Suppliers and packagers for tavalisse

tavalisse

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

Last updated: July 28, 2025

ppliers for the Pharmaceutical Drug: Tavalisse

Introduction
Tavalisse (generic name: fostamatinib) is an oral kinase inhibitor developed by Rigel Pharmaceuticals primarily for the treatment of chronic immune thrombocytopenia (ITP), a condition characterized by an abnormally low platelet count. As with many innovative biologic and small-molecule drugs, securing reliable suppliers for Tavalisse involves navigating complex supply chains, regulatory compliance, and market exclusivity. Understanding the current landscape of Tavalisse suppliers is essential for manufacturers, healthcare providers, investors, and compliance bodies seeking insight into product availability, potential market risks, and opportunities for partnerships.

Manufacturing and Supply Chain Overview
Tavalisse was approved by the U.S. Food and Drug Administration (FDA) in 2018, with Rigel Pharmaceuticals holding the rights to manufacture and distribute the drug. The active pharmaceutical ingredient (API), fostamatinib, is a small-molecule synthesized through a multi-step chemical process, typically involving specialized chemical contract manufacturing organizations (CMOs). These CMOs are responsible for producing the API at quality standards compliant with regulatory agencies such as the FDA, EMA, and other regional authorities.

Key Suppliers and Manufacturing Partners

1. Rigel Pharmaceuticals

Rigel remains the primary authorizing entity for Tavalisse’s distribution and marketing. While Rigel develops and controls the formulation and final product, its manufacturing operations rely heavily on external CMOs for API production. The company maintains strategic relationships with trusted manufacturing partners to ensure a consistent supply chain capable of meeting market demand.

2. Contract Manufacturing Organizations (CMOs)

The active ingredient fostamatinib is produced by specialized chemical manufacturing firms with expertise in complex synthesis, often located in Asia, Europe, or North America. Known API manufacturing companies involved in fostamatinib’s supply chain include:

• Large-scale chemical manufacturers in China and India, known for bulk chemical synthesis and API production. While specific identities often remain confidential due to commercial sensitivity, recent industry trends suggest that Chinese API manufacturers play a significant role in the supply chain, providing cost-effective production capacity.
• European and North American Contract Manufacturing Organisations (CMOs) with GMP-compliant facilities capable of handling complex chemical synthesis. These firms are often involved in early-stage development, scale-up, and commercial supply.

3. Formulation and Packaging Suppliers

Post-API production, Tavalisse is formulated and packaged primarily in facilities managed or contracted by Rigel Pharmaceuticals. These facilities are typically located within the United States or Europe, ensuring tamper-proof packaging and compliance with stringent pharmaceutical manufacturing standards.

4. Distribution Partners

Distribution channels include direct relationships with wholesalers, specialty pharmacies, and hospital networks across the U.S. and selected international markets. These partners are critical to ensuring Tavalisse’s broad accessibility while maintaining cold chain and delivery standards.

Supply Chain Challenges and Risks
The supply of Tavalisse faces typical challenges associated with small-molecule drugs. These include:

• Raw Material Availability: Disruption in sourcing key chemical precursors from regions affected by geopolitical tensions or regulatory updates can impact API supply.
• Manufacturing Capacity Constraints: Limited API manufacturing capacity, especially in high-demand scenarios, may lead to shortages or delays.
• Regulatory Compliance and Quality Controls: Ensuring all suppliers meet Good Manufacturing Practice (GMP) standards is essential; failure can lead to recalls or production halts.
• Intellectual Property and Confidentiality: The proprietary synthesis processes heighten the importance of secure supply relationships.

Market Dynamics and Recent Developments
Since its approval, Tavalisse’s market performance and supply reliability have been influenced by competition, patent exclusivity periods, and clinical pipeline developments. The enzyme inhibitor’s competitive landscape includes potential biosimilar or alternative therapies that could impact demand for original formulations and, consequently, the motivation of suppliers to invest in capacity expansion.

1. Supply Security from Rigel

Rigel’s strategy emphasizes establishing diverse manufacturing partners to mitigate risks associated with dependency on single sources. The company has indicated its intent to expand API production capacity through partnerships, which would enhance supply stability for Tavalisse.

2. Partnerships for Global Expansion

In markets outside the US, licensing agreements and local manufacturing partnerships facilitate Tavalisse’s availability. For example, licensing agreements in Europe and Asia often specify approved local formulators and distributors, adding layers of supply chain complexity but increasing geographic reach.

Regulatory and Quality Assurance Considerations
Suppliers must adhere to rigorous regulatory standards, including ISO certifications and GMP compliance. Routine audits, batch testing, and certification ensure that API quality remains consistent. The recent trend of globalized pharmaceutical manufacturing underscores the importance of a resilient supply chain with multiple qualified suppliers to avoid shortages or contamination issues.

Future Outlook
As Tavalisse’s patent protection extends and generic competition remains limited due to its mechanistic, targeted kinase inhibition, the supply chain’s stability will likely improve. Additionally, advancements in synthetic processes could reduce costs and enhance capacity, promising a more robust supply environment in the coming years.

Key Takeaways

• Rigel Pharmaceuticals is the central orchestrator of Tavalisse’s supply, contracting APIs from global chemical manufacturers primarily in Asia and Europe.
• API manufacturing involves complex chemical synthesis requiring specialized CMOs compliant with GMP standards.
• Supply chain resilience depends on diversified manufacturing partnerships, supply chain transparency, and stringent quality control.
• Regional licensing influences distribution and manufacturing arrangements in international markets.
• Challenges like raw material shortages, capacity limits, and compliance risks necessitate proactive risk management strategies.

FAQs

Q1: Who are the primary API suppliers for Tavalisse?
A: While specific companies are often confidential, prominent chemical manufacturers in China, India, Europe, and North America supply fostamatinib’s API, with Rigel contracting multiple organizations to mitigate supply risks.

Q2: How does Rigel Pharmaceuticals ensure supply chain stability?
A: Rigel employs diversified manufacturing partnerships, rigorous GMP compliance, and quality control processes, along with strategic capacity expansion to prevent shortages.

Q3: Are there any known alternatives or biosimilars for Tavalisse?
A: As of now, no biosimilars or direct alternatives have achieved regulatory approval, maintaining Tavalisse’s market exclusivity and supplier relationships.

Q4: What are the main risks in Tavalisse’s supply chain?
A: Primary risks include raw material shortages, manufacturing capacity constraints, geopolitical disruptions, and compliance failures.

Q5: How might future market developments impact Tavalisse suppliers?
A: Patent expirations or the emergence of competing therapies could influence demand, prompting suppliers to adapt by increasing capacity or shifting focus to newer products.

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Sources
[1] FDA. (2018). Tavalisse (fostamatinib) approval information.
[2] Rigel Pharmaceuticals. Corporate disclosures and press releases.
[3] Industry reports on pharmaceutical API manufacturing trends.
[4] WHO GMP guidelines and regulatory standards for pharmaceutical manufacturing.