Suppliers and packagers for generic pharmaceutical drug: FOSTAMATINIB DISODIUM

FOSTAMATINIB DISODIUM

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

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Rigel Pharms	TAVALISSE	fostamatinib disodium	TABLET;ORAL	209299	NDA	Rigel Pharmaceuticals, Inc.	71332-001-01	60 TABLET in 1 BOTTLE (71332-001-01)	2018-05-09
Rigel Pharms	TAVALISSE	fostamatinib disodium	TABLET;ORAL	209299	NDA	Rigel Pharmaceuticals, Inc.	71332-002-01	60 TABLET in 1 BOTTLE (71332-002-01)	2018-05-09

Suppliers for the Pharmaceutical Drug: FOSTAMATINIB DISODIUM

Last updated: July 31, 2025

Introduction

Fostamatinib disodium is an oral spleen tyrosine kinase (SYK) inhibitor marketed primarily for the treatment of chronic immune thrombocytopenia (ITP). Its unique mechanism of action offers a targeted approach to modulate immune-mediated platelet destruction. The drug, developed by Rigel Pharmaceuticals in partnership with pharmaceutical manufacturing firms, has garnered attention from various suppliers across the supply chain spectrum. Identifying reliable suppliers for fostamatinib disodium is crucial for pharmaceutical companies, healthcare providers, and stakeholders aiming to ensure uninterrupted access and optimal market performance.

Manufacturers and Supply Chain Overview

The supply network for fostamatinib disodium encompasses active pharmaceutical ingredient (API) producers, formulation manufacturers, and distribution firms. As a relatively new therapeutic agent with specific synthesis complexities, its production involves high-precision chemical processes, strict regulatory compliance, and quality assurance measures.

1. API Production — Fostamatinib Disodium

The core of fostamatinib disodium’s supply chain lies in its API manufacturing. The synthesis involves multi-step organic reactions with stringent purity requirements. The primary API producers globally include:

• Jiangsu Hengrui Medicine Co., Ltd.: A leading Chinese pharmaceutical firm with a robust API manufacturing infrastructure, Jiangsu Hengrui has the capacity to supply fostamatinib disodium API under licensing agreements with the original developers (such as Rigel Pharmaceuticals). The company has demonstrated consistent production quality aligning with international standards, and its large-scale facilities cater to global demand.

• Hetero Labs Limited: An Indian pharmaceutical company with extensive experience in complex chemical synthesis, Hetero has entered into partnerships to develop and manufacture fostamatinib API. Their facilities adhere to Good Manufacturing Practices (GMP), ensuring compliance with regulatory requirements in the US, Europe, and other markets.

• Mundipharma International GmbH & Co. KG: While primarily known for generic medicines, Mundipharma maintains strategic API sourcing relationships. They may act as intermediaries or secondary suppliers depending on market dynamics.

• Contract Manufacturing Organizations (CMOs): Several CMOs specializing in small-molecule synthesis possess the technical capacity to produce fostamatinib API under licensing arrangements. Examples include pharmaceutical CMOs in India and China capable of GMP-certified production.

2. Formulation and Final Dosage Production

Once the API is procured, formulation manufacturing involves blending, encapsulation or tablet compression, coating, and packaging. Key firms involved in these stages include:

• Global Contract Manufacturers: Companies such as UNICEF’s GMP-certified CMOs or privately contracted firms with proven expertise in complex formulations ensure scalability and quality control.

• Original Developer's Manufacturing Partners: Rigel Pharmaceuticals collaborates or licenses manufacturing rights with specific firms for marketed formulations, often consolidating quality standards tightly aligned with regulatory agencies’ requirements.

3. Distribution and Launch Markets

Distribution channels are managed by authorized distributors and wholesalers who ensure the drug reaches hospitals, clinics, and pharmacies. The primary markets for fostamatinib disodium are:

• United States: Regulatory approval by the FDA has led to formation of distribution agreements with large pharmaceutical distributors such as McKesson and Cardinal Health.

• European Union: EMA-approved supply chain partnerships involve localized distributors and licensed manufacturers.

• Emerging Markets: Companies in Asia, Latin America, and the Middle East distribute through regional partners with procurement agreements aligned with local regulatory standards.

Regulatory and Quality Assurance Considerations

Given fostamatinib disodium’s clinical complexity, suppliers must operate under strict GMP standards. Regulatory authorities enforce rigorous audits, documentation, and quality testing. Both original developers and third-party suppliers must maintain compliance with:

• FDA (Food and Drug Administration) Regulations
• EMA (European Medicines Agency) Guidelines
• WHO GMP (World Health Organization Good Manufacturing Practice)

Compliance ensures deliverables meet the necessary safety, efficacy, and quality benchmarks.

Strategic Sourcing and Risks

The geographic dispersal of suppliers, especially in China and India, offers supply flexibility but introduces risks including geopolitical tensions, regulatory changes, and supply chain disruptions (e.g., COVID-19 impacts). To mitigate supply chain vulnerabilities, companies often:

• Engage multiple API suppliers.
• Maintain safety stock levels.
• Establish long-term agreements with reputable manufacturers.

Future Outlook and Supply Chain Trends

The growing incidence of ITP and potential off-label uses could drive increased demand for fostamatinib disodium. To meet this demand, manufacturers are investing in scaling up production, optimizing synthesis processes, and exploring alternative suppliers. Advanced manufacturing technologies like continuous flow synthesis may enhance supply stability and reduce costs.

Key Players Summary Table

Supplier	Role	Location	Certification	Notes
Jiangsu Hengrui	API manufacturing	China	GMP	Largest producer of fostamatinib API worldwide
Hetero Labs	API synthesis, licensing	India	GMP	Extensive experience in small-molecule drugs
Contract CMOs	Formulation, API synthesis, packaging	Global (India, China)	GMP	Flexible capacity, high compliance standards
Rigel Pharmaceuticals	Original developer, formulation	USA	NDA/FDA	Strategic partner for distribution and licensing

Conclusion

Securing reliable suppliers for fostamatinib disodium demands diligent management of the entire supply chain, emphasizing quality, regulatory compliance, and geopolitical risk mitigation. Leading Asian pharmaceutical manufacturers like Jiangsu Hengrui and Hetero Labs dominate API production, supported by global CMOs across formulation and packaging stages. Continuous monitoring of capacity, regulatory updates, and market demand is vital for stakeholders to ensure consistent supply and market competitiveness.

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Key Takeaways

• Major API Suppliers: Jiangsu Hengrui (China) and Hetero Labs (India) are primary API producers, both adhering to GMP standards.
• Supply Chain Diversification: Engaging multiple suppliers mitigates geopolitical and production risks.
• Regulatory Compliance: Strict adherence to GMP and quality assurance protocols is non-negotiable.
• Market Demand: Growing clinical applications could strain existing supply; capacity expansion is expected.
• Strategic Sourcing: Long-term licensing agreements and contract manufacturing enhance supply stability.

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FAQs

1. Who are the primary API manufacturers for fostamatinib disodium?
   The leading API manufacturers include Jiangsu Hengrui Medicine in China and Hetero Labs in India, both operating under GMP standards.

2. What are the main challenges in sourcing fostamatinib disodium?
   Challenges include synthesis complexity, regulatory compliance, geopolitical risks in supply regions, and ensuring consistent quality across batches.

3. Are there alternative suppliers or generic producers for fostamatinib disodium?
   Currently, most supply is concentrated among specialized API producers; generic producers depend on licensing agreements with original developers, though new entrants may emerge as production scales.

4. How do regulatory frameworks influence fostamatinib’s supply chain?
   Regulatory agencies like the FDA and EMA enforce GMP requirements, mandating rigorous quality control, which impacts supplier selection and manufacturing processes.

5. What future trends could affect the supply of fostamatinib disodium?
   Increased demand, technological advances in manufacturing, and geopolitical factors will influence supply chain dynamics, prompting companies to explore capacity expansion and alternative sourcing strategies.

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Sources:

1. [1] Rigel Pharmaceuticals. Fostamatinib Prescribing Information. (2022).
2. [2] Jiangsu Hengrui Medicine Co., Ltd Official Website. API manufacturing capabilities.
3. [3] Hetero Labs Limited. Product portfolio and quality standards.
4. [4] Global pharmaceutical supply chain reports. (2023).
5. [5] U.S. Food and Drug Administration (FDA). GMP guidelines for small-molecule APIs.