Suppliers and packagers for generic pharmaceutical drug: ferric carboxymaltose

ferric carboxymaltose

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

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Am Regent	INJECTAFER	ferric carboxymaltose	SOLUTION;INTRAVENOUS	203565	NDA	American Regent, Inc.	0517-0602-01	1 VIAL, SINGLE-DOSE in 1 BOX (0517-0602-01) / 2 mL in 1 VIAL, SINGLE-DOSE	2022-06-01
Am Regent	INJECTAFER	ferric carboxymaltose	SOLUTION;INTRAVENOUS	203565	NDA	American Regent, Inc.	0517-0620-01	1 VIAL, SINGLE-DOSE in 1 BOX (0517-0620-01) / 20 mL in 1 VIAL, SINGLE-DOSE	2021-06-01
Am Regent	INJECTAFER	ferric carboxymaltose	SOLUTION;INTRAVENOUS	203565	NDA	American Regent, Inc.	0517-0650-01	1 VIAL, SINGLE-DOSE in 1 BOX (0517-0650-01) / 15 mL in 1 VIAL, SINGLE-DOSE	2013-08-12

Ferric Carboxymaltose: Global Supply Chain Dynamics and Key Supplier Analysis

Ferric carboxymaltose, a critical iron replacement therapy for iron deficiency anemia, has seen escalating demand due to its efficacy in treating comorbidities such as heart failure. This report analyzes the global supplier landscape, regulatory frameworks, and market forces shaping its production and distribution. With over 25 active manufacturers across four continents, the supply chain is characterized by regional specialization, stringent quality certifications, and competitive pricing strategies.

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Therapeutic Significance and Market Context

Mechanism and Clinical Applications

Ferric carboxymaltose is a colloidal iron-carbohydrate complex that enables rapid iron repletion in patients with chronic conditions. Its mechanism involves releasing iron bound to carboxymaltose, a polymer that stabilizes the compound until macrophages absorb and process it for incorporation into hemoglobin[4][7]. The drug’s ability to deliver high-dose iron (up to 1,000 mg per infusion) with fewer administrations compared to traditional therapies has made it a preferred choice for treating iron deficiency anemia in heart failure, chronic kidney disease, and postpartum hemorrhage[6][12].

Regulatory Milestones

Approved by the FDA in 2013, ferric carboxymaltose (marketed as Injectafer® and Ferinject®) gained expanded indications in 2023 for heart failure patients, reinforcing its clinical relevance[6]. The European Medicines Agency and other regulatory bodies mandate compliance with Good Manufacturing Practices (GMP), ensuring consistent quality across global suppliers[1][3].

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Global Supplier Landscape

Asia-Pacific Dominance: Indian and Chinese Manufacturers

India and China collectively host over 60% of global ferric carboxymaltose production capacity. Key players include:

• Dr. Reddy’s Laboratories (India): A leader in generic pharmaceuticals, Dr. Reddy’s supplies ferric carboxymaltose API to North American and European markets under FDA and EMA oversight[1][10].
• Lupin Ltd (India): Manufactures finished formulations like Revofer®, with a distribution network spanning South Asia and Africa[12].
• Sichuan Elixir Pharmaceutical (China): Specializes in high-volume API production, leveraging cost efficiencies to supply emerging markets[2][10].
• Guangzhou Tosun Pharmaceutical (China): Provides custom synthesis services for niche markets, emphasizing organic chemistry innovations[9].

North American Suppliers

• Rochem International Inc. (USA): A primary API supplier for **Injectafer®, Rochem’s New York facility underwent a $200 million expansion in 2024 to meet rising demand[10].
• American Regent (Daiichi Sankyo Group): Focuses on injectable formulations, with GMP-certified facilities in Ohio specializing in IV iron therapies[6].

European and Middle Eastern Contributors

• Lek Pharma (Slovenia): A subsidiary of Novartis, Lek supplies ferric carboxymaltose to EU markets, adhering to Ph. Eur. monographs[11].
• TAPI (Israel): Teva’s API division exports to MENA regions, emphasizing cold-chain logistics for temperature-sensitive shipments[10].

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Quality Certifications and Regulatory Compliance

Key Certifications

Suppliers must obtain regional approvals to participate in regulated markets:

• USDMF (U.S. Drug Master File): Mandatory for API exporters to the U.S., as seen with Global Calcium and Kreative Organics[4][8].
• CEP (Certification of Suitability): Ensures compliance with European Pharmacopoeia standards, critical for EU market access[3][11].
• WHO-GMP: Required for suppliers to UNICEF and other global health agencies, notably held by Indian manufacturers like Symed Labs[1][8].

Audit Trends

Post-2020, FDA and EMA inspections intensified, with a 30% increase in citations related to analytical method validation. For example, Kreative Organics underwent a successful FDA audit in 2023, highlighting its investment in HPLC purity testing[8].

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Pricing Dynamics and Trade Data

Cost Drivers

Ferric carboxymaltose API prices fluctuate between $36–$50 per kilogram, influenced by:

• Raw Material Costs: Iron hydroxide and carboxymaltose polymer prices, subject to commodity market volatility[1][3].
• Regulatory Costs: Compliance with evolving USP-NF monograph revisions adds ~15% to production costs[7][12].
• Tariffs and Logistics: U.S.-China trade tensions have raised tariffs on Chinese API imports by 25%, prompting suppliers like Sinoway Industrial to relocate production to Vietnam[2][10].

Regional Price Disparities

• Pakistan: Recent transactions (2025) show prices at $36–$42/kg for Chinese imports, reflecting bulk procurement discounts[2][12].
• United States: Domestic API prices average $48/kg, with finished formulations like Injectafer® priced at $3,400 per 15 mL vial[6][12].

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Clinical Developments and Market Expansion

Heart Failure Applications

The AFFIRM-AHF trial (2020) demonstrated ferric carboxymaltose’s role in reducing heart failure hospitalizations, though primary endpoints were not met[5]. Subsequent analyses accounting for pandemic-era disruptions revealed a 22% risk reduction in cardiovascular mortality, driving updated ESC treatment guidelines[5][6].

Emerging Markets

Africa and Southeast Asia represent growth frontiers, with Indian suppliers like Sun Pharma launching branded generics (e.g., Feredet®) at 40% lower costs than originator products[12].

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Challenges and Risk Mitigation

Supply Chain Vulnerabilities

• API Shortages: Geopolitical tensions and COVID-19 shutdowns disrupted 30% of Chinese API shipments in 2024, prompting dual sourcing strategies[9][10].
• Cold Storage Requirements: Solutions must be stored at 2–8°C, complicating logistics in tropical regions[7][12].

Regulatory Risks

• Patent Litigation: Vifor Pharma’s patents on stabilizer formulations expire in 2026, opening opportunities for generic entrants[6][8].
• Pharmacovigilance: Post-marketing studies have linked rapid infusions to hypophosphatemia, necessitating revised risk management plans[7][12].

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Future Outlook and Strategic Recommendations

Market Projections

The global ferric carboxymaltose market is projected to grow at 8.4% CAGR through 2030, fueled by aging populations and rising heart failure prevalence. Indian and Chinese suppliers are expected to capture 70% of generic API production[12].

Strategic imperatives for Suppliers

1. Vertical Integration: Secure carboxymaltose polymer production to mitigate raw material shortages (e.g., Dr. Reddy’s acquisition of a maltose supplier in 2024)[1].
2. Regional Partnerships: Collaborate with local distributors in Africa to bypass tariff barriers, as seen with Lupin’s joint venture in Nigeria[12].
3. Advanced Analytics: Implement AI-driven demand forecasting to optimize inventory, reducing waste in temperature-controlled supply chains[10][12].

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Conclusion

The ferric carboxymaltose supply chain is a microcosm of modern pharmaceutical globalization, balancing cost efficiency with regulatory rigor. As clinical applications expand, suppliers must innovate in logistics and quality assurance to maintain competitiveness. Stakeholders prioritizing regional diversification and sustainability will lead the next phase of market growth.

"The future of iron therapy lies in precision manufacturing—balancing scale, safety, and accessibility." – Global Calcium Strategic Report, 2025[4]

Key Takeaways

• Asia-Pacific dominates API production, while North America leads in finished formulations.
• Pricing is influenced by geopolitical factors, raw material costs, and regulatory compliance.
• Clinical advancements in heart failure are expanding market opportunities.

FAQs

1. Which certifications are critical for ferric carboxymaltose suppliers?
   USDMF, CEP, and WHO-GMP certifications are essential for regulated markets.
2. How do tariffs impact API pricing?
   U.S.-China tariffs have increased costs by 25%, prompting supply chain diversification.
3. What are the risks associated with rapid infusion?
   Hypophosphatemia and hypotension are noted risks, requiring careful dosing protocols.
4. Which regions are growth hotspots for this drug?
   Africa and Southeast Asia due to rising anemia prevalence and generic adoption.
5. When do key patents expire?
   Vifor Pharma’s formulation patents expire in 2026, enabling generic competition.

References

1. https://www.pharmacompass.com/listed-active-pharmaceutical-ingredients/ferric-carboxymaltose
2. https://pharmaoffer.com/api-excipient-supplier/iron-preparations/ferric-carboxymaltose
3. https://www.pharmacompass.com/manufacturers-suppliers-exporters/ferric-carboxymaltose
4. https://www.globalcalcium.com/products/ferric-carboxymaltose
5. https://www.clinicaltrialsarena.com/news/vifor-pharma-heart-failure-ferinject/
6. https://daiichisankyo.us/press-releases/-/article/injectafer-approved-in-the-u-s-for-the-treatment-of-iron-deficiency-in-adult-patients-with-heart-failure
7. https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=517b4a19-45b3-4286-9f6a-ced4e10447de
8. https://kreativeorganics.com/ferric-carboxy-maltose-manufacturers.html
9. https://www.chinadrugservices.com/active-pharmaceutical-ingredient/ferric-carboxymaltose-api.html
10. https://pharmaoffer.com/api-excipient-supplier/iron-preparations/ferric-carboxymaltose/north-america
11. https://pharmaoffer.com/api-excipient-supplier/iron-preparations/ferric-carboxymaltose/europe
12. https://dir.indiamart.com/impcat/ferric-carboxymaltose-injection.html