Suppliers and packagers for neuraceq

neuraceq

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

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Lantheus	NEURACEQ	florbetaben f-18	SOLUTION;INTRAVENOUS	204677	NDA	Lantheus Biosciences Ltd., a Lantheus Company	54828-001-50	1 VIAL, MULTI-DOSE in 1 CONTAINER (54828-001-50) / 50 mL in 1 VIAL, MULTI-DOSE	2014-03-20

Suppliers and packagers for neuraceq

Last updated: May 29, 2026

NEURACEQ (florbetaben F 18) suppliers: Which companies make it and supply the drug in the US and EU?

NEURACEQ is a fluorine-18 (18F) PET imaging drug (active ingredient: florbetaben). Because NEURACEQ is radiopharmaceutical supply-chain constrained, “supplier” most often means (i) the contracted manufacturers of the radiopharmaceutical under the marketing authorization and (ii) the logistics network that receives and distributes short half-life product.

What companies supply NEURACEQ florbetaben F 18 to the market?

NEURACEQ is supplied as a licensed radiopharmaceutical under a marketing-authorisation holder (MAH) structure and is produced through specialized GMP radiochemistry manufacturing sites. The supply chain typically involves:

1. Radiopharmaceutical manufacturer(s) producing florbetaben 18F with GMP release and batch certification for each lot.
2. MAH oversight for pharmacovigilance, release authorization frameworks, and distribution arrangements.
3. Radiopharmacy distribution partners (hubs, distributors, and imaging centers) that can receive 18F product quickly after manufacture because the effective logistics window is governed by the 18F half-life (109.8 minutes) and radiochemical purity specifications.

Actionable supplier identification requires NEURACEQ’s regulator-facing product dossier listing (USP/EP MA dossier, SmPC/label “manufactured by/for” statements, and FDA/EMA reference product documentation). With only the drug name provided, a complete and accurate supplier map cannot be produced.

Is NEURACEQ manufactured by GE Healthcare, Lantheus, or another radiopharma CDMO?

NEURACEQ is not a typical “generic tablet” supply where multiple branded and generic manufacturers compete. The key market reality is that radiopharmaceutical production is tied to contracted sites capable of cyclotron availability, automated synthesis, QC release, and rapid cold-chain logistics for 18F.

Common radiopharma categories that can appear as “manufactured by” in labeling include:

• Cyclotron-based radiochemistry manufacturing sites under the MAH contract
• Specialist radiopharmaceutical contract manufacturers (CDMOs) with hot-cell synthesis and release testing capability
• Regional distributors that operate within the authorization and cold-chain requirements

A company-level callout (GE Healthcare vs Lantheus vs others) depends on the specific labeling “manufactured by” line(s) for NEURACEQ in the jurisdiction of interest (US vs EU member states). That dossier-level detail is not present in the prompt.

What are the NEURACEQ manufacturing sites listed on the package insert or SmPC?

SmPC/package insert “Manufactured by” and “Marketing authorisation holder” fields usually list:

• The MAH name (entity responsible for the product in the EU)
• One or more manufacturing sites (address-level)
• Sometimes the batch release site and Q.C. testing site
• Distributor/holder arrangements for local supply

Without the exact NEURACEQ label version and jurisdiction (FDA US label vs specific EMA authorization/SmPC or national product details), a correct supplier-site listing cannot be generated.

How does NEURACEQ supply differ across the US vs EU (and why does it matter for contracting)?

• US (FDA): radiopharmaceutical distribution generally hinges on FDA labeling/manufacturing information and the operational ability of radiopharmacies to receive and handle 18F product on a tight timescale.
• EU (EMA + national): the SmPC often reflects the centralized MA plus site-level manufacturing arrangements, while distribution depends on national release logistics and radiopharmacy operations.

From a procurement and contracting perspective, the difference matters because:

• A supplier change at the manufacturing site level can affect batch release timelines, availability, and QC release capacity.
• Contract terms must match the radiochemical purity and specific activity requirements and the release testing workflow.

A cross-jurisdiction supplier list requires the authoritative label/SmPC texts, which are not provided.

Which distributors supply NEURACEQ to imaging centers?

For 18F PET imaging drugs, distributor selection typically focuses on:

• Short transport window feasibility
• Validated cold-chain routing
• Radiation safety logistics
• Radiopharmacy receiving capability at the imaging centers

But distributor identity is usually included in:

• jurisdiction-specific prescribing information
• local distribution agreements
• radiopharmacy network lists

No such jurisdiction-specific distributor roster can be stated from the prompt alone.

What NEURACEQ supply risk exists if you rely on a single supplier?

Radiopharmaceutical supply risk concentrates around:

• cyclotron scheduling and capacity (18F availability),
• synthesis module uptime,
• release testing and batch disposition capacity,
• shelf-life constraints governed by 18F decay,
• regulatory batch release constraints.

A litigation-oriented or business-risk supplier map requires the specific manufacturing site list. Without that, “single supplier” risk quantification and mitigation planning cannot be tied to factual supplier identities.

How many suppliers can carry NEURACEQ florbetaben F 18 under GMP?

NEURACEQ’s supply is typically constrained to the authorized manufacturing sites under the MA dossier and product-specific GMP approvals. The number of “suppliers” for procurement is therefore usually smaller than for non-radiopharma products.

However, the actual count depends on:

• how many manufacturing sites are listed,
• whether EU includes multiple release/testing sites,
• and whether alternative sites exist for contingencies.

The prompt does not include the dossier listing needed to count authorized manufacturers.

Key Takeaways

• NEURACEQ is an 18F PET radiopharmaceutical, so “suppliers” are mainly authorized manufacturing sites plus the radiopharmacy/distribution network required for rapid delivery.
• A precise, company- and site-level supplier list for NEURACEQ cannot be produced from the provided input.
• For contracting, the decisive facts to anchor supplier selection are the jurisdiction-specific “manufactured by/for” and MAH/distribution lines in the official label/SmPC.

FAQs

1. What is the active ingredient in NEURACEQ and why does that constrain suppliers?
   NEURACEQ’s active ingredient is florbetaben labeled with fluorine-18 (18F). 18F’s short half-life makes supply-chain feasibility and cyclotron-to-synthesis timing central.

2. Do NEURACEQ suppliers differ between EU member states?
   They can, because distribution partners and radiopharmacy receipt logistics vary by country even when the MA dossier is centralized.

3. Can radiopharmacy chains distribute NEURACEQ directly without a designated distributor?
   Distribution is governed by authorization, labeling, and local radiopharmacy receiving rules; direct sourcing is tied to how the MA dossier and distribution network are structured.

4. What procurement document should define NEURACEQ’s approved manufacturer/supply chain?
   The jurisdiction-specific package insert or SmPC fields naming “manufactured by” and MAH/distribution arrangements.

5. What is the biggest operational risk in NEURACEQ supply?
   Batch availability tied to 18F production and synthesis plus fast release logistics for short-lived radiopharmaceutical product.

References

1. European Medicines Agency (EMA). NEURACEQ (florbetaben (18F)) product information (SmPC).
2. U.S. Food and Drug Administration (FDA). NEURACEQ (florbetaben (18F)) prescribing information and product labeling.