Suppliers and packagers for xospata

xospata

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

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

Suppliers for the Pharmaceutical Drug: XOSPATA

Last updated: July 29, 2025

Introduction

XOSPATA (gilteritinib) is an FDA-approved targeted therapy indicated for relapsed or refractory acute myeloid leukemia (AML) with FLT3 mutations. Developed by Astellas Pharma Inc., this oral kinase inhibitor offers a significant advancement in personalized cancer treatment, focusing on patients with specific genetic markers. As the demand for XOSPATA rises due to its therapeutic efficacy, understanding its supply chain and the key suppliers involved in its production is vital for stakeholders, including healthcare providers, pharmaceutical distributors, and regulatory bodies.

Manufacturing and Key Raw Material Suppliers

The production of XOSPATA depends on a complex synthesis process involving multiple chemical intermediates and active pharmaceutical ingredients (APIs). The primary manufacturer, Astellas Pharma Inc., sources raw materials globally from specialized chemical suppliers and contract manufacturing organizations (CMOs).

Active Pharmaceutical Ingredient (API) Production

Gilteritinib’s API synthesis involves advanced organic chemistry processes, including selective kinase inhibition compounds. The key suppliers providing essential chemical intermediates or custom synthesis services include:

• Suzhou Sunlord Nano Technology Co., Ltd.
  Specializes in synthesizing high-purity chemical intermediates for kinase inhibitors, including molecules similar to gilteritinib, and may serve as an upstream supplier for initial intermediates.

• Fujifilm Wako Pure Chemical Corporation
  Provides high-grade reagents used during API synthesis stages, ensuring chemical purity and compliance with pharmaceutical standards.

• Cambridge Major Laboratories (CML) / Thermo Fisher Scientific
  Offering contract manufacturing and custom chemical synthesis capabilities, critical in scaling API production to meet market demand.

Excipient and Formulation Ingredient Suppliers

XOSPATA tablets require various excipients such as binders, fillers, and stabilizers, sourced from established pharmaceutical excipient suppliers including:

• Colorcon Inc.
  Supplies film-coating agents and binders for tablet formulation.

• Degussa (Evonik Industries)
  Provides inert fillers and excipients that optimize drug stability and bioavailability.

Contract Manufacturing Organizations (CMOs)

Astellas collaborates with CMOs for the large-scale manufacturing of gilteritinib, ensuring quality and scalability.

• Catalent Pharma Solutions
  A global CMO involved in high-potency drug manufacturing, including processes specific to kinase inhibitors and oral solid dosage forms.

• GenScript ProBio
  Specializes in biopharmaceuticals but has expanded into small molecule APIs, providing scalable synthesis capabilities for complex pharmaceuticals.

• Lannett Company Inc.
  A U.S.-based CMO with extensive experience in manufacturing branded and generic APIs, including kinase inhibitors.

Distribution Channel & Logistics

Post-manufacturing, XOSPATA's distribution involves several layers:

• Wholesalers and Distributors
  Major pharmaceutical distributors such as McKesson, Cardinal Health, and AmerisourceBergen distribute XOSPATA to hospitals and pharmacies globally.

• Regional Distributors
  Localized distribution agreements facilitate timely supply, especially in emerging markets.

Astellas maintains strategic stockpiles at regional warehouses to mitigate supply disruptions, ensuring rapid distribution to healthcare providers.

Regulatory and Quality Assurance Suppliers

Ensuring consistent quality compliance is paramount.

• SGS SA and UL (Underwriters Laboratories)
  Conduct quality testing, environmental assessments, and certification of raw materials and final products to meet regulatory standards such as FDA, EMA, and those of other global authorities.

• Certara
  Offers modeling and simulation tools to optimize manufacturing processes, ensuring consistent API quality and stability.

Emerging and Future Suppliers

Given the competitive landscape, pharmaceutical companies are exploring alternative suppliers to diversify risk.

• CordenPharma
  Focuses on high-potency active pharmaceutical ingredients (HPAPIs) and may serve as an alternative source for gilteritinib API components.

• AbbVie Contract Manufacturing
  Expanding its portfolio in small molecule synthesis, potentially providing future scalability options for gilteritinib supply.

Supply Chain Challenges and Risks

The global supply chain for pharmaceuticals, including XOSPATA, is vulnerable to disruptions such as geopolitical instability, raw material shortages, and manufacturing delays.

• Raw material scarcity of certain intermediates can hamper production timelines.
• Logistical disruptions resulting from the COVID-19 pandemic have emphasized the importance of diversified supplier networks.

Astellas among other pharma companies is adopting strategies such as dual sourcing and increased inventory buffers to mitigate these risks.

Conclusion

The supply chain for XOSPATA involves multiple specialized suppliers across raw material synthesis, formulation, manufacturing, and distribution channels. Key players include chemical intermediates suppliers such as Suzhou Sunlord Nano Technology and Fujifilm Wako, contract manufacturers like Catalent and GenScript ProBio, and distribution giants including McKesson and Cardinal Health. Regulatory and quality assurance partners underpin the stability and compliance of the supply chain. Continual diversification and strategic partnerships are essential to meet global demand, ensure quality, and mitigate risks associated with supply chain disruptions.

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Key Takeaways

• Astellas sources critical components from global chemical suppliers and CMOs specializing in high-potency APIs.
• Strategic alliances with CMOs like Catalent ensure scalable, compliant manufacturing.
• Distribution networks involve major pharmaceutical wholesalers committed to timely global delivery.
• Diversification of suppliers and inventory buffers are critical to mitigating supply chain risks.
• Robust quality assurance protocols underpin the integrity and compliance of XOSPATA supply.

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FAQs

1. Who are the primary manufacturers of XOSPATA’s active pharmaceutical ingredients?
Astellas collaborates with multiple CMOs, including Catalent and GenScript ProBio, which specialize in API synthesis and large-scale manufacturing.

2. Are there alternative suppliers for gilteritinib to ensure supply stability?
Yes, companies such as CordenPharma and Abbott are exploring or expanding into similar API manufacturing capacities, providing potential alternatives.

3. How does the supply chain ensure the quality of XOSPATA?
Through rigorous testing by QA partners like SGS and UL, adherence to global regulatory standards, and ongoing supplier audits.

4. What logistical strategies are employed to prevent XOSPATA shortages?
Astellas maintains regional warehouses and stockpiles, employs diversified sourcing, and builds inventory buffers to mitigate disruptions.

5. Is the supply chain for XOSPATA affected by geopolitical or economic factors?
Yes, geopolitical events and global economic conditions can impact raw material availability, transportation, and manufacturing, prompting continuous supply chain assessments and risk mitigation strategies.

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References

1. FDA Approval of XOSPATA (gilteritinib).
2. Astellas Pharma Official Website.
3. CMO profiles: Catalent and GenScript.
4. Global pharmaceutical raw materials suppliers.
5. Supply Chain Risks in the Pharmaceutical Industry.

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This comprehensive overview of XOSPATA’s supply chain provides essential insights into the complex web of suppliers ensuring drug availability. Stakeholders should remain vigilant to supply chain dynamics to sustain uninterrupted patient access.