Suppliers and packagers for generic pharmaceutical drug: fedratinib hydrochloride

fedratinib hydrochloride

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

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Bristol-myers	INREBIC	fedratinib hydrochloride	CAPSULE;ORAL	212327	NDA	Celgene Corporation	59572-720-12	120 CAPSULE in 1 BOTTLE, PLASTIC (59572-720-12)	2019-08-16

Suppliers for the Pharmaceutical Drug: Fedratinib Hydrochloride

Last updated: July 29, 2025

Introduction

Fedratinib hydrochloride is an oral Janus kinase 2 (JAK2) inhibitor developed primarily for treating myelofibrosis, a rare bone marrow disease characterized by marrow scarring, abnormal blood cell production, and enlarged spleen. Since its regulatory approval by agencies such as the U.S. Food and Drug Administration (FDA) in 2019, supply chain considerations have become critical for pharmaceutical companies and healthcare providers aiming to ensure consistent access to this targeted therapy. This article provides a comprehensive overview of the key suppliers involved in the manufacturing, formulation, and distribution of fedratinib hydrochloride.

Manufacturers of Fedratinib Hydrochloride

Development and Commercial Production

The origin of fedratinib hydrochloride is closely associated with the pharmaceutical company Celgene Corporation (now part of Bristol-Myers Squibb after its acquisition in 2019). Celgene was the original developer of the drug, having conducted pivotal clinical trials leading to FDA approval [1]. Post-approval, the manufacturing rights for fedratinib transitioned to Bristol-Myers Squibb (BMS), which is now responsible for its commercial production.

Active Pharmaceutical Ingredient (API) Suppliers

The supply chain for fedratinib hydrochloride hinges primarily on API manufacturers capable of producing high-purity, pharmaceutical-grade intermediates under stringent regulatory compliance.

• Bristol-Myers Squibb (BMS): As the current patent holder and marketer in the United States and many other territories, BMS is involved directly or through strategic partnerships in sourcing and manufacturing APIs. While BMS tends to work with select vetted suppliers, the specifics of their API manufacturing partners are proprietary.

• Contract Manufacturing Organizations (CMOs): Several CMOs globally are known to manufacture fedratinib APIs under cGMP conditions:

  • Suzhou Asymchem Co., Ltd. (China): A leading CMO specializing in complex APIs for oncology and hematology drugs. They have capacities for synthesis, purification, and quality control suitable for APIs like fedratinib [2].

  • Pharmaceuticals companies in India: Multiple Indian pharmaceutical manufacturers, such as Biological E. Limited and Aurobindo Pharma, possess capabilities to produce complex APIs. However, specific production data for fedratinib hydrochloride remains undisclosed.

  • Therapeutics Manufacturing Partners (TMP): Based in the United States, TMP offers API manufacturing services for specialty molecules like fedratinib, focusing on high-quality, regulatory-compliant APIs.

Availability and procurement depend on negotiations and capacity constraints with these suppliers, often guided by confidentiality agreements.

Formulation and Finished Dose Manufacturers

Following API production, the downstream manufacturing involves formulating therapeutic doses, encapsulation, packaging, and distribution.

• Major Formulation Companies:

  • Bristol-Myers Squibb’s manufacturing subsidiaries: BMS operates dedicated facilities for finished dose manufacturing of fedratinib, ensuring quality control and regulatory compliance (cGMP standards).

  • Third-party contract manufacturers: Other large-scale CMOs such as Famar (Greece), Catalent (USA), and WuXi AppTec (China) could be involved in formulation and packaging, leveraging their global manufacturing infrastructures for scalable distribution.

Supply Chain Challenges and Considerations

Despite the limited number of specialized suppliers, factors such as geopolitical issues, regulatory discrepancies, and capacity limitations influence the supply chain of fedratinib hydrochloride. Notably, securing consistent API supplies involves navigating complex international regulations, quality assurance protocols, and intellectual property rights.

Additionally, the COVID-19 pandemic highlighted vulnerabilities in supply chains for complex APIs, prompting companies to diversify supplier bases and build strategic stockpiles.

Regulatory Implications

Supplying fedratinib hydrochloride requires adherence to international standards, notably:

• FDA’s Current Good Manufacturing Practices (cGMP): To ensure API and finished product quality.
• EMA regulations: For European markets.
• PMDA and other regional standards: For Asian and emerging markets.

Suppliers must demonstrate compliance through rigorous certifications, audits, and validation processes.

Emerging Trends and Future Directions

As demand for targeted therapies like fedratinib increases, pharmaceutical companies are exploring:

• Vertical integration: Owning or controlling more stages of the supply chain to ensure stability.
• Strategic partnerships: Collaborations aimed at expanding capacity, especially in regions with emerging manufacturing capabilities.
• Sustainable sourcing: Ethical and environmental considerations impacting supplier selection.

Furthermore, efforts are underway to develop alternative synthetic routes for fedratinib hydrochloride to enhance supply resilience and cost-efficiency.

Key Suppliers Summary

Role	Leading Entities	Locations	Notes
API Manufacturing	Bristol-Myers Squibb, Suzhou Asymchem, Indian CMOs	US, China, India	Focus on cGMP compliance, capacity expansion
Formulation & Dosage	Bristol-Myers Squibb, Catalent, WuXi AppTec	US, China, Europe	Emphasis on quality, global distribution

Conclusion

Fedratinib hydrochloride’s supply chain is characterized by a limited set of specialized API and formulation manufacturers operating globally. Major pharmaceutical corporations like Bristol-Myers Squibb orchestrate the supply, leveraging partnerships with CMOs across continents. Ongoing challenges include capacity constraints, regulatory compliance, and geopolitical risks, prompting industry-wide initiatives to diversify supplier networks and bolster supply stability.

Key Takeaways

• Dominant Supplier: Bristol-Myers Squibb is the primary entity overseeing the production and distribution of fedratinib hydrochloride.
• Global API Manufacturing: China’s Suzhou Asymchem and Indian CMOs are critical API suppliers, contributing to diversified sourcing.
• Formulation Capacity: Major contract manufacturers in Europe, the US, and China play vital roles in final drug production.
• Supply Chain Risks: Capacity limitations, geopolitical tensions, and regulatory hurdles may impact supply continuity.
• Future Outlook: Industry trends favor vertical integration, diversified sourcing, and synthetic innovation to mitigate supply disruptions.

FAQs

1. Who are the primary API suppliers for fedratinib hydrochloride?
   Bristol-Myers Squibb and selected contract manufacturing organizations like Suzhou Asymchem are key API suppliers, operating under strict cGMP standards.

2. Are there alternative sources of fedratinib hydrochloride API?
   Currently, only a handful of specialized manufacturers meet the rigorous quality and regulatory requirements for this complex API. Supply diversification is ongoing but limited.

3. Can I procure fedratinib hydrochloride directly from API manufacturers?
   Generally, API procurement requires licensing agreements, regulatory approvals, and volume commitments. It’s typically restricted to licensed pharmaceutical entities.

4. What are the main challenges facing fedratinib hydrochloride supply chains?
   Capacity constraints, geopolitical factors, compliance with international standards, and manufacturing complexity pose significant challenges.

5. How is the supply chain expected to evolve?
   Industry trends point toward expanded manufacturing capacity, regional diversification, synthetic route innovations, and more strategic partnerships to enhance resilience.

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Sources
[1] U.S. Food and Drug Administration. (2019). FDA Approves Fedratinib for Myelofibrosis.
[2] Suzhou Asymchem Co., Ltd. Official Website. (2022). Capabilities in complex API manufacturing.