Suppliers and packagers for VIZAMYL

VIZAMYL

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

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Ge Healthcare	VIZAMYL	flutemetamol f-18	INJECTABLE;INTRAVENOUS	203137	NDA	GE Healthcare Inc. (Medi-Physics, Inc. dba GE Healthcare)	17156-067-30	1 VIAL, MULTI-DOSE in 1 CONTAINER (17156-067-30) / 30 mL in 1 VIAL, MULTI-DOSE	2014-01-01

Suppliers and packagers for VIZAMYL

Last updated: May 27, 2026

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VIZAMYL (florbetaben F 18 injection) supply chains are constrained by the need for cyclotron-produced F-18, GMP radiopharmaceutical manufacturing, and time-sensitive distribution. The supplier set is defined primarily by (1) the radiopharmaceutical manufacturer listed for U.S. supply, (2) the imaging kit supplier(s) used to prepare doses on-site or by contract manufacturing, and (3) cyclotron/radiochemistry production partners that supply F-18/fluorination intermediates or finished bulk drug substance equivalents.

This analysis provides the supplier map only where the underlying, citable supplier identities are available from the public record.

Who are the FDA-listed suppliers for VIZAMYL (florbetaben F 18) distribution?

Answer (featured snippet): VIZAMYL is supplied in the U.S. through the FDA commercial supply chain for the approved radiopharmaceutical product. The U.S. “supplier” for regulatory and distribution purposes is the company holding the FDA marketing authorization for VIZAMYL, with radiopharmaceutical preparation supported by manufacturing/contract partners used under that marketing authorization.

What supplier roles exist for VIZAMYL?

• Marketing authorization holder / U.S. manufacturer or distributor on labeling: the entity responsible for commercial supply to radiopharmacies/hospitals under the approved product listing.
• Radiopharmaceutical manufacturing partner(s): contract manufacturing organizations (CMOs) or internal manufacturing units that assemble, label, test, and release the injected doses under GMP.
• Radiochemistry inputs and F-18 supply partners: cyclotron production and radiochemistry vendors that provide F-18 intermediates used to generate florbetaben F 18.

VIZAMYL product form that drives sourcing

• Radiopharmaceutical injection (F-18): short half-life and batch release windows shift sourcing power to F-18 availability and local dose preparation capacity. Supply bottlenecks are typically tied to radiochemistry release and courier/delivery timelines rather than conventional chemical API logistics.

Which companies supply the florbetaben F 18 radiochemistry for VIZAMYL?

Answer (featured snippet): Suppliers for florbetaben F 18 are the entities that produce the F-18-based radiochemical material used to manufacture VIZAMYL doses. In practice, these are radiopharmaceutical manufacturing sites and cyclotron/radiochemistry production partners integrated into the approved manufacturing and release pathway.

Supply-chain checkpoints

• F-18 production: cyclotron run schedules determine batch readiness.
• Radiolabeling and purification: production step must match validated specifications for florbetaben F 18 identity, radiochemical purity, and specific activity.
• GMP release testing: quality control timing limits same-day or next-day distribution.

What contract manufacturing and co-manufacturing models apply to VIZAMYL?

Answer (featured snippet): VIZAMYL supply can be supported by either a single radiopharmaceutical GMP site or a network model where formulation/assembly is performed at one site and released doses are distributed through another entity’s logistics chain.

Common models for radiopharmaceuticals

• Single-site model: the marketing authorization holder manufactures and releases doses at one GMP radiopharmacy/production facility.
• Network model: manufacturing, QC release, and distribution are split across entities, often with a CMO performing some manufacturing steps under quality agreements.

Who supplies VIZAMYL to hospitals and imaging centers in the U.S.?

Answer (featured snippet): The delivery channel is typically through radiopharmacy fulfillment tied to approved distribution practices for short half-life products. The “supplier” customers experience is usually the company distributing finished VIZAMYL doses to clinical sites.

Distribution constraints that shape supplier selection

• Time-to-imaging: scheduling and dose decay management dictate reliable weekly/monthly supply cadence.
• Courier logistics: validated packaging for radiation safety and temperature/radiochemical stability affects where finished doses can come from.
• Site preparation capability: hospitals/authorized radiopharmacies depend on dose preparation instructions and validated system compatibility.

How does VIZAMYL sourcing compare with other F-18 amyloid PET tracers?

Answer (featured snippet): Like other F-18 PET tracers, VIZAMYL sourcing is primarily supply-driven by cyclotron availability and manufacturing-release turnaround, not by multi-year API contracting.

Competitive tracer sourcing dynamics

• F-18 scarcity risk: affects all F-18 PET compounds that rely on external or region-limited cyclotron production.
• Regional distribution efficiency: favors manufacturers able to ship to imaging markets within short half-life windows.

What patent or regulatory exclusivity does supplier structure depend on?

Answer (featured snippet): Supplier structure is governed less by patent exclusivity and more by manufacturing authorization, GMP capability, and the approved drug product’s regulatory dossier linkage for radiolabeled dosing.

Where IP impacts sourcing

• Process validation and radiolabeling IP: can restrict alternative manufacturing methods even when a product is already approved.
• Drug substance and formulation-specific controls: may require validated vendor qualification and comparability to approved specifications.

What is the Orange Book status of VIZAMYL, and how does it affect supplier entry?

No Orange Book exclusivity can be used as a direct determinant of supplier entry without the Orange Book listing details for VIZAMYL in the public record. If VIZAMYL is listed, it would be the principal reference for patent-linked exclusivity and any drug product exclusivity that impacts generic or alternative-manufacturing pathways.

Key suppliers and names: What is the record-supported list for VIZAMYL?

No supplier names can be provided from the available information in this prompt. The required identifying supplier details must be drawn from citable public sources such as the FDA Orange Book listing, FDA label/manufacturer/distributor sections, prescribing information, or FDA inspection/manufacturing site references.

Key Takeaways

• VIZAMYL sourcing is driven by radiochemistry and F-18 production availability plus radiopharmaceutical GMP release timing.
• “Supplier” in practice splits into marketing authorization supply and radiochemistry manufacturing support that enables finished-dose distribution.
• Patent/exclusivity and Orange Book status can constrain alternative supply pathways, but supplier selection remains operationally dominated by F-18 and dose-release logistics.

FAQs

1. Who is listed as the manufacturer/distributor for VIZAMYL on the U.S. label?
2. Which cyclotron or radiochemistry partners supply the F-18 needed for florbetaben F 18 production?
3. What delivery and scheduling constraints affect VIZAMYL availability for PET imaging sites?
4. Does VIZAMYL have Orange Book-listed patents that block alternative manufacturers or generics?
5. How do contract manufacturing and site release testing impact VIZAMYL dose availability in the U.S.?

References (APA)

1. FDA. Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations. U.S. Food and Drug Administration.
2. U.S. FDA. Labeling and prescribing information for VIZAMYL (florbetaben F 18) injection.
3. FDA. Drug approvals and postmarket regulatory information for radiopharmaceutical products.