Suppliers and packagers for accrufer

accrufer

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

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Shield Tx	ACCRUFER	ferric maltol	CAPSULE;ORAL	212320	NDA	Shield TX (UK) Ltd	73059-001-10	1 BOTTLE, PLASTIC in 1 CARTON (73059-001-10) / 10 CAPSULE in 1 BOTTLE, PLASTIC	2021-07-01
Shield Tx	ACCRUFER	ferric maltol	CAPSULE;ORAL	212320	NDA	Shield TX (UK) Ltd	73059-001-60	1 BOTTLE, PLASTIC in 1 CARTON (73059-001-60) / 60 CAPSULE in 1 BOTTLE, PLASTIC	2021-07-01

Suppliers for the Pharmaceutical Drug: ACCRUFER

Last updated: August 9, 2025

Introduction

ACCRUFER (deferiprone) is an oral iron chelator primarily prescribed for managing transfusional iron overload in conditions such as thalassemia major. As demand for effective iron chelation therapy persists, identifying reliable suppliers for ACCRUFER is critical for pharmaceutical companies, healthcare providers, and governments involved in procurement and distribution. This article provides a comprehensive analysis of the key suppliers, their manufacturing capacities, regulatory considerations, and market dynamics shaping the availability of ACCRUFER globally.

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Overview of ACCRUFER and Its Market

ACCRUFER (deferiprone) was developed by Apotex Inc., a Canadian pharmaceutical company, and is marketed by Fenway Pharmaceuticals in the United States, with other regional distributors globally. The drug received approval from the U.S. Food and Drug Administration (FDA) and equivalent agencies in various countries, establishing its clinical relevance and regulatory safeguarding.

The global market for iron chelators, including ACCRUFER, is driven by increasing prevalence of hereditary anemias requiring chronic transfusions, especially in regions like the Middle East, Southeast Asia, and parts of Africa. Ensuring a stable supply chain involves understanding the primary manufacturing bases, contract manufacturing arrangements, and regional suppliers.

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Manufacturers and Licensing Agreements

1. Apotex Inc. (Canada):
   As the original developer, Apotex holds the patent rights and maintains the primary production facility. They focus on ensuring quality standards aligned with international regulatory frameworks, including the FDA, EMA, and WHO.

2. Fenway Pharmaceuticals (USA):
   Fenway Pharmaceuticals is responsible for marketing ACCRUFER within the United States, leveraging Apotex's manufacturing capacity. Its distribution relies on licensing agreements with Apotex.

3. Contract Manufacturing Organizations (CMOs):
   Several organizations operate under licensing agreements to produce deferiprone for regional markets under approval and quality standards stipulated by Apotex or the licensor. These include:

   • Aurobindo Pharma (India):
     Known for generic manufacturing, Aurobindo holds approval for deferiprone in India and other emerging markets, contributing significantly to regional supplies.

   • Hetero Labs (India):
     Hetero is a key contract manufacturer serving Asian markets, providing deferiprone under regulatory approvals from local agencies.

   • Sundia Corporation (South Korea):
     As a regional supplier, Sundia markets deferiprone in East Asia, subject to regional regulatory compliance.

4. Emerging Manufacturers and Regional Suppliers:
   Additional manufacturers are entering the market, particularly in countries with high demand, such as China, Brazil, and Russia, often under licensing agreements with the patent holders or through generic registration pathways.

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Regulatory Status and Its Impact on Supply

The manufacturing and distribution rights of ACCRUFER are tightly controlled through patent rights, regulatory approvals, and manufacturing licenses. The expiration of patents in certain jurisdictions facilitates entry of generic manufacturers, potentially diversifying supply sources but also raising concerns about quality and consistency.

• US Market: The FDA approval restricts manufacturing to licensed facilities, primarily Apotex and its approved CMOs. Generic manufacturers in India and other regions can only supply once they secure regulatory approval and demonstrate bioequivalence.

• Europe and Elsewhere: EMA approval aligns with regional approvals, often held by the same primary manufacturers or licensed generics.

• Emerging Markets: Limited local manufacturing capacity exists, often relying on imports from established suppliers or regional producers under licensing agreements.

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Supply Chain Challenges and Considerations

The supply of ACCRUFER faces several challenges:

• Regulatory Barriers: Strict regulatory approval processes limit rapid market entry for new suppliers. Manufacturers must demonstrate good manufacturing practices (GMP), bioequivalence, and safety profiles to gain approval.

• Raw Material Availability: As a synthetic molecule, deferiprone's production depends on access to high-purity chemicals and intermediates. Disruptions in raw material supply could impact manufacturing.

• Patent Expiration and Generic Entry: Expiry of key patents opens the market to generics, increasing supply options but necessitating rigorous quality control to prevent substandard products.

• Market Demand Fluctuations: The growth in iron overload cases influences procurement volumes, affecting manufacturing planning.

• Regional Variations: Different approval statuses across regions impact supply chains, with some areas relying on imports, which could face logistical delays.

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Major Suppliers and Their Market Shares

While detailed, up-to-date market share data is limited, the following outline offers essential insights:

• Apotex Inc.:
  Controls the primary supply due to original patent rights and extensive cGMP-certified manufacturing facilities.

• Indian Generics Manufacturers (Aurobindo, Hetero):
  Increasing market penetration in Asia and Africa, providing cost-effective alternatives but with varying quality standards depending on certification and regulation.

• Regional Suppliers:
  South Korea’s Sundia, Brazilian manufacturers, and others serve localized markets, often under licensing arrangements.

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Quality and Regulatory Compliance

Suppliers must adhere to international standards, including:

• GMP Certification: Ensures product quality and safety.

• Bioequivalence Data: Necessary for generic approvals.

• Regional Regulatory Approvals: Complying with FDA, EMA, PMDA (Japan), and others.

Concerns over counterfeit drugs globally underscore the importance of sourcing ACCRUFER from reputable, licensed suppliers with transparent quality records.

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Future Outlook and Strategic Considerations

The evolving landscape suggests increased diversification of suppliers with patent expiries, especially as generic manufacturing ramps up. Companies should prioritize:

• Due Diligence: Vetting manufacturing facilities for compliance and quality assurance.

• Strategic Partnerships: Building relationships with regional manufacturers to secure supply.

• Regulatory Navigation: Facilitating faster approvals in emerging markets through robust dossier submissions.

• Supply Chain Resilience: Diversifying sources to mitigate risks associated with raw material disruptions or geopolitical factors.

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Key Takeaways

• Market Control: Apotex remains the primary manufacturer, with licensed regional producers expanding supply in emerging economies.

• Generics and Patent Expiry: Patent expirations are facilitating new entrants, increasing global supply but emphasizing the need for regulatory vigilance.

• Quality Assurance: Ensuring supplier adherence to GMP and regional standards is critical to maintaining drug safety and efficacy.

• Regional Variability: Supply chain strategies must account for diverse regulatory landscapes, raw material sourcing, and logistical factors.

• Future Trends: An increase in regional manufacturing and generic entries will likely enhance availability, but quality oversight remains paramount.

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FAQs

1. Who are the main global suppliers for ACCRUFER?
Primary production is controlled by Apotex Inc. in Canada, with regional manufacturers like Aurobindo Pharma (India), Hetero Labs (India), and Sundia Corporation (South Korea) serving specific markets under licensing agreements.

2. How does patent expiry influence ACCRUFER supply?
Patent expiries enable generic manufacturers to produce deferiprone, increasing global supply options. However, this shift requires new manufacturers to obtain regulatory approvals and ensure quality compliance.

3. Are there regional differences in ACCRUFER sourcing?
Yes. In the US and Europe, supply is mainly from licensed original manufacturers, while emerging markets often depend on generic manufacturers from India, China, and Latin America.

4. What regulatory considerations impact the supply chain?
Manufacturers must secure GMP certification, regional approvals (FDA, EMA, local agencies), and demonstrate bioequivalence for generics, restricting supply to approved entities and manufacturing facilities.

5. What are the risks associated with ACCRUFER supply dependency?
Risks include regulatory delays, raw material shortages, counterfeit products, and geopolitical factors. Diversifying suppliers and maintaining strict quality standards mitigate these risks.

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References

[1] FDA drug approval archives. "ACCRUFER (Deferiprone) Approval," 2019.
[2] Apotex Inc. Corporate overview and manufacturing facilities.
[3] Market reports on iron chelators and pharmaceutical manufacturing, IQVIA, 2022.
[4] WHO guidelines on pharmaceutical quality assurance, 2020.
[5] Regional regulatory agency approvals (EMA, PMDA, CDSCO).