Bulk Pharmaceutical API Sources for FERRIC DERISOMALTOSE

Bulk Pharmaceutical API Sources for FERRIC DERISOMALTOSE

Vendor	Vendor Homepage	Vendor Sku	API Url
Smolecule		S978497
BenchChem		B1515865
THE BioTek		bt-1804796
Molecule Market		2078132

Bulk Active Pharmaceutical Ingredient (API) Sources for: FERRIC DERISOMALTOSE

Last updated: July 30, 2025

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Introduction

Ferric derisomaltose (FD), also known as iron isomaltoside 1000, is a high-dose intravenous iron formulation widely used in the treatment of iron deficiency anemia, especially in cases where oral iron therapy is ineffective or contraindicated. As a synthetic iron carbohydrate complex, its production and supply chain depend heavily on reliable sources of high-quality bulk APIs. Ensuring a consistent, compliant, and cost-effective supply of ferric derisomaltose API is critical for pharmaceutical manufacturers, formulators, and healthcare providers.

This article examines the global landscape of wholesale API suppliers capable of producing ferric derisomaltose, emphasizing regulatory considerations, manufacturing capabilities, and market dynamics.

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Manufacturing Chemistry and Quality Considerations

Ferric derisomaltose’s synthesis involves complex carbohydrate chemistry, where ferric iron is chelated with derisomaltose, a modified isomaltooligosaccharide. This intricate process demands specialized manufacturing capacity, rigorous quality control, and adherence to Good Manufacturing Practices (GMP). The API must exhibit high purity, stability, and consistent bioavailability, conforming to pharmacopeial standards such as USP, EP, or JP, depending on the market.

The high molecular weight and carbohydrate complex structure of ferric derisomaltose necessitate advanced synthesis and purification technologies, often limiting production to large, specialized pharmaceutical ingredient manufacturers.

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Key Global API Suppliers for Ferric Derisomaltose

1. Established Pharmaceutical Ingredient Manufacturers

Fresenius Kabi
As a market leader in intravenous iron formulations, Fresenius Kabi manufactures and supplies high-grade ferric derisomaltose APIs for commercial use. Leveraging extensive GMP-certified facilities, they produce APIs that meet stringent quality standards suitable for global markets [1].

Patheon (Thermo Fisher Scientific)
Patheon has demonstrated capabilities in complex carbohydrate APIs, including secure manufacturing pathways for high-value intravenous iron APIs. Their global footprint ensures supply chain flexibility and regulatory compliance across various regions [2].

Kelun Pharmaceutical Group
A Chinese pharmaceutical giant with growing biochemical manufacturing expertise, Kelun specializes in iron complex APIs. Their manufacturing facilities are GMP-compliant, and they supply ferric derisomaltose APIs to regional and international clients [3].

Nippon Steel & Sumitomo Metal Corporation
Nippon Steel’s chemical division offers advanced iron chelate manufacturing, including high-purity APIs such as ferric derisomaltose. They emphasize quality assurance aligned with global standards, especially for the Japanese and Asian markets [4].

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2. Contract Development & Manufacturing Organizations (CDMOs)

Fujifilm Diosynth Biotechnologies
Known for biopharmaceutical and complex chemical manufacturing, Fujifilm has capabilities in carbohydrate-based APIs, including customized complex iron formulations. Their GMP facilities and process expertise make them a key CDMO option [5].

BASF
While primarily a chemical company, BASF’s custom synthesis divisions have expanded into complex carbohydrate and metal chelate manufacturing, offering APIs with high purity levels suitable for intravenous applications [6].

Wuxi AppTec
Operating a broad portfolio of pharmaceutical manufacturing solutions, Wuxi AppTec provides GMP-grade APIs and has experience with complex carbohydrate drug ingredients, possibly including iron chelates such as ferric derisomaltose [7].

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Regional and Emerging Manufacturers

Emerging manufacturers in China and India have begun investing in the production of complex APIs driven by domestic demand and export expansion. Notable names include:

• Shanxi Zhendong Chemical Co., Ltd.
  Specializes in carbohydrate-based APIs, with potential capacity for ferric derisomaltose synthesis [8].

• Aurobindo Pharma and Serum Institute
  Both firms are expanding their API portfolios into specialty and complex API segments, including iron complexes, aligning with global GMP standards [9].

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Regulatory and Quality Considerations

Securing a high-quality API source for ferric derisomaltose requires rigorous assessment of compliance with international regulatory standards:

• GMP Certification: Ensures manufacturing processes meet international quality benchmarks.
• DMF Availability: Drug Master Files facilitate regulatory submissions by documenting manufacturing and quality data.
• Quality Attributes: High purity (>99%), low residual solvents, and batch-to-batch consistency.
• Regulatory Approvals: Documentation confirming adherence to FDA, EMA, or other regional authorities.

Few suppliers currently have DMFs specific to ferric derisomaltose, which may influence sourcing decisions. Partners with established regulatory dossiers streamline approval processes for commercial distribution.

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Supply Chain and Market Dynamics

The API market for ferric derisomaltose is characterized by limited, concentrated sourcing due to the complexity of manufacture and quality requirements. Major suppliers such as Fresenius Kabi and Patheon dominate global supply, with regional players supplementing through partnerships or contract manufacturing.

Recent geopolitical shifts and trade restrictions influence sourcing, emphasizing the importance of diversifying suppliers while maintaining compliance standards. Manufacturers are also focused on scaling production and improving cost-efficiency to meet escalating global demand, especially in the context of rising anemia prevalence.

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Conclusion

Reliable sourcing of ferric derisomaltose API depends on access to specialized, high-quality manufacturers capable of producing complex carbohydrate-iron chelate APIs at GMP standards. Leading global suppliers include large pharmaceutical ingredient companies like Fresenius Kabi, Patheon, and Kelun Pharmaceutical, backed by a growing number of regional producers and CDMOs.

Strategic sourcing must prioritize regulatory compliance, consistent quality, and supply chain resilience. Given the complexity and high standards required for this API, collaborations with established manufacturers are advisable to ensure regulatory approval and market competitiveness.

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Key Takeaways

• Specialized Production: Ferric derisomaltose API synthesis demands advanced carbohydrate chemistry expertise, limiting the pool of qualified suppliers.
• Leading Suppliers: Prominent manufacturers include Fresenius Kabi, Patheon, and Kelun Pharmaceutical, all maintaining GMP-compliant facilities.
• Regulatory Readiness: Suppliers with established DMFs and proven compliance facilitate smoother approval processes in global markets.
• Regional Expansion: Emerging Asian manufacturers are entering the market, offering potential cost advantages but requiring rigorous qualification.
• Supply Chain Resilience: Diversification of suppliers mitigates risks associated with geopolitical and logistical disruptions in the complex API landscape.

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FAQs

1. What are the primary manufacturing challenges associated with ferric derisomaltose API?
The synthesis involves complex carbohydrate chelation chemistry requiring precise control over molecular parameters, high purity standards, and robust purification techniques, limiting production to specialized facilities.

2. How can I verify the quality of a ferric derisomaltose API supplier?
Ensure the supplier holds GMP certification, provides comprehensive documentation such as DMFs, and has a proven track record of consistent batch quality and regulatory compliance in relevant markets.

3. Are there regional differences in API sourcing for ferric derisomaltose?
Yes, Western suppliers like Fresenius Kabi dominate in Europe and North America, while Asian manufacturers, notably in China and India, are expanding capacity and market share, often at lower costs.

4. What regulatory considerations influence API sourcing decisions?
Prioritize suppliers with documented GMP compliance, accessible regulatory filings, and those capable of supporting regulatory inspections and audits aligned with US FDA or EMA requirements.

5. What are future trends in the API supply landscape for ferric derisomaltose?
Increased manufacturing capacity, regional diversification, and technological advancements in carbohydrate chemistry may improve supply resilience, alongside regulatory harmonization efforts to streamline approvals.

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References

[1] Fresenius Kabi official documentation and product dossiers.
[2] Thermo Fisher Scientific Patheon API portfolio disclosures.
[3] Kelun Pharmaceutical Group reports and GMP certifications.
[4] Nippon Steel & Sumitomo Metal Corporation technical datasheets.
[5] Fujifilm Diosynth Biotechnologies manufacturing capabilities.
[6] BASF custom synthesis and carbohydrate API offerings.
[7] Wuxi AppTec API manufacturing overview.
[8] Shanxi Zhendong Chemical Co., Ltd. supplier information.
[9] Aurobindo Pharma API segment expansion reports.