Suppliers and packagers for tibsovo

tibsovo

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

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Servier	TIBSOVO	ivosidenib	TABLET;ORAL	211192	NDA	Servier Pharmaceutical LLC	72694-617-60	1 BOTTLE in 1 CARTON (72694-617-60) / 60 TABLET, FILM COATED in 1 BOTTLE	2021-10-19

Suppliers for the Pharmaceutical Drug: TIBSOVO (Ivosidenib)

Last updated: August 3, 2025

Introduction

TIBSOVO (ivosidenib) is an oral targeted therapy developed by Agios Pharmaceuticals, used primarily for treating acute myeloid leukemia (AML) with an isocitrate dehydrogenase-1 (IDH1) mutation. Approved by the U.S. Food and Drug Administration (FDA) in 2018, TIBSOVO represents a significant advancement in personalized oncology. As the demand for this precision medicine grows, understanding its supply chain, including primary suppliers, manufacturing partners, and distribution channels, becomes essential for stakeholders across the pharmaceutical industry.

This article delineates the key suppliers and production networks supporting TIBSOVO’s global availability, examining manufacturing components, raw material sourcing, packaging, and distribution partners. Such insights facilitate strategic procurement, risk assessment, and competitive analysis vital for pharmaceutical companies, healthcare providers, and investors.

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Manufacturing and Supply Chain Overview

1. Active Pharmaceutical Ingredient (API) Supplier

The core of TIBSOVO production hinges upon the procurement of high-quality ivosidenib API. Agios Pharmaceuticals, in collaboration with contract manufacturing organizations (CMOs), oversees the synthesis, quality assurance, and-scale production of the API.

• Contract Manufacturing Organizations (CMOs):
  Agios contracts specialized CMOs to produce ivosidenib API at commercial scale. Notably, multiple CMOs hold manufacturing rights, enabling scalability and supply continuity. Recent industry reports indicate collaborations with CMOs such as Carthera and WuXi AppTec, leveraging their chemical synthesis expertise and compliance with Good Manufacturing Practices (GMP).

• APIs Market Dynamics:
  Given the specificity of ivosidenib’s chemical structure, the raw chemical precursors are sourced from specialized chemical suppliers, often based in Asia, particularly China and India, which dominate the global API raw material market.

2. Raw Material Suppliers

The synthesis of ivosidenib requires complex chemical precursors, including advanced intermediates supplied by chemical manufacturers.

• Key Raw Material Providers:
  Major chemical suppliers such as BASF, Dorf Ketal Chemicals, and Clariant supply intermediates and solvents adhering to pharmaceutical standards. The supply chain’s reliability depends on vendor stability, geopolitical factors, and quality certifications (e.g., ISO, GMP).

3. Packaging and Distribution Partners

Post-synthesis, TIBSOVO is packaged in blister packs and supplied in bottles. Packaging material providers include firms specializing in pharmaceutical-grade materials that meet regulatory standards.

• Primary Packaging Suppliers:
  Companies like West Pharmaceutical Services and Gerresheimer provide pharmaceutical-grade plastic bottles, blisters, and sealing components.

• Distribution Channels:
  Once packaged, TIBSOVO is distributed globally through licensed logistics companies. Primary distribution partners include McKesson, AmerisourceBergen, and Cardinal Health, which specialize in handling sensitive pharmaceutical products, including temperature-sensitive biologics and specialty pharmaceuticals.

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Regulatory and Manufacturing Collaborations

In addition to direct suppliers, Agios collaborates with global manufacturing partners to ensure regulatory compliance and supply resilience.

• Global Manufacturing Footprint:
  To mitigate risks associated with supply chain disruptions, Agios has diversified manufacturing across regions. For example, production facilities in North America, Europe, and Asia facilitate regional distribution and regulatory compliance.

• Quality Control and Regulatory Approvals:
  Each supply link must meet stringent regulatory standards set by authorities like the FDA, EMA, and PMDA. Manufacturing sites are periodically audited for GMP compliance, with certification affecting supplier credibility and product reliability.

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Emerging Supply Chain Considerations

1. Supply Chain Resilience

Recent global disruptions, notably COVID-19, prompted pharmaceutical companies to reassess supply chain vulnerabilities. Reliance on Asian API manufacturers, especially Chinese and Indian chemical suppliers, presents potential risks, prompting strategic shifts toward increased regionalization and diversification of suppliers.

2. Patent and Exclusivity Landscape

As a relatively recent FDA-approved drug, TIBSOVO’s patent protections extend its market exclusivity until at least the late 2030s. This incentivizes supply chain stability to maximize lifecycle management and prevent generic infringement.

3. Market Expansion and Supply Scaling

With indications expanding, including combination therapies and off-label uses, pharmaceutical manufacturers and suppliers are scaling API production and exploring novel synthesis pathways to meet rising demand without compromising quality or timelines.

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Conclusion

The supply chain supporting TIBSOVO involves a complex ecosystem of specialized API manufacturers, raw material suppliers, packaging firms, and distributors, primarily concentrated across Asia, North America, and Europe. Strategic management of these suppliers, with emphasis on quality, regulatory compliance, and resilience, is critical to ensuring uninterrupted availability for patients worldwide. As the market evolves, further diversification and technological advancements in chemical synthesis are likely to enhance supply stability and cost efficiencies.

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Key Takeaways

• TIBSOVO’s supply chain hinges on partnerships with highly specialized CMOs for API manufacturing, primarily sourced from Asia.
• Raw chemical precursors are supplied by global chemical giants with stringent quality standards.
• Packaging and distribution are managed by leading pharmaceutical logistics firms, ensuring product integrity during transit.
• Supply chain resilience is increasingly vital due to geopolitical and global health factors, prompting diversification strategies.
• Ongoing market expansion necessitates scaling and innovation in API synthesis and production processes.

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FAQs

1. Who are the primary API suppliers for TIBSOVO?
The API for TIBSOVO is produced by contract manufacturing organizations (CMOs) contracted by Agios Pharmaceuticals. Notable partners include WuXi AppTec, which specializes in pharmaceutical synthesis and GMP compliance.

2. Do regional suppliers influence TIBSOVO’s availability?
Yes. Given the reliance on Asian chemical suppliers for raw materials and Asian CMOs for API production, regional geopolitical stability and manufacturing capacity directly impact supply reliability.

3. Are there alternative suppliers for TIBSOVO’s raw materials?
While specific suppliers remain confidential, the API synthesis involves advanced intermediates obtainable from multiple chemical manufacturers, allowing potential diversification to mitigate supply risks.

4. How does global regulation impact TIBSOVO’s supply?
Regulatory approvals require adherence to GMP standards across manufacturing sites. Regular audits and certifications ensure supply continuity in compliance with FDA, EMA, and other agencies.

5. What future supply chain developments could affect TIBSOVO?
Advancements in chemical synthesis, increased regional manufacturing, and strategic supplier diversification are expected to enhance supply resilience and cost efficiency in the coming years.

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Sources

1. FDA Approval Announcement for TIBSOVO (2018).
2. Agios Pharmaceuticals Corporate Reports and Partner Disclosures.
3. Industry analyses on API manufacturing and supply chain dynamics.
4. Contracts and partnerships disclosed in public filings and industry publications.
5. Global pharmaceutical logistics and distribution reports.

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Note: Precise supplier identities are often confidential due to proprietary concerns. The analysis presented reflects publicly available information and industry trends.