status data is provided. A correct status read requires confirming:

  • NDA/ANDA identifiers if listed
  • Orange Book exclusivity categories
  • Supplement history that can affect allowable manufacturing sources

How many suppliers can realistically exist for TECHNETIUM TC 99M MERTIATIDE KIT?

No supplier count can be stated without a sourced supplier universe. In practice, the number of viable kit suppliers is limited by:

  • sterile radiopharmaceutical kit manufacturing capability
  • regulatory radioactive drug manufacturing quality systems
  • distribution network licensing constraints
  • demand size economics for a specialty imaging kit

What generic or alternative kits can substitute for TECHNETIUM TC 99M MERTIATIDE KIT?

No substitute-product mapping is provided. Substitution depends on:

  • active ingredient identity (Tc-99m mertiatide)
  • labeled indications and dosing equivalence
  • imaging protocol compatibility at radiopharmacy level
  • FDA labeling and interchangeability in practice

Key Takeaways

  • TECHNETIUM TC 99M MERTIATIDE KIT is typically supplied through kit manufacturers and licensed radiopharmacy distribution networks.
  • A definitive, business-useful supplier list cannot be produced without a sourced FDA labeling and distribution dataset specific to this product.
  • Supplier selection in practice depends on kit availability, radiopharmacy processing fit, and licensed radioactive distribution coverage.

FAQs

  1. Can radiopharmacies source TECHNETIUM TC 99M MERTIATIDE KIT from multiple suppliers?
  2. What lead times and supply-chain risks exist for Tc-99m mertiatide kits?
  3. Are there interchangeable Tc-99m renal imaging kits with the same preparation workflow?
  4. How do radioactive drug distribution licenses affect where kits can be shipped?
  5. What documentation do hospitals require when changing TECHNETIUM TC 99M MERTIATIDE KIT suppliers?

References

  1. FDA Orange Book database.
  2. FDA SPL (Structured Product Labeling) for TECHNETIUM TC 99M MERTIATIDE KIT.
  3. FDA Drug Establishment Registration and radioactive drug distribution authorization listings.

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