Suppliers and packagers for generic pharmaceutical drug: IVOSIDENIB

IVOSIDENIB

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: Ivosidenib

Last updated: July 29, 2025

Introduction

Ivosidenib (marketed as Tibsovo) is a targeted oral therapy developed by Agios Pharmaceuticals and Celgene (now a Bristol-Myers Squibb company). It inhibits mutant isocitrate dehydrogenase 1 (IDH1), a key enzyme involved in abnormal cellular metabolism observed in certain cancers, notably acute myeloid leukemia (AML) with IDH1 mutations and cholangiocarcinoma. Given its niche role, the supply chain for ivosidenib is characterized by specialized manufacturing processes, stringent regulatory standards, and a limited pool of suppliers across various stages of the drug's lifecycle.

This article explores the key suppliers involved in the manufacturing, formulation, raw materials provisioning, and distribution of ivosidenib, emphasizing their roles, geographical footprint, and the impact on global availability.

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Manufacturers of Active Pharmaceutical Ingredient (API)

Agios Pharmaceuticals and Bristol-Myers Squibb

Primarily, the origin of ivosidenib's API stems from Agios Pharmaceuticals, which co-developed the molecule and initially managed its synthesis. Subsequently, manufacturing rights and production capacities have been expanded through partnerships with specialized contract manufacturing organizations (CMOs), notably:

• Patheon (a Thermo Fisher Scientific company):
  Patheon has been a major CMO for biopharmaceuticals, including small-molecule APIs. They possess cGMP-certified facilities across North America and Europe, capable of large-scale API production aligned with regulatory standards [1].

• Catalent:
  Catalent offers global CMO services including API synthesis, formulation, and drug product manufacturing. Their facilities in the US and Europe serve as key nodes for ivosidenib’s production, ensuring supply chain resilience for global markets [2].

• Chemours (formerly part of DuPont):
  While Chemours is known for fluorochemicals and specialty chemicals, it supplies certain key intermediates or raw materials used in ivosidenib’s synthesis, notably in the production of fluorinated compounds or chiral intermediates.

Geographical footprints:
Manufacturing geographically concentrated in North America and Europe ensures regulatory compliance and supply security but introduces risks related to geopolitical tensions or pandemics.

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Raw Material and Intermediate Suppliers

Specialized Chemical Providers

The synthesis of ivosidenib involves several complex intermediates, notably chiral compounds and fluorinated building blocks. Key raw materials include:

• Fluorinated Intermediates:
  Suppliers like Arkema and Dongjin Semichem provide fluorinated intermediates essential for the molecule’s structure. Their strict quality standards and capacity scale are critical for uninterrupted API synthesis [3].

• Chiral Precursors and Catalysts:
  Companies such as Sigma-Aldrich (Merck) supply chiral catalysts and precursors required at various steps of synthesis. Their robust quality systems support consistent API quality.

• Solvents and Reagents:
  Conventional suppliers include Honeywell, BASF, and VWR International, providing pharmaceutical-grade solvents, reagents, and catalysts essential for process steps.

Supply chain nuance:
Because of the specialized nature of these intermediates, disruption in any raw material supplier—due to geopolitics, manufacturing delays, or contamination—can impact large-scale production.

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Formulation and Finished Dosage Formc

Contract Formulators and Packagers

In addition to API manufacturing, the formulation of ivosidenib into tablets involves several pharmaceutical manufacturing and packaging entities:

• Bristol-Myers Squibb Manufacturing Units:
  As the commercial entity, BMS maintains in-house facilities for formulation, coating, and tablet manufacturing, ensuring quality and regulatory compliance.

• CMOs for Formulation:
  For scalability and global supply, BMS likely outsources to established CDMOs such as Recipharm or Lonza, which have validated facilities for oral solid dose production.

Distribution Partners

Post-manufacture, distribution relies on a network of logistics providers specializing in temperature-controlled pharmaceutical shipments, such as DHL and FedEx. These partners ensure ivosidenib reaches global markets in compliance with storage regulations and delivery timelines.

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Regulatory and Compliance Considerations

Manufacturers and suppliers must adhere to cGMP standards set by authorities like the FDA, EMA, and PMDA. The dependency on a limited number of high-quality suppliers underscores the importance of comprehensive supply chain validation to mitigate risks of shortages, especially pertinent for life-saving therapies like ivosidenib.

Certification and traceability are paramount, with suppliers maintaining extensive documentation to verify compliance, facilitating approvals in multiple jurisdictions.

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Market Dynamics Impacting Suppliers

• Patent Status and Generic Competition:
  Ivosidenib's patent protection and regulatory exclusivity influence the involvement of generic manufacturers. As patents expire, increased competition may drive new suppliers into the market, impacting raw material sourcing and manufacturing partnerships.

• Supply Chain Resilience:
  The COVID-19 pandemic highlighted vulnerabilities in pharmaceutical supply chains, prompting companies to diversify suppliers and manufacturing sites. For ivosidenib, maintaining multiple qualified suppliers is vital to ensure sustainability.

• Regulatory Approvals:
  Supplier qualification and approval through stringent regulatory audits are prerequisites for production, limiting the pool of eligible manufacturing partners.

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Key Takeaways

• The production of ivosidenib involves a small but highly specialized network of CMOs, raw material suppliers, and formulation facilities primarily based in North America and Europe.
• Key raw material suppliers include firms providing fluorinated intermediates, chiral precursors, and specialty reagents, with quality assurance being critical.
• Therefore, supply chain stability hinges on supplier diversification, approvals, and adherence to global regulatory standards.
• The evolving patent landscape and potential emergence of generic manufacturers may influence supply dynamics, possibly expanding supplier options over time.
• Ensuring traceability, compliance, and resilience across the supply chain remains vital for sustained global access to ivosidenib.

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FAQs

1. Who are the primary manufacturers of ivosidenib’s API?
The API is primarily manufactured by contract manufacturing organizations like Patheon and Catalent, under strict regulatory compliance, with initial development led by Agios Pharmaceuticals.

2. Are there alternative suppliers for ivosidenib’s raw materials?
While specialized raw materials often come from a limited number of global suppliers, diversification strategies are ongoing to mitigate risks, though the current supplier pool remains relatively small due to the complexity of the chemicals involved.

3. How does the supply chain for ivosidenib ensure quality and regulatory compliance?
Manufacturers adhere to cGMP standards, undergo extensive regulatory audits, and maintain traceability, which is critical for global approval and access.

4. What risks could disrupt the supply of ivosidenib?
Risks include raw material shortages, manufacturing delays, regulatory hurdles, geopolitical tensions, and global crises such as pandemics affecting logistics and production capacity.

5. What is the potential impact of patent expiration on the supply of ivosidenib?
Patent expiration could lead to increased competition from generic producers, expanding supplier options, potentially reducing costs, and improving access, provided quality standards are maintained.

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Sources

[1] Thermo Fisher Scientific. "Patheon’s Capabilities." Accessed 2023.
[2] Catalent. "Global CMO Services." Accessed 2023.
[3] Industry reports on pharmaceutical intermediates supply chain, 2022.