Bulk Pharmaceutical API Sources for HYFTOR

Bulk Pharmaceutical API Sources for HYFTOR

Vendor	Vendor Homepage	Vendor Sku	API Url
Sigma-Aldrich		R0395_SIGMA
MolPort		MolPort-003-959-433
Hangzhou APIChem Technology		AC-722
Alsachim		811

Bulk Active Pharmaceutical Ingredient (API) Sources for HYFTOR

Last updated: July 30, 2025

Introduction

HYFTOR (ferric maltol) is a pharmaceutical agent approved primarily for the treatment of iron deficiency anemia in adult patients with inflammatory bowel disease (IBD). As a novel oral iron supplement, HYFTOR’s efficacy hinges critically on the quality, purity, and consistent supply of its active pharmaceutical ingredient (API) — ferric maltol. Securing reliable API sources is essential for manufacturers, distributors, and stakeholders to maintain regulatory compliance, ensure product efficacy, and meet global demand.

This report explores the landscape of bulk API sourcing for HYFTOR, emphasizing key suppliers, manufacturing considerations, and strategic procurement pathways. Emphasis is placed on understanding the global API market, quality standards, and regulatory frameworks that influence sourcing decisions.

Understanding Ferric Maltol as the API

Ferric maltol is a specialized iron complex consisting of ferric iron coordinated with the maltol ligand. Its unique formulation enhances bioavailability and reduces gastrointestinal side effects compared to traditional iron salts. The chemical nature of ferric maltol necessitates rigorous synthesis, purification, and quality control, making its API sourcing highly specialized.

The synthesis involves complex coordination chemistry, usually requiring advanced manufacturing facilities compliant with Good Manufacturing Practices (GMP). The API must meet strict standards for purity, particle size, solubility, and stability, aligning with pharmacopeial specifications (e.g., USP, EP, JP).

Key API Manufacturers and Suppliers for Ferric Maltol

1. Established Contract Manufacturing Organizations (CMOs) and API Producers

The synthesis of ferric maltol is limited to a handful of specialized API producers with expertise in iron coordination complexes. Major global CMO and API manufacturers with capabilities in this domain include:

• BASF SE: Known for complex pharmaceutical intermediates and APIs, BASF possesses the expertise and infrastructure to produce ferric complexes at scale, adhering to GMP standards. Their vertical integration enables control over raw materials and synthesis pathways, ensuring high quality.

• Carbogen Amcis AG: A Swiss-based, GMP-compliant CMO specializing in small molecule APIs and complex APIs such as iron complexes. They provide custom synthesis and high-quality APIs for niche pharmaceutical applications.

• Recipharm AB: A global contract development and manufacturing organization with capabilities to produce solid and liquid APIs, including complex metallic APIs, tailored to pharmaceutical specifications.

2. Specialized Iron Complex API Manufacturers

Certain manufacturers focus explicitly on iron-based APIs and complexes:

• Singapore-based Vitex Pharma: Known for iron formulations and APIs, they have the capacity to produce iron complexes suitable for pharmaceutical use, including ferric maltol.

• Indovax Chemicals: While primarily focused on antigens and vaccines, their synthetic expertise extends into complex small molecules, including iron complexes, with GMP accreditation.

3. Emerging and Regional API Suppliers

Emerging players in Asia and Eastern Europe are increasingly entering the iron API space:

• Shilpa Medicare (India): Specializes in iron-based APIs and formulations, offering competitive pricing and scalable production capabilities, with compliance to Indian and global GMP standards.

• Hetero Labs (India): With extensive experience in iron APIs and pharmaceutical intermediates, Hetero supplies bulk ferric compounds to the global market.

4. Raw Material Suppliers

Quality raw materials, such as maltol and ferric salts, are critical for API synthesis:

• Sigma-Aldrich (Merck Group): Supplies high-purity maltol and ferric salts suitable for pharmaceutical manufacturing, ensuring consistency in raw materials.

• Fisher Scientific: Provides pharmaceutical-grade raw materials, matching the purity specifications required for API synthesis.

Quality Standards and Regulatory Considerations

The API must comply with international regulatory standards:

• GMP Compliance: All suppliers must operate under GMP for APIs, including rigorous batch validation, process controls, and documentation.

• Pharmacopoeial Standards: APIs should meet USP, EP, or JP monographs for ferric maltol, particularly concerning impurity profiles, residual solvents, and endotoxin levels.

• Regulatory Certainty: Suppliers with validated manufacturing processes and robust quality assurance systems are preferred to mitigate regulatory risks and facilitate smoother registration pathways.

Supply Chain and Strategic Sourcing Considerations

• Certifications and Approvals: Prefer suppliers with established GMP certification, FDA approval, and international regulatory compliance to streamline global distribution.

• Raw Material Traceability: Ensuring traceability of raw materials minimizes compliance risks and ensures consistency in final API quality.

• Scale and Capacity: Suppliers must demonstrate capacity for high-volume production to meet global demand spikes and supply continuity.

• Lead Times: Engaging suppliers with optimized lead times reduces delays in manufacturing cycles.

• Pricing and Contractual Arrangements: Competitive procurement contracts, including clauses on quality, delivery, and liability, are vital for long-term partnerships.

Future Trends in API Sourcing for HYFTOR

• Vertical Integration: Companies may seek integrated manufacturing models combining API synthesis and finished product formulation for greater control.

• Alternative Synthesis Routes: Innovations in green chemistry and process optimization could diversify API suppliers, reducing dependency on limited sources.

• Regional Diversification: Diversifying sources geographically diminishes supply chain risks, especially amid geopolitical or pandemic-related disruptions.

• Digital Traceability: Implementing blockchain and digital tracking enhances transparency and quality assurance across the supply chain.

Conclusion

The sourcing of ferric maltol API critical to HYFTOR’s commercial success depends on a tightly controlled, quality-assured supply chain. Leading global API manufacturers like BASF, Carbogen Amcis, and Recipharm stand out due to their proven GMP compliance and manufacturing expertise. Regionally, Indian suppliers like Shilpa Medicare and Hetero Labs offer competitive options, though due diligence regarding regulatory compliance is essential.

To optimize procurement strategies, stakeholders should prioritize suppliers with robust quality standards, scalable capacity, and reliable regulatory approval profiles. Diversifying suppliers and emphasizing raw material traceability further enhances supply resilience, safeguarding HYFTOR’s market position.

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Key Takeaways

• The active pharmaceutical ingredient (API) for HYFTOR, ferric maltol, has a limited number of specialized global suppliers with GMP-compliant manufacturing capabilities.

• Leading API manufacturers include BASF, Carbogen Amcis, and Recipharm, emphasizing the importance of quality, regulatory compliance, and capacity for high-volume production.

• Raw material sourcing (maltol and ferric salts) from suppliers like Sigma-Aldrich ensures consistent quality for API synthesis.

• Strategic sourcing should focus on supplier certification, traceability, lead times, and cost competitiveness to mitigate risks.

• Future supply stability depends on diversification, process innovation, and digital traceability in the supply chain.

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FAQs

1. What are the primary challenges in sourcing ferric maltol API for HYFTOR?
The main challenges include limited supplier availability due to the complex synthesis required for iron coordination complexes, stringent regulatory compliance demands, and ensuring consistent quality across batches.

2. Are there alternative APIs similar to ferric maltol for treating iron deficiency?
Yes, traditional iron salts like ferrous sulfate, ferrous fumarate, and ferrous gluconate are alternatives. However, ferric maltol offers better gastrointestinal tolerability and bioavailability, making it preferable for certain patient populations.

3. How does GMP certification influence API sourcing decisions?
GMP certification ensures that API suppliers adhere to rigorous manufacturing and quality assurance standards, reducing regulatory risks and facilitating faster approval processes for finished products.

4. What role does raw material purity play in API quality for HYFTOR?
High raw material purity directly impacts the final API's safety, efficacy, and stability, making the sourcing of pharmaceutical-grade maltol and ferric salts critical to meet pharmacopeial standards.

5. How might geopolitical factors affect the global supply of ferric maltol API?
Geopolitical tensions, trade restrictions, or disruptions (e.g., pandemics) can impede the supply chain, emphasizing the importance of regional diversification and strategic stockpiling.

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Sources

1. U.S. Pharmacopeia (USP). Monograph for Ferric Maltol, USP NF.
2. European Pharmacopoeia (EP). Monograph for Ferric Maltol.
3. BASF Annual Report 2022, Section on Pharmaceutical Intermediates.
4. Carbogen Amcis. Capabilities in Iron Complex APIs.
5. Recipharm. API manufacturing expertise and GMP accreditation data.