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Suppliers and packagers for generic pharmaceutical drug: TECHNETIUM TC-99M SUCCIMER
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TECHNETIUM TC-99M SUCCIMER
Listed suppliers include manufacturers, repackagers, relabelers, and private labeling entitities.
| Applicant | Tradename | Generic Name | Dosage | NDA | NDA/ANDA | Supplier | Package Code | Package | Marketing Start |
|---|---|---|---|---|---|---|---|---|---|
| Theragnostics | NEPHROSCAN | technetium tc-99m succimer | POWDER;INTRAVENOUS | 214993 | NDA | Theragnostics Inc | 71083-0020-5 | 5 VIAL, SINGLE-DOSE in 1 CARTON (71083-0020-5) / 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL, SINGLE-DOSE (71083-0020-1) | 2022-02-18 |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >NDA/ANDA | >Supplier | >Package Code | >Package | >Marketing Start |
Who Supplies Technetium Tc-99m Succimer?
What is the supply chain for TECHNETIUM TC-99M SUCCIMER?
TECHNETIUM TC-99M SUCCIMER is a radiopharmaceutical combination in which:
- Technetium Tc-99m is supplied via molybdenum-99 (Mo-99) / Tc-99m generator systems (typically “generator-produced” Tc-99m).
- Succimer is supplied as a chemical precursor (kit component) that is formulated into a drug kit and reconstituted with Tc-99m at the point of use.
In practice, suppliers fall into three tiers: 1) Radionuclide generator suppliers (Mo-99 to Tc-99m). 2) Radiopharmacy kit manufacturers for Tc-99m succimer (succimer kit components and labeling/assembly). 3) Logistics and distribution partners for cold-chain and short half-life handling.
Which companies supply Tc-99m generators used to make Tc-99m radiopharmaceuticals?
Common generator suppliers to the nuclear medicine market include:
- Curium (global Tc-99m generator supply network)
- GE HealthCare (Tc-99m generator products and related infrastructure)
These companies supply Tc-99m as generator eluate for downstream kit preparation across many Tc-99m radiopharmaceuticals, including succimer-containing products where commercially marketed kits are reconstituted with Tc-99m.
Which companies supply Tc-99m succimer kits (the succimer drug product components)?
Tc-99m succimer is marketed in some jurisdictions as a Tc-99m labeled radiopharmaceutical kit (succimer kit plus Tc-99m). The kit supply is typically provided by radiopharmaceutical manufacturers and pharmacy-assembly networks tied to national distribution frameworks.
For this specific molecule, a complete, jurisdiction-accurate supplier list cannot be produced from the information provided. A reliable supplier table requires product-specific confirmation of:
- the brand name(s) in each market,
- the marketing authorization holder (MAH) and kit manufacturer,
- the kit composition and labeling holder as listed in regulatory product databases.
What are the typical inputs and sourcing specs suppliers control?
A defensible procurement view for Tc-99m succimer relies on three measurable input streams:
1) Tc-99m eluate quality from Mo-99 generators
- radionuclidic purity (Tc-99m fraction),
- activity concentration,
- elution volume and schedule,
- supplier qualification to pharmacopoeia and regulatory standards for generator eluate.
2) Succimer kit component
- chemical purity and assay,
- sterility status for kit components (where applicable),
- container closure integrity,
- validated reconstitution instructions and stability.
3) Radiopharmacy assembly and distribution
- validated preparation method per labeling,
- short half-life logistics,
- documentation to support batch traceability.
Supplier landscape by tier (actionable mapping)
| Tier | What you buy | What it covers for Tc-99m succimer | Typical supplier type |
|---|---|---|---|
| 1 | Mo-99/Tc-99m generator system | Tc-99m source used during kit reconstitution | Generator manufacturer |
| 2 | Tc-99m succimer kit | Succimer precursor + kit components, reconstitution instructions | Radiopharmaceutical manufacturer / MAH |
| 3 | Distribution services | Same-day/short window delivery and chain-of-custody | Specialist logistics / authorized distributors |
What is the most reliable way to identify the actual Tc-99m succimer kit supplier?
The supplier you need for R&D or contracting is the kit manufacturer / MAH for the specific market product presentation (brand and strength). That is typically documented in:
- the regulatory label and package insert,
- the national product registration database,
- the distributor listing tied to the authorized product.
Because product-name and market-specific details are not provided here, a complete supplier roster for Tc-99m succimer cannot be stated without risking incorrect attributions.
Key Takeaways
- Tc-99m succimer production depends on Tc-99m generator eluate plus succimer kit components.
- Curium and GE HealthCare are established Tc-99m generator suppliers used across the Tc-99m radiopharmaceutical ecosystem.
- A market-specific list of Tc-99m succimer kit suppliers requires the exact marketed product/brand presentation because kit manufacturing and MAH vary by jurisdiction and labeling holder.
FAQs
1) Are Tc-99m succimer kits built from any Tc-99m generator?
In practice, kits are validated to use Tc-99m eluate meeting labeling and pharmacopoeial requirements, which comes from Mo-99/Tc-99m generators supplied to nuclear medicine networks.
2) Do generator suppliers also manufacture the succimer kit?
Generator suppliers generally supply radionuclide eluate. The succimer kit is typically manufactured by radiopharmaceutical firms or MAHs that assemble and label the complete radiopharmaceutical kit.
3) Who is the “supplier” for contracting: the generator maker or the kit maker?
For drug product supply, procurement targets the authorized kit manufacturer/MAH for the specific labeled presentation; generators are an upstream input.
4) Does distribution matter for availability of Tc-99m succimer?
Yes. Tc-99m radiopharmaceutical kits and preparation windows depend on rapid logistics and chain-of-custody, usually handled by authorized radiopharma distributors.
5) Can the same supplier provide both radionuclide and the kit?
Some organizations span multiple parts of the supply chain, but the most consistent approach is to treat radionuclide supply and kit manufacturing as separate procurement workstreams unless a single company is explicitly identified as the kit MAH in the target jurisdiction.
References
[1] Curium. (n.d.). Mo-99/Tc-99m generator and radiopharmaceutical supply information. Curium. https://www.curiumpharma.com/
[2] GE HealthCare. (n.d.). Nuclear medicine Tc-99m generator offerings and related information. GE HealthCare. https://www.gehealthcare.com/
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