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Suppliers and packagers for generic pharmaceutical drug: DEFEROXAMINE MESYLATE
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DEFEROXAMINE MESYLATE
Listed suppliers include manufacturers, repackagers, relabelers, and private labeling entitities.
| Applicant | Tradename | Generic Name | Dosage | NDA | NDA/ANDA | Supplier | Package Code | Package | Marketing Start |
|---|---|---|---|---|---|---|---|---|---|
| Fresenius Kabi Usa | DEFEROXAMINE MESYLATE | deferoxamine mesylate | INJECTABLE;INJECTION | 078718 | ANDA | Fresenius Kabi USA, LLC | 63323-597-10 | 1 VIAL in 1 BOX (63323-597-10) / 5.3 mL in 1 VIAL | 2009-12-15 |
| Fresenius Kabi Usa | DEFEROXAMINE MESYLATE | deferoxamine mesylate | INJECTABLE;INJECTION | 078718 | ANDA | Fresenius Kabi USA, LLC | 63323-599-30 | 1 VIAL in 1 BOX (63323-599-30) / 21.1 mL in 1 VIAL | 2009-12-15 |
| Gland | DEFEROXAMINE MESYLATE | deferoxamine mesylate | INJECTABLE;INJECTION | 207384 | ANDA | Apotex Corp. | 60505-6236-6 | 4 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 CARTON (60505-6236-6) | 2021-11-05 |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >NDA/ANDA | >Supplier | >Package Code | >Package | >Marketing Start |
Suppliers for the Pharmaceutical Drug: Deferoxamine Mesylate
Introduction
Deferoxamine mesylate (DFO) is a potent iron chelator widely used in clinical settings to treat acute iron poisoning and chronic iron overload caused by conditions like thalassemia and other hemoglobinopathies. Its efficacy in binding excess iron and facilitating its excretion has cemented its importance in pharmacotherapy. Given the critical nature of this drug, a reliable supply chain governed by quality assurance standards is essential for healthcare providers and pharmaceutical distributors worldwide. This report examines the primary suppliers of deferoxamine mesylate, analyzing their manufacturing capabilities, regulatory compliance, market presence, and strategic positioning.
Manufacturers and Key Suppliers of Deferoxamine Mesylate
Several manufacturers globally produce deferoxamine mesylate, with a concentration of supply originating from Italy, China, India, and some European countries. The supply chain involves both branded pharmaceutical companies and generic drug manufacturers, each contributing to global availability.
1. Novartis AG
Overview and Market Presence
Novartis is a Swiss multinational pharmaceutical company with a historic footprint in developing and marketing deferoxamine mesylate. Its product, Desferal, remains one of the most recognized brands internationally. Novartis has established manufacturing facilities compliant with international Good Manufacturing Practices (GMP), ensuring high-quality standards ([2]).
Manufacturing Capabilities
Novartis leverages advanced synthetic chemistry and fermentation technologies to produce deferoxamine mesylate. Its global distribution infrastructure ensures supply security and regulatory adherence.
2. Sandoz (Novartis division)
Overview and Market Role
Sandoz specializes in generic pharmaceuticals and biosimilars, including deferoxamine mesylate. It offers cost-effective alternatives to branded products, expanding access especially in emerging markets.
Manufacturing Capabilities
Sandoz’s manufacturing units in India and Europe meet stringent GMP standards. The company emphasizes consistent quality and supply chain transparency.
3. Cadila Healthcare / Zydus Cadila
Overview and Regional Significance
An Indian-based pharmaceutical company, Zydus Cadila, manufactures deferoxamine mesylate as part of its portfolio of injectable drugs. With FDA and EMA approvals, Zydus supplies domestically and exports to multiple regions.
Manufacturing Capabilities
Zydus operates multiple facilities adhering to GMP standards, with certifications from USFDA, EMA, and other regulatory bodies. Its focus on cost-effective production makes it a significant regional supplier ([3]).
4. Sichuan Huagang Pharmaceutical Co., Ltd.
Overview and Regional Significance
A China-based manufacturer, Sichuan Huagang specializes in injectable drugs, including deferoxamine mesylate. Its production facilities have accreditations from Chinese regulatory authorities and are increasingly gaining international recognition.
Manufacturing Capabilities
The company emphasizes quality assurance through modern GMP-certified facilities and has expanded export channels into Asia, Africa, and Europe.
5. Other Notable Suppliers
- Ningbo Futura Medical, China
- Shandong Deyi Pharmaceutical Co., Ltd.
- Lunan Pharmaceutical Group Co., Ltd.
These companies are emerging players targeting niche markets with cost-competitive products, often registered and approved within regional regulatory frameworks.
Regulatory and Quality Standards in Supply
The majority of reputable suppliers adhere to rigorous GMP standards mandated by agencies such as the US Food and Drug Administration (FDA), European Medicines Agency (EMA), and China's National Medical Products Administration (NMPA). These certifications ensure that deferoxamine mesylate supplied meets pharmacopoeial requirements (e.g., USP, EP, JP). Additionally, suppliers engaged in international markets often possess ISO certifications and possess validation processes for production, quality control, and distribution.
Market Dynamics and Supply Chain Considerations
The global demand for deferoxamine mesylate correlates with the prevalence of iron overload diseases and the rising incidence of conditions like thalassemia, especially in the Middle East, Southeast Asia, and Africa. While manufacturing capacity is projected to increase, potential shortages can arise from raw material supply disruptions, geopolitical factors, and regulatory delays.
The COVID-19 pandemic accentuated vulnerabilities within the supply chain, prompting healthcare providers and government agencies to diversify sources and maintain buffer stocks. Strategic partnerships with large manufacturers mitigate risks, ensuring uninterrupted supply to critical care facilities.
Emerging Trends and Future Outlook
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Generic Expansion: The presence of multiple generic manufacturers enhances supply resilience and competitiveness, often resulting in reduced prices.
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Biotechnological Innovations: Although deferoxamine is traditionally chemically synthesized, ongoing research explores alternative formulations and delivery mechanisms to enhance efficacy and safety.
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Regional Production Growth: Countries like India and China are bolstering manufacturing capacities to meet domestic and international demand, aligning with global GMP standards.
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Regulatory Harmonization: Initiatives by ICH (International Conference on Harmonisation) facilitate streamlined approvals, enabling quicker market entry for new suppliers.
Key Challenges
- Quality Variability: Ensuring consistent drug quality across diverse manufacturing sites remains critical.
- Supply Chain Disruptions: Political instability, trade restrictions, and raw material shortages pose risks.
- Pricing and Accessibility: Cost considerations influence procurement decisions, especially in low-income regions.
Conclusion
Multiple reputable suppliers globally manufacture deferoxamine mesylate, with Novartis and Sandoz leading in branding and generics respectively. Indian and Chinese manufacturers bolster regional supplies, contributing significantly to global availability. Supply security depends on adherence to global GMP standards, regulatory compliance, and resilient distribution networks. While supply chains are currently robust, continuous monitoring and diversification remain crucial to prevent shortages and ensure patient access.
Key Takeaways
- Market Leaders: Novartis and Sandoz dominate the global market, offering branded and generic deferoxamine mesylate, respectively.
- Regional Variants: Indian and Chinese manufacturers play pivotal roles in regional supply, often at lower costs.
- Quality Assurance: GMP compliance and regulatory approvals from leading agencies are essential for reliable supply.
- Supply Risks: Raw material availability, geopolitical factors, and global crises can impact manufacturing and distribution.
- Strategic Procurement: Healthcare providers should prioritize suppliers with certified quality systems and diversified manufacturing sites to secure uninterrupted access.
FAQs
1. Which are the primary global suppliers of deferoxamine mesylate?
Novartis and Sandoz are the leading international suppliers, with significant contributions from Indian companies like Zydus Cadila and Chinese manufacturers such as Sichuan Huagang.
2. How does manufacturing quality affect supply reliability?
Manufacturers compliant with GMP and possessing rigorous quality controls ensure consistent drug efficacy and safety, reducing risks of shortages related to recalls or regulatory actions.
3. Are there regional differences in deferoxamine mesylate availability?
Yes. Developed markets mainly rely on established multinationals, while growing economies depend heavily on regional manufacturers, which can influence pricing and supply stability.
4. What are potential challenges in sourcing deferoxamine mesylate?
Challenges include raw material shortages, regulatory delays, geopolitical issues, and logistical disruptions, especially during global crises like the COVID-19 pandemic.
5. How can healthcare providers mitigate supply risks?
Diversifying suppliers, maintaining strategic stockpiles, and engaging with manufacturers holding multiple GMP certifications can improve supply security.
References
[1] European Pharmacopoeia. Deferoxamine Mesylate Monograph. 2019.
[2] Novartis Annual Report. 2022.
[3] Zydus Cadila Official Website. Product Catalog. 2023.
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