Bulk Pharmaceutical API Sources for INREBIC

Bulk Pharmaceutical API Sources for INREBIC

Vendor	Vendor Homepage	Vendor Sku	API Url
ZINC		ZINC19862646
ABBLIS Chemicals		AB1008513
ChemMol		44022659
Amadis Chemical		A25534

Bulk Active Pharmaceutical Ingredient (API) Sources for Inrebic (Fedratinib)

Last updated: July 29, 2025

Introduction

Inrebic (fedratinib) is a targeted medical treatment approved by the U.S. Food and Drug Administration (FDA) for the management of myelofibrosis, a rare bone marrow disorder characterized by abnormal blood cell production and fibrosis of the marrow. As a first-in-class Janus kinase 2 (JAK2) inhibitor, Inrebic has gained significant clinical relevance for its efficacy in symptom management and disease progression control. Central to its production is the procurement of high-quality Active Pharmaceutical Ingredient (API) — fedratinib. Ensuring reliable, high-purity bulk API sourcing is vital for manufacturing consistency, regulatory compliance, and supply chain resilience.

This article explores the current landscape of bulk fedratinib API suppliers, analyzing their manufacturing capabilities, quality standards, and strategic positioning within the global pharmaceutical supply chain.

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Market Landscape Overview

Fedratinib’s API manufacturing is a specialized niche, given the molecule's complex synthesis and stringent purity requirements. As of 2023, few pharmaceutical-grade API manufacturers have the capacity to produce fedratinib at scale, primarily due to the molecule's complex chemical structure and regulatory hurdles.

Key Players in API Sourcing for Fedratinib

The leading authorities in fedratinib API supply are primarily large-scale contract manufacturing organizations (CMOs) and biotech firms with capabilities in complex synthesis, fine chemical production, and stringent quality management systems. They typically serve as primary suppliers for pharmaceutical companies developing or commercializing Inrebic.

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Major API Suppliers for Inrebic (Fedratinib)

1. Shenghua Biotechnology (Shanghai, China)

Overview: Shenghua Biotechnology has established a reputation for producing high-purity active pharmaceutical ingredients, especially for kinase inhibitors. Their facility adheres to Good Manufacturing Practice (GMP) standards, and they possess advanced synthesis and purification processes suitable for complex molecules like fedratinib.

Capabilities:

• GMP-certified production lines for small molecule APIs.
• Extensive experience in kinase inhibitor APIs, aligning with fedratinib’s molecular profile.
• Ability to deliver large-volume batches with high consistency.

Regulatory & Quality Assurance: Shenghua maintains rigorous quality controls, including analytical testing aligned with international standards. Their API batches often undergo comprehensive impurity profiling and stability testing as per ICH guidelines.

Supply Chain Considerations: Shenghua is known for competitive pricing and reliable delivery timelines, given their established manufacturing base in China.

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2. WuXi STA (Suzhou, China)

Overview: WuXi STA operates as a global contract development and manufacturing organization, emphasizing complex chemical synthesis and API production for innovative medicines, including kinase inhibitors.

Capabilities:

• Custom API synthesis for early-phase clinical development and commercial supply.
• Advanced purification techniques, such as chromatography, for high purity API production.
• Extensive experience in small molecule APIs that demand tight control over residual impurities.

Regulatory & Quality Assurance: As part of WuXi AppTec, WuXi STA adheres to cGMP standards, and their APIs are routinely evaluated against international pharmacopoeial specifications.

Supply Chain Considerations: WuXi benefits from a global footprint, enabling flexible scaling and reliable global shipping logistics, including export from China to North America and Europe.

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3. Jubilant Ingrevia (Gurgaon, India)

Overview: Jubilant Ingrevia is an integrated pharmaceutical and specialty chemicals manufacturer with capability for complex API synthesis within India’s regulatory environment.

Capabilities:

• Production of high-value APIs, including kinase inhibitors.
• Access to a robust chemical supply chain and in-house R&D.
• Ability to produce sustained batches for clinical and commercial supply.

Regulatory & Quality Assurance: Compliant with Indian GMP (Schedule M) and global standards, with certifications allowing exports to the US, Europe, and other regions.

Supply Chain Considerations: Jubilant’s strategic location and established export channels make it a competitive choice for bulk API sourcing.

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4. Specialized API Manufacturers in Europe

Although fewer firms operate at scale for fedratinib in Europe, certain specialized CMOs with European GMP certification can produce fedratinib API upon demand.

Potential Candidates:

• Recipharm (Sweden) — Known for complex API synthesis.
• CordenPharma (Germany) — Focused on high-potency APIs with regulatory expertise.

Capabilities & Considerations: These companies often offer tailored synthesis, stringent quality controls, and transfer of technology agreements, catering to biopharmaceutical companies seeking regional supply options.

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Emerging and Future API Supply Trends

Biotech Contract Manufacturers & Localized API Production

Increasing demand for supply chain resilience has led to strategic interest in diversifying API sources, particularly within North America and Europe. Emerging manufacturers are investing in fedratinib synthesis capabilities, driven by the molecule’s clinical importance, regulatory support, and potential for expanded indications.

Synthesis Innovation & Process Optimization

Recent advancements focus on optimizing fedratinib synthesis to reduce costs and the environmental impact. Innovative process development is likely to lead to new API suppliers capable of scalable production, especially in high-growth regions.

Regulatory Considerations

API suppliers must comply with increasingly stringent regulatory standards, including ICH Q7 guidelines and FDA cGMP requirements. Suppliers with extensive regulatory track records are preferred, reducing validation hurdles and supply risks.

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Quality and Regulatory Compliance

Suppliers’ ability to produce API batches that meet pharmacopoeial standards (USP, Ph. Eur.) and pharmaceutical company specifications is essential. Analytical profiling, impurity testing, and stability data underpin the acceptance of bulk API batches. Only CMO partners with strong regulatory histories, comprehensive documentation, and proven quality management systems will be suitable for FDA-approved drug product manufacturing.

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Supply Chain Resilience & Strategic Sourcing

Given the global challenges such as geopolitical tensions and pandemic disruptions, diversification of API sources is increasingly critical. Establishing multiple qualified suppliers across different regions reduces dependency risks and ensures uninterrupted supply of fedratinib API.

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Key Takeaways

• Limited but Focused API Manufacturing Base: Few companies worldwide possess the capacity to produce high-quality fedratinib API at scale. Shenghua, WuXi STA, and Jubilant Ingrevia stand out as leading suppliers.
• Regulatory & Quality Standards Are Paramount: Suppliers with proven GMP compliance, robust analytical controls, and regulatory track records are preferred for reliable, compliant API sourcing.
• Strategic Diversification Is Critical: Relying on multiple API sources across different geographies mitigates supply disruptions and aligns with global supply chain resilience strategies.
• Technological Advances Enhance Supply Stability: Innovations in synthesis processes and purification methods can optimize cost-efficiency and environmental footprint, favoring upcoming API manufacturers.
• Global Trade Dynamics Influence API Availability: Trade policies, tariffs, and geopolitical factors impact sourcing options, emphasizing the importance of regional API development in Europe, North America, and Asia.

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FAQs

1. What are the main criteria for selecting a supplier of fedratinib API?
Suppliers must demonstrate compliance with cGMP standards, deliver high-purity API batches, have proven analytical and impurity testing capabilities, and maintain reliable logistics and supply chain stability.

2. How does the complexity of fedratinib synthesis affect API sourcing?
The complex chemical structure requiring advanced synthesis and purification techniques limits the number of capable manufacturers, making it critical to partner with experienced and certified production facilities.

3. Are there emerging API manufacturers for fedratinib outside of China and India?
Yes, some European contract manufacturers are investing in complex API synthesis, and new entrants in North America are exploring supply options, driven by supply chain resilience initiatives.

4. What regulatory considerations should be factored into API sourcing decisions?
Manufacturers should possess a robust history of compliance with ICH guidelines, have successful regulatory audits, and provide comprehensive documentation for batch release and stability data.

5. How does geopolitical risk influence API sourcing for pharmaceutical companies?
Political tensions, tariffs, export restrictions, and trade policies can disrupt supply chains, making regional diversification and local API production strategies increasingly important.

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References

[1] U.S. Food and Drug Administration. Inrebic (fedratinib) prescribing information.
[2] European Medicines Agency. Summary of Product Characteristics for Inrebic.
[3] Contract Pharma. "The Future of API Manufacturing: Trends and Valuations," 2022.
[4] ICH Q7 Guidelines. Good Manufacturing Practice Guide for Active Pharmaceutical Ingredients.
[5] PharmaConnect. "API Supply Chain Strategies in Oncology," 2023.