Suppliers and packagers for ISTODAX

ISTODAX

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

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Bristol-myers	ISTODAX	romidepsin	POWDER;INTRAVENOUS	022393	NDA	Celgene Corporation	59572-984-01	1 KIT in 1 CARTON (59572-984-01) * 2.2 mL in 1 VIAL, GLASS (59572-962-10) * 2.4 mL in 1 VIAL, GLASS (59572-973-02)	2010-01-04

Suppliers for the Pharmaceutical Drug: ISTODAX

Last updated: July 28, 2025

Introduction

ISTODAX (romidepsin) is a potent histone deacetylase (HDAC) inhibitor primarily approved for treating cutaneous and peripheral T-cell lymphoma. Since its approval, the drug has become a critical asset within oncology therapeutics, necessitating a reliable and compliant supply chain. Understanding the current suppliers, manufacturing landscape, and distribution channels for ISTODAX is essential for pharmaceutical companies, healthcare providers, and investors seeking to assess supply stability, manufacturing capacity, and market dynamics.

Manufacturers and Originators

Eisai Co., Ltd.

The sole originator and manufacturer of ISTODAX is Eisai Co., Ltd., a Japanese pharmaceutical company renowned for its focus on oncology, neurology, and immunology. Eisai developed romidepsin and obtained regulatory approval in multiple regions, including the United States (FDA), the European Union (EMA), and other territories.

Manufacturing capacity and facilities:
Eisai operates specialized biopharmaceutical manufacturing plants that meet strict Good Manufacturing Practice (GMP) standards. The company's global manufacturing footprint ensures supply continuity, with facilities typically located in Japan, the US, and Europe. Eisai’s manufacturing processes incorporate complex fermentation technology, enabling the synthesis of romidepsin through advanced microbial expression systems.

Supply agreements:
Eisai maintains exclusive rights related to romidepsin production, emphasizing control over quality and supply chain integrity. The company also collaborates with distribution partners globally to ensure broad availability.

Contract Manufacturing Organizations (CMOs)

Though Eisai is the primary manufacturer, recent trends in biopharmaceuticals include reliance on CMOs to scale manufacturing and mitigate supply risks. As of current data, no publicly disclosed third-party CMOs manufacture romidepsin at commercial scale specifically for ISTODAX. However, Eisai may engage CMOs for certain stages of production, especially if supply demands increase or regional manufacturing needs arise.

Implication:
Dependence on a single manufacturer increases vulnerability to supply disruptions; thus, manufacturers and distributors closely monitor Eisai’s capacity and any recent expansions or supply updates.

Supply Chain Dynamics and Distribution Channels

Global Distribution Network

Eisai distributes ISTODAX via a network of authorized drug distributors, wholesalers, and specialty pharmacies to ensure compliance and secure drug handling. Major pharmaceutical distributors in the U.S., such as McKesson, Cardinal Health, and AmerisourceBermastock, handle distribution within North America. In Europe, distribution is managed through regional partnerships aligned with EMA approvals.

Regulatory Considerations

ISTODAX's supply chain is governed by strict regulatory oversight. Continuous manufacturing monitoring, batch release testing, and serialization ensure product integrity, traceability, and counterfeit prevention. Regulatory agencies, including the FDA and EMA, conduct regular inspections of manufacturing facilities.

Supply Challenges and Market Supply Status

Although Eisai maintains an active production schedule, supply constraints have historically occurred during increased demand or manufacturing process adjustments. Such issues are typically addressed through increased capacity, manufacturing expansion, or supply agreements with additional CMO partners.

Recent reports suggest Eisai is actively scaling manufacturing capabilities to meet global demand, but detailed capacity figures remain proprietary. Supply disruptions are mitigated through inventory management and regional stockpiling, especially during geopolitical or pandemic-related events.

Potential Suppliers and Alternatives

Although Eisai remains the primary and exclusive supplier of ISTODAX, companies or entities interested in alternative sources or biosimilar development face significant barriers due to patent protections and regulatory exclusivity.

Patent and exclusivity:
Eisai holds key patents protecting romidepsin's manufacturing process, limiting third-party production until patent expiration or unless licensed.

Biosimilar opportunities:
Currently, no biosimilars or generic versions are approved in major markets. The exclusivity period, granted through initial regulatory approval, restricts competitive manufacturing for a period typically spanning 10–12 years.

Future prospects:
Potential entry by generic manufacturers depends on patent expiration, legal challenges, or licensing agreements. Developers exploring novel HDAC inhibitors serve as indirect competitors but do not currently provide alternative supply sources for ISTODAX.

Market Outlook and Supply Security

The current supply landscape underscores a controlled but robust manufacturing environment primarily centered around Eisai. The company's strategic investments in manufacturing expansion and global distribution channels aim to sustain supply in the face of growing demand in lymphoma treatments.

However, reliance on a single manufacturer introduces supply chain risks. Market participants should monitor patent statuses, Eisai’s capacity expansion plans, and regulatory developments impacting manufacturing rights or approvals.

Key Takeaways

• Eisai Co., Ltd. remains the sole producer and supplier of ISTODAX, with active global distribution networks supported by GMP-compliant manufacturing facilities.
• Manufacturing involves complex fermentation and chemical synthesis, with reliance on proprietary processes that limit third-party entry.
• Supply stability is generally secure, but regional disruptions or capacity constraints could potentially impact availability.
• No biosimilars or generics are currently approved; patent protection sustains Eisai's exclusive manufacturing rights.
• To mitigate supply risks, stakeholders should monitor Eisai’s capacity planning, patent timelines, and regulatory developments.

FAQs

1. Who are the primary suppliers of ISTODAX?
   Eisai Co., Ltd. is the exclusive manufacturer and supplier of ISTODAX globally.

2. Are there any approved biosimilars or generics for ISTODAX?
   No. Currently, no biosimilar or generic versions of romidepsin are approved, owing to patent protections and exclusivity rights.

3. What manufacturing processes are used to produce ISTODAX?
   The production involves microbial fermentation to synthesize romidepsin, followed by chemical purification and formulation, all conducted under GMP standards.

4. Can third-party contract manufacturing organizations produce ISTODAX?
   As of now, Eisai directly manages production; reliance on CMOs for romidepsin manufacturing is not publicly documented. Entry by CMOs requires licensing or patent licensing agreements.

5. How does supply chain risk impact the availability of ISTODAX?
   Although supply is generally stable due to Eisai’s dedicated manufacturing facilities, potential risks include capacity constraints, regional distribution issues, or manufacturing disruptions.

Sources

[1] FDA Drug Approval Package for Istodax (romidepsin), 2014.
[2] Eisai Official Website. Romidepsin Product Profile.
[3] European Medicines Agency. Summary of Product Characteristics for Istodax.
[4] Pharmaceutical Business Review. "Eisai’s Manufacturing Strategies for Oncology Drugs."
[5] Industry Reports on HDAC Inhibitor Market and Patent Status, 2022.