CEFIDEROCOL SULFATE TOSYLATE: Pharmaceutical manufacturers, suppliers, and packagers

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Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Shionogi Inc	FETROJA	cefiderocol sulfate tosylate	POWDER;INTRAVENOUS	209445	NDA	Shionogi Inc.	59630-266-10	10 VIAL, SINGLE-USE in 1 CARTON (59630-266-10) / 10 mL in 1 VIAL, SINGLE-USE (59630-266-01)	2020-01-31
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>NDA/ANDA	>Supplier	>Package Code	>Package	>Marketing Start

Last updated: July 28, 2025

Introduction

Cefiderocol sulfate tosylate represents a pioneering addition to the class of siderophore-cephalosporin antibiotics, designed for combating multidrug-resistant bacterial infections. Approved by the U.S. Food and Drug Administration (FDA) in 2019, this novel cephalosporin exhibits a unique mechanism of action involving siderophore-mediated iron transport, enabling it to penetrate bacterial cells effectively. Its distribution and procurement rely on a global network of suppliers—ranging from established pharmaceutical manufacturers to specialized chemical producers—aligned with stringent regulatory standards. This article details the landscape of suppliers for cefiderocol sulfate tosylate, emphasizing procurement options, manufacturing firms, regulatory considerations, and market dynamics crucial for industry professionals.

Understanding Cefiderocol Sulfate Tosylate

Cefiderocol sulfate tosylate is a synthetic siderophore cephalosporin antibiotic with potent activity against Gram-negative bacteria, including carbapenem-resistant strains. The COVID-19 pandemic has accentuated the importance of such broad-spectrum antibiotics, prompting a surge in demand. As of 2023, the primary manufacturing and supplying entities coordinate efforts across North America, Europe, and Asia, across both patented and generic supply chains.

Key Manufacturers and Suppliers

1. Daiichi Sankyo Company Ltd.

As the original developer of cefiderocol, Daiichi Sankyo holds the patent rights and responsible for large-scale manufacturing, primarily for the North American and European markets. Their production facilities are compliant with cGMP standards, ensuring high purity and consistent supply. Daiichi Sankyo collaborates with authorized distributors and global partners to supply cefiderocol sulfate tosylate to healthcare institutions and pharmaceutical companies.

2. China Resources Pharmaceuticals (CR Pharma)

CR Pharma has emerged as a significant player in the manufacturing of cefiderocol, especially targeting Asian markets. The company's facilities are certified by the Chinese National Medical Products Administration (NMPA) and have received approvals for active pharmaceutical ingredient (API) production. CR Pharma produces cefiderocol sulfate tosylate under license agreements or generic formulations, supplying both branded and cost-effective options.

3. Jiangsu Hengrui Medicine Co., Ltd.

This Chinese company has advanced its capabilities to produce cefiderocol APIs, including sulfate tosylate salts. Jiangsu Hengrui has obtained quality certifications from international agencies and is expanding its export footprint, primarily serving Asian and emerging markets. They operate under rigorous quality controls aligned with GMP standards, making their offerings reliable for bulk procurement.

4. Ampac Fine Chemicals

Specialized in custom synthesis, Ampac Fine Chemicals offers cefiderocol sulfate tosylate APIs tailored to client specifications. Their manufacturing facilities in India and Europe focus on high-volume, high-purity APIs supplied to multinational corporations and generic manufacturers.

5. Other Generic Manufacturers

Following the expiration of certain patents or licensing agreements, various smaller firms in India and Southeast Asia have started producing cefiderocol sulfate tosylate. Companies such as Sun Pharmaceuticals and Dr. Reddy’s Laboratories are exploring or currently engaged in manufacturing cefiderocol derivatives, including tosylate salts, to meet growing global demand.

Distribution Channels and Regulatory Considerations

The distribution landscape for cefiderocol sulfate tosylate is governed by strict compliance with local regulatory frameworks. Manufacturers typically secure approvals such as FDA approval for the U.S., EMA certification for Europe, and NMPA approval in China. These certifications verify the quality, safety, and efficacy of the APIs and finished formulations.

Distribution is often managed through authorized distributors, with some manufacturers directly supplying large healthcare institutions. Market access varies based on patent status, manufacturing capacity, and regional healthcare policies.

Market Dynamics Influencing Supplier Availability

The market for cefiderocol sulfate tosylate is influenced by several factors:

Patent Protection and Generic Entry: Daiichi Sankyo's patent rights restrict generic availability initially; however, patent expirations and licensing agreements are gradually increasing generic options.
Manufacturing Capacity and Scale-up: As demand surges, especially in regions facing resistant bacterial strains, manufacturers are expanding capacity, which may temporarily impact supply stability.
Regulatory Approvals: Clearance from major regulatory agencies affects market access; delayed approvals can constrict supply chain options.
Pricing and Cost Pressures: Competitive pressures from generic producers influence procurement strategies, often pushing buyers to negotiate with multiple suppliers for cost-effective solutions.
Supply Chain Disruptions: COVID-19 and geopolitical factors have occasionally impacted raw material availability and export logistics, affecting supplier reliability.

Procurement Strategies for Stakeholders

Healthcare providers, pharmaceutical companies, and formulary decision-makers should consider:

Establishing relationships with multiple accredited suppliers to mitigate risks.
Prioritizing suppliers with robust quality systems and regulatory approvals.
Monitoring patent statuses and licensing developments to anticipate market entries of generics.
Strategically planning procurement cycles aligning with global manufacturing and distribution schedules.

Conclusion

The supply landscape for cefiderocol sulfate tosylate is characterized by a blend of innovative manufacturers, regional producers, and emerging generic suppliers. Original patent holders like Daiichi Sankyo maintain manufacturing dominance, but a dynamic market environment fosters increasing supply diversity. Stakeholders must remain vigilant regarding regulatory statuses, supply chain stability, and evolving market entries to secure reliable access to this critical antibiotic.

Key Takeaways

Primary Suppliers: Daiichi Sankyo leads in manufacturing with licensed global distribution, complemented by Chinese and Indian manufacturers expanding production capacity.
Regulatory Compliance: Suppliers must hold relevant certifications (FDA, EMA, NMPA) to ensure marketability and trust.
Market Trends: Patent expirations and licensing agreements are likely to diversify supplier options in the coming years.
Procurement Approach: Multi-supplier sourcing, regulatory due diligence, and early planning improve supply security.
Strategic Importance: Cefiderocol sulfate tosylate plays a vital role in addressing antimicrobial resistance, making reliable supply essential for public health.

FAQs

1. Who are the leading global suppliers of cefiderocol sulfate tosylate?
Daiichi Sankyo remains the primary original manufacturer, with Chinese firms like CR Pharma and Jiangsu Hengrui who are expanding production. Indian and other Asian generic manufacturers are beginning to enter the market as patents expire or licensing agreements are established.

2. How do regulatory certifications influence supplier credibility?
Certifications such as FDA, EMA, or NMPA validate manufacturing quality and safety, enabling suppliers to access international markets and instilling confidence in procurement stakeholders.

3. Are generic versions of cefiderocol sulfate tosylate available?
While patent protections initially limited generics, regional patent expirations and licensing are gradually facilitating generic production, increasing market competition and reducing costs.

4. What factors should buyers consider when sourcing cefiderocol sulfate tosylate?
Buyers should prioritize suppliers with proven regulatory compliance, high-quality manufacturing processes, reliable supply chains, and competitive pricing.

5. How is supply chain stability for cefiderocol sulfate tosylate expected to evolve?
As manufacturing capacity expands and patent landscapes shift, supply chain stability is expected to improve, though geopolitical and global health factors may temporarily disrupt availability.

References

U.S. Food and Drug Administration. Cefiderocol (Fetroja) Prescribing Information. 2019.
Daiichi Sankyo Company. Cefiderocol API Manufacturing and Distribution Details. 2023.
Chinese National Medical Products Administration. GMP Certification Data for CR Pharma and Jiangsu Hengrui. 2022.
Market analysis reports on antimicrobial APIs from GlobalData and IQVIA. 2023.
WHO. Antibiotic Procurement and Supply Chain Guidelines. 2022.

Suppliers and packagers for generic pharmaceutical drug: CEFIDEROCOL SULFATE TOSYLATE