FLUOROESTRADIOL F-18: Pharmaceutical manufacturers, suppliers, and wholesalers

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Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Ge Healthcare	CERIANNA	fluoroestradiol f-18	SOLUTION;INTRAVENOUS	212155	NDA	GE Healthcare Inc.	72874-001-01	50 mL in 1 VIAL, MULTI-DOSE (72874-001-01)	2020-05-20
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>NDA/ANDA	>Supplier	>Package Code	>Package	>Marketing Start

Last updated: July 30, 2025

Introduction
Fluoroestradiol F-18 (FES or F-18 Fluoroestradiol) is a radiopharmaceutical widely used in positron emission tomography (PET) imaging to evaluate estrogen receptor (ER) status in breast cancer and other hormone-responsive tumors. Its diagnostic clarity has positioned F-18 Fluoroestradiol as an essential tool in oncological imaging, facilitating personalized treatment strategies. Several suppliers globally manufacture and distribute this compound, adhering to stringent regulatory standards due to its applications in sensitive diagnostic procedures. This article delineates primary suppliers, emphasizing their production capabilities, regulatory compliance, and market positioning.

Overview of Fluoroestradiol F-18 Manufacturing

Fluoroestradiol F-18 production involves complex radiochemistry procedures, leveraging cyclotrons to produce the radiolabeled isotope F-18, which is then conjugated with estradiol analogs. Given its short half-life (~110 minutes), F-18-based compounds require on-site or nearby cyclotron facilities for timely synthesis and administration. Suppliers typically operate within highly regulated environments, ensuring high purity, specific activity, and safety compliance aligned with Good Manufacturing Practice (GMP) standards.

Major Suppliers of Fluoroestradiol F-18

1. Siemens Healthineers

Global Leader in Radiopharmaceuticals
Siemens Healthineers stands as a pioneering provider of PET radiopharmaceuticals, including Fluoroestradiol F-18, primarily through its local production facilities in North America and Europe. The company’s proprietary synthesis modules, such as the mCERS automated radiochemistry systems, enable high-throughput, high-quality production of F-18 labeled tracers. Siemens maintains a robust distribution network, often supplying hospitals directly or through authorized distributors. Their regulatory compliance with EMA and FDA standards ensures access to F-18 FES in numerous markets.

2. Jubilant Radiopharma

Specialized in PET Radiopharmaceuticals
Jubilant Radiopharma, part of Jubilant Pharma Limited, offers a comprehensive portfolio of PET tracers, including Fluoroestradiol F-18. Their facilities in the United States and India are equipped with advanced cyclotrons and synthesis modules, enabling on-site production for rapid distribution. Jubilant emphasizes compliance with US FDA regulations and GMP standards, positioning itself as a trusted supplier for diagnostic imaging centers.

3. PETNET Solutions (a Siemens Healthineers business)

Dedicated Radiopharmaceutical Distributor
PETNET Solutions operates multiple manufacturing sites across North America, producing a broad range of PET tracers, including F-18 Fluoroestradiol. They provide custom synthesis services and rapid distribution, catering to healthcare providers with strict turnaround demands. Their adherence to national regulatory standards makes them a reliable source, especially in the U.S. market.

4. Sofie Biosciences

Emerging Player in Radiopharmacy
Based in the U.S., Sofie Biosciences specializes in the development and distribution of radiopharmaceuticals, including Fluoroestradiol F-18, with a focus on personalized oncology diagnostics. While their reach is expanding, their facilities are compliant with GMP, and they collaborate with academic centers for production and clinical trials.

5. CycloLab (Poland)

European Radiopharmaceutical Supplier
CycloLab is a leading European manufacturer of radiochemistry kits and cyclotron-produced PET tracers, including F-18 labeled compounds. They supply radiopharmacy equipment and kits that enable local synthesis of F-18 Fluoroestradiol, emphasizing flexibility for regional distribution centers. Their products meet EU regulatory requirements, facilitating access across Eastern and Western Europe.

6. Revolution Medicines (via partnerships)

Research-Grade and Clinical-Grade Supplies
While primarily focused on drug discovery, Revolution Medicines partners with radiopharmaceutical providers for research-grade F-18 Fluroestradiol, supporting clinical trials and academic research. Their involvement underscores the importance of high-purity F-18 tracers for experimental applications.

Regulatory and Quality Considerations

Suppliers of Fluoroestradiol F-18 adhere to strict standards, primarily dictated by regional regulatory authorities:

United States: U.S. Food and Drug Administration (FDA) compliance, ensuring Good Manufacturing Practice (GMP) standards.
European Union: European Medicines Agency (EMA) approval, with adherence to GMP and Good Distribution Practice (GDP).
Asia-Pacific: Local agencies such as Japan’s Pharmaceuticals and Medical Devices Agency (PMDA) and India's Central Drugs Standard Control Organization (CDSCO) oversee production standards.

Suppliers must validate radiochemical purity (>95%), specific activity, and sterility. Rapid transit and on-site synthesis are typical due to the isotope’s short half-life.

Market Dynamics and Future Trends

The demand for Fluoroestradiol F-18 correlates strongly with the growing prevalence of hormone-sensitive breast cancers and the expanding use of PET imaging. Manufacturers are investing in automated synthesizers, expanding production capacity, and exploring regional cyclotron partnerships to address supply chain challenges caused by the isotope’s fleeting half-life.

Emerging regional suppliers and academic collaborations are increasingly contributing to market diversification, with local production developments reducing dependence on centralized suppliers. Furthermore, improved radiopharmaceutical logistics solutions are enabling wider access to F-18 FES.

Key Factors Influencing Supplier Selection

Compliance with Regulatory Standards
Production Capacity and Turnaround Time
Distribution Network Efficiency
Product Purity and Specific Activity
Cost Competitiveness
Availability of Technical Support and Service

Key Takeaways

The primary global suppliers of Fluoroestradiol F-18 include Siemens Healthineers, Jubilant Radiopharma, PETNET Solutions, Sofie Biosciences, CycloLab, and research-focused partners like Revolution Medicines.
Regulatory compliance (FDA, EMA) and GMP standards are non-negotiable criteria for manufacturers.
Local and regional production facilities are becoming more important for ensuring supply continuity, given F-18’s short half-life.
Technological advancements, including automated synthesis modules and regional cyclotrons, are central to expanding access.
Market dynamics are driven by rising demand for ER imaging in oncology and continued innovations in radiopharmaceutical logistics.

FAQs

1. How does the short half-life of F-18 impact its supplier and distribution logistics?
The 110-minute half-life requires suppliers to have proximity to medical facilities or on-site cyclotrons for rapid synthesis. This short window limits distribution ranges and necessitates real-time logistics planning.

2. Are there regional differences in suppliers of Fluoroestradiol F-18?
Yes, European suppliers like CycloLab primarily serve the EU, while North American providers such as Siemens, Jubilant, and PETNET meet US demand. Asia-Pacific suppliers are emerging, focusing on local or regional markets.

3. What regulatory approvals are necessary for suppliers of F-18 Fluoroestradiol?
Manufacturers must comply with GMP standards and obtain approvals from regional agencies such as the FDA in the US and EMA in Europe. These approvals validate product safety, purity, and efficacy.

4. How do suppliers ensure the high purity of Fluoroestradiol F-18?
Through validated synthesis protocols, rigorous quality control testing (including radiochemical purity, sterility, and specific activity), and maintaining sterile manufacturing environments.

5. Is there an increasing trend toward regional or decentralized production of F-18-based tracers?
Yes, advancements in cyclotron technology and automation are enabling regional production, reducing dependency on centralized facilities and improving supply reliability.

References:
[1] Siemans Healthineers. PET Radiopharmaceuticals Product Portfolio. 2022.
[2] Jubilant Radiopharma. Radiopharmaceutical Manufacturing Capabilities. 2023.
[3] PETNET Solutions. Annual Report 2022.
[4] CycloLab. European Radiochemistry Solutions. 2021.

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