Bulk Pharmaceutical API Sources for FERRIC CITRATE

Bulk Pharmaceutical API Sources for FERRIC CITRATE

Vendor	Vendor Homepage	Vendor Sku	API Url
ChemExper Chemical Directory		HgLN`hret{AXC\{^odEnmYfjjY`@@
NovoSeek		61300
ISpharm		I14-8077
ABI Chem		AC1L1UYI
ChemMol		49412810

Bulk Active Pharmaceutical Ingredient (API) Sources for FERRIC CITRATE

Last updated: August 2, 2025

Introduction

Ferric citrate, an oral iron-based compound, is predominantly utilized for treating iron deficiency anemia and managing hyperphosphatemia in chronic kidney disease (CKD) patients. Its therapeutic success hinges on the consistent, high-quality supply of its active pharmaceutical ingredient (API), ferric citrate. The API sourcing landscape encompasses global chemical manufacturers, contract manufacturing organizations (CMOs), and specialty chemical suppliers. This article provides a comprehensive overview of prominent sources, evaluating their capacities, regulatory compliance, and strategic positioning in supplying ferric citrate API.

Understanding Ferric Citrate API

Ferric citrate is a complex compound comprising ferric ions and citrate ions, stabilized in solution or as a crystalline powder for pharmaceutical formulation. As an iron-based product, its API must meet stringent pharmacopeial standards for purity, bioavailability, and stability. The synthesis involves complex coordination chemistry, requiring precise control during manufacturing to ensure batch-to-batch consistency.

Global API Manufacturers for Ferric Citrate

1. Major Chemical Producers in China

China remains a dominant force in bulk pharmaceutical chemicals, including ferric citrate API, leveraging cost advantages and extensive manufacturing capacity.

• Wuhan Huishen Pharmaceutical Co., Ltd.
  Specializing in iron compounds, Wuhan Huishen offers ferric citrate API with GMP compliance for export markets. The firm emphasizes high purity standards compliant with Chinese pharmacopeia and international GMP norms.

• Liaoning Hezhong Pharmaceutical Co., Ltd.
  Known for iron preparations and citrate derivatives, Hezhong's API production facilities are certified by Chinese authorities and seek international GMP accreditation to expand global export.

• Zhengzhou Great Wall Chemical Co., Ltd.
  Provides ferric citrate intermediates and has invested in advanced synthesis and purification technologies ensuring consistent API quality.

2. Indian API Manufacturers

India continues to strengthen its position as a significant API supplier, with several firms supplying ferric citrate or related iron compounds:

• Indo Biotech Laboratories
  Focused on specialty APIs, Indo Biotech adheres to WHO-GMP standards, positioning itself as a reliable supplier of ferric citrate API for emerging markets.

• Gulshan Polyols Ltd.
  A diversified chemical manufacturer with iron citrate derivatives, aiming to expand into pharmaceutical-grade APIs, maintaining stringent quality standards.

3. European and North American Suppliers

While less prevalent, a few high-quality, compliance-focused manufacturers serve the international pharmaceutical industry:

• Fresenius Kabi (Germany)
  Known for parenteral iron products, they explore oral formulations, including ferric citrate APIs, leveraging robust quality systems and regulatory expertise.

• American Precoat Manufacturing Inc. (USA)
  Specializes in specialty iron compounds, including potential API development for oral iron therapies. Their production facilities comply with FDA regulations.

4. Contract Manufacturing Organizations (CMOs)

CMOs play a pivotal role by producing ferric citrate API on behalf of brand owners and generic companies:

• Lonza (Switzerland)
  Offers custom synthesis of iron-based APIs, with rigorous validation systems aligned with EMA and FDA standards.

• Ajinomoto Bio-Pharma Services (Japan/USA)
  Provides contract manufacturing for complex APIs like ferric citrate, ensuring GMP compliance and scalable production.

• Boehringer Ingelheim (Germany)
  Engaged in contract API manufacturing, including iron complexes, with a focus on regulatory support and international quality standards.

Key Considerations in API Sourcing

Regulatory Compliance

Sourcing ferric citrate API necessitates strict adherence to pharmacopeial standards and regulatory approvals, including GMP certification, stability, and impurity profiles. Manufacturers with audited facilities and robust quality systems reduce compliance risks.

Manufacturing Capacity and Scalability

Given the growing prevalence of iron deficiency treatments, API suppliers must possess scalable manufacturing processes capable of supporting both small-scale clinical trials and large-scale commercial production.

Quality Assurance and Certification

High-purity API production requires comprehensive analytical capabilities, including chromatography, spectroscopy, and impurity profiling. Suppliers should provide detailed Certificates of Analysis (CoA) and be subject to regular audits.

Supply Chain Security

Geopolitical factors, trade policies, and logistical reliability impact API sourcing. A diversified supplier base reduces risk and ensures continuity of supply.

Cost and Lead Times

Cost competitiveness is critical, especially in the generic pharmaceutical market. Lead time considerations can influence procurement strategies and inventory planning.

Emerging Trends and Future Outlook

The API manufacturing landscape for ferric citrate is evolving with advances in green chemistry, process intensification, and biotechnological methods. Companies investing in sustainable synthesis routes, such as solvent-free processes, and enhanced purification techniques will likely maintain competitive advantages. Additionally, regulatory trends favoring transparency and data integrity are shaping supplier qualification processes globally.

Conclusion

Sourcing ferric citrate API involves navigating a complex ecosystem of global manufacturers, CMOs, and specialty chemical suppliers. China remains a leading producer, complemented by Indian and European firms expanding their reach. High-quality, compliant suppliers—whether in-house manufacturers or CMOs—are crucial for the consistent supply of safe, effective ferric citrate. Strategic procurement should prioritize regulatory compliance, manufacturing capacity, quality assurance, and supply chain robustness to mitigate risks and meet market demands.

---

Key Takeaways

• China dominates ferric citrate API production, offering cost-effective and scalable manufacturing, but regulatory compliance varies.
• Indian manufacturers are strengthening their presence, emphasizing WHO-GMP standards and expanding export capabilities.
• European and North American suppliers focus on high-quality, regulatory-compliant production, often via CMOs.
• Procurement strategies must consider regulatory adherence, quality certifications, capacity, and supply chain security.
• Emerging green synthesis trends and regulatory rigor will shape future API supply chain dynamics.

---

FAQs

1. What are the main regulatory standards for sourcing ferric citrate API?
Manufacturers must comply with GMP regulations, pharmacopeial standards (such as USP, EP, or Chinese pharmacopeia), and international quality certifications to ensure safety, purity, and efficacy.

2. How does geographic diversification reduce API supply risks?
Diversifying suppliers across regions mitigates risks associated with geopolitical disruptions, trade restrictions, or localized manufacturing issues, ensuring continuous supply.

3. Are contract manufacturing organizations suitable for sourcing ferric citrate API?
Yes. CMOs offer flexibility, scalability, and expertise in complex synthesis, often complying with strict regulatory standards, making them suitable partners.

4. What quality attributes should buyers prioritize in ferric citrate API?
Purity levels, impurity profiles, chromatography data, stability, bioavailability, and compliance certificates are critical attributes for safe and effective pharmaceutical use.

5. What are the future trends in ferric citrate API manufacturing?
Adoption of green chemistry, process intensification, enhanced analytical technologies, and increased regulatory transparency will influence the API supply landscape.

---

Sources:

[1] Chinese pharmaceutical raw material manufacturers, industry reports, and company websites.
[2] WHO and FDA guidelines on pharmaceutical manufacturing practices.
[3] Market analyses on global iron compounds production.