Suppliers and packagers for deferasirox

deferasirox

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

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Alkem Labs Ltd	DEFERASIROX	deferasirox	GRANULE;ORAL	213374	ANDA	Ascend Laboratories, LLC	67877-675-84	30 PACKET in 1 CARTON (67877-675-84) / 1 GRANULE in 1 PACKET (67877-675-71)	2020-07-16
Alkem Labs Ltd	DEFERASIROX	deferasirox	GRANULE;ORAL	213374	ANDA	Ascend Laboratories, LLC	67877-676-84	30 PACKET in 1 CARTON (67877-676-84) / 1 GRANULE in 1 PACKET (67877-676-72)	2020-07-16
Alkem Labs Ltd	DEFERASIROX	deferasirox	GRANULE;ORAL	213374	ANDA	Ascend Laboratories, LLC	67877-677-84	30 PACKET in 1 CARTON (67877-677-84) / 1 GRANULE in 1 PACKET (67877-677-73)	2020-07-16
Annora Pharma	DEFERASIROX	deferasirox	GRANULE;ORAL	216229	ANDA	Camber Pharmaceuticals, Inc.	31722-029-32	30 PACKET in 1 CARTON (31722-029-32) / 1 GRANULE in 1 PACKET	2023-03-16

Suppliers for the Pharmaceutical Drug: Deferasirox

Last updated: July 28, 2025

Introduction

Deferasirox is an oral iron chelator primarily used to treat chronic iron overload resulting from repeated blood transfusions, such as in thalassemia, sickle cell disease, and other hematologic disorders. Since its approval by the U.S. Food and Drug Administration (FDA) in 2005 under the brand name Exjade, and later as Jadenu, deferasirox has become a cornerstone in iron overload management. The global supply chain for this critical medication is complex, involving multiple manufacturers, suppliers of active pharmaceutical ingredients (APIs), excipients, and finished dosage forms. Understanding the landscape of deferasirox suppliers is vital for pharmaceutical companies, healthcare providers, and policymakers to ensure uninterrupted access and control over pricing and quality.

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Global Manufacturing and Supply Landscape

The supply chain for deferasirox is predominantly dominated by a set of key manufacturers based in different regions, particularly India, China, and Europe. These manufacturers operate under strict regulatory oversight to meet global quality standards, including Good Manufacturing Practices (GMP) enforced by agencies such as the FDA, European Medicines Agency (EMA), and other national regulatory bodies.

1. Active Pharmaceutical Ingredient (API) Suppliers

APIs form the backbone of pharmaceutical manufacturing, and their quality directly impacts drug efficacy and safety. For deferasirox, several companies supply high-grade APIs:

• Sai Baba Pharmaceuticals Ltd. (India): One of the prominent API producers specializing in iron-chelating agents, Sai Baba supplies deferasirox API for generic formulations. Their capacity is certified by multiple regulatory agencies, and they export to several regions globally.

• Shandong Xinhua Pharmaceutical Co. Ltd. (China): A significant API manufacturer for deferasirox, with facilities accredited by the Chinese FDA and international bodies. They produce bulk API for both domestic and export markets.

• Hetero Labs Ltd. (India): A leading generic pharmaceutical producer, Hetero supplies deferasirox API along with multiple other APIs, leveraging their extensive manufacturing infrastructure.

• MingYang Pharmaceutical (China): An emerging API supplier with GMP certification, focusing on affordable APIs for various chelators, including deferasirox.

2. Finished Dosage Form Manufacturers

• Novartis (Switzerland): Originally developed and marketed deferasirox under the brand name Exjade and Jadenu, Novartis remains a significant producer of finished formulations, although it has largely transitioned manufacturing to third-party suppliers for the generic market.

• Dr. Reddy’s Laboratories (India): An influential generic pharmaceutical company producing deferasirox in tablet form, leveraging licensed APIs from various suppliers.

• Mylan (USA/India): Mylan manufactures deferasirox tablets sourced either through licensed APIs or through partnerships with API suppliers, offering competitively priced options worldwide.

• GENIX Pharma (Pakistan): A regional player manufacturing deferasirox in South Asia, ensuring local supply and affordability.

3. Distributors and Regional Suppliers

Apart from direct manufacturers, numerous regional distributors facilitate the distribution of deferasirox to hospitals, clinics, and pharmacies worldwide. Companies such as IDIS (Indian Drug Import & Supply) and Sun Pharmaceutical Industries often act as intermediaries, sourcing from primary manufacturers and ensuring regional regulatory compliance.

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Regulatory Considerations and Quality Assurance

Suppliers of deferasirox must adhere to strict regulatory standards. In the U.S., the FDA mandates compliance with GMP as part of the New Drug Application (NDA) process. In Europe, the EMA’s Good Manufacturing Practice requirements apply, while in India and China, local regulatory bodies enforce compliance. These standards ensure the API and finished formulations are of high quality, free from contamination, and effective.

Manufacturers often seek approvals from multiple agencies to facilitate global distribution. For example, Indian companies such as Hetero and Dr. Reddy’s have approved manufacturing sites recognized by both US and European authorities facilitating exports to North America and Europe.

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Market Dynamics and Supply Chain Challenges

The supply chain for deferasirox faces several challenges, including:

• Regulatory Hurdles: Stringent approvals and ongoing compliance requirements can create delays or shortages.
• Raw Material Availability: Fluctuations in the supply of raw materials for API synthesis impact production capacity.
• Manufacturing Disruptions: COVID-19 pandemic-related supply chain interruptions and geopolitical issues have temporarily impacted availability.
• Pricing and Patent Issues: While several generic suppliers produce deferasirox, patent expirations have increased market competition, impacting pricing.

Notably, the transition from branded formulations to generics has expanded the pool of suppliers but intensified competition, often leading to price reductions. However, ensuring quality and regulatory compliance remains a priority for procurement agencies.

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Future Outlook

The global demand for deferasirox is expected to grow concomitant with the rise in blood disorders requiring transfusions and iron overload management. As patent protections expire or are litigated, more manufacturers are likely to enter the market, further diversifying the supply base. Additionally, the development of alternative chelators and formulations—such as injectable or long-acting versions—may influence the overall supply landscape.

Emerging suppliers from developing markets are also expanding capacity, driven by increasing healthcare investments and technological advancements. As a result, the supply chain is poised for greater robustness but also demands vigilant quality assurance and regulatory oversight.

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Key Takeaways

• The deferasirox supply chain is globally dispersed, with major API producers in India and China, and finished formulation manufacturing led by both global pharmaceutical firms and regional producers.
• Quality assurances are maintained through strict regulatory compliance, with multiple suppliers holding certifications from authorities such as the FDA, EMA, and local regulators.
• Supply chain challenges include raw material shortages, regulatory delays, and geopolitical disruptions, which can impact drug availability.
• Market dynamics favor increased competition, especially following patent expirations, leading to diverse supplier options and potential cost savings.
• Future growth hinges on expanding manufacturing capacity, regulatory alignment, and ongoing innovation in delivery formulations.

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FAQs

1. Who are the leading API suppliers for deferasirox globally?
Top API suppliers include Sai Baba Pharmaceuticals (India), Shandong Xinhua Pharmaceutical (China), and Hetero Labs (India), all holding GMP certifications to supply high-quality deferasirox API internationally.

2. Are there regional differences in deferasirox supply?
Yes, while India and China dominate API production, finished formulations are supplied by regional manufacturers in South Asia, Southeast Asia, Europe, and North America, ensuring regional access and affordability.

3. How does patent expiration impact the deferasirox supply chain?
Patent expirations have facilitated increased generic manufacturing, diversifying suppliers, reducing costs, and potentially improving drug availability, but also necessitating rigorous quality control.

4. What regulatory requirements do suppliers of deferasirox need to meet?
Suppliers must adhere to GMP standards enforced by agencies like the FDA, EMA, and local authorities, ensuring the safety, efficacy, and quality of both APIs and finished products.

5. What are the future supply chain trends for deferasirox?
Increasing manufacturing capacity in emerging markets, advancements in drug formulations, and stricter regulatory compliance are key trends shaping the future landscape of deferasirox supply.

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Sources

[1] U.S. Food and Drug Administration (FDA). FDA Approved Drugs Database.
[2] European Medicines Agency (EMA). Community Register of Suppliers and Manufacturing Sites.
[3] IQVIA. Global Pharmaceutical Market Reports.
[4] Pharmaceutical Technology. API Manufacturing and Quality Standards.
[5] Industry reports on generic drug markets in India and China.

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This comprehensive overview provides professionals with a detailed understanding of deferasirox suppliers, enabling informed supply chain management, procurement strategies, and market analysis.