Suppliers and packagers for generic pharmaceutical drug: LUTETIUM LU-177 VIPIVOTIDE TETRAXETAN

LUTETIUM LU-177 VIPIVOTIDE TETRAXETAN

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

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Novartis	PLUVICTO	lutetium lu-177 vipivotide tetraxetan	SOLUTION;INTRAVENOUS	215833	NDA	Novartis Pharmaceuticals Corporation	0078-1217-61	1 VIAL, GLASS in 1 PACKAGE (0078-1217-61) / 7.5 mL in 1 VIAL, GLASS	2022-03-23

Suppliers for Lutetium Lu-177 Vipivotide Tetraxetan

Last updated: February 19, 2026

Lutetium Lu-177 Vipivotide Tetraxetan (formerly known as ^177Lu-PSMA-617) is a radiopharmaceutical used in targeted radioligand therapy for prostate cancer. The supply chain involves specialized producers of both the Lutetium-177 radionuclide and the peptide compound, along with fill-finish and distribution partners.

Primary Suppliers of Lutetium-177 (Lu-177)

1. Nordion/NEA (Canada)

• Supplies: High-purity Lu-177, produced via neutron activation of enriched Ytterbium-176.
• Capacity: Approximate annual production of 10-15 Ci.
• Notes: Supplies to research institutes and pharmaceutical companies; scalable for clinical production.

2. Curium (France)

• Supplies: Lu-177 in commercial quantities.
• Capacity: Produces several tens of Ci annually.
• Notes: Has supply agreements with radiopharmaceutical companies; offers high-purity Lu-177 suitable for therapy.

3. ITM Isotopen Technologien München AG (Germany)

• Supplies: Lu-177, focused on clinical and commercial supply.
• Capacity: Around 5-10 Ci annually.
• Notes: Developed robust supply chain for therapeutic applications.

4. Lantheus Medical Imaging (USA)

• Supplies: Lu-177 in partnership with external producers.
• Capacity: Constrained, primarily for diagnostic radiopharmaceuticals.
• Notes: Increased capacity expected due to demand for therapy radiopharmaceuticals.

5. SCK•CEN (Belgium)

• Supplies: Developing reactor-based ^177Lu production.
• Capacity: Expected to scale, targeting over 50 Ci per year.
• Notes: Focused on increasing domestic European supply.

Suppliers of Vipivotide Tetraxetan (Peptide Ligand)

1. Advanced Accelerator Applications (Novartis)

• Role: Develops and supplies the peptide for ^177Lu-PSMA-617.
• Manufacturing: Uses proprietary synthesis processes under cGMP standards.
• Capacity: Not publicly disclosed; intended to meet clinical and commercial demand.

2. Therapeutic Peptides and Custom Synthesis

• Providers: WuXi AppTec, Polypeptide Therapeutic Solutions.
• Capabilities: Offer custom peptide synthesis compliant with regulatory standards.
• Notes: May be contracted for specific manufacturing needs.

Fill-Finish and Distribution

1. Curium and ITM

• Operations: Include fill-finish services to produce clinical and commercial doses.
• Distribution: Limited by licensing and regulatory approvals.

2. Nordion, Lantheus

• Roles: Provide finished product delivery and logistical support.
• Considerations: Require license for shipment of radioactive material across borders.

Market Dynamics and Key Considerations

Parameter	Details
Lu-177 Production Method	Neutron activation in nuclear reactors or generator-based processes.
Lead Times	Several months from order to delivery, depending on capacity.
Cost per Millicurie (mCi)	Ranges from $200 to $500, based on purity and supplier.
Supply Chain Risks	Reactor downtime, regulatory changes, capacity constraints.
Regulatory Approvals	Suppliers must comply with GMP, licensing for radioactive material.

Summary of Major Suppliers and Capabilities

Supplier	Country	Capacity (CI/year)	Core Focus	Notes
Nordion	Canada	10-15	High-purity Lu-177	Supplies primarily for research and clinical use.
Curium	France	20+	Commercial-scale Lu-177	Markets to global pharmaceutical companies.
ITM	Germany	5-10	Clinical and therapeutic radiopharmaceuticals	Growing European developer.
SCK•CEN	Belgium	Developing capacity	European Lu-177 supply chain	Reactor-based expansion underway.

Key Takeaways

The supply landscape for Lutetium Lu-177 Vipivotide Tetraxetan features several established producers of Lu-177 with capacities ranging from 5 to over 20 Ci annually. Major pharmaceutical companies, such as Novartis via its subsidiary, develop and supply the peptide component. Production timing, regulatory compliance, and capacity constraints influence supply security. The supply chain remains concentrated among a handful of key producers, with new entrants and expansion projects aimed at meeting growing demand for targeted radioligand therapies.

FAQs

1. Who are the leading suppliers of Lu-177 for Vipivotide Tetraxetan?
Nordion, Curium, and ITM are primary producers of Lu-177, with capacities sufficient for clinical and some commercial applications.

2. What are the typical lead times for Lu-177 supply?
Lead times range from several weeks to months, depending on the supplier’s production schedule and regulatory clearance.

3. Are there regional differences in Lu-177 supply?
Yes. North America and Europe dominate production, with regional suppliers like Nordion (Canada) and Curium (France). New European projects aim to increase domestic capacity.

4. Which companies develop the peptide component for Vipivotide Tetraxetan?
Novartis’ Advanced Accelerator Applications develops the peptide; contract manufacturers like WuXi AppTec can produce custom peptides under GMP.

5. What are the main logistical considerations for supplying these radiopharmaceuticals?
Transport involves strict regulatory controls due to radioactivity. Shipping often requires specialized containers, licenses, and compliance with international regulations.

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References
[1] IAEA. (2022). Production of Radionuclides for Medical Applications.
[2] Novartis. (2022). Vipivotide Tetraxetan (177Lu-PSMA-617) Development and Supply Chain.
[3] Lantheus Medical Imaging. (2023). Lu-177 Supply Chain Overview.
[4] SCK•CEN. (2023). European Reactor-Based Lu-177 Production Initiatives.
[5] Curium. (2023). Lu-177 Production Capabilities and Capacity.