Bulk Pharmaceutical API Sources for VIZAMYL

Bulk Pharmaceutical API Sources for VIZAMYL

Vendor	Vendor Homepage	Vendor Sku	API Url
BenchChem		B1252642
THE BioTek		bt-1585270
RR Scientific		R6353148
InvivoChem		V41591

Bulk Active Pharmaceutical Ingredient (API) Sources for: VIZAMYL

Last updated: July 29, 2025

Introduction

VIZAMYL (flutemetamol F18 injection) is a radiopharmaceutical used in positron emission tomography (PET) imaging to detect amyloid-beta plaques associated with Alzheimer’s disease (AD). As a critical diagnostic agent, VIZAMYL’s production hinges on high-quality Active Pharmaceutical Ingredients (APIs), notably the radioactive compound Flutemetamol F18. Ensuring consistency, purity, and regulatory compliance of the API source is vital for pharmaceutical manufacturers and healthcare providers. This report examines global API sourcing strategies for Flutemetamol F18, evaluates key suppliers, and offers insights pertinent to stakeholders involved in VIZAMYL’s manufacturing and procurement.

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Understanding the API: Flutemetamol F18

Flutemetamol F18 is a fluorine-18 labeled radiotracer synthesized for PET imaging. Its production involves complex radiochemistry processes, primarily radiolabeling a precursor molecule with F18, a positron-emitting isotope generated via cyclotron irradiation. The stability and radiochemical purity of the API are central to ensuring diagnostic accuracy and patient safety.

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Global API Production Landscape

1. Lead Manufacturers and Suppliers

The primary API source for VIZAMYL—Flutemetamol F18—is synthesized by specialized radiopharmaceutical manufacturers with integrated cyclotron facilities. Notable suppliers include:

• GE Healthcare: As the developer of VIZAMYL, GE Healthcare operates in-house cyclotron facilities for API production, ensuring a vertically integrated supply chain. Their in-house API production guarantees regulation compliance, consistency, and controlled quality.

• PETNET Solutions: Acquired by Siemens Healthineers, PETNET operates multiple regional GMP-compliant radiopharmaceutical manufacturing sites with capabilities to produce Flutemetamol F18, either internally or through licensed agreements.

• IIT (Indian Institute of Technology) and other Academic Labs: While primarily research-focused, some academic institutions possess cyclotron capabilities producing radiotracers, potentially acting as API suppliers under licensing agreements.

• Third-party Radiopharmaceutical Contract Manufacturers: A limited number of specialized facilities worldwide produce Flutemetamol F18 API under contract for commercial supply. These entities often operate under stringent GMP standards and possess cyclotron infrastructure.

2. Regional API Production and Distribution

• North America & Europe: Dominated by in-house or affiliated production via GE Healthcare and Siemens. These sources supply regional markets with minimal reliance on external API vendors.

• Asia-Pacific: Growing centers, including India and Japan, develop cyclotron infrastructure, producing Flutemetamol F18 API for local markets or export under licensing and regulatory frameworks.

• Emerging Markets: Some countries outsource API synthesis to accredited contract manufacturers, provided they meet GMP standards and quality assurance criteria.

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Criteria for API Source Selection

When considering API sources for VIZAMYL, the following parameters are critical:

• Regulatory Compliance: Suppliers must adhere to GMP standards, with comprehensive documentation for manufacturing, quality control, and traceability.

• Quality and Purity: Radiochemical purity (>95%) and specific activity influence the diagnostic efficacy. Suppliers should provide validated analytical data confirming compliance.

• Supply Chain Reliability: The inherently short half-life of F18 (~110 minutes) necessitates rapid, dependable logistics from production to clinical use.

• Production Capacity: Manufacturers need sufficient capacity and flexibility to support clinical trials, commercial demand, and potential supply disruptions.

• Regulatory Approvals and Certifications: Suppliers should possess approvals from bodies such as the FDA, EMA, or equivalent, streamlining regulatory pathways for marketed products.

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Challenges in API Sourcing for Flutemetamol F18

• Short Half-life: The rapid decay of F18 constrains manufacturing, storage, and transportation, demanding proximity between cyclotron facilities and end-users.

• Complex Radiochemistry: Radiolabeling procedures require specialized expertise, quality control, and compliance with radiation safety standards.

• Limited Number of Producers: The specialized nature limits the number of API suppliers, risking supply chain vulnerabilities.

• Regulatory Hurdles: Variability across regions in GMP standards and licensing can complicate API procurement.

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Emerging Trends and Future Outlook

• Vertical Integration: Increasingly, companies like GE Healthcare control upstream production to meet quality, regulatory, and supply chain demands.

• Regional Cyclotron Expansion: Investment in local cyclotron infrastructure in emerging markets aims to diversify sources and reduce dependency on imports.

• Technological Advances: Innovations in radiochemistry and automation are improving yield, purity, and logistics, expanding the scope of API production capabilities.

• Regulatory Harmonization: Efforts to standardize GMP and licensing frameworks will facilitate global API sourcing and reduce barriers.

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Conclusion

The sourcing of Flutemetamol F18 API for VIZAMYL primarily involves specialized, high-compliance radiopharmaceutical manufacturers with integrated cyclotron capabilities. The dominant suppliers include in-house production by GE Healthcare and Siemens Healthineers, supported by regional and contracted third-party providers. Given the highly specialized nature of the API, manufacturing reliability, regulatory adherence, and supply chain robustness are paramount. As demand for amyloid PET imaging grows globally, investments in regional cyclotron infrastructure and technological innovations will be key to expanding and securing API supply.

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Key Takeaways

• Vertical integration by manufacturers ensures regulatory compliance and supply stability for VIZAMYL’s API.
• The short half-life of F18 demands proximity between cyclotron facilities and healthcare providers to maintain supply continuity.
• Limited number of specialized API producers heightens the importance of diversified sourcing strategies and contingency planning.
• Emerging markets are investing in cyclotron infrastructure, promising augmentation of regional API production capacity.
• Regulatory harmonization and technological advancements are critical in expanding secure and compliant API sourcing globally.

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FAQs

1. Who are the leading suppliers of Flutemetamol F18 API globally?
Leading suppliers are primarily integrated within major radiopharmaceutical companies such as GE Healthcare and Siemens Healthineers, which produce the API in-house. Contract radiopharmaceutical manufacturers with GMP compliance also serve regional markets.

2. What are the key quality considerations for sourcing Flutemetamol F18 API?
Key considerations include radiochemical purity (>95%), specific activity, compliance with GMP standards, validated analytical testing, and radiation safety measures.

3. How does the short half-life of F18 impact API supply?
The approximately 110-minute half-life of F18 necessitates production close to the point of use, rapid logistics, and synchronization with imaging schedules to ensure timely availability.

4. Are regional API production capabilities sufficient to meet rising demand?
While established in North America and Europe, emerging markets are investing in cyclotron infrastructure, which will enhance regional supply but may still face capacity constraints amid growing demand.

5. What future developments could affect API sourcing for VIZAMYL?
Advancements in radiochemistry, automation, and regional cyclotron expansion, coupled with regulatory harmonization efforts, will facilitate more robust and accessible API supply chains.

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References:

1. [1] GE Healthcare. "VIZAMYL (flutemetamol F18 injection) prescribing information." 2022.
2. [2] Siemens Healthineers. "PET Radiopharmaceuticals – Production and Supply." 2021.
3. [3] IAEA. "Cyclotron Production of Positron Emission Tomography (PET) Radioisotopes." 2020.
4. [4] FDA. "Guidance for Industry: Radiopharmaceuticals—Production and Quality Control." 2019.
5. [5] European Medicines Agency (EMA). "Guidelines on Good Manufacturing Practice (GMP) for Radiopharmaceuticals." 2021.