Suppliers and packagers for FERRIPROX

FERRIPROX

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

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Chiesi	FERRIPROX	deferiprone	SOLUTION;ORAL	208030	NDA	Chiesi USA, Inc.	10122-101-50	500 mL in 1 BOTTLE, PLASTIC (10122-101-50)	2015-09-09
Chiesi	FERRIPROX	deferiprone	TABLET;ORAL	021825	NDA	Chiesi USA, Inc.	10122-100-10	100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (10122-100-10)	2011-11-25
Chiesi	FERRIPROX	deferiprone	TABLET;ORAL	021825	NDA	Chiesi USA, Inc.	10122-103-05	50 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (10122-103-05)	2019-08-01
Chiesi	FERRIPROX	deferiprone	TABLET;ORAL	212269	NDA	Chiesi USA, Inc.	10122-104-01	50 TABLET in 1 BLISTER PACK (10122-104-01)	2020-05-19
Chiesi	FERRIPROX	deferiprone	TABLET;ORAL	212269	NDA	Chiesi USA, Inc.	10122-104-05	50 TABLET in 1 BOTTLE, PLASTIC (10122-104-05)	2020-05-19

Suppliers for the Pharmaceutical Drug: Ferriprox (Deferiprone)

Last updated: July 31, 2025

Introduction

Ferriprox, the brand name for deferiprone, is an oral iron chelator primarily used to treat iron overload in patients with conditions such as thalassemia major, sickle cell anemia, or other iron-loading anemias. The drug is essential in managing iron accumulation due to frequent transfusions, preventing organ damage, and maintaining patient health. As a critical pharmaceutical, access to Ferriprox hinges on a reliable supply chain rooted in manufacturing companies, authorized distributors, and regional regulatory providers.

This analysis explores the key suppliers of Ferriprox, highlighting manufacturing firms, their global reach, regulatory considerations, and the competitive landscape. Understanding the supply sources is imperative for stakeholders including healthcare providers, pharmaceutical distributors, and investors aiming for continuity, affordability, and regulation compliance.

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Manufacturers of Ferriprox (Deferiprone)

1. Apotex Inc.

Overview:
Apotex, a Canadian pharmaceutical company, is a significant manufacturer of deferiprone, including Ferriprox. While originally producing generic formulations, Apotex has secured licensing agreements in multiple regions, extending access to deferiprone globally.

Manufacturing & Distribution:
Apotex's facilities are compliant with Good Manufacturing Practices (GMP). Their distribution network spans North America, Latin America, and parts of Asia. In recent years, Apotex expanded its manufacturing capacity to meet increasing demand, especially in regions with high prevalence of iron overload in transfusion-dependent patients.

Regulatory Approvals:
Apotex's deferiprone formulations are approved in Canada, certain Latin American countries, and are registered under various regulatory agencies, including the U.S. FDA through partnerships or import authorizations.

2. Zydus Cadila

Overview:
Zydus Cadila, based in India, is a key supplier of deferiprone under its brand name Desferriprox. Zydus manufactures deferiprone at its GMP-certified facilities, serving both domestic and international markets.

Manufacturing & Distribution:
Zydus’s production facilities are approved by the Drugs Controller General of India (DCGI). Their distribution network covers Asia, the Middle East, and Africa. The company manufactures both branded and generic versions, providing a cost-effective solution for regions with limited healthcare budgets.

Regulatory Approvals:
Zydus’s deferiprone is approved in India and has received approval or registration in several other countries through registration and import licenses.

3. Anhui Biochem council (China)

Overview:
Anhui Biochem, a Chinese biotechnology firm, has developed deferiprone formulations that serve local markets and are increasingly seeking approval for export. Their role as a supplier is primarily regional but expanding.

Manufacturing & Distribution:
Their facilities are GMP-compliant, and they have partnerships with domestic distributors. The Chinese government’s push to integrate traditional and modern medicines has facilitated Anhui Biochem’s entry into international markets.

Regulatory Approvals:
Currently, their deferiprone products are approved by Chinese regulatory authorities; international approvals are pending or under review.

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Authorized Distributors and Suppliers

While large manufacturing firms are primary suppliers, regional authorized distributors play critical roles in ensuring accessibility, especially in low- and middle-income countries:

• Hetero Labs (India): Distributes generic deferiprone across India and neighboring markets.
• Aurobindo Pharma: Provides deferiprone formulations in select Asian markets.
• Teva Pharmaceuticals: As a major generic manufacturer, Teva supplies deferiprone in North America and Europe through licensing agreements.

Note: The availability and licensing status of Ferriprox vary based on regional regulations. Some countries rely on imports of generic deferiprone formulations, while others have local manufacturing.

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Regulatory Considerations and Impact on Supply

Regulatory approval influences the supply chain dynamics of Ferriprox:

• FDA and EMA Approvals: Currently, Ferriprox is approved by the U.S. FDA and EMA, primarily based on the originator drug and licensed generics. This impacts the number of suppliers and competitive pricing.
• Regional Approvals: Many generic manufacturers obtain registration through local regulatory agencies like India's DCGI, Brazil’s ANVISA, or China's NMPA.
• Supply Chain Risks: Regulatory delays, manufacturing disruptions, or patent issues can threaten supply stability. For example, patent protections in certain markets may limit licensing or generic entry.

Global Supply Landscape and Challenges

The global supply landscape for Ferriprox faces multiple challenges:

• Manufacturing Capacity: Few firms hold extensive manufacturing capacity due to the specialized nature of iron chelators.
• Price Pressures: Generic manufacturers increase accessibility but may face quality control issues if manufacturing standards are lax.
• Patent & Licensing Constraints: Patent protections in the U.S. and Europe influence the number of suppliers and market competition.
• Regulatory Barriers: Regional approval processes can delay the entry of new suppliers and limit supply diversity.

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Conclusion

The supply of Ferriprox (deferiprone) hinges on a handful of key manufacturing firms, predominantly Apotex in North America, Zydus Cadila in India, and Anhui Biochem in China. These entities, along with regional distributors, form a supply network that ensures access to this critical medication across diverse geographies. Their ability to meet regulatory standards, manufacturing demands, and respond to regional needs will determine the drug’s availability.

In an evolving regulatory environment and competitive landscape, stakeholders must monitor manufacturing capacity expansions, licensing arrangements, and regional approval statuses to sustain supply continuity, patient safety, and cost management.

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Key Takeaways

• Major Manufacturers: Apotex Inc., Zydus Cadila, and Anhui Biochem are primary producers of deferiprone globally.
• Regional Distribution: Licensed generic manufacturers and authorized distributors facilitate access across different markets.
• Regulatory Impact: Approvals by agencies like the FDA, EMA, DCGI, and NMPA significantly influence supply stability.
• Supply Challenges: Capacity limitations, patent protection, and regional regulatory hurdles may impact availability.
• Strategic Monitoring: Stakeholders should closely follow licensing agreements, manufacturing capacity, and regional approvals to mitigate risks.

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FAQs

1. Which companies are the largest suppliers of Ferriprox globally?
Apotex Inc. (Canada), Zydus Cadila (India), and Anhui Biochem (China) are the primary manufacturers, supplying deferiprone to multiple regions.

2. Is Ferriprox available as a generic medication?
Yes, multiple generics of deferiprone are available, primarily produced by companies like Apotex and Zydus Cadila, under various brand names or as unbranded generics.

3. How does regulatory approval affect the supply chain of Ferriprox?
Regulatory approvals determine manufacturing licenses and market access. Approval delays or restrictions can limit supply and impact drug availability.

4. Are there regional differences in Ferriprox manufacturing and supply?
Yes, manufacturing is concentrated in specific regions (North America, India, China), with local distributors ensuring access in their respective markets.

5. What are the main challenges in ensuring a stable supply of Ferriprox?
Limited manufacturing capacity, patent protections, regulatory delays, and regional approval disparities pose ongoing challenges.

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References

[1] U.S. Food and Drug Administration (FDA). Ferriprox Drug Approval Details.
[2] European Medicines Agency (EMA). Deferiprone Summary of Product Characteristics.
[3] Apotex Inc. Corporate Website and Product Portfolio.
[4] Zydus Cadila. Official Website and Regulatory Filings.
[5] Chinese NMPA. Anhui Biochem Pharma Approvals and Regulatory Status.