Bulk Pharmaceutical API Sources for FEDRATINIB HYDROCHLORIDE

Bulk Pharmaceutical API Sources for FEDRATINIB HYDROCHLORIDE

Vendor	Vendor Homepage	Vendor Sku	API Url
Debye Scientific Co., Ltd		DA-45538
Chemieliva Pharmaceutical Co., Ltd		PBCM0246877
Acadechem		ACDS-0781664
BioChemPartner		BCP24783
MedChemexpress MCE		HY-10409A
AbaChemScene		CS-0028556
THE BioTek		bt-268261

Bulk Active Pharmaceutical Ingredient (API) Sources for: FEDRATINIB HYDROCHLORIDE

Last updated: July 30, 2025

Introduction

Fedratinib hydrochloride, marketed under the brand name INREBIC among others, is an oral kinase inhibitor primarily employed in the treatment of myelofibrosis. As a targeted therapy for certain hematologic malignancies, it is a high-value pharmaceutical ingredient that necessitates a reliable and compliant supply chain. The procurement of high-quality bulk APIs, such as fedratinib hydrochloride, is critical for pharmaceutical developers, contract manufacturing organizations (CMOs), and healthcare providers. This report delineates the key sources for bulk fedratinib hydrochloride, analyzing market dynamics, manufacturing landscape, and supply chain considerations relevant to industry stakeholders.

Market Overview of Fedratinib Hydrochloride

Fedratinib hydrochloride was developed by Jinshan and subsequently acquired by Sanofi for commercialization. Approved by the U.S. Food and Drug Administration (FDA) in 2019 for myelofibrosis, it commands premium pricing due to its targeted mechanism of action. The API's manufacturing complexity limits the number of suppliers capable of ensuring regulatory compliance and consistent quality standards. Given the relative novelty and specialized synthesis pathway, the supply landscape remains somewhat concentrated.

Leading Suppliers and Manufacturing Sources

1. Original Equipment Manufacturers (OEMs)

The primary sources of fedratinib hydrochloride are large-scale chemical and pharmaceutical manufacturers with proven expertise in complex kinase inhibitors. Many of these entities are long-standing contract manufacturing organizations (CMOs) or proprietary API producers within the pharmaceutical supply chain.

• Sanofi’s API Manufacturing Network:
  Sanofi, the patent owner, has strict oversight over API production, often utilizing a network of approved CMOs across Asia and Europe. Their validated manufacturing facilities, typically accredited by regulatory agencies such as the FDA and EMA, serve as primary sources. However, Sanofi’s confidentiality limits transparency into specific manufacturing sites.

• Contract Manufacturing Organizations:
  A select number of CMOs globally possess the capability to produce fedratinib hydrochloride at commercial scale. These include:

  • WuXi AppTec:
    With a robust portfolio of kinase inhibitors, WuXi offers custom synthesis and scaled manufacturing of fedratinib hydrochloride, adhering to cGMP standards, primarily servicing North American and European clients.

  • Fujifilm Diosynth Biotechnologies:
    Their chemical manufacturing division manages complex APIs for oncology drugs, including fedratinib, utilizing advanced synthetic routes conforming to global regulatory standards.

  • Samsung Biologics (or comparable Asian CMOs):
    Known for scalable chemical synthesis, these firms provide supply chain security backed by established regulatory footings in Asia.

2. API Ingredient Suppliers and Distributors

Beyond direct manufacturers, the API landscape comprises specialized chemical suppliers and distributors who procure, stock, and distribute bulk fedratinib hydrochloride globally. Notable among these are:

• Hikal Ltd.:
  An Indian CDMO and chemical supplier that offers small to large-scale synthesis of kinase inhibitors, including fedratinib. They maintain rigorous quality systems aligned with international cGMP standards.

• Jubilant Life Sciences:
  Based in India, Jubilant supplies bulk APIs for anticancer agents, including complex kinase inhibitors, leveraging extensive chemical synthesis expertise.

• M/s. ChemPartner:
  A Chinese company offering custom synthesis and supply chain services for niche APIs, including fedratinib, focusing on Asia-Pacific markets.

3. Regional Supply Dynamics

• Asia-Pacific Region:
  The dominant source for APIs like fedratinib hydrochloride, primarily due to lower manufacturing costs, established chemical synthesis infrastructure, and a large base of contract manufacturers in India, China, and South Korea. The trade-off involves navigating regulatory, patent, and compliance considerations.

• Europe and North America:
  These regions favor APIs produced under strict cGMP standards, often from integrated manufacturers aligned with Western regulatory agencies. Partnering with suppliers compliant with FDA and EMA guidelines ensures regulatory continuity and reduces risks.

Compliance and Regulatory Factors

Manufacturers of fedratinib hydrochloride must adhere to stringent cGMP standards, with facilities undergoing regular audits by health authorities such as the FDA, EMA, and PMDA (Japan). Ensuring supplier compliance is critical due to the potency and targeted nature of the API. Suppliers are typically required to provide batch records, stability data, and facility certifications to qualify for pharmaceutical applications.

Supply Chain Considerations

• Intellectual Property (IP):
  Due to patent protections held by Sanofi and the proprietary synthesis routes, licensing agreements or direct procurement from Sanofi-approved suppliers are typical pathways.

• Lead Time & Capacity:
  The complex synthesis process involves multi-step organic reactions, demanding significant production lead times, often extending to several months. Capacity constraints at key manufacturing sites can impact supply stability, especially under surge conditions.

• Quality Assurance:
  Due to the high potency of fedratinib hydrochloride, APIs must meet strict specifications for purity (>99%), residual solvent limits, and impurity profiles, necessitating suppliers with validated analytical and quality control systems.

Emerging Sources and Strategic Considerations

As demand for fedratinib hydrochloride grows, especially with expanding approval and off-label use, strategic sourcing becomes increasingly pivotal. Pharmaceutical firms are exploring:

• Vertical integration with API manufacturing to mitigate supply disruptions.

• Dual sourcing strategies involving multiple qualified suppliers across regions to diversify risk.

• Partnerships with emerging manufacturers in Southeast Asia and Eastern Europe seeking regulatory approvals and certifications for API production.

Conclusion

The bulk supply chain for fedratinib hydrochloride remains concentrated, primarily driven by high synthesis complexity and regulatory requirements. Leading API manufacturers and contract suppliers in Asia-Pacific, North America, and Europe offer validated, compliant supply options. Strategic sourcing involves evaluating capacity, quality endorsement, regulatory acceptability, and political-economic stability to ensure consistent supply. As the market matures, diversification and vertical integration are anticipated to further stabilize supply chains for this high-value API.

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Key Takeaways

• Limited, specialized supply sources: Due to synthesis complexity and regulatory rigor, only select global manufacturers provide fedratinib hydrochloride at commercial scale.

• Asia as dominant supplier region: India and China dominate API manufacturing for fedratinib, leveraging cost efficiencies and established chemical synthesis infrastructure.

• Regulatory compliance is critical: Only suppliers with validated cGMP facilities and regulatory approvals meet the stringent standards required for pharmaceutical APIs.

• Supply chain resilience strategies: Diversifying suppliers, engaging with approved CMOs, and considering vertical integration reassure supply continuity amid growing demand.

• Emerging manufacturers: Tier-two and Tier-three suppliers in emerging markets are gradually cultivating capabilities to meet future demand, potentially lowering costs and expanding supply options.

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FAQs

1. What are the primary challenges in sourcing fedratinib hydrochloride API?
   The main challenges include complex multi-step synthesis procedures, maintaining high purity and impurity profiles, regulatory compliance, potential capacity constraints, and navigating IP restrictions.

2. Which regions dominate the supply of fedratinib hydrochloride?
   Asia-Pacific, particularly India and China, are the dominant regions due to cost advantages and manufacturing infrastructure, whereas North America and Europe rely on approved manufacturers complying with strict quality standards.

3. Are there any approved alternative suppliers for fedratinib hydrochloride?
   Currently, supply is concentrated largely among a few high-quality, validated manufacturers. No widespread alternative suppliers with approved supply chains currently exist outside these core providers.

4. How does regulatory compliance influence API sourcing?
   Suppliers must provide cGMP certification, batch records, analytical validation data, and regulatory dossier support to ensure that APIs meet international standards, minimizing risks for pharma developers.

5. What strategies can pharmaceutical companies adopt to mitigate supply chain risks for fedratinib hydrochloride?
   Companies should diversify suppliers, establish long-term partnerships with approved manufacturers, consider vertical integration, and maintain strategic stockpiles aligned with regulatory guidelines.

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References

[1] Sanofi Official Website. “INREBIC (Fedratinib) API Details.”
[2] FDA Approval Document for Fedratinib (2019).
[3] GlobalData Pharmaceutical Supply Chain Analysis, 2022.
[4] Contract Pharma. “Top API Manufacturers and Their Capabilities,” 2021.
[5] WHO Guidelines for Good Manufacturing Practices for Active Pharmaceutical Ingredients.