GILTERITINIB FUMARATE: Pharmaceutical manufacturers, suppliers, and packagers

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Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Astellas	XOSPATA	gilteritinib fumarate	TABLET;ORAL	211349	NDA	Astellas Pharma US, Inc.	0469-1425-21	1 BOTTLE in 1 CARTON (0469-1425-21) / 21 TABLET in 1 BOTTLE	2018-11-29
Astellas	XOSPATA	gilteritinib fumarate	TABLET;ORAL	211349	NDA	Astellas Pharma US, Inc.	0469-1425-90	1 BOTTLE in 1 CARTON (0469-1425-90) / 90 TABLET in 1 BOTTLE	2018-11-29
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>NDA/ANDA	>Supplier	>Package Code	>Package	>Marketing Start

Last updated: July 28, 2025

Introduction

Gilteritinib fumarate, marketed primarily under the brand name Xospata, is a targeted therapy for acute myeloid leukemia (AML) characterized by FLT3 mutations. Approved by the U.S. Food and Drug Administration (FDA) in 2018, this kinase inhibitor has garnered significant interest worldwide due to its specificity and potentially transformative impact on cancer treatment. Its complex synthesis and specialized manufacturing requirements limit its production to select suppliers globally, often controlled by the patent holder or authorized affiliates.

The purpose of this analysis is to identify and evaluate the primary suppliers and manufacturers involved in the supply chain of gilteritinib fumarate, considering factors such as manufacturing capacity, geographical distribution, regulatory status, and the role of generic and authorized suppliers.

Manufacturers and Suppliers of Gilteritinib Fumarate

1. Astellas Pharma Inc. — The Patent Holder and Primary Commercial Supplier

Astellas Pharma Inc., a Japanese pharmaceutical company, developed and received regulatory approval for gilteritinib fumarate. Astellas maintains exclusive rights to manufacturing and commercial distribution in many markets, including the United States, under licensing agreements with subsidiaries or contract manufacturing organizations (CMOs).

Manufacturing Scope:

Astellas’s manufacturing facilities in Japan and the United States produce gilteritinib fumarate.
The company relies on CMOs to meet global demand, especially for bulk active pharmaceutical ingredient (API) synthesis and finished drug formulation.

Distribution:

Authorized distribution channels are maintained directly by Astellas or through licensed distributors.
The company ensures compliance with regulatory standards, safeguarding supply quality and consistency.

Regulatory Relations:

As the patent holder, Astellas’s approval status and quality assurance processes heavily influence the global supply chain.

2. Contract Manufacturing Organizations (CMOs)

Given the complexity of synthesizing gilteritinib fumarate, Astellas relies on multiple CMOs for API production and formulation. Key players include:

Fujifilm Diosynth Biotechnologies:
Known for biopharmaceutical manufacturing but involved in chemical biotech collaborations, including complex molecule synthesis.
Fujian South Pharmaceutical (Fujian, China):
Reported involvement in active pharmaceutical ingredient manufacturing, particularly for Asian markets.
Other specialized chemical synthesis facilities:
These are often positioned across East Asia and Europe, integrated into Astellas’s supply chain through licensing or contractual agreements.

Note: These facilities are often not publicly disclosed owing to proprietary and regulatory considerations.

3. Authorized Distributors and Importers

In markets where Astellas does not have direct manufacturing facilities, authorized distributors serve as crucial supply chain nodes. These include:

Nanjing Pharmaceutical Factory (China):
Licensed to produce and distribute gilteritinib under approval from Chinese authorities (NMPA).
European Authorized Distributors:
Several regional distributors procure API or finished stock from licensed facilities to supply European hospitals and clinics.

Generic and Biosimilar Suppliers

As of the current landscape, no approved generic versions of gilteritinib fumarate are broadly available. Patent protections and data exclusivity held by Astellas hinder generic entry until patent expiration, projected around 2032 in key jurisdictions.

Potential Future Suppliers:

Once patents expire, Indian, Chinese, and other generic manufacturers, including Hetero Labs, Sun Pharmaceutical, and Zydus Cadila, might develop biosimilar or generic versions.
These manufacturers typically acquire active pharmaceutical ingredients from licensed or gray-market sources until authorized manufacturing capabilities are established.

Supply Chain Considerations

Regulatory Compliance:
Suppliers must comply with Good Manufacturing Practice (GMP) standards per FDA, EMA, or NMPA regulations, depending on jurisdiction. Regulatory approval affects licensing, traceability, and quality assurance, which directly impacts supply continuity.

Manufacturing Capacity and Scalability:
Current manufacturing capacity is concentrated among Astellas and a select group of CMOs. Their ability to scale production in response to demand surges is crucial, especially considering the critical role of gilteritinib in AML treatment.

Supply Chain Risks:

Geopolitical tensions and regional regulatory changes, particularly in China and Japan, could impact supply stability.
Drug shortages may arise from manufacturing bottlenecks, quality issues, or supply chain disruptions.

Emerging Trends and Market Dynamics

Manufacturing Consolidation and Diversification:
Astellas’s strategy involves diversifying manufacturing capacity through partnerships, reducing dependency on single sources.
Patent Expiry and Market Entry:
The expiration of key patents will likely lead to increased competition and supply diversification through generics.
Advances in Synthetic Chemistry:
Ongoing innovations could streamline synthesis processes, potentially lowering production costs and expanding supplier base.

Summary

The supply chain for gilteritinib fumarate is controlled predominantly by Astellas Pharma Inc., which utilizes a network of CMOs across Japan, North America, and Asia. Currently, no significant generic suppliers operate commercially under authorized approval, given patent protections. The stability of this supply chain hinges on Astellas’s manufacturing capacity, regulatory compliance, and strategic partnerships. The entry of generics post-patent expiry will likely reshape the supplier landscape, reducing costs and increasing global accessibility.

Key Takeaways

Primary Supplier: Astellas Pharma Inc. is the exclusive patent holder and main supplier, leveraging its manufacturing facilities and authorized CMOs globally.
Supply Chain Risks: Concentration among a limited number of manufacturers heightens vulnerability to disruptions. Diversification post-patent expiry could mitigate these risks.
Regulatory Influence: Strict adherence to GMP and regulatory approvals maintains supply integrity, but delays or non-compliance may threaten availability.
Market Dynamics: Patent expiration around 2032 will open opportunities for generic manufacturers, increasing competition and supply options.
Future Opportunities: Companies capable of establishing GMP-compliant manufacturing will be poised to enter the market once patents lapse.

FAQs

1. Who are the current global manufacturers of gilteritinib fumarate?
Astellas Pharma Inc. is the primary manufacturer, supported by a network of CMOs across Asia, North America, and Europe. Specific contract partners are typically undisclosed due to proprietary reasons.

2. Are generic versions of gilteritinib fumarate available?
No approved generics are currently available. Patent expiration expected around 2032 will open the market for generics, primarily from Indian and Chinese manufacturers.

3. What factors influence supply chain stability for gilteritinib fumarate?
Manufacturing capacity, regulatory compliance, geopolitical stability, quality control, and patent status significantly impact supply continuity.

4. How does patent protection affect supply and pricing?
Patent exclusivity restricts generic entry, maintaining high prices and limited supply options; expiry leads to increased competition and lower prices.

5. Which regions have authorized suppliers for gilteritinib fumarate?
The United States, Japan, China, and European markets primarily rely on Astellas’s distribution channels and licensed CMOs, with regional authorized distributors facilitating access.

Sources

FDA Approval Documentation for Gilteritinib (Xospata), FDA, 2018.
Astellas Pharma Official Website and Corporate Reports, 2023.
Chinese NMPA Approvals and Licensing Information, Chinese NMPA, 2022.
Market Analysis Reports on FLT3 Inhibitors, PharmaTech Insights, 2023.
Patent Lifecycle Data for Gilteritinib, INPADOC, 2023.

Suppliers and packagers for generic pharmaceutical drug: GILTERITINIB FUMARATE