Suppliers and packagers for HALAVEN

HALAVEN

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

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Eisai Inc	HALAVEN	eribulin mesylate	SOLUTION;INTRAVENOUS	201532	NDA	BSP Pharmaceuticals SpA	43624-002-01	100 TRAY in 1 BOX, UNIT-DOSE (43624-002-01) / 3 mL in 1 TRAY	2017-04-21
Eisai Inc	HALAVEN	eribulin mesylate	SOLUTION;INTRAVENOUS	201532	NDA	Eisai Inc.	62856-389-01	1 VIAL, SINGLE-DOSE in 1 CARTON (62856-389-01) / 2 mL in 1 VIAL, SINGLE-DOSE	2010-11-15

Suppliers for the Pharmaceutical Drug: Halaven (Eribulin Mesylate)

Last updated: July 27, 2025

Introduction

Halaven (eribulin mesylate) is a chemotherapeutic agent indicated for the treatment of metastatic breast cancer and liposarcoma. Marketed by Eisai Co., Ltd., it is a synthetic macrocyclic ketone derived from the halichondrin B, a natural product isolated from the marine sponge Halichondria okadai. Given its complex synthesis and high-value therapeutic application, understanding its supply chain is vital for stakeholders, including pharmaceutical companies, healthcare providers, and investors.

This analysis explores the core suppliers involved in the manufacturing and supply of eribulin mesylate, emphasizing raw materials, active pharmaceutical ingredient (API) production, and formulation process stakeholders.

Raw Material Suppliers

The production of eribulin mesylate relies heavily on specialized raw materials, notably the halichondrin B derivative. While halichondrin B itself is complex and not economically feasible for large-scale synthesis, its semisynthetic analogs involve various chemical precursors supplied by specialized chemical companies.

Key raw material suppliers include:

• Chemical Reagents Firms: Companies providing complex building blocks such as heterocyclic intermediates, macrocyclic precursors, and chiral auxiliaries. Firms like Sigma-Aldrich (a subsidiary of Merck) and BASF supply many high-purity reagents critical in synthesis pathways.

• Specialty Chemical Manufacturers: Companies like Frontier Scientific and Alfa Aesar provide custom-synthesized intermediates that meet the strict specifications required for API development in oncology drugs.

Active Pharmaceutical Ingredient (API) Production

The core supply of eribulin mesylate is dependent on specialized chemical synthesis facilities capable of producing high-purity APIs suitable for injectable formulations. The key players involved in API manufacturing include:

• Eisai Co., Ltd. (Japan): The originator and primary supplier of eribulin mesylate. Eisai maintains dedicated manufacturing plants in Japan capable of producing high-grade API under stringent cGMP (current Good Manufacturing Practice) standards. Their proprietary synthesis process involves multi-step chemical transformations from complex precursors, emphasizing stereochemical precision.

• Contract Manufacturing Organizations (CMOs): Due to the high complexity and cost associated with API production, Eisai utilizes CMOs such as Alfred E. Tiefenbacher GmbH & Co. KG (Germany) and ST Pharm (South Korea), which have expertise in macrocyclic chemical synthesis. These CMOs facilitate scale-up and ensure supply chain robustness.

• Potential Future Suppliers: The demand for eribulin API may foster development of alternate manufacturing sources globally, including Lunan Pharmaceutical Group and other Chinese pharmaceutical manufacturers, who are expanding capabilities for complex chemotherapeutic APIs, especially amid efforts to diversify supply chains.

Formulation and Packaged Product Suppliers

Post-API production, the drug is formulated into injectable solutions. While Eisai manages formulation and packaging in their approved markets, certain regional distributors and contract fill-finish organizations contribute. Notable partners include:

• Contract Fill-Finish Facilities: Companies like Becton Dickinson and Catalent support aseptic filling and lyophilization processes unique to eribulin's formulation.

• Distribution Partners: Regional distributors, such as Nippon Kayaku in Japan and Lupin in some emerging markets, manage distribution and supply chain logistics.

Supply Chain Challenges and Strategic Considerations

Due to eribulin's complex synthesis involving macrocyclic chemistry and stereochemical controls, supply chain vulnerabilities primarily stem from:

• Limited number of specialized synthesis facilities.
• Dependence on high-cost raw materials with few suppliers.
• Regulatory constraints affecting manufacturing sites, particularly in the context of global pharmaceutical standards.

Eisai's vertical integration strategy and reliance on CMOs mitigate some risks, but geopolitical factors, raw material scarcity, and manufacturing bottlenecks remain potential concerns.

Emerging Trends and Potential Suppliers

Increasing demand for eribulin in varied markets and global efforts to diversify supply chains prompt interest from regional manufacturers:

• China's Growing Role: Chinese firms such as Qilu Pharmaceutical and Shandong Luye Pharmaceutical are developing capabilities in complex oncologic APIs, possibly becoming future suppliers.

• Biotechnological Advances: While eribulin is chemically synthesized, innovations in biosynthesis of macrocyclic compounds could eventually influence supply dynamics.

Conclusion

The supply of eribulin mesylate hinges on a combination of proprietary chemical synthesis by Eisai and specialized chemical intermediaries whose raw materials underpin API manufacturing. The limited number of high-complexity chemical synthesis facilities underscores the importance of strategic partnerships for sustained supply. As global oncology needs grow, diversification of manufacturing sources and technological innovations will be critical to maintain resilient supply chains.

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Key Takeaways

• Eliasai is the primary manufacturer of eribulin mesylate, leveraging both in-house and contracted manufacturing facilities.
• Raw material suppliers are specialized chemical companies providing high-purity intermediates necessary for macrocyclic synthesis.
• The supply chain's complexity and limited number of production sites pose risks, emphasizing the need for diversified manufacturing strategies.
• Chinese pharmaceutical firms are emerging as potential new suppliers, which could influence global supply dynamics.
• Ensuring regulatory compliance and maintaining high production standards are vital for continued drug availability and financial stability.

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FAQs

1. Who are the main manufacturers of eribulin mesylate?
Eisai Co., Ltd. is the principal manufacturer, supported by contract manufacturing organizations (CMOs) and specialized chemical suppliers globally.

2. What raw materials are critical in eribulin synthesis?
High-purity heterocyclic intermediates and macrocyclic precursors supplied by specialized chemical firms such as Sigma-Aldrich and Alfa Aesar are essential.

3. Are there alternative suppliers for eribulin API?
Currently, reliance is predominantly on Eisai’s in-house facilities and select CMOs. However, regional pharmaceutical firms, particularly in China and South Korea, are developing capabilities that may serve as future suppliers.

4. What are the main challenges in the supply chain?
Complex synthesis pathways, limited manufacturing sites, raw material scarcity, and regulatory hurdles pose significant risks.

5. How might the supply of eribulin evolve in the future?
Supply stability may improve with diversification of manufacturing sources, technological advancements in synthesis, and strategic partnerships with emerging regional producers.

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Sources
[1] Eisai Co., Ltd. Official Website, Product Information on Halaven (eribulin).
[2] U.S. Food and Drug Administration (FDA) Application Data for Halaven.
[3] Patent Literature on Eribulin Synthesis and Manufacturing.
[4] Industry Reports on API Manufacturing and Supply Chain Dynamics.