pluvicto: Pharmaceutical manufacturers, suppliers, and packagers

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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	Advanced Accelerator Applications USA, Inc	69488-010-61	1 VIAL, GLASS in 1 PACKAGE (69488-010-61) / 7.5 mL in 1 VIAL, GLASS	2022-03-23
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>NDA/ANDA	>Supplier	>Package Code	>Package	>Marketing Start

Last updated: September 30, 2025

Introduction

PLUVICTO (generic: tivozanib) is a targeted therapy approved by the U.S. Food and Drug Administration (FDA) for the treatment of advanced renal cell carcinoma (RCC). As a kinase inhibitor, it operates by selectively inhibiting vascular endothelial growth factor receptors (VEGFRs), thereby impeding tumor angiogenesis. The global pharmaceutical supply chain for drugs like PLUVICTO is complex, involving multiple layers of manufacturing, procurement, and distribution. Understanding the primary suppliers involved in the production of active pharmaceutical ingredients (APIs), formulation, and packaging is crucial for stakeholders aiming to navigate market dynamics, supply security, and regulatory compliance.

Manufacturers of the Active Pharmaceutical Ingredient (API)

1. Pharmaceutical Companies Producing Tivozanib API

The core component of PLUVICTO, tivozanib, is manufactured by specialized chemical and biopharmaceutical companies. These firms focus on synthesizing complex kinase inhibitors through advanced chemical processes, often operating under strict Good Manufacturing Practice (GMP) standards.

Eisai Co., Ltd.
As the originator of PLUVICTO, Eisai is the primary developer and likely to produce or source the API in-house or via dedicated partners. Their manufacturing facilities, predominantly based in Japan and Europe, are equipped for high-quality API production, ensuring consistent potency and purity (FDA approval documents confirm proprietary manufacturing capabilities)[1].
External Contract Manufacturing Organizations (CMOs)
Eisai has partnered with multiple CMOs globally to bolster supply chains and meet regional demand. While specific CMO identities are classified, top-tier global CMOs specializing in complex APIs include companies like:
- Lonza Group (Switzerland)
  For small molecule APIs, Lonza offers end-to-end manufacturing, including synthesis, purification, and scale-up processes.
- Samsung Biologics (South Korea)
  While primarily a biologics manufacturer, Samsung collaborates with various chemical firms for APIs, especially in integrated supply chains.
- Recipharm (Sweden) and Hikma Pharmaceuticals (UK) are also known for large-scale API manufacturing capacity, potentially involved in the supply chain for kinase inhibitors like tivozanib.

2. Regional API Suppliers

In addition to primary manufacturers, regional suppliers in India, China, and Southeast Asia play a key role in API production, often supplying APIs or intermediates for generic formulations. These suppliers may not produce tivozanib specifically but contribute to the broader supply chain ecosystem.

Chinese API producers—such as Zhejiang Hisun Pharmaceutical and Zhejiang Huahai Pharmaceutical—have historically supplied high-quality small molecule APIs to global markets. However, compliance with regulatory standards remains critical.
Indian API producers—including Dr. Reddy’s Laboratories, Aurobindo Pharma, and Sun Pharmaceutical Industries—are integral in producing high-volume APIs and intermediates for various oncology drugs, with some capabilities aligned towards kinase inhibitors.

Formulation and Finished Dosage Production

Once APIs are manufactured, pharmaceutical partners or contract manufacturing organizations (CMOs) undertake formulation, filling, packaging, and distribution.

Eisai's manufacturing partners:
- Eisai has manufacturing facilities in Japan, the U.S., and Europe, often producing finished dosages in-house for quality assurance.
- For commercial distribution, Eisai collaborates with global CMO networks capable of producing tablets conforming to regional regulatory standards.
Contract Fill-Finish Partners:
- Major companies like Patheon (part of Thermo Fisher Scientific), Catalent, and Almac are pivotal in filling, finishing, and packaging PLUVICTO, ensuring global supply chain integrity and compliance.

Distribution Channels and Suppliers

The distribution of PLUVICTO involves a network of authorized wholesalers and specialty pharmacies:

Major Wholesalers
Companies like McKesson, Cardinal Health, and AmerisourceBergen serve as primary distribution channels in North America.
Regional Distributors
For European markets, distributors such as Alliance Healthcare play a central role.
Specialty Pharmacies and Oncology Networks
These entities often source PLUVICTO directly from authorized distributors, ensuring supply for oncology clinics and hospitals.

Regulatory and Quality Assurance Considerations

The integrity of the supply chain hinges on adherence to regulatory standards, particularly Good Manufacturing Practices (GMP), Good Distribution Practices (GDP), and regional compliance requirements such as the FDA, EMA, and PMDA approvals.

Regulatory Oversight
The FDA inspects manufacturing facilities, including those of CROs and CMOs, to ensure compliance. For companies involved in API production, ongoing audits are mandatory to maintain approval status.
Supply Chain Transparency
Increased push for transparency is shaping how companies disclose suppliers. However, specific supplier identities—especially for highly proprietary APIs like tivozanib—are often kept confidential, shared only with regulatory authorities and strategic partners.

Future Trends in Supplier Landscape

Vertical Integration:
Eisai’s potential move toward vertically integrating API production may reduce reliance on external suppliers, enhancing supply security.
Supply Chain Diversification:
To mitigate geopolitical risks and meet global demand, pharmaceutical companies diversify their supplier base, engaging multiple CMOs across different regions.
Emerging Manufacturing Technologies:
Innovations in continuous manufacturing and green chemistry are enabling more sustainable and flexible API production, potentially altering supplier dynamics.

Key Takeaways

Primary APIs for PLUVICTO are predominantly manufactured by Eisai’s in-house facilities and select CMOs globally, with contributions from regional chemical suppliers.
Formulation, filling, and packaging are handled both in-house and through specialized CMOs, ensuring broad geographic availability.
Distribution relies on a combination of large pharmaceutical wholesalers, regional distributors, and specialty oncology pharmacies.
Stringent regulatory oversight and quality standards maintain supply chain integrity, yet confidentiality regarding specific supplier identities persists due to proprietary concerns.
Market trends favor supply chain diversification and technological advancements to mitigate risks and ensure continuous availability of PLUVICTO.

FAQs

1. Who are the principal manufacturers of tivozanib API for PLUVICTO?
Eisai predominantly manufactures tivozanib API internally, with supplementary production by approved CMOs in Switzerland and Asia. The specific identities of all external API suppliers are proprietary.

2. Are there regional suppliers for PLUVICTO’s raw materials?
Yes. Regional chemical companies in China, India, and Southeast Asia supply intermediates and bulk APIs for global sale, though direct supply of tivozanib is usually controlled by primary manufacturers.

3. Does Eisai outsource any part of PLUVICTO production?
Yes. Eisai collaborates with multiple CMOs for manufacturing and formulation to meet global demand efficiently while maintaining quality standards.

4. How does supply chain regulation ensure drug quality?
Regulatory bodies like the FDA and EMA enforce GMP standards, requiring manufacturing audits, batch testing, and compliance certification, which manufacturers must uphold for continued market authorization.

5. What are the risks associated with the PLUVICTO supply chain?
Risks include dependency on single-source suppliers, geopolitical disruptions, regulatory non-compliance, and manufacturing delays. Diversification and technological innovation are key mitigation strategies.

References

[1] FDA Approval Documentation for PLUVICTO (Tivozanib).
[2] Eisai Co., Ltd. Corporate Reports.
[3] Industry Reports on API manufacturing and global supply chains.
[4] Regulatory guidelines from FDA and EMA on GMP standards.

Suppliers and packagers for pluvicto

pluvicto

Suppliers for the Pharmaceutical Drug: PLUVICTO