Suppliers and packagers for generic pharmaceutical drug: FLORTAUCIPIR F-18

FLORTAUCIPIR F-18

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

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Avid Radiopharms Inc	TAUVID	flortaucipir f-18	SOLUTION;INTRAVENOUS	212123	NDA	Eli Lilly and Company	0002-1220-48	1 VIAL, MULTI-DOSE in 1 CAN (0002-1220-48) / 100 mL in 1 VIAL, MULTI-DOSE	2022-07-01
Avid Radiopharms Inc	TAUVID	flortaucipir f-18	SOLUTION;INTRAVENOUS	212123	NDA	Eli Lilly and Company	0002-1220-50	1 VIAL, MULTI-DOSE in 1 CAN (0002-1220-50) / 50 mL in 1 VIAL, MULTI-DOSE	2022-07-01

Suppliers for the Pharmaceutical Drug: Flortaucipir F-18

Last updated: July 30, 2025

Introduction

Flortaucipir F-18, also known by its research code AV-1451 or Tauvid®, is a radiopharmaceutical compound primarily used in positron emission tomography (PET) imaging for detecting tau protein aggregations associated with neurodegenerative diseases such as Alzheimer's disease. As a critical diagnostic tool, the supply chain for Flortaucipir F-18 is highly concentrated among specialized manufacturers and distributors globally, given the stringent regulatory requirements, complex synthesis, and the short half-life of the F-18 isotope. Ensuring reliable sourcing is essential for healthcare providers, research institutions, and diagnostic imaging centers.

Manufacturers of Flortaucipir F-18

1. Avid Radiopharmaceuticals / Lilly

Avid Radiopharmaceuticals, a subsidiary of Eli Lilly and Company, is the proprietary developer of Flortaucipir F-18 (Tauvid®). Since its FDA approval in 2018, Lilly has taken the lead in commercial manufacturing and distribution. This end-to-end control ensures quality, regulatory compliance, and supply chain integrity. Lilly operates a dedicated manufacturing facility for Flortaucipir F-18, located in the United States, adhering to Good Manufacturing Practices (GMP). Their nationwide distribution network supports hospitals and imaging centers across the U.S., with expanding international partnerships.

2. Radioisotope Production Facilities

Given F-18’s 110-minute half-life, on-site or nearby production capabilities are essential for timely distribution. While Lilly primarily manages production at its facilities, several external radiopharmacies and isotope generators supply the radioactive component:

• PETNET Solutions (Part of Siemens Healthineers): Global leader in radiopharmaceutical production, PETNET offers synthesis and distribution of F-18 labeled tracers, including Flortaucipir in select regions, through licensed production facilities and radiopharmacies.

• Triad Isotopes: Based in Texas, Triad offers F-18 isotopes and related radiopharmaceuticals, leveraging its network of radiochemistry labs and mobile units for distribution.

• NorthStar Medical Radioisotopes: Focuses on producing F-18 via reactor-based or linear accelerator methods, supporting regional distribution needs.

3. Regional Radiopharmacies and Distributors

Independent radiopharmacies and specialized distributors supply Flortaucipir F-18 to healthcare providers, especially outside the United States. These entities often source from primary manufacturers (like Lilly or PETNET) and handle the logistical complexities of short-lived isotopes:

• GE Healthcare: Offers PET imaging solutions and often works in collaboration with regional radiopharmacies for F-18 tracers.
• SYNOVIS Radiopharmaceuticals: Operates in certain European markets, providing F-18 compounds compatible with regional regulatory approvals.

Global Supply Chain Considerations

Regulatory Approvals

Manufacturers require approval from agencies such as the FDA (U.S.), EMA (Europe), and other national bodies to market Flortaucipir F-18. Since it is classified as a radiopharmaceutical, manufacturing involves rigorous quality control, radiation safety standards, and traceability. Only licensed entities can produce or distribute the compound.

Distribution Challenges

• Short Half-life: The 110-minute half-life of F-18 necessitates rapid transportation and proximity between production sites and medical facilities.
• Regional Availability: As of 2023, Flortaucipir F-18 remains primarily available in the U.S., with select European and Asian markets gaining approvals.
• Supply Constraints: Limited manufacturing capacity and high demand for Alzheimer's diagnosis contribute to potential shortages or seasonal distribution fluctuations.

Market Dynamics

The market landscape is concentrated among Lilly and its partnered radiopharmacies, with increasing competition from emerging production methods, such as cyclotron-based F-18 synthesis, expanding supply options. Nonetheless, regulatory hurdles and high capital investment limit rapid expansion.

Emerging Suppliers and Future Outlook

Innovations in isotope production, including large-scale cyclotron facilities and regional radiopharmacies, promise to expand the global supply landscape. Companies investing in scalable, compliant production could diversify the supply chain, reducing dependency on a few dominant players.

Furthermore, regulatory pathways for generic or biosimilar versions of Flortaucipir F-18 remain under exploration. If approved, these could alter the supply dynamics substantially.

Conclusion

The primary supplier of Flortaucipir F-18 is Avid Radiopharmaceuticals, under Eli Lilly's stewardship, complemented by a network of licensed radiopharmacies and regional distributors. Due to the complex synthesis, regulatory oversight, and isotope's short half-life, supply reliability hinges on a tightly controlled manufacturing and distribution system regulated by agencies like the FDA. Market evolution, driven by technological advancements in isotope production and regulatory developments, is anticipated to diversify supply sources in the coming years.

---

Key Takeaways

• Lilly remains the dominant supplier of Flortaucipir F-18, controlling its production and global distribution.
• Supply chain robustness depends on proximity to production sites owing to the isotope’s 110-minute half-life.
• Regional radiopharmacies serve as critical intermediaries, especially outside the U.S.
• Regulatory approval and quality compliance are central to market access and supply stability.
• Innovation in isotope production methods will likely expand capacity, diversify suppliers, and mitigate shortages.

---

FAQs

1. Can I obtain Flortaucipir F-18 outside the United States?
Yes. Some European and Asian markets have regulatory approvals for Flortaucipir F-18, supplied through regional radiopharmacies or licenced distributors. Availability remains limited compared to the U.S., primarily due to regulatory and logistical factors.

2. How does the short half-life of F-18 impact supply?
The 110-minute half-life requires production facilities to be located near imaging centers or for rapid transport logistics. This limits distribution range and necessitates on-demand synthesis, constraining global supply.

3. Are there any alternative tau PET tracers with more extensive supply?
While several tau imaging tracers exist, Flortaucipir F-18 is among the most widely approved. Alternatives like [18F]MK-6240 and [18F]RO-948 are under development but have limited commercial availability currently.

4. What are the regulatory considerations for new suppliers?
New suppliers must obtain appropriate approvals (FDA, EMA, or other agencies), demonstrate GMP-compliant manufacturing, and secure radiochemistry licensing, which entails significant regulatory and infrastructural investment.

5. Is it possible to produce Flortaucipir F-18 via cyclotron-based methods?
Yes. Advancements aim to produce F-18 isotopes locally using cyclotrons, which could decentralize supply and improve availability. However, regulatory approval and technical validation are ongoing challenges.

---

Sources

[1] Eli Lilly and Company. “Tauvid (Flortaucipir F-18) Prescribing Information.” 2018.
[2] FDA. “FDA Approves First Imaging Drug for Alzheimer’s Disease,” 2018.
[3] PETnet Solutions. “Radiopharmaceuticals and Distribution Capabilities,” 2022.
[4] Triad Isotopes. “F-18 Supply Chain and Distribution,” 2023.
[5] European Medicines Agency. “Assessment Report on Tauvid,” 2019.