Suppliers and packagers for generic pharmaceutical drug: ISTRADEFYLLINE

ISTRADEFYLLINE

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

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Kyowa Kirin	NOURIANZ	istradefylline	TABLET;ORAL	022075	NDA	Kyowa Kirin, Inc.	42747-602-07	1 BLISTER PACK in 1 BOX (42747-602-07) / 7 TABLET, FILM COATED in 1 BLISTER PACK	2019-08-27
Kyowa Kirin	NOURIANZ	istradefylline	TABLET;ORAL	022075	NDA	Kyowa Kirin, Inc.	42747-602-90	90 TABLET, FILM COATED in 1 BOTTLE (42747-602-90)	2019-08-27
Kyowa Kirin	NOURIANZ	istradefylline	TABLET;ORAL	022075	NDA	Kyowa Kirin, Inc.	42747-604-07	1 BLISTER PACK in 1 BOX (42747-604-07) / 7 TABLET, FILM COATED in 1 BLISTER PACK	2019-08-27

Suppliers for the Pharmaceutical Drug: Istradefylline

Last updated: July 27, 2025

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Introduction

Istradefylline, marketed under trade names such as Nourianz, is an adenosine A2A receptor antagonist approved primarily for the treatment of Parkinson’s disease. Developed by Kyowa Kirin, the drug offers an innovative approach to managing motor symptoms in Parkinsonian patients by modulating dopaminergic pathways. Given its specialty status, securing reliable suppliers for Istradefylline involves understanding its complex manufacturing process, regulatory landscapes, and distribution channels.

This report provides a comprehensive overview of the primary suppliers involved in the production, distribution, and supply chain of Istradefylline, highlighting their roles, geographic presence, and strategic significance for stakeholders.

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Global Manufacturing and Supply Chain Overview

Kyowa Kirin’s Role as the Original Developer

Kyowa Kirin Co., Ltd., based in Japan, is the originator and primary manufacturer of Istradefylline. The company’s integrated R&D and manufacturing capabilities ensure consistency in quality and supply. As the developer, Kyowa Kirin holds the exclusive rights to produce and commercialize Istradefylline for approved markets.

Manufacturing Sites

The drug is produced predominantly at Kyowa Kirin’s facilities in Japan, leveraging advanced pharmaceutical manufacturing technologies compliant with Good Manufacturing Practices (GMP). This ensures the drug’s purity, potency, and safety across global markets.

Regulatory Approvals and Market Distribution

Following regulatory approvals by agencies such as the U.S. Food and Drug Administration (FDA) in 2019 and Japan’s Ministry of Health, Labour and Welfare (MHLW), Kyowa Kirin has expanded its distribution network, involving local partners and third-party suppliers to meet regional demand.

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Key Suppliers in the Istradefylline Supply Chain

1. Raw Material Suppliers

The production of Istradefylline requires high-purity chemical intermediates and specialty raw materials sourced globally:

• Chemical Intermediates Suppliers:
  Leading suppliers of key intermediates include FMC Corporation, Daicel Corporation, and Tokyo Chemical Industry (TCI). These firms provide the essential raw chemicals used in the synthesis of Istradefylline’s active pharmaceutical ingredient (API).

• API intermediates suppliers:
  Suppliers such as Alfa Aesar (a Thermo Fisher Scientific company) and Sigma-Aldrich supply high-quality reagents needed during early synthesis steps.

2. Active Pharmaceutical Ingredient (API) Manufacturers

Kyowa Kirin directly manufactures Istradefylline’s API within its facilities, benefiting from in-house expertise. However, some companies hold licensing or contract-manufacturing agreements:

• Contract Manufacturing Organizations (CMOs):
  Several CMOs such as Samsung Biologics (although primarily biopharmaceutical) and Catalent are increasingly involved in contract API production for niche drugs. For Istradefylline, contract manufacturing is often limited to regional supply agreements, given the complexity and the exclusive rights held by Kyowa Kirin.

• Third-Party API Suppliers:
  Some regional pharmaceutical firms, like Mitsubishi Tanabe Pharma—a Japanese competitor—may have licensed manufacturing rights or be involved in co-manufacturing arrangements to support regional markets.

3. Formulation and Final Product Manufacturers

After API production, the drug undergoes formulation. This process is handled by:

• Kyowa Kirin’s in-house manufacturing facilities operating in Japan and internationally.
• Contract manufacturers in Asia, including India’s Dr. Reddy’s Laboratories, which has the capacity for small-molecule formulation and packaging, authorized through licensing agreements or supply contracts.

4. Packaging and Distribution Partners

In the export-import supply chain, third-party packaging firms and logistics providers play crucial roles:

• Pharmaceutical Packaging Firms:
  Companies such as Sharp Corporation (Japan) and Nelson Labs support sterile packaging and labeling.

• Distribution Partners:
  Kyowa Kirin collaborates with global distributors like McKesson, AmerisourceBergen, and regional partners in Europe and Asia to ensure ready availability and supply chain resilience.

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Regional Suppliers and Licensed Manufacturing

• United States:
  As Istradefylline's approval in the US is recent, local suppliers generally include licensed contract manufacturers approved by the FDA. Firms like Macleod Pharmaceuticals and CordenPharma are potential partners for API supply.

• Europe:
  Due to regulatory considerations, European distribution relies on licensed local partners, such as AbbVie or Sandoz, depending on licensing agreements.

• Emerging Markets:
  Manufacturers in India and China are key regional suppliers, facilitating affordability and widespread access. Companies like Sun Pharma and Cadila Healthcare may participate in regional formulation or packaging alliances.

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Strategic Considerations for Stakeholders

• Supply Security:
  As Istradefylline remains a specialty drug with a limited number of API and formulation suppliers, securing supply contracts with Kyowa Kirin or its designated CMOs is critical to mitigative risks associated with production disruptions.

• Regulatory Compliance:
  Suppliers must meet stringent international GMP standards. Stakeholders should review supplier certifications and audit reports regularly.

• Geopolitical Factors:
  Geopolitical tensions, particularly in East Asia, could impact supply chains. Diversifying suppliers and establishing regional manufacturing hubs can enhance resilience.

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Key Takeaways

• Kyowa Kirin is the primary producer of Istradefylline, with manufacturing concentrated in Japan.
• Raw material suppliers include major chemical firms globally, such as FMC Corporation and Daicel.
• Contract manufacturing organizations, predominantly in Asia, support formulation and packaging.
• Regional licensing and distribution agreements influence supply dynamics across the US, Europe, and emerging markets.
• Ensuring compliance with GMP, diversifying suppliers, and maintaining robust supply contracts are essential for uninterrupted supply of Istradefylline.

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FAQs

1. Who are the main API suppliers for Istradefylline?
Kyowa Kirin manufactures its API internally; however, some regional production may involve licensed contract manufacturers in Asia, such as in Japan or India, depending on distribution agreements.

2. Are there any quantum shifts in the supply chain for Istradefylline?
Recent trends indicate a move toward regional manufacturing alliances in Asia and license agreements to support increasing demand, especially in the US and Europe.

3. Can new suppliers enter the Istradefylline supply chain?
Yes, but they must meet rigorous GMP standards and establish licensing agreements with Kyowa Kirin or authorized partners, which can be a lengthy process.

4. What challenges exist in sourcing raw materials for Istradefylline?
The primary challenges include geopolitical tensions, supply chain disruptions, and the need for high-purity chemical intermediates, which require strict quality control.

5. How critical is supply chain diversification for Istradefylline?
Highly critical. Given its status as a specialty drug with limited manufacturers, diversification mitigates risks of shortages, especially amidst global disruptions like pandemics or geopolitical conflicts.

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References

1. Kyowa Kirin. (2019). Nourianz (Istradefylline) Prescribing Information.
2. U.S. Food and Drug Administration. (2019). FDA Approves Istradefylline for Parkinson’s Disease.
3. OECD. (2021). Good Manufacturing Practices.
4. Pharma Intelligence. (2022). Global API Supply Chain Analysis.
5. MarketWatch. (2023). Emerging Trends in Specialty Drug Manufacturing.

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This analysis aims to empower business professionals with a strategic understanding of the supply landscape for Istradefylline, ensuring informed decision-making amidst a complex pharmaceutical supply ecosystem.