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Suppliers and packagers for pylarify
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pylarify
Listed suppliers include manufacturers, repackagers, relabelers, and private labeling entitities.
| Applicant | Tradename | Generic Name | Dosage | NDA | NDA/ANDA | Supplier | Package Code | Package | Marketing Start |
|---|---|---|---|---|---|---|---|---|---|
| Progenics Pharms Inc | PYLARIFY | piflufolastat f-18 | SOLUTION;INTRAVENOUS | 214793 | NDA | Progenics Pharmaceuticals, Inc. | 71258-022-01 | 50 mL in 1 VIAL, MULTI-DOSE (71258-022-01) | 2021-05-26 |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >NDA/ANDA | >Supplier | >Package Code | >Package | >Marketing Start |
Suppliers for the Pharmaceutical Drug: Pylarify
Introduction
Pylarify (piflufolastat F-18) is a diagnostic radiopharmaceutical used in positron emission tomography (PET) imaging to detect prostate cancer metastases. Approved by the U.S. Food and Drug Administration (FDA) in May 2021, Pylarify has become a valuable tool for oncologists in staging and restaging prostate cancer. As a specialized radiotracer, the production and supply chain of Pylarify involve multiple key players in the pharmaceutical and radiopharmaceutical industries. This article provides a comprehensive overview of the primary suppliers involved in the manufacturing, distribution, and supply of Pylarify, highlighting the current ecosystem, market dynamics, and strategic considerations for stakeholders.
Manufacturers of Pylarify
1. Progenics Pharmaceuticals (a Gilead Company)
Progenics Pharmaceuticals was the original developer of Pylarify. Subsequently acquired by Gilead Sciences in 2020, Progenics remains central to the production process. The company specializes in targeted cancer therapies and imaging agents, with facilities optimized for radiopharmaceutical manufacturing. Gilead's acquisition leverages extensive resources, including advanced production infrastructure, to maintain a consistent supply of Pylarify.
2. Radiopharmaceutical Production Facilities
Given the radioactive nature of Pylarify, manufacturing requires specialized facilities compliant with Good Manufacturing Practices (GMP) and nuclear regulatory standards. These facilities are often run by:
- Gilead’s internal manufacturing units: Located in the United States, with plans for expanding manufacturing capacity to meet increasing demand.
- Third-party contract manufacturing organizations (CMOs): Some companies partner with CMOs that hold appropriate licenses and facilities to scale production rapidly, especially in response to demand surges or geographic expansion.
Key Suppliers in the Radiopharmaceutical Supply Chain
1. Radioisotope Suppliers
The production of Pylarify centers on F-18 fluorine, a positron-emitting isotope with a half-life of approximately 110 minutes. Core suppliers include:
- Nordion (Canada): Supplies cyclotron-produced F-18 to pharmaceutical manufacturers globally.
- Eckert & Ziegler (Germany): Provides enriched target materials and F-18 production modules.
- IBA (Belgium): Offers cyclotrons and related equipment for in-house isotope production at certain facilities.
2. Cyclotron Equipment Providers
Cyclotrons are essential for producing F-18 isotopes. Major suppliers include:
- Elekta (Sweden): Offers cyclotron systems integrated with radiochemistry modules.
- Siemens Healthineers (Germany): Provides high-energy cyclotrons used in F-18 production.
- GE Healthcare (USA): Engages in cyclotron technology for F-18 manufacturing, supporting regional production hubs.
These equipment suppliers underpin the raw isotope supply chain for Pylarify manufacturing.
3. Radiochemistry Synthesis Modules
Post-isotope production, F-18 undergoes chemical synthesis to produce Pylarify. Leading vendors include:
- POETIC (a division of Eckert & Ziegler): Supplies automated synthesis modules adhering to GMP standards.
- Siemens Healthineers: Offers radiochemistry platforms for on-site manufacturing.
- GE Healthcare: Provides synthesis modules for radiotracer production.
Distribution and Logistics Providers
1. Specialty Pharmaceutical Distributors
Accelerated and secure distribution is vital, given radioactive decay constraints. Key players include:
- Curium Pharma (UK): Distributes radiopharmaceuticals across Europe, ensuring timely delivery.
- IANAL (International Atomic Energy Agency)-certified distributors specializing in radiopharmaceutical logistics.
- Cardinal Health and McKesson: U.S.-based distributors operating licensed channels for Pylarify delivery.
2. Cold Chain and Transportation Solutions
Proper logistics maintain isotope integrity and patient safety:
- FedEx Express (Temperature-controlled shipments)
- DHL Medical Express (Specialized radiopharmaceutical transport)
- UPS Healthcare: Provides compliant, fast transit options for radioactive supplies.
Regulatory and Quality Compliance
Suppliers must adhere to stringent regulations enforced by agencies such as:
- U.S. Food and Drug Administration (FDA): Certifies manufacturing sites and inspects radiopharmaceutical production.
- Nuclear Regulatory Commission (NRC): Oversees radioactive material handling and transportation.
- European Medicines Agency (EMA): Ensures compliance for European suppliers.
Market Dynamics and Supplier Ecosystem
The limited number of manufacturers and suppliers underscores the specialized nature of Pylarify’s supply chain. Currently, Gilead’s Progenics dominates production, with an expanding network of radiopharmaceutical partners and distribution channels. The short half-life of F-18 constrains manufacturing locations close to distribution centers and end-users, influencing supplier geographic concentration.
The industry is witnessing investments in new cyclotron facilities and synthesis modules, aimed at increasing regional supply confidence and reducing reliance on centralized production. Strategic partnerships between pharmaceutical companies, CMOs, and isotope suppliers are facilitating capacity expansion and supply chain resilience.
Future Outlook and Strategic Considerations
- Capacity Expansion: Gilead and third-party manufacturers are exploring increased production facilities to meet increasing global demand.
- Supply Chain Diversification: To mitigate risks associated with isotope shortages or logistical disruptions, stakeholders are investing in regional cyclotron and synthesis units.
- Innovation in Isotope Production: Exploration of alternative production methods, such as generator-based isotopes, could diversify F-18 supply sources.
- Regulatory Harmonization: Streamlined approval processes across jurisdictions could accelerate the introduction of new suppliers and reduce bottlenecks.
Key Takeaways
- Gilead’s Progenics remains the primary manufacturer of Pylarify, leveraging specialized GMP-compliant facilities and global distribution networks.
- The supply chain hinges on specialized isotope suppliers and cyclotron manufacturers, given F-18’s short half-life and the need for timely production.
- Distribution relies heavily on licensed cold chain logistics providers, emphasizing safety and regulatory compliance.
- Market capacity is constrained by the limited number of dedicated radiopharmaceutical producers, prompting ongoing investments to expand manufacturing capabilities.
- Industry trends favor regionalized production and supply chain diversification to reduce dependence on centralized facilities and enhance resilience.
FAQs
1. Who are the primary suppliers of F-18 for Pylarify production?
Major suppliers include Nordion, Eckert & Ziegler, and IBA, which provide cyclotron-produced F-18 isotopes to pharmaceutical manufacturers globally.
2. Can I produce Pylarify in-house?
In-house production is feasible only for facilities with licensed cyclotrons, radiochemistry labs, and regulatory approval, which limits such capabilities to specialized centers.
3. How does the short half-life of F-18 impact Pylarify supply?
F-18’s 110-minute half-life necessitates centralized production near clinical sites or rapid transportation logistics to ensure the radiotracer remains viable upon delivery.
4. Are there any new entrants expected in the Pylarify supply chain?
Yes, ongoing investments in regional cyclotron infrastructure and partnerships aim to diversify suppliers and increase capacity, especially outside the U.S. and Europe.
5. What are the key considerations for stakeholders in the Pylarify supply chain?
Ensuring regulatory compliance, maintaining cold chain logistics, expanding production capacity, and establishing diversified supply sources are crucial for a reliable supply.
References
[1] FDA Approval Announcement for Pylarify (2021).
[2] Gilead Sciences. Progenics Pharmaceuticals overview.
[3] Eckert & Ziegler. Radiopharmaceutical production modules.
[4] IBA Group. Cyclotron and isotope manufacturing solutions.
[5] European Association of Nuclear Medicine. Isotope supply chain insights.
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