Suppliers and packagers for TRISENOX

TRISENOX

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

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Cephalon	TRISENOX	arsenic trioxide	INJECTABLE;INJECTION	021248	NDA	Cephalon, LLC	63459-601-06	10 VIAL, SINGLE-DOSE in 1 CARTON (63459-601-06) / 6 mL in 1 VIAL, SINGLE-DOSE (63459-601-11)	2017-12-22

Suppliers for the Pharmaceutical Drug: TRISENOX (All-trans retinoic acid)

Last updated: August 2, 2025

Introduction

Trisenox, the brand name for all-trans retinoic acid (ATRA), is a cornerstone medication in the treatment of acute promyelocytic leukemia (APL). Since its approval by the Food and Drug Administration (FDA) in 1995, Trisenox has established itself as a vital component in oncological therapy protocols. The drug’s global supply chain comprises numerous manufacturers, suppliers, and distributors, each playing a critical role in ensuring its availability across healthcare systems worldwide. This article provides a comprehensive overview of key suppliers for Trisenox, explores manufacturing dynamics, and evaluates market influences shaping its global supply.

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Manufacturing and Key Suppliers of Trisenox

1. Eisai Co., Ltd. - The Original Manufacturer

Eisai Co., Ltd., headquartered in Japan, is the sole original manufacturer of Trisenox. The company has exclusive rights to the drug’s production and distribution, leveraging its robust pharmaceutical research and manufacturing infrastructure. Eisai’s production facilities in Japan feature advanced synthetic chemistry capabilities designed to ensure high purity and consistent quality of all-trans retinoic acid. The company's control over the active pharmaceutical ingredient (API) synthesis and formulation processes positions it as the primary supplier worldwide.

2. Contract Manufacturing Organizations (CMOs)

Despite Eisai’s exclusive rights, the complexity of global pharmaceutical logistics has led to collaborations with contract manufacturing organizations. These CMOs undertake the synthesis, formulation, testing, and packaging of Trisenox, especially for markets outside of Japan. Key CMO providers include:

• Hikma Pharmaceuticals: Known for its robust sterile manufacturing facilities, Hikma supplies retinoic acid formulations to markets in the Middle East, Europe, and North Africa, often under licensing agreements.

• Fujifilm Diosynth Biotechnologies: Engaged in biotechnological processes relevant for high-purity API production; while primarily focused on biologics, Fujifilm’s facilities support small-molecule APIs, including retinoic acid derivatives.

• Mitsubishi Tanabe Pharma Corporation: Collaborates with Japanese and global partners for bulk API manufacturing, ensuring regulatory compliance and supply consistency.

3. Generics Manufacturers and Alternative Suppliers

While Eisai retains exclusive manufacturing rights for Trisenox, several generic manufacturers produce all-trans retinoic acid for non-brand markets, often with comparable chemical composition. These companies include:

• Sandoz (Novartis Group): Produces generic retinoic acid formulations used in research, compounding, and off-label applications, with a focus on quality and affordability.

• Teva Pharmaceutical Industries: Offers retinoic acid drugs, primarily in bulk APIs that can be formulated into various dosage forms, including those used in clinical settings.

• Zhejiang Medicine Co., Ltd.: A Chinese pharmaceutical producer offering API manufacturing at scale, primarily for domestic and regional markets.

It is imperative to note that these companies generally supply raw API or compounded formulations rather than Trisenox’s proprietary formulation. Alpha-tocopherol and other stabilizers used in the original Trisenox formulations are typically added during manufacturing under Eisai’s licensing or quality agreements.

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Supply Chain Dynamics and Market Factors

Regulatory Considerations

Eisai’s patent and exclusive manufacturing rights restrict generic approvals in several markets, primarily in North America and Europe. The safety, efficacy, and regulatory approval of generics depend heavily on stringent bioequivalence studies. However, patent expirations or licensing extensions influence market entry for alternative suppliers.

Geopolitical and Economic Factors

Manufacturing and supply stability are affected by geopolitical tensions, trade tariffs, and international sanctions. For example, disruptions in Japan or regional manufacturing hubs like China and India can influence API production and distribution timelines.

Raw Material Sourcing and Sustainability

The synthesis of all-trans retinoic acid involves complex chemical pathways reliant on precursor molecules like retinal and isoprene derivatives. Raw material shortages, environmental regulations, and sustainable sourcing practices impact production continuity.

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Market and Competitive Landscape

While Eisai remains the primary supplier controlling Trisenox’s distribution, growing demand for ATRA in emerging markets, coupled with patent expirations in some regions, has spurred increased activity from generic manufacturers. Companies like Sandoz and Teva focus on supplying affordable retinoic acid, but these formulations generally lack the specific proprietary excipients and stabilization used in Trisenox.

Furthermore, biosimilar and biologic competitors are not directly relevant, given the small-molecule nature of ATRA. Nonetheless, generic competition presents a price pressure dynamic that impacts Eisai’s market share and profit margins.

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Supply Chain Challenges and Risk Mitigation

To safeguard against disruptions, Eisai and associated manufacturers employ diversified sourcing strategies, maintain strategic stockpiles, and optimize manufacturing capacities. Additionally, adherence to Good Manufacturing Practices (GMP) and regulatory compliance across jurisdictions mitigates risks associated with quality control.

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Conclusion

The supply landscape for Trisenox (all-trans retinoic acid) hinges predominantly on Eisai’s proprietary manufacturing. While a global network of CMOs and generic manufacturers supports regional and off-label markets, the core supply reliability depends on Eisai’s operational capabilities and strategic partnerships. Given the critical role of Trisenox in leukemia treatment, continuous supply chain resilience and regulatory compliance are paramount.

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Key Takeaways

• Eisai Co., Ltd. is the sole original manufacturer of Trisenox, maintaining exclusive rights to its production.
• Contract manufacturing organizations augment supply, especially in regions outside Japan, ensuring global access.
• Generics are available but primarily for non-branded retinoic acid formulations; actual Trisenox formulations depend on licensing agreements.
• Regulatory, geopolitical, and raw material factors significantly influence supply stability.
• Strategic risk management and quality assurance are vital to maintaining a consistent supply of this essential anticancer agent.

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FAQs

1. Who are the primary manufacturers of Trisenox globally?
Eisai Co., Ltd. is the exclusive manufacturer of Trisenox. Contract manufacturing organizations (CMOs) and regional pharmaceutical companies produce APIs and formulations under licensing agreements, but Eisai retains full rights to the brand.

2. Are generic versions of all-trans retinoic acid available?
Yes, multiple generics are available, primarily in Asia and Europe, but these are typically non-branded formulations. They may lack the specific stabilizers and formulation excipients present in Trisenox.

3. How does patent exclusivity influence Trisenox’s supply chain?
Patent protections restrict generic competition in many markets, allowing Eisai to control pricing, manufacturing, and supply. Expiry or licensing extensions can open markets to generic suppliers, affecting pricing and availability.

4. What risks threaten the supply of Trisenox?
Risks include manufacturing disruptions, raw material shortages, regulatory delays, geopolitical tensions, and trade restrictions, all potentially impacting supply continuity.

5. How can healthcare providers ensure continuous access to Trisenox?
Providers should establish relationships with authorized distributors, monitor regulatory developments, maintain inventory buffers, and stay informed about licensing and patent statuses to manage supply risks effectively.

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Sources:

[1] FDA Drug Approval Database, Trisenox approval history.
[2] Eisai Co., Ltd. Official Website, product manufacturing and licensing details.
[3] Market analysis reports on all-trans retinoic acid manufacturing, 2022.
[4] Global pharmaceutical manufacturing standards, WHO guidelines.
[5] Patent and regulatory landscape for retinoic acid drugs.