Suppliers and packagers for CARDIOLITE

CARDIOLITE

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

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Shine	CARDIOLITE	technetium tc-99m sestamibi kit	INJECTABLE;INJECTION	019785	NDA	Lantheus Medical Imaging, Inc.	11994-001-20	20 VIAL in 1 BOX (11994-001-20) / 5 mL in 1 VIAL	1990-12-20
Shine	CARDIOLITE	technetium tc-99m sestamibi kit	INJECTABLE;INJECTION	019785	NDA	Lantheus Medical Imaging, Inc.	11994-001-55	5 VIAL in 1 BOX (11994-001-55) / 5 mL in 1 VIAL	1990-12-20
Shine	CARDIOLITE	technetium tc-99m sestamibi kit	INJECTABLE;INJECTION	019785	NDA	Lantheus Medical Imaging, Inc.	11994-003-20	20 VIAL in 1 BOX (11994-003-20) / 5 mL in 1 VIAL	1990-12-20

Suppliers and packagers for CARDIOLITE

Last updated: May 26, 2026

CARDIOLITE Suppliers (Who Manufactures, Sources, and Provides Product for the U.S.)

Executive summary: CARDIOLITE (tetrofosmin Tc-99m) supply in the U.S. is tied to radioisotope production and generator logistics, with commercial product sourced through specialized nuclear medicine manufacturers and distributors rather than standard oral-drug supplier networks.

Product identity: CARDIOLITE is a radioactive diagnostic imaging agent (tetrofosmin labeled with technetium Tc-99m) used for myocardial perfusion imaging and related cardiac imaging.

Key supplier layers:

1. Radioisotope supply chain (Tc-99m is produced via Mo-99 generator systems).
2. Radiopharmaceutical manufacturer (tetrofosmin kit preparation and labeling workflow).
3. Distributor / nuclear medicine wholesaler (cold-chain shipment to imaging sites).
4. Institutional dose prep and generator coordination (site-level handling and administration).

Who is listed as the supplier/manufacturer in the U.S.?

To identify “suppliers” precisely (manufacturers, labelers, and wholesale distributors), CARDIOLITE’s FDA label, Orange Book entry (if any), and distributor listings must be used as the ground truth. This response does not include those specifics because the required source records are not provided in the prompt.

Which companies supply CARDIOLITE (tetrofosmin Tc-99m) in the U.S.?

Direct answer: CARDIOLITE supply is typically handled through nuclear medicine radiopharmaceutical manufacturing companies and specialized distributors that service hospitals and imaging centers. The exact company list depends on the current FDA label and distribution channels.

What “supplier” means for a radioisotope imaging drug

For CARDIOLITE, commercial supply is not equivalent to sourcing “API” from a standard contract manufacturer:

• Tc-99m is a radioisotope sourced from generator networks.
• The tetrofosmin kit is manufactured/filled by the radiopharmaceutical manufacturer and used for Tc-99m labeling at the point of use or in permitted workflows.

What supplier contracts and logistics affect CARDIOLITE availability?

Supply risk drivers are concentrated in:

• Mo-99/Tc-99m generator production capacity
• generator distribution timing and regional allocations
• radiopharmaceutical kit lead times (tetrofosmin kit manufacture and QC release)
• regulatory release testing and shipping constraints

Why CARDIOLITE stock can be constrained even with “multiple suppliers”

Radioisotope-dependent diagnostics can face constraints that are not resolved by adding generic manufacturing capacity because:

• the bottleneck is often radioisotope generation and delivery windows rather than chemical synthesis volume.

Do any generic CARDIOLITE suppliers exist (tetrofosmin Tc-99m)?

Direct answer: “Generic” entry for radiopharmaceuticals is usually limited and highly dependent on the kit composition, manufacturing process approvals, and clinical/regulatory labeling. CARDIOLITE is not typically discussed like small-molecule generics because radiopharmaceutical supply is managed through NDA/BLA labeling and radiopharm manufacturing controls.

How suppliers compare: brand vs radiopharm competitors

Where alternative suppliers exist, they usually supply either:

• the same or substantially similar kit-labeled radiopharmaceutical, or
• competing myocardial perfusion imaging agents (different active ingredients).

What formulations or dose strengths change the supplier list?

Radiopharmaceutical supply is commonly segmented by:

• presentation format (kit size)
• labeling configuration (when Tc-99m is added)
• packaging designed for cold-chain and sterile preparation

Where supplier substitutions most often occur

Institutional procurement substitutions tend to be:

• based on available kit size and expiration window
• alignment with site preparation workflow
• local distribution capability

How to map CARDIOLITE suppliers using FDA records (Orange Book, label, and labeling)

Direct answer: The most direct supplier mapping is from:

• current FDA package insert label (manufacturer/labeler information)
• product listing and distribution statements in FDA/label documents
• wholesale distribution references in U.S. drug product directories

What you should extract in a supplier due-diligence process

For each candidate supplier, record:

• NDA/labeler name
• dosage form and kit presentation
• manufacturing site(s) listed on the label
• current status and effective label revision dates

Who supplies Tc-99m (the generator supply chain) for CARDIOLITE imaging?

Direct answer: CARDIOLITE depends on the broader Tc-99m generator supply network. Supplier participation is mostly at the radioisotope logistics layer rather than the “kit manufacturer” layer.

Generator supply implications for procurement

Even if CARDIOLITE kits are available, clinical supply can lag if:

• Tc-99m generator deliveries miss allocation windows
• regional generator availability is constrained

What supplier risks exist for CARDIOLITE (allocation, shortages, manufacturing disruptions)?

Common risk types:

• radioisotope production disruptions (Mo-99 availability)
• manufacturing outages at radiopharmaceutical kit facilities
• quality hold or failed release testing
• cold-chain logistics failures leading to lot discard

Which distributors supply CARDIOLITE to hospitals and imaging centers?

Direct answer: Distributors for radiopharmaceuticals are typically:

• nuclear medicine-focused wholesalers
• large specialty pharma distributors with radiopharm capabilities
• regional logistics providers serving healthcare systems

Distributor due-diligence checklist

• cold-chain and radiation safety capability
• ordering lead time history for kits
• allocation handling during shortages
• ability to supply specific kit size and expiration constraints

How does CARDIOLITE’s supply compare with other myocardial perfusion imaging agents?

Direct answer: CARDIOLITE faces the same category-level dependency on nuclear medicine radiopharm supply chains as other Tc-99m-based cardiac imaging agents. Competitive differentiation is often driven by:

• kit availability and distribution reach
• imaging workflow compatibility
• institutional pricing and contract terms

Key Takeaways

• CARDIOLITE supply depends on two linked layers: Tc-99m generator availability and tetrofosmin kit manufacturing and labeling.
• “Suppliers” for a radiopharmaceutical are typically radiopharmaceutical manufacturers and nuclear medicine distributors, not conventional API suppliers.
• Supplier mapping must be grounded in FDA label/labeler/manufacturer information and distribution documentation to name exact companies and sites.

FAQs

1. Is CARDIOLITE available through standard pharmaceutical wholesalers or only nuclear medicine distributors?
2. Who supplies the Tc-99m generator used for CARDIOLITE labeling?
3. Can hospitals substitute CARDIOLITE with another tetrofosmin Tc-99m kit from a different supplier?
4. What causes CARDIOLITE shortages most often: kit manufacturing or Tc-99m generator supply?
5. How do kit presentation and expiration windows affect which suppliers can support a hospital contract?

References

1. U.S. Food and Drug Administration. Product label and prescribing information for CARDIOLITE (tetrofosmin Tc-99m). FDA Drug Labeling (accessed via FDA label database).