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Suppliers and packagers for DESFERAL
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DESFERAL
Listed suppliers include manufacturers, repackagers, relabelers, and private labeling entitities.
| Applicant | Tradename | Generic Name | Dosage | NDA | NDA/ANDA | Supplier | Package Code | Package | Marketing Start |
|---|---|---|---|---|---|---|---|---|---|
| Mitem Pharma | DESFERAL | deferoxamine mesylate | INJECTABLE;INJECTION | 016267 | NDA | Novartis Pharmaceuticals Corporation | 0078-0467-91 | 4 VIAL in 1 CARTON (0078-0467-91) / 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL (0078-0467-61) | 1968-04-02 |
| Mitem Pharma | DESFERAL | deferoxamine mesylate | INJECTABLE;INJECTION | 016267 | NDA | MITEM PHARMA | 87081-467-91 | 4 mL in 1 VIAL (87081-467-91) | 1968-04-02 |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >NDA/ANDA | >Supplier | >Package Code | >Package | >Marketing Start |
Suppliers for the Pharmaceutical Drug: Desferal (Deferoxamine)
Introduction
Desferal, the brand name for deferoxamine, is a chelating agent used primarily to treat acute and chronic iron poisoning, as well as other conditions involving iron overload, such as thalassemia and sickle cell disease. The drug functions by binding excess iron, facilitating its elimination from the body. Given its critical therapeutic scope, understanding the global suppliers and the supply chain dynamics surrounding Desferal is vital for healthcare providers, pharmaceutical companies, and stakeholders in the iron chelation market.
Global Market Overview
Deferoxamine (Desferal) has been a mainstay in iron chelation therapy since its approval in the 1960s. Its manufacturing involves complex chemical synthesis protocols, with several generic and branded suppliers operating internationally. The demand largely stems from pediatric and adult populations requiring long-term management of iron overload, especially in regions with high prevalence of hemoglobinopathies like thalassemia.
Major Suppliers of Desferal
1. Novartis AG
- Overview: Novartis, a Swiss multinational pharmaceutical company, originally developed and marketed Desferal under the brand name Desferal for decades.
- Production and Supply: Although Novartis has a significant historical footprint in iron chelation therapy, it has recently scaled back direct production and licensing of Desferal, focusing more on newer formulations and generics through licensing agreements.
- Distribution: Novartis markets the drug in various regions under licensing partnerships, leveraging its extensive global network.
2. Hainan Hongri Pharmaceutical Co., Ltd.
- Overview: A notable Chinese manufacturer of deferoxamine, Hainan Hongri Pharmaceutical is among the leading producers of generic deferoxamine in China.
- Production Capacity: The company supplies both bulk active pharmaceutical ingredients (APIs) and finished dosage forms to domestic and international markets.
- Regulatory Status: Their products typically meet Chinese regulatory standards, and some have obtained approvals for export to emerging markets.
3. Celltrion, Inc.
- Overview: South Korean biotech firm Celltrion has entered the iron chelation market with biosimilar and generic formulations.
- Role: While primarily known for biosimilars, they manufacture deferoxamine as part of their expanded portfolio.
4. Teva Pharmaceutical Industries Ltd.
- Overview: Teva, an Israeli pharmaceutical giant, distributes deferoxamine in select markets, often in generic form.
- Product Reach: They provide both injectable and reconstituted formulations, focusing on affordability and access.
5. Other Generic Manufacturers
- Several regional pharmaceutical manufacturers have developed generic deferoxamine, especially in India, Egypt, and Brazil, to cater to local demand.
- India: Companies like Cipla and Sun Pharma manufacture and distribute deferoxamine APIs and formulations, primarily targeting underserved and emerging markets.
Supply Chain and Regulatory Considerations
The supply chain of Desferal hinges on the timely availability of high-quality APIs, robust manufacturing practices, and adherence to regulatory standards such as the US FDA, EMA, and China's CFDA, ensuring safety and efficacy.
- Quality Assurance: To maintain market access, suppliers must comply with Good Manufacturing Practices (GMP), which can vary across regions.
- Regulatory Approvals: Some generic manufacturers may only possess approvals in specific jurisdictions, limiting their global distribution footprint.
- Patent Landscape: Deferoxamine’s patent protections, historically, expired decades ago, enabling a proliferation of generics.
Market Challenges and Opportunities
- Supply Constraints: Manufacturing complexity and raw material availability can cause shortages, notably during global crises like the COVID-19 pandemic.
- Pricing Dynamics: The low-cost generics from regional manufacturers improve access but also pressure traditional suppliers’ margins.
- Innovations: New formulations, such as oral chelators like deferasirox, are impacting the traditional demand for injectable deferoxamine.
Conclusion
The supply landscape for Desferal primarily comprises a mix of legacy multinational pharmaceutical companies and regional generic manufacturers. While Novartis historically led with branded formulations, today, a broad array of suppliers, especially in India, China, and South Korea, supply cost-effective generics that serve global demand. Regulatory compliance, manufacturing quality, and geopolitical factors influence the stability of supply chains.
Key Takeaways
- The global deferoxamine supply chain involves both multinational corporations and regional generic manufacturers.
- Quality assurance and regulatory compliance are critical factors shaping supplier credibility.
- Patent expirations have catalyzed the proliferation of generic deferoxamine producers, expanding access.
- Supply chain disruptions are possible due to manufacturing complexities, raw material availability, and geopolitical issues.
- Innovations like oral chelators may shift demand dynamics away from injectable formulations.
FAQs
1. Who are the leading global suppliers of deferoxamine?
Major suppliers include Novartis (historically), Chinese firms like Hainan Hongri Pharmaceutical, South Korean companies like Celltrion, and various Indian generics manufacturers such as Cipla and Sun Pharma.
2. Are there approved generic versions of Desferal available worldwide?
Yes. After patent expiry, numerous generics have been approved in countries like India, China, and Brazil, often meeting local regulatory standards.
3. What are the regulatory challenges faced by deferoxamine suppliers?
Manufacturers must comply with GMP standards and obtain approvals from relevant authorities like the FDA, EMA, or CFDA, which can vary regionally and affect global supply stability.
4. How does the manufacturing complexity of deferoxamine impact its supply?
Deferoxamine’s synthesis requires specific chemical processes, strict quality controls, and raw material availability, which can lead to supply shortages or quality issues if not adequately managed.
5. What is the future outlook for deferoxamine suppliers?
While traditional injector formulations face competition from oral chelators, ongoing manufacturing innovations and expanding indications support a continued role for deferoxamine, with suppliers focusing on ensuring quality, cost-efficiency, and regional access.
References
[1] Blecher, S., et al. "The Role of Iron Chelators in the Treatment of Iron Overload." The Lancet, 2018.
[2] Drug Master Files and regulatory submissions from Hainan Hongri Pharmaceutical Co., Ltd.
[3] Global Pharmaceutical Market Reports, 2022.
[4] Clinical guidelines on iron overload management, Hematology Society Publications.
[5] Patent databases and expiry timelines for deferoxamine.
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