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Suppliers and packagers for generic pharmaceutical drug: thallous chloride tl-201
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thallous chloride tl-201
Listed suppliers include manufacturers, repackagers, relabelers, and private labeling entitities.
| Applicant | Tradename | Generic Name | Dosage | NDA | NDA/ANDA | Supplier | Package Code | Package | Marketing Start |
|---|---|---|---|---|---|---|---|---|---|
| Curium | THALLOUS CHLORIDE TL 201 | thallous chloride tl-201 | INJECTABLE;INJECTION | 018150 | NDA | Curium US LLC | 69945-120-56 | 1 VIAL in 1 CAN (69945-120-56) / 5.6 mL in 1 VIAL | 2015-11-04 |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >NDA/ANDA | >Supplier | >Package Code | >Package | >Marketing Start |
Suppliers and packagers for generic pharmaceutical drug: thallous chloride tl-201
Suppliers for Thallous Chloride (Tl-201): Who Makes and Distributes Tl-201 for Nuclear Imaging
Thallous chloride Tl-201 (often sold as thallous chloride injection) is sourced through a limited set of specialized radiopharmaceutical manufacturers and distributors that handle radioactive materials, radionuclide procurement, quality control, and licensed logistics. Availability is typically channelled through US- and EU-authorized radiopharmacy supply chains rather than broad “pharma excipient” supplier networks.
Who supplies thallous chloride Tl-201 injection in the US?
In the US, Tl-201 is supplied through radiopharmaceutical manufacturers and distributors that support FDA-regulated radiopharm products and state-licensed facilities that prepare and administer doses.
What distributor model is typical for Tl-201
- A radiopharmaceutical company produces and releases Tl-201-containing drug product (or assembled ready-to-use product, depending on the branded supply chain).
- Authorized distributors then ship to nuclear medicine providers and radiopharm centers under radioactive material transport rules.
- Many hospital sites procure through radiopharmacy wholesalers/distributors that already hold the required licenses and cold-chain/regulated transport infrastructure.
What to look for on the label or packaging
High-intent purchasing teams typically verify:
- NDA/BLA holder (if applicable) and NDC labeling on the administered unit
- Lot/serial traceability
- Sterility, radionuclidic identity, and assay/release specs
- Expiration tied to activity decay
- Chain of custody documentation for radioactive drug shipments
Which companies produce Tl-201 radiopharmaceuticals for sale?
Tl-201 supply tends to concentrate among firms that either:
- produce thallium-201 source material and formulate into clinical injection, or
- contract-manufacture and distribute under a branded radiopharmaceutical license with radionuclide sourcing control.
How production is usually constrained
Tl-201 has tight upstream constraints because the value is in radionuclide sourcing and radiopharmaceutical release controls, not standard chemical synthesis scale.
Key constraints that shape supplier lists:
- radionuclide availability and yield
- target irradiation and post-processing capacity (upstream for Tl-201)
- licensed radiopharmaceutical manufacturing lines
- validation of QC release tests for radionuclidic purity, sterility, and activity concentration
What suppliers carry thallous chloride Tl-201 for hospitals and radiopharm centers?
Hospitals and nuclear medicine departments generally source Tl-201 via radiopharm distribution partners that can:
- store and handle radioactive drug products
- provide rapid shipment windows compatible with activity half-life considerations
- support documentation for regulatory and inventory compliance
What procurement channels typically work
- Radiopharmaceutical distributors serving nuclear medicine providers
- Hospital radiopharmacy procurement workflows routed through GPO or specialty distribution contracts (where Tl-201 is cataloged)
- Direct allocation from the radiopharmaceutical manufacturer to authorized customers in constrained supply periods
What suppliers exist for Tl-201 outside the US (EU/UK/other markets)?
Outside the US, Tl-201 availability usually follows national licensing frameworks for radiopharmaceuticals and radioactive medicinal products.
How EU supply differs
- Radiopharmaceuticals are often distributed under marketing authorizations within each member state or via parallel trade where permitted.
- Hospital procurement typically goes through local radiopharmacy networks and licensed radio-pharmaceutical distributors.
UK procurement pattern
- Similar to the EU in that distribution is dominated by licensed radiopharmacy wholesalers and authorized radiopharmaceutical marketing authorization holders.
How do you qualify a thallous chloride Tl-201 supplier for clinical use?
Qualification is usually driven by documentation and cold-chain or regulated-transport readiness rather than routine pharma procurement.
Supplier qualification checklist (operational)
- Regulatory status of the marketed product in the destination jurisdiction
- Batch/lot traceability and COA availability
- QC testing package: radionuclidic identity/purity, sterility, endotoxin, assay method
- Shipment frequency and lead times compatible with decay constraints
- Stability/expiration governance tied to activity
- Returns, incident reporting, and deviation handling for radioactive shipments
Contracting points that matter
- Allocation policy during shortages
- Pricing structure based on activity (commonly activity concentration and dose unitization)
- Guaranteed activity at time of delivery versus activity at reference time
- Service-level terms for dose readiness and traceability documentation
What generic or alternative sources exist for thallous chloride Tl-201?
Tl-201 is a specific radiopharmaceutical active ingredient. In practice, there are limited “generic” substitutes, because:
- the radionuclide supply and radiopharm release are the bottleneck, and
- regulatory approval is product- and jurisdiction-specific.
Therapeutic equivalence reality
- Clinical interchange is generally governed by approved product labeling, dosing, and facility protocols, not just chemical similarity.
What are the Orange Book and FDA exclusivity implications for Tl-201 suppliers?
Tl-201’s key procurement implication is that supply is dominated by the approved marketed radiopharmaceutical(s). Supplier entry is limited by:
- approved product status,
- radionuclide and manufacturing constraints,
- and regulatory requirements for radioactive medicinal products.
Why this affects supplier options
- A new entrant needs a regulatory pathway plus radionuclide and manufacturing capability
- Many facilities rely on continuity of supply because decay-sensitive dosing requires dependable shipments
What patent and litigation risk affects Tl-201 supply?
Patent estates can affect manufacturing capacity or formulation or labeling. However, supplier risk for Tl-201 procurement is more commonly driven by:
- radionuclide sourcing constraints,
- manufacturing capacity/QA release constraints,
- and regulatory lot release readiness, rather than active Paragraph IV-style generic battles typical for small-molecule generics.
Practical view for procurement
Even when there are no active exclusivity barriers, qualified supply remains limited by the upstream radionuclide ecosystem.
What is the competitive landscape for Tl-201 supplier contracts?
Competition is based on:
- reliable radionuclide sourcing
- production and QC throughput
- allocation management during shortages
- distributor coverage in the target region
How buyers reduce supply risk
- Dual-source contracting where possible (manufacturer and/or distributor diversification)
- Inventory planning using realistic activity decay windows
- Standardizing receiving and QC verification steps at facility level
Key Takeaways
- Thallous chloride Tl-201 is supplied through specialized radiopharmaceutical manufacturers and licensed distributors; the supplier universe is narrow versus mainstream chemical/pharma supply.
- Procurement is dominated by radionuclide availability, licensed radiopharmaceutical release, and decay-sensitive logistics.
- Supplier qualification should focus on regulatory status, COA/QC completeness, batch traceability, and delivery-activity performance, not just list pricing.
- Non-US supply is governed by local radioactive medicinal product frameworks and radiopharmacy distribution networks.
FAQs
- How do radiopharm distributors price thallous chloride Tl-201 (activity vs dose unit)?
- What documents do hospitals need to receive Tl-201 injections under radioactive shipment rules?
- How is radionuclidic purity verified for Tl-201 thallous chloride releases?
- What lead times are realistic for Tl-201 procurement given its decay profile?
- Are there any clinically approved substitutes for Tl-201 when it is unavailable?
References
- U.S. Food and Drug Administration. Radiopharmaceutical labeling and regulations. FDA guidance and regulations. (FDA website).
- European Medicines Agency. Guidelines and regulatory framework for radioactive medicinal products. (EMA website).
- IAEA. Safety and transport of radioactive materials (regulatory principles affecting distribution). International Atomic Energy Agency.
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