Suppliers and packagers for TECHNETIUM TC 99M SESTAMIBI

TECHNETIUM TC 99M SESTAMIBI

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

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Cardinal Health 414	TECHNETIUM TC 99M SESTAMIBI	technetium tc-99m sestamibi kit	INJECTABLE;INJECTION	078809	ANDA	Cardinal Health 414, LLC	65857-500-20	20 VIAL in 1 CARTON (65857-500-20) / 5 mL in 1 VIAL	2010-06-01
Curium	TECHNETIUM TC 99M SESTAMIBI	technetium tc-99m sestamibi kit	INJECTABLE;INJECTION	078098	ANDA	Curium US LLC	69945-092-20	5 VIAL in 1 CELLO PACK (69945-092-20) / 10 mL in 1 VIAL	2011-10-31
Curium	TECHNETIUM TC 99M SESTAMIBI	technetium tc-99m sestamibi kit	INJECTABLE;INJECTION	078098	ANDA	Curium US LLC	69945-092-40	30 VIAL in 1 CARTON (69945-092-40) / 10 mL in 1 VIAL	2011-10-31

Suppliers and packagers for TECHNETIUM TC 99M SESTAMIBI

Last updated: May 24, 2026

TECHNETIUM TC 99M SESTAMIBI Supplier Landscape: Who Manufactures, Supplies, and Distributes Sestamibi Radiopharmaceuticals

Executive summary

• TECHNETIUM TC 99M SESTAMIBI is supplied in the US as radiopharmaceutical kits and generator-produced technetium-99m labeling components, with distribution typically handled by radiopharmacy networks and specialty distributors.
• The supplier picture in the US is shaped by (1) the kit manufacturers that supply labeling components and (2) regional radiopharmacies that reconstitute/label from technetium-99m generators and distribute to imaging providers.
• A complete supplier list requires cross-checking the FDA National Drug Code (NDC) and package-level labeling availability, because sourcing varies by dose form, kit strength, and NDC package configuration.

Which companies supply TECHNETIUM TC 99M SESTAMIBI radiopharmaceutical kits in the US?

Answer: Supplier identity depends on the NDC package and the radiopharmacy fulfillment channel. The practical market includes kit manufacturers (for labeling) plus radiopharmacy distributors that deliver the labeled product to hospitals and imaging centers.

Common US supply channels for Tc-99m sestamibi

• Generator and labeling workflow: hospitals or radiopharmacies use technetium-99m generators, then label sestamibi kits to produce TECHNETIUM TC 99M SESTAMIBI for immediate imaging use.
• Specialty distribution: labeled doses are often distributed through radiopharmacy networks rather than traditional wholesaler channels for commercial tablets or biologics.
• NDC-driven variation: multiple NDCs can exist for the same active ingredient and name but differ in strength, kit configuration, or package size, which changes which manufacturer/distributor appears in listings.

What to search on FDA drug listings to enumerate suppliers

• Active ingredient: technetium tc 99m sestamibi
• Drug name / dosage form: kit for radiolabeling (the labeled dose is short-lived and time-critical)
• Package NDC: used to reconcile “manufacturer” versus “labeler” and “distributor” in public databases

What is the FDA/Orange Book status for TECHNETIUM TC 99M SESTAMIBI suppliers?

Answer: TECHNETIUM TC 99M SESTAMIBI is governed by radiopharmaceutical regulations and typically does not map cleanly to the Orange Book exclusivity framework used for traditional small-molecule drugs. Supplier listings are best validated via FDA’s NDC directory and current package labeling availability.

What “status” implies for supplier access

• No typical Orange Book exclusivity gating like NCE/NDA exclusivity or listed patents controlling generics.
• Supply constraints often relate to manufacturing capacity, sterile non-pyrogenic kit production, quality systems, generator supply, and radiochemistry logistics rather than exclusivity.

How are TECHNETIUM TC 99M SESTAMIBI kits sourced and labeled (generator vs. direct supply)?

Answer: Most end users receive labeled doses either from their own radiopharmacy labeling workflow or via a partner radiopharmacy that labels per schedule using generator and kit inputs.

Supplier roles split by workflow

• Kit supplier: provides sestamibi kit components for Tc-99m labeling.
• Generator supplier (upstream): technetium-99m generator producers are separate from kit manufacturers.
• Radiopharmacy operator: labels, QC releases, packages doses, and ships time-sensitive product to imaging sites.

Which distributors deliver TECHNETIUM TC 99M SESTAMIBI to hospitals and imaging centers?

Answer: Delivery is typically performed by radiopharmacies and nuclear medicine distribution groups that manage short shelf-life and “time-to-use” logistics.

Practical distributor categories

• Hospital-based radiopharmacies that self-label from generators.
• Commercial radiopharmacies that provide labeled doses to satellite sites.
• Specialty nuclear medicine distributors that route through radiopharmacy labeling partners.

What supply risks affect TECHNETIUM TC 99M SESTAMIBI availability?

Answer: The main risks are capacity and logistics across the generator chain and kit manufacturing, plus regulatory and quality events that force temporary holds.

Risk drivers to monitor

• Technetium-99m generator production constraints (upstream supply for labeling).
• Sestamibi kit manufacturing capacity (sterile radiochemistry component production).
• Shelf-life and shipment constraints (narrow windows between labeling and imaging).
• Regulatory deviations and quality events (batch holds, recalls, or distribution interruptions).

How does TECHNETIUM TC 99M SESTAMIBI compare with alternative Tc-99m myocardial perfusion agents for suppliers?

Answer: Competing agents (e.g., Tc-99m tetrofosmin) have different kit and supplier sets, but the same distribution model: generator supply plus kit manufacturing plus radiopharmacy labeling.

Supplier implications of switching agents

• If a health system changes from sestamibi to an alternative, supply continuity depends on whether the replacement has independent kit sourcing and whether radiopharmacy labeling capacity is sized to the new reagent.

What generic entry risks exist for TECHNETIUM TC 99M SESTAMIBI suppliers?

Answer: “Generic” entry risk is less about legal exclusivity and more about the ability to manufacture and validate a radiopharmaceutical kit under current GMP and meet radiolabeling performance requirements.

Entry barriers

• Radiochemistry validation, sterility assurance, QC release testing, and stability documentation for kit performance.
• Manufacturing scale and batch release timelines for time-critical radiopharmacy workflows.

Key supplier-data extraction checklist (to build a complete supplier roster)

Because supplier identity varies by NDC package and distribution channel, the operational roster is built from:

• FDA NDC directory entries for “technetium tc 99m sestamibi” by strength/package size.
• Current labeler/manufacturer/distributor fields per NDC.
• Radiopharmacy provider networks for “delivered labeled doses” sourcing.

Key Takeaways

• TECHNETIUM TC 99M SESTAMIBI supply is structurally split across kit manufacturers, technetium-99m generator supply, and radiopharmacy labeling/distribution networks.
• A complete “who supplies” list is NDC-specific and should be assembled by reconciling FDA NDC directory package-level labeler and manufacturer fields with radiopharmacy distribution channels.
• Availability risks track generator and kit manufacturing capacity plus radiochemistry logistics rather than Orange Book exclusivity.

FAQs

1. How can I identify the exact manufacturer of TECHNETIUM TC 99M SESTAMIBI for a given dose?
   Use the NDC for the specific pack and reconcile the FDA NDC “labeler/manufacturer” fields with package insert labeling.

2. Do hospitals generally receive TECHNETIUM TC 99M SESTAMIBI as a kit or labeled doses?
   Many self-label from kits using technetium-99m generators, while others receive labeled doses from contracted radiopharmacies.

3. What upstream supplier constraints most often impact TECHNETIUM TC 99M SESTAMIBI supply?
   Technetium-99m generator production and kit manufacturing capacity are the dominant upstream constraints.

4. Are there patent or exclusivity barriers that prevent additional TECHNETIUM TC 99M SESTAMIBI suppliers?
   Supply expansion is primarily controlled by radiopharmaceutical manufacturing capability and regulatory release capacity rather than Orange Book-style exclusivity.

5. What’s the fastest way to audit alternatives if TECHNETIUM TC 99M SESTAMIBI is temporarily unavailable?
   Switch readiness depends on which kits and radiopharmacy networks are already qualified for alternative Tc-99m myocardial perfusion agents.

References

1. FDA. NDC Directory. U.S. Food and Drug Administration.
2. FDA. Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations. U.S. Food and Drug Administration.