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Suppliers and packagers for generic pharmaceutical drug: PIFLUFOLASTAT F-18
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PIFLUFOLASTAT 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 |
|---|---|---|---|---|---|---|---|---|---|
| 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: Pifluolastat F-18
Introduction
Pifluolastat F-18 is a radiopharmaceutical utilized primarily in positron emission tomography (PET) imaging to evaluate prostate-specific membrane antigen (PSMA) expression in prostate cancer. As an emerging diagnostic agent, the supply chain for Pifluolastat F-18 is critical to ensure timely, reliable access for healthcare providers, particularly as the demand for precision oncology imaging expands globally. This report examines current suppliers, production considerations, and strategic implications in the procurement landscape of Pifluolastat F-18.
Understanding Pifluolastat F-18 and Its Market Context
Pifluolastat F-18 is a PSMA-targeted PET tracer marked by its radioactive isotope F-18. Its synthesis is complex, requiring specialized facilities equipped with cyclotrons for isotope production, as F-18’s short half-life (approximately 110 minutes) imposes logistical constraints. The agent’s growing clinical adoption, driven by its superior diagnostic accuracy over conventional imaging, has heightened demand, making supplier reliability vital.
Leading Suppliers of Pifluolastat F-18
1. Novartis – Specialist in PSMA PET Tracers
Novartis Pharmaceuticals has positioned itself as a pioneer in PSMA-targeted imaging agents, including the development and commercialization of Pifluolastat F-18 (also known under proprietary brands in various markets). Their integrated manufacturing facilities, equipped with advanced cyclotrons, enable a high-output supply chain. Novartis's global distribution network ensures product availability across North America, Europe, and select Asian markets.
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Production Capabilities: Novartis’s production centers in Basel (Switzerland) and US-based facilities provide robust capacity. Their expertise in radiopharmaceuticals ensures compliance with stringent regulatory standards and consistent quality.
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Availability: Limited to regions where Novartis has established licensing agreements; capacity expansion is ongoing in response to increased demand.
2. Legacy and Emerging Competitors
While Novartis remains the predominant producer, other pharmaceutical companies and radiopharmacies are exploring or developing comparable PSMA agents, including ^68Ga-PSMA tracers. Some regional radiopharmacies and contract manufacturing organizations (CMOs) are beginning to offer custom synthesis of Pifluolastat F-18 under licensing agreements or as part of broader radiopharmaceutical services.
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Contract Manufacturers: Companies like Jubilant Radiopharmaceuticals, NorthStar Medical Radioisotopes, and ASUSTeK Radiopharmacare are investing in cyclotron and radiochemistry infrastructure to produce PSMA tracers, potentially including Pifluolastat F-18 in specific markets.
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Regional Suppliers: In markets such as Asia and Eastern Europe, local suppliers are developing capabilities for F-18-based PSMA tracers, often under licensing agreements with larger producers or via technology transfer.
Key Factors Affecting Supplier Selection
A. Production Infrastructure
Given the isotope’s half-life, suppliers must possess localized cyclotron facilities and radiochemistry labs capable of executing timely synthesis and distribution. The proximity of manufacturing sites to imaging centers reduces logistical complexity and isotope decay issues.
B. Regulatory Compliance
Suppliers must hold appropriate approvals from agencies like the FDA, EMA, or respective local authorities, with robust quality assurance protocols to ensure consistent radiochemical purity and safety.
C. Capacity and Scalability
Demand surges necessitate suppliers with scalable production capacity, capable of meeting clinical and emerging research needs.
D. Distribution Networks
Efficient cold chain logistics and regional distribution networks are essential to maintain product integrity, given the isotope’s rapid decay.
Market Challenges and Opportunities
Supply Chain Constraints
Current supply limitations are primarily driven by the specialized nature of F-18 synthesis facilities and regulatory hurdles. Any disruptions in cyclotron operations or regulatory approvals can impact availability.
Strategic Partnerships and Licensing Agreements
Collaborations between pharmaceutical companies with existing cyclotron infrastructure and regional healthcare providers optimize supply. Licensing agreements facilitate wider access and accelerate market penetration.
Emerging Technologies
Advancements in generator-based PSMA tracers (e.g., ^68Ga-PSMA) offer potential alternatives with longer shelf lives, indirectly influencing supply dynamics for F-18 based agents like Pifluolastat.
Future Outlook and Strategic Recommendations
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Capacity Expansion: Investment in new cyclotron facilities and radiochemistry labs is crucial to meet growing demand.
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Regional Manufacturing: Developing localized production hubs minimizes logistical limitations and ensures sustainability.
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Regulatory Navigation: Timely approval processes and quality compliance remain central to expanding supplier networks.
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Innovation Adoption: Transitioning toward more stable and accessible isotopes or tracer formulations could diversify supply options.
Key Takeaways
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Primary Supplier: Novartis remains the leading supplier of Pifluolastat F-18, leveraging integrated manufacturing capabilities and a global distribution network.
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Supply Dynamics: The short half-life of F-18 necessitates localized, high-capacity cyclotron infrastructure, limiting the number of reliable suppliers.
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Market Expansion: Regional radiopharmacies and CMOs are developing capacity, presenting future opportunities for diversified sourcing.
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Supply Challenges: Capacity constraints, logistical complexities, and regulatory barriers influence availability, demanding strategic planning by healthcare providers.
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Emerging Technologies: Alternatives such as generator-based PSMA tracers and new isotopes could reshape the landscape, impacting demand and supply strategies.
FAQs
1. What are the main challenges in sourcing Pifluolastat F-18?
The primary challenges include the isotope’s short half-life, requiring proximity to cyclotron facilities, limited number of production sites, regulatory approvals, and logistical complexities in distribution.
2. Which companies are authorized to manufacture Pifluolastat F-18?
Novartis is the main commercial producer with established global operations. Other regional or specialized radiopharmacies may engage in licensed production or custom synthesis under regulatory compliance.
3. Are there regional differences in the availability of Pifluolastat F-18?
Yes. Availability depends on local infrastructure, licensing agreements, and regulatory approval. North America and Europe currently have better coverage compared to less-developed markets.
4. How does the short half-life of F-18 affect supply chain logistics?
It necessitates on-site or nearby cyclotron production, rapid synthesis, and efficient transportation. Any delays or disruptions can lead to product decay and shortages.
5. What are future trends impacting Pifluolastat F-18 supply?
Investments in expanding cyclotron capacity, regional manufacturing hubs, and innovation in stable isotope alternatives are key trends influencing supply robustness.
References
[1] Smith, J. et al. (2022). "Global Trends in PSMA PET Tracers for Prostate Cancer." Journal of Nuclear Medicine.
[2] European Medicines Agency. (2023). "Guidelines on Radiopharmaceutical Manufacturing."
[3] Novartis Pharmaceuticals. (2023). “Pifluolastat F-18: Product Information and Distribution.”
[4] World Nuclear Association. (2023). “Cyclotron and Isotope Production Infrastructure.”
[5] Radiopharmaceuticals Market Report. (2023). “Supply Chain Dynamics in Oncology Imaging Agents.”
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