Last Updated: May 23, 2026

Suppliers and packagers for MYOVIEW 30ML


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MYOVIEW 30ML

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

Applicant Tradename Generic Name Dosage NDA NDA/ANDA Supplier Package Code Package Marketing Start
Medi-physics MYOVIEW 30ML technetium tc-99m tetrofosmin kit INJECTABLE;INJECTION 020372 NDA Medi-Physics Inc. dba GE Healthcare 17156-024-05 5 VIAL in 1 KIT (17156-024-05) / 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL 1996-02-09
Medi-physics MYOVIEW 30ML technetium tc-99m tetrofosmin kit INJECTABLE;INJECTION 020372 NDA Medi-Physics Inc. dba GE Healthcare 17156-026-30 5 VIAL in 1 KIT (17156-026-30) / 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL 2009-02-26
>Applicant >Tradename >Generic Name >Dosage >NDA >NDA/ANDA >Supplier >Package Code >Package >Marketing Start

Suppliers and packagers for MYOVIEW 30ML

Last updated: May 1, 2026

Who Supplies MYOVIEW (30 mL) and How Is the Supply Chain Structured?

MYOVIEW 30 mL is a radiopharmaceutical product used in nuclear medicine for myocardial perfusion imaging. Supply is typically organized around (1) the radiopharmaceutical active ingredient producer and (2) the finished-dosage manufacturer/distributor for the finished product (30 mL vial).

Who makes the active ingredient for MYOVIEW?

MYOVIEW contains technetium Tc 99m sestamibi. The supply chain for the active ingredient hinges on access to:

  • Technetium-99m obtained from molybdenum-99 (Mo-99) generator production, and
  • Sestamibi (cold kit and/or precursor components) used to formulate the Tc-99m labeled agent.

The active ingredient is therefore not sourced from “one vendor” in the ordinary sense; it depends on licensed radiopharmaceutical supply and labeling infrastructure tied to Tc-99m availability.

Who manufactures and supplies the finished MYOVIEW 30 mL product?

MYOVIEW is supplied as a finished radiopharmaceutical packaged in a 30 mL container for clinical use. Finished-product supply is controlled by:

  • the marketing authorization holder and
  • the finished-dosage manufacturer and releaser for radiolabeling and quality release.

In practice, the finished product’s supplier identity is determined by the US label and distribution network for MYOVIEW 30 mL, which lists the company responsible for distribution in the market and the manufacturing/release site.

What organizations are in the MYOVIEW supply chain?

A MYOVIEW supply chain for 30 mL typically includes these roles:

Supply chain role What it covers for MYOVIEW
Tc-99m generator supply Mo-99 generator access and Tc-99m availability feeding radiolabeling operations
Radiolabeling and kit formulation Labeling Tc-99m to sestamibi under GMP radiopharmacy controls
Finished-dose manufacturing Final container fill, labeling, vial packaging for the 30 mL presentation
Quality control and release Identity, radiochemical purity, sterility, endotoxins, stability testing and product release
Market distribution Distribution to radiopharmacies and imaging centers under temperature, handling, and regulatory requirements

What does “supplier” mean for MYOVIEW 30 mL in procurement terms?

For procurement, “suppliers” usually map to two contractable touchpoints:

  1. Finished-product supplier / distributor (MYOVIEW 30 mL)
    The party responsible for distribution of the finished radiopharmaceutical into the market.

  2. Radiopharmacy production partner (where labeling is performed)
    Some systems supply finished kits that radiopharmacies label; other systems supply fully prepared doses. MYOVIEW distribution in a specific market determines which route applies.

MYOVIEW 30 mL procurement reality: constraints that shape supplier selection

Unlike conventional small-molecule drugs, radiopharmaceutical sourcing is driven by:

  • Tc-99m generator scheduling (daily supply rhythms from generator sites)
  • short shelf-life logistics (release and distribution windows)
  • radiopharmacy labeling capability (availability of licensed facilities and validated processes)
  • GMP and radiochemical release testing requirements

These constraints often reduce the practical number of effective “suppliers” for the 30 mL presentation even when multiple upstream entities exist.

Key regulatory and quality documents used to identify suppliers

Supplier identity in radiopharmaceutical procurement is typically supported by:

  • Prescribing information / US label (lists manufacturer/distributor and supplier responsibilities)
  • FDA product and label information (market authorization and labeling references)
  • NDC and packaging-specific labeling (30 mL presentation tied to specific listing)
  • CGMP manufacturing and QC release references cited in labeling

Key Takeaways

  • MYOVIEW 30 mL is a Tc-99m sestamibi radiopharmaceutical, so supplier selection is constrained by Tc-99m generator supply, radiolabeling capability, and GMP release testing.
  • “Suppliers” in this category are best understood as (1) finished-product distributor/manufacturer for the 30 mL vial and (2) upstream Tc-99m and labeling/kit supply.
  • Definitive supplier names for MYOVIEW 30 mL must be taken from the product label and NDC-specific labeling, because radiopharmaceutical roles vary by market and presentation.

FAQs

  1. Is MYOVIEW 30 mL sourced from one single supplier?
    No. The product supply chain depends on upstream Tc-99m availability and downstream finished-product manufacturing and distribution.

  2. What determines who can supply MYOVIEW?
    Licensing and capability to handle Tc-99m and perform validated radiopharmaceutical labeling, filling, QC, and GMP release.

  3. How do I identify the finished-product supplier for the 30 mL vial?
    Use the MYOVIEW 30 mL label and its NDC/packaging-specific listing, which states the manufacturer/distributor responsible for market supply.

  4. Does the supplier change by region or market?
    It can, because distribution networks and release sites for radiopharmaceuticals can vary by geography.

  5. Why is Tc-99m supply central to MYOVIEW supplier decisions?
    Because Tc-99m availability drives the radiolabeling schedule and limits production, release, and shipping windows.


References (APA)

[1] Food and Drug Administration. (n.d.). Drugs@FDA: MYOVIEW (technetium Tc 99m sestamibi). FDA. https://www.accessdata.fda.gov/scripts/cder/daf/
[2] FDA. (n.d.). Prescribing information/label (MYOVIEW) and NDC-specific product labeling. U.S. Food and Drug Administration. https://www.accessdata.fda.gov/scripts/cder/daf/

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