TECHNETIUM TC-99M TILMANOCEPT: Pharmaceutical manufacturers, suppliers, and wholesalers

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Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Cardinal Health 414	LYMPHOSEEK KIT	technetium tc-99m tilmanocept	INJECTABLE;INJECTION	202207	NDA	Cardinal Health 414, LLC	65857-425-05	1 KIT in 1 CARTON (65857-425-05) / 1 KIT in 1 KIT * 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL (65857-400-01)	2017-09-20
Cardinal Health 414	LYMPHOSEEK KIT	technetium tc-99m tilmanocept	INJECTABLE;INJECTION	202207	NDA	Cardinal Health 414, LLC	65857-450-05	1 KIT in 1 CARTON (65857-450-05) / 1 KIT in 1 KIT * 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL (65857-400-01) * 1 INJECTION, SOLUTION in 1 VIAL (65857-401-45)	2017-09-20
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>NDA/ANDA	>Supplier	>Package Code	>Package	>Marketing Start

Last updated: May 30, 2026

ecutive summary: Public procurement and labeling data tie TECHNETIUM TC-99M TILMANOCEPT (Lymphoseek; anti-CD206 tilmanocept, Tc-99m) supply chain to a small set of specialized radiopharmacy production and distribution partners. In the US, Lymphoseek is marketed by Cardinal Health as “Radiopharmaceuticals” and supplied through Cardinal Health’s radiopharmacy network (Cardinal Health may also operate as product distributor/fulfillment for the commercially released radiopharmaceutical, depending on contract). Outside the US, supply is generally handled through national radiopharmacy distributors licensed to receive and dispense Tc-99m agents under local nuclear/radiation regulations.

Which companies supply TECHNETIUM TC-99M TILMANOCEPT (Lymphoseek) in the US and globally?

Answer (US): The commercially delivered product is sourced through Cardinal Health’s radiopharmaceutical operations/network for US market fulfillment, with dispensing through licensed radiopharmacies and hospital-based nuclear medicine departments.

Answer (non-US): Supply is handled by country-specific radiopharmacy distributors that hold the necessary authorization to receive Tc-99m radiopharmaceuticals and dispense within each jurisdiction’s nuclear medicine distribution framework.

Cardinal Health radiopharmacy network

Product: TECHNETIUM TC-99M TILMANOCEPT (Lymphoseek)
US commercial supply and distribution: delivered through Cardinal Health radiopharmacy channels to licensed dispensing sites.

Hospital and licensed radiopharmacy dispensing

Endpoint suppliers in practice are the licensed radiopharmacies that receive the shipment and prepare the dose for administration (dose-assay, labeling, and radiation safety handling).
Many hospital systems source from a nearby licensed radiopharmacy distributor rather than taking direct manufacturer shipment.

What suppliers deliver Lymphoseek to nuclear medicine departments and radiopharmacies?

Answer: Delivery partners are typically radiopharmacy distributors and logistics providers operating under:

Tc-99m radioactive material transport authorization
chain-of-custody controls
temperature and shielded-container requirements
dose labeling and documentation compliance

Typical delivery model

Central radiopharmacy/distributor receives product under licensed conditions.
Product is dose-assayed and labeled for the patient-specific or site-specific schedule.
Orders are fulfilled to nuclear medicine departments and surgical services on a time-critical basis.

Contracting patterns that affect “supplier” identification

Some contracts list the supplier as the radiopharmacy distributor even if the drug originates with a specific commercial radiopharmaceutical manufacturer/distributor entity.
Many hospitals use group purchasing organizations or procurement portals where the “supplier” is the contracting radiopharmacy partner.

What is the Orange Book and FDA status of TECHNETIUM TC-99M TILMANOCEPT that constrains supply partners?

Answer: Lymphoseek is an FDA-regulated radiopharmaceutical product whose commercial distribution is constrained to licensed radiopharmacies and authorized nuclear medicine supply chains. That regulatory handling limit narrows the practical list of eligible “suppliers” to entities with radiopharmacy licenses and radioactive materials logistics capability.

FDA regulatory handle points that shape supply availability

Radiopharmaceuticals must move through licensed channels for receipt, storage, dose preparation, and dispensing.
Product availability is tied to the manufacturer/distributor’s ability to release, transport, and meet short shelf-life operational windows.

Which licensed radiopharmacies are eligible suppliers of Tc-99m tilmanocept doses?

Answer: The suppliers are the licensed radiopharmacies that:

can legally receive Tc-99m products
can lawfully dispense/administer under radiopharmacy/nuclear medicine rules
can comply with radiation safety, labeling, and chain-of-custody

Eligibility filters used by contracting buyers

FDA/State radiopharmacy licensure
radioactive materials transport certification for shipment acceptance
fulfillment capability for same-day or scheduled dosing

How many suppliers are in the TECHNETIUM TC-99M TILMANOCEPT distribution chain?

Answer: In practice, the chain concentrates at:

a small number of entities providing commercial radiopharmaceutical distribution (US centered on Cardinal Health)
a broader but still limited set of licensed radiopharmacies that fulfill local hospital orders

Market structure implication

“Suppliers” for procurement are usually fewer than the number of hospital users because local delivery requires radiopharmacy licensing and controlled radiological logistics.

What alternative sources exist if Lymphoseek is out of stock?

Answer: If Lymphoseek supply is constrained, procurement typically shifts to:

the next available licensed radiopharmacy distributor within the same chain
scheduling adjustments in the hospital’s nuclear medicine workflow
substitutions are generally not “therapeutic equivalents” due to tracer specificity and regulatory labeling

Why tracer substitution is limited

TECHNETIUM TC-99M TILMANOCEPT has tracer-specific clinical and labeling context.
Switching to a different tracer often changes protocol, imaging performance, and regulatory alignment for the indication.

What manufacturing and licensing constraints impact supply continuity?

Answer: The main constraints are radioactive material production and release logistics plus radiopharmacy licensing capacity.

Constraints that frequently drive shortages in radiopharmaceuticals

production slot limitations for Tc-99m radiopharmaceutical runs
availability of cGMP release and QC release capacity
shipping capacity within shielded containers and time windows
staffing at licensed radiopharmacies to dose-assay and deliver

Supplier comparison: Cardinal Health vs other radiopharmacy distributors (how to assess reliability)

Answer: Cardinal Health is the primary commercial distribution reference point in the US for Lymphoseek. Other “suppliers” are typically downstream radiopharmacy distributors and hospital servicing partners.

Procurement scoring dimensions

lead time for scheduled doses
ability to deliver on short notice
dose fill-rate for typical surgical schedules
chain-of-custody documentation completeness
service coverage radius and daily delivery frequency

Key Takeaways

TECHNETIUM TC-99M TILMANOCEPT (Lymphoseek) is supplied to US dispensing sites through Cardinal Health’s radiopharmaceutical distribution network, with dose fulfillment by licensed radiopharmacies.
Outside the US, supply is handled through country-specific licensed radiopharmacy distributors.
The eligible supplier universe is constrained by radiopharmacy licensing and radioactive materials transport compliance, which compresses the supplier set versus typical non-radioactive pharmaceuticals.
Practical supplier risk management focuses on downstream dispensing partner reliability: delivery lead time, fulfillment capacity, and chain-of-custody performance.

FAQs

1) Who is the distributor for Lymphoseek (TECHNETIUM TC-99M TILMANOCEPT) in the US?
Cardinal Health is the US commercial distribution reference point for Lymphoseek, with fulfillment through licensed radiopharmacies.

2) Can any pharmacy supply TECHNETIUM TC-99M TILMANOCEPT?
No. Only entities with appropriate radiopharmacy authorization and radioactive materials logistics for receipt, dose preparation, and dispensing can supply doses.

3) Are there generic or alternate-tracer suppliers that can replace Lymphoseek at the pharmacy counter?
Not as a simple pharmacy substitution. Availability and clinical protocol alignment are tracer- and labeling-specific, so sourcing typically remains within licensed channels for Lymphoseek or another protocol-approved tracer.

4) How do hospitals typically choose a supplier for Tc-99m radiopharmaceuticals?
Hospitals contract with licensed radiopharmacy partners that can deliver reliable lead times and meet time-sensitive dosing schedules.

5) What causes Lymphoseek distribution disruptions from a supplier standpoint?
Radioisotope production/release timing, cGMP/QC release, radioactive shipment capacity, and radiopharmacy capacity to dose-assay and deliver within short windows.

References (APA)

U.S. FDA. (n.d.). Product information and labeling database for Lymphoseek (technetium Tc 99m tilmanocept). FDA. https://www.fda.gov/
Cardinal Health. (n.d.). Radiopharmacy and radiopharmaceutical distribution materials for radiopharmaceutical product fulfillment (Cardinal Health radiopharmaceuticals). Cardinal Health. https://www.cardinalhealth.com/

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