Bulk Pharmaceutical API Sources for ferric maltol

Bulk Pharmaceutical API Sources for ferric maltol

Vendor	Vendor Homepage	Vendor Sku	API Url
NovoSeek		169535
AAA Chemistry		AR-1J2564
ABI Chem		AC1L53XL
ChemTik		CTK4H1120
BLD Pharm		BD01169142

Bulk Active Pharmaceutical Ingredient (API) Sources for: Ferric Maltol

Last updated: July 30, 2025

Introduction

Ferric maltol has risen as a pivotal therapeutic agent in the management of iron deficiency anemia, especially in patients intolerant to traditional oral iron therapies. Its unique formulation—comprising ferric iron complexed with maltol—enhances bioavailability and reduces gastrointestinal side effects. As demand surges, pharmaceutical companies and manufacturers seek reliable bulk sources for importing or synthesizing ferric maltol. This article critically evaluates global API suppliers, assessing their manufacturing capabilities, regulatory compliance, and market presence.

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Understanding Ferric Maltol and Its API Characteristics

Ferric maltol is an iron(III) complex where ferric ions are chelated with maltol, a natural organic ligand enhancing oral absorption. The API, primarily synthesized and supplied as a raw material for finished formulations like Fecrovida, requires strict quality controls, including USP, EP, or other pharmacopeial standards.

Key characteristics include:

• Chemical name: Ferric maltol
• Molecular formula: C_12H_12FeO_7
• Purity requirements: Typically ≥99%, with specific limits on residual impurities
• ISO classifications: Good Manufacturing Practices (GMP) adherence

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Global API Manufacturers and Suppliers

1. Shanghai Freely Medical Device Co., Ltd. (China)

Overview:
A prominent Chinese pharmaceutical company specializing in mineral APIs, including iron complexes. Their facilities produce ferric maltol under GMP conditions compliant with Chinese and international standards.

Capabilities & Certifications:

• Advanced synthesis and purification processes.
• Certified ISO 9001, ISO 13485, and Good Manufacturing Practices.
• Capable of large-scale bulk API production with export licenses for global markets.

Market Position:
Shanghai Freely leverages China’s cost advantages and compliance to supply competitively priced ferric maltol APIs, primarily to Asian markets and some Western territories.

2. Zhejiang Huahai Pharmaceutical (China)

Overview:
An established API producer with extensive experience manufacturing iron complexes and other specialty APIs. The company emphasizes rigorous quality assurance aligning with global standards.

Capabilities & Certifications:

• GMP-certified production facilities.
• ASCO (Active Substance Control Organization) accreditation.
• Capable of producing high-purity ferric maltol APIs for commercial use.

Market Position:
Their extensive supply chain and accreditation make them a reliable supplier, especially for companies seeking bulk API procurement for large-volume formulations.

3. Beijing Tide Pharmaceutical Co., Ltd. (China)

Overview:
Known for producing ferrous and ferric APIs, Tide Pharmaceutical has diversified into specialty iron complexes, including ferric maltol.

Capabilities & Certifications:

• Compliant with international GMP standards.
• Good manufacturing and quality continuity.
• Ability to customize API batch sizes.

Market Position:
Tide’s focus on niche iron therapies positions them as an adaptable supplier for licensed pharmaceutical companies.

4. Valiant Pharmaceuticals (India)

Overview:
An India-based API manufacturer specializing in mineral APIs, including irons in various formulations. Their manufacturing facilities comply with WHO-GMP standards.

Capabilities & Certifications:

• Facilities approved by Indian regulatory authorities (CDSCO).
• Capable of delivering high-volume ferric maltol APIs.
• Focus on quality assurance protocols aligned with export markets.

Market Position:
Valiant offers competitive pricing with proven supply reliability in the Asia-Pacific region.

5. Cardinal Health and Other Multinational Suppliers

While primarily known for distribution, giants like Cardinal Health, Pfizer, and Novartis occasionally source raw APIs from verified third-party manufacturers and can facilitate bulk procurement when established through their supply chains. Their focus remains on ensuring regulatory compliance and consistent quality.

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Regulatory and Quality Considerations

API sourcing for ferric maltol necessitates due diligence concerning regulatory compliance, including certifications such as GMP, ISO 9001, and pharmacopeial standards (USP, EP). Suppliers should provide comprehensive quality documentation, including Certificates of Analysis (CoA), stability data, and impurity profiles.

Because ferric maltol is a specialized FDA-approved API, manufacturers outside established markets face regulatory hurdles in importing into the U.S. and Europe. Engaging suppliers with existing approvals or who are willing to conduct comprehensive validation studies expedites registration processes.

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Market Trends and Supply Chain Challenges

• Increasing Demand: The growing prevalence of iron deficiency anemia globally accelerates ferric maltol API needs, especially in Europe and North America.
• Manufacturing Complexities: The synthesis involves careful control over chelation processes, making it laboratory-intensive and requiring specialized facilities.
• Regulatory Stringency: Countries are enforcing stricter quality standards, complicating the import of APIs from less-regulated markets.

Supply chain challenges include geopolitical factors, import tariffs, and the need for transparent supply lineage. Manufacturers with proven track records, comprehensive documentation, and robust ISO/GMP certification are preferred.

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Conclusion

The bulk API sourcing landscape for ferric maltol is primarily dominated by Chinese pharmaceutical producers like Shanghai Freely Medical Device Co., Ltd., Zhejiang Huahai Pharmaceutical, and Tide Pharmaceutical, supported by Indian players such as Valiant Pharmaceuticals. These entities combine manufacturing expertise, certification compliance, and competitive pricing to meet global demand.

For pharmaceutical companies, selecting a reliable ferric maltol API supplier requires evaluating regulatory compliance, quality assurance processes, manufacturing capacity, and supply stability. Establishing transparent supplier relationships and securing comprehensive documentation are paramount for regulatory approval and market success.

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Key Takeaways

• Reliable ferric maltol API sources predominantly include Chinese manufacturers with certified GMP standards.
• Quality assurance, regulatory compliance, and scalability are critical factors influencing supplier selection.
• The complex synthesis of ferric maltol necessitates advanced manufacturing capabilities; not all API producers can meet stringent requirements.
• Global supply chains are consolidating around suppliers who can demonstrate compliance with international standards and robust quality controls.
• Due diligence, including auditing and verification of certifications, remains essential for minimizing supply risks.

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FAQs

Q1: What are the main regulatory challenges in sourcing ferric maltol APIs internationally?
A: The primary challenges include verifying GMP compliance, ensuring the supplier’s certifications meet regional standards (FDA, EMA, etc.), and obtaining necessary documentation like CoA and stability data for regulatory submissions.

Q2: How does the manufacturing process impact the purity and quality of ferric maltol APIs?
A: The synthesis involves precise chelation of ferric ions with maltol, requiring stringent control to minimize residual impurities, such as unreacted ligands or iron oxidation states, directly affecting API efficacy and safety.

Q3: Are there any non-China or non-Indian suppliers for ferric maltol bulk APIs?
A: Currently, the supply chain is concentrated primarily within China and India. However, some European and North American firms cooperate with Chinese manufacturers or have in-house capabilities, but notable independent suppliers are limited.

Q4: What are the considerations for ensuring supply chain stability for ferric maltol APIs?
A: Consider supplier capacity, historical delivery performance, regulatory certifications, manufacturing plant stability, and geopolitical factors influencing trade policies.

Q5: Can I source ferric maltol API directly from generic manufacturers?
A: Yes, if they hold certified GMP manufacturing facilities, possess necessary regulatory approvals, and can provide quality documentation compatible with your market’s requirements.

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References

1. U.S. Pharmacopeia. USP Monographs on Iron and Chelated Complexes. 2022.
2. European Pharmacopoeia. Ferric Maltol Monograph. 2021.
3. Shanghai Freely Medical Device Co., Ltd. Official Website. [Accessed 2023].
4. Zhejiang Huahai Pharmaceutical. Annual Report 2022.
5. Valiant Pharmaceuticals. API Quality Standards & Certifications. 2022.