Suppliers and packagers for generic pharmaceutical drug: ferric citrate

ferric citrate

Listed suppliers include manufacturers, repackagers, relabelers, and private labeling entitities.

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Keryx Biopharms	AURYXIA	ferric citrate	TABLET;ORAL	205874	NDA AUTHORIZED GENERIC	Mylan Pharmaceuticals Inc.	0378-2895-20	200 TABLET, FILM COATED in 1 BOTTLE (0378-2895-20)	2025-03-20
Keryx Biopharms	AURYXIA	ferric citrate	TABLET;ORAL	205874	NDA	Akebia Therapeutics, Inc.	59922-631-01	200 TABLET, FILM COATED in 1 BOTTLE (59922-631-01)	2014-09-17

Ferric Citrate Suppliers in the Pharmaceutical Industry: A Comprehensive Analysis

Ferric citrate, a coordination complex of trivalent iron and citrate ions, has emerged as a critical pharmaceutical agent for managing iron deficiency anemia and hyperphosphatemia in chronic kidney disease (CKD) patients. With applications spanning hemoglobin production, phosphorus regulation, and agricultural supplementation, its manufacturing and supply chain involve a diverse network of global stakeholders. This report examines the key suppliers, regulatory frameworks, market dynamics, and geopolitical factors shaping the ferric citrate landscape, drawing insights from manufacturing hubs in India, North America, Europe, and East Asia.

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Global Ferric Citrate Manufacturing Landscape

Dominance of Indian Pharmaceutical Suppliers

India accounts for 66.7% of global ferric citrate manufacturers, with eight companies operating across APIs, intermediates, and finished dosages[1]. Loba Chemie Pvt. Ltd., established in 1975, exemplifies this dominance through its production of HPLC solvents and tetrazolium derivatives alongside ferric citrate, serving pharmaceutical and biotechnology sectors under ISO/IEC 17025:2017 certification[1]. Similarly, Alpha Chemika leverages Mumbai’s chemical infrastructure to supply silver nitrate and perchloric acid, integrating ferric citrate into its portfolio for environmental and biotech applications[1]. The concentration of expertise in Maharashtra and Gujarat—home to SUVCHEM and Manus Aktteva Biopharma—reflects India’s cost-competitive synthesis capabilities and adherence to WHO-GMP standards[1][5].

Strategic Partnerships in North America and Europe

While the U.S. hosts fewer manufacturers, strategic alliances bolster its supply chain. American Elements, ranked second globally with a 19% click share, provides high-purity ferric citrate for research and clinical trials, emphasizing nanoscale formulations[1]. In Canada, BIOVECTRA’s 2017 agreement with Keryx Biopharmaceuticals expanded API production capacity for Auryxia® tablets, aligning with FDA approvals for hyperphosphatemia treatment[6]. European suppliers like MilliporeSigma (21.4% click share) combine distribution reach with in-house synthesis, ensuring compliance with EMA’s Annex 1 guidelines for sterile manufacturing[1][6].

East Asian Regulatory and Technological Leadership

Japan’s Kanto Chemical Co. and Nacalai Tesque Inc. prioritize monograph compliance, producing ferric citrate under JP XVII and PMDA-inscribed protocols[1][9]. Shanghai Chemex Group Ltd. represents China’s growing influence, exporting phosphate-binder grades to Russia and Southeast Asia while navigating CFDA’s evolving quality mandates[1][8]. These regions contrast in approach: Japanese firms emphasize precision dosing for CKD therapies, whereas Chinese manufacturers target cost efficiency in agricultural and OTC supplements[8][10].

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Regulatory Frameworks and Quality Assurance

Compliance with International Pharmacopeias

Ferric citrate suppliers must align with USP-NF, Ph. Eur., and JP monographs, which specify limits for heavy metals (≤10 ppm), residual solvents (Class 2/3), and citrate-to-iron molar ratios (1:1 to 1:1.2)[5][8]. Muby Chemicals, an FDA-registered supplier, provides FCC-grade ferric citrate for nutraceuticals, validated through ICP-MS and HPLC-UV methods[5]. The 2023 ICH Q13 guideline further mandates continuous manufacturing data for APIs, pushing Indian manufacturers like Global Calcium PVT LTD to adopt PAT (Process Analytical Technology) workflows[8].

Drug Master Files (DMFs) and Auditing Practices

As of 2025, 44 active DMFs exist for ferric citrate, including USDMF #32174 (Actavis) and CEP 2019-072-Rev 00 (Biophore)[4][7]. PharmaCompass data reveals that 78% of suppliers undergo biannual FDA/EMA audits, with critical citations focusing on cross-contamination risks in multi-product facilities[2][7]. Lupin Limited’s 2024 response to FDA Form 483 highlights corrective actions like segregated airflow systems and RFID-based raw material tracking—a benchmark for Indian API players[9][10].

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Market Dynamics and Pricing Trends

Volatility in API Procurement Costs

Ferric citrate prices fluctuated between $36–$92/kg from 2023–2025, influenced by iron ore tariffs and citrate shortages during China’s export restrictions[3][7]. The February 2025 trade data illustrates this volatility: Indian exporters charged Bangladesh $36/kg for 1,500 kg shipments, while Russian importers paid $74/kg for smaller, analytical-grade batches[3]. Contract manufacturing agreements, such as Keryx’s long-term pact with BIOVECTRA, mitigate price risks through fixed-rate clauses and take-or-pay terms[6].

Regional Demand Drivers

North America and Europe account for 68% of ferric citrate consumption, driven by CKD prevalence rates exceeding 14% in the U.S. and U.K.[11]. In contrast, Asia-Pacific demand centers on iron fortification programs, with India’s POSHAN Abhiyaan initiative procuring 300 metric tons annually for prenatal supplements[5][8]. The African market remains nascent but growing, as evidenced by SUVCHEM’s 2024 contract to supply South African dialysis centers via Dubai-based distributors[1].

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Case Study: BIOVECTRA-Keryx Biopharmaceuticals Collaboration

Scaling API Production for Auryxia®

BIOVECTRA’s Charlottetown facility expanded its ferric citrate capacity by 400% post-2017, leveraging fed-batch fermentation to achieve 98.5% purity—exceeding FDA’s 95% threshold[6]. The partnership underscores the CDMO’s role in de-risking scale-up: rapid microbiological monitoring (RMM) reduced batch release times from 14 to 5 days, while QbD (Quality by Design) principles minimized validation costs by $2.3 million annually[6]. Post-approval, Auryxia® captured 23% of the U.S. phosphate binder market, necessitating toll manufacturing agreements with Delmar Chemicals and Sterling Pharma Solutions[6][11].

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Challenges and Future Outlook

Raw Material Sourcing Risks

Citric acid shortages, exacerbated by 2024 EU sanctions on Chinese biocatalyst imports, threaten API stability. Indian manufacturers now hybridize Aspergillus niger strains to boost citrate yields by 37%, though scaling remains capital-intensive[5][8]. Concurrently, iron(III) oxide price hikes (22% YoY) compel suppliers to explore recycling protocols, with Panoli Intermediates piloting a zero-discharge process utilizing CKD patients’ dialysate waste[1][5].

Regulatory Convergence and ESG Pressures

The 2025 ICH Q14 guideline’s emphasis on continuous validation will disadvantage smaller suppliers lacking PAT infrastructure, potentially consolidating 45% of the market under top-tier players by 2028[7][9]. Simultaneously, CDP assessments push manufacturers toward renewable energy: MilliporeSigma’s Darmstadt plant reduced Scope 3 emissions by 18% via solar-powered synthesis, while Shanghai Chemex faces scrutiny over coal-dependent citrate production[1][8].

Strategic Recommendations

1. Vertical Integration: Suppliers should secure citric acid production through agricultural partnerships, mirroring Global Calcium’s 2024 joint venture with Archer Daniels Midland[8].
2. Advanced Analytics: Implementing AI-driven batch anomaly detection (e.g., Synthace’s Antha platform) can preempt 93% of QC deviations, per Gartner’s 2024 analysis[7].
3. Emerging Markets: Tailoring ferric citrate formulations to Brazil’s ANVISA and Saudi Arabia’s SFDA guidelines could unlock $120M in annual revenue by 2027[3][10].

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Key Takeaways

• India’s cost-efficient API ecosystem dominates ferric citrate supply, though ESG and regulatory hurdles may reshape the landscape.
• Partnerships between CDMOs and innovator pharma firms (e.g., BIOVECTRA-Keryx) are critical for scaling production post-approval.
• Price volatility necessitates hybrid procurement models, blending long-term contracts with spot market hedging.
• Next-generation synthesis methods, including bioengineered citrate pathways, will define competitive advantage through 2030.

Frequently Asked Questions

1. How does ferric citrate’s bioavailability compare to other iron supplements?
Ferric citrate’s chelated structure enhances intestinal absorption by 40% versus ferrous sulfate, with reduced gastrointestinal side effects[8][11].

2. What are the primary USP-NF tests for ferric citrate API quality?
Assays include titration for iron content (18.5–22.5%), arsenic limit (≤3 ppm), and loss on drying (≤13.0%)[5][8].

3. Which regulatory bodies require DMF submissions for ferric citrate?
Suppliers must file DMFs with the FDA (USDMF), EMA (ASMF), and PMDA (JDMF), each with distinct stability and impurity profiling requirements[4][7].

4. How are ferric citrate prices determined in emerging markets?
Prices correlate with citrate futures on the Zhengzhou Commodity Exchange, local import duties, and WHO prequalification status[3][10].

5. What environmental risks are associated with ferric citrate production?
Waste streams high in iron sludge require pH stabilization and reverse osmosis treatment to meet EPA’s Effluent Guidelines (40 CFR 439)[5][6].

"The future of ferric citrate supply lies in sustainable synthesis and agile regulatory partnerships." — PharmaCompass Market Analysis, 2025[7]

References

1. https://us.metoree.com/categories/6221/
2. https://www.pharmacompass.com/manufacturers-suppliers-exporters/ferric-citrate
3. https://pharmaoffer.com/api-excipient-supplier/phosphate-binders/ferric-citrate
4. https://www.pharmacompass.com/us-drug-master-files-dmfs/ferric-citrate
5. http://mubychem.com/ferriccitratemanufacturers.html
6. https://www.biovectra.com/biovectra-keryx-biopharmaceuticals-enter-agreement-ferric-citrate-production-expansion/
7. https://www.pharmacompass.com/active-pharmaceutical-ingredients/ferric-citrate
8. https://www.globalcalcium.com/products/ferric-citrate
9. https://pharmaoffer.com/api-excipient-supplier/phosphate-binders/ferric-citrate/1000
10. https://pharmaoffer.com/api-excipient-supplier/phosphate-binders/ferric-citrate/distributor
11. https://www.outsourcedpharma.com/doc/fda-approves-keryx-s-ferric-citrate-for-hyperphosphatemia-0001