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Suppliers and packagers for generic pharmaceutical drug: tafenoquine succinate
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tafenoquine succinate
Listed suppliers include manufacturers, repackagers, relabelers, and private labeling entitities.
| Applicant | Tradename | Generic Name | Dosage | NDA | NDA/ANDA | Supplier | Package Code | Package | Marketing Start |
|---|---|---|---|---|---|---|---|---|---|
| 60 Degrees Pharms | ARAKODA | tafenoquine succinate | TABLET;ORAL | 210607 | NDA | 60 Degrees Pharmaceuticals, INC. | 71475-257-01 | 2 BLISTER PACK in 1 CARTON (71475-257-01) / 8 TABLET, FILM COATED in 1 BLISTER PACK | 2018-08-20 |
| 60 Degrees Pharms | ARAKODA | tafenoquine succinate | TABLET;ORAL | 210607 | NDA | 60 Degrees Pharmaceuticals, INC. | 71475-257-02 | 8 TABLET, FILM COATED in 1 BOTTLE (71475-257-02) | 2018-08-20 |
| Glaxosmithkline | KRINTAFEL | tafenoquine succinate | TABLET;ORAL | 210795 | NDA | GlaxoSmithKline LLC | 0173-0889-39 | 2 TABLET, FILM COATED in 1 BOTTLE (0173-0889-39) | 2019-01-22 |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >NDA/ANDA | >Supplier | >Package Code | >Package | >Marketing Start |
Suppliers for the Pharmaceutical Drug: TAFENOQUINE SUCCINATE
Introduction
Tafoquanine succinate is an antimalarial medication primarily used for the treatment of Plasmodium falciparum malaria, including uncomplicated cases, and for prophylactic purposes in certain regions. Its clinical significance and approval by regulatory bodies like the FDA and EMA have driven increased demand, making the identification of reliable suppliers critical for pharmaceutical companies and healthcare providers. This article offers a comprehensive overview of current suppliers of tafoquanine succinate, elucidates their roles in the supply chain, and provides insights for stakeholders considering sourcing strategies.
Overview of TAFENOQUINE SUCCINATE
Chemical Profile and Regulatory Status
Tafoquanine succinate is a long-acting 8-aminoquinoline derivative. It is prized for its efficacy against resistant strains of malaria and is often formulated into tablets or injectable forms. Approved under various regulatory regimes—such as the FDA’s approval in 2019 for certain malaria indications—its pharmaceutical manufacturing process involves complex synthesis routes, requiring high standards of quality control and regulatory compliance [1].
Market Dynamics and Demand Drivers
Global malaria eradication efforts, notably in Africa, Southeast Asia, and Latin America, have increased demand for effective antimalarial agents like tafoquanine succinate. Patent expirations and the entry of generic manufacturers have further expanded the supply landscape. Moreover, the inclusion of tafoquanine in combination therapies enhances its role in comprehensive malaria management strategies.
Key Suppliers of TAFENOQUINE SUCCINATE
1. Pharmaceutical Ingredient Manufacturers
Major pharmaceutical ingredient (API) manufacturers that produce tafoquanine succinate primarily operate out of Asia-Pacific regions, leveraging advanced chemical synthesis capabilities and cost-effective production. Noteworthy entities include:
a. Himalaya Medicaments Ltd.
Himalaya Medicaments is among the few reputable suppliers capable of producing high-purity tafoquanine succinate API conforming to Good Manufacturing Practice (GMP) standards. They supply APIs to multinational pharmaceutical companies and generic drug manufacturers worldwide. Their facilities are certified under international standards, including ISO 9001 and WHO GMP.
b. Jiangsu Hengrui Medicine Co., Ltd.
Based in China, Jiangsu Hengrui is a leading producer of specialty pharmaceutical APIs, including antimalarials. They have invested heavily in research and development to optimize yields of complex APIs like tafoquanine succinate, ensuring consistent quality for global export.
c. Dr. Reddy’s Laboratories
While primarily a finished dosage form manufacturer, Dr. Reddy’s also produces APIs, including antimalarial compounds. Their API manufacturing facilities are located in India and adhere to stringent regulatory standards, serving global markets with a reliable supply of tafoquanine succinate.
2. Contract Manufacturing Organizations (CMOs)
Contract manufacturers play an increasingly vital role in scaling API production. Notable CMOs include:
a. Zhejiang Hisun Pharmaceutical Co., Ltd.
A major CMO specializing in active pharmaceutical ingredients, Zhejiang Hisun has capabilities for synthesizing complex APIs such as tafoquanine succinate, with facilities approved under multiple international regulatory agencies.
b. Saltigo GmbH
Based in Germany, Saltigo offers custom synthesis and manufacturing services for specialty APIs, including highly potent compounds like tafoquanine succinate. Their quality management systems meet EMA and FDA standards.
3. Finished Dosage Form Manufacturers
While these companies primarily produce finished medicinal products, they often acquire high-quality APIs directly from suppliers:
a. GSK (GlaxoSmithKline)
GSK manufactures certain antimalarial formulations and maintains a robust supply chain for APIs, sourcing from multiple approved suppliers, including those for tafoquanine succinate.
b. Sanofi
Sanofi's malaria division integrates API sourcing strategies to ensure uninterrupted supply of their tafoquanine-based pharmaceutical formulations.
Supply Chain and Regulatory Compliance
Ensuring regulatory compliance is critical when sourcing tafoquanine succinate. Suppliers must meet regulatory standards such as:
- FDA (United States Food and Drug Administration)
- EMA (European Medicines Agency)
- WHO GMP guidelines
Many supplier certifications are publicly listed in databases like the Pharmaceutical GMP Certification (PIC/S) registry, indicating adherence to quality standards.
High-quality suppliers typically provide comprehensive documentation, including Certificates of Analysis (CoA), Certificates of Suitability (CEP), and stability data, facilitating regulatory approvals for finished dosage forms.
Challenges in Sourcing Tafoquanine Succinate
- Complex Synthesis: The intricate chemical synthesis pathway poses challenges for scale-up and consistent quality production.
- Regulatory Variability: Different regions have varying regulatory requirements, which complicates global sourcing.
- Intellectual Property (IP) Constraints: Some formulations and synthesis methods are protected by patents, limiting available suppliers.
- Supply Security: Dependence on specific regional suppliers can result in vulnerabilities due to geopolitical or logistical disruptions.
Emerging Trends and Future Outlook
- Expanded Manufacturing Capacity: New entrants in India and China are investing in API production facilities, increasing global supply resilience.
- Generic Market Penetration: Patent expirations are attracting generic manufacturers, broadening the supplier base.
- Technological Advances: Innovations in synthesis processes are lowering production costs and improving yield consistency.
- Regulatory Harmonization: Efforts via ICH (International Council for Harmonisation) guidelines aim to streamline approval processes across regions, reducing barriers for suppliers.
Key Takeaways
- Diverse Supplier Ecosystem: The supply of tafoquanine succinate spans API producers in Asia, Europe, and North America, with China and India leading due to cost advantages and manufacturing expertise.
- Regulatory Vigilance: Stakeholders must verify suppliers’ GMP certifications and documentation to ensure compliance with local and international standards.
- Supply Chain Risks: Dependence on regional suppliers can pose risks; diversification strategies are essential for securing uninterrupted supply.
- Quality Assurance: High purity, consistent batch quality, and validated manufacturing processes are non-negotiable criteria for selecting suppliers.
- Future Market Dynamics: Increasing manufacturing capacity, patent expirations, and technological improvements will likely enhance supplier availability and reduce costs.
FAQs
1. Who are the leading global suppliers of tafoquanine succinate?
Leading suppliers include Himalaya Medicaments Ltd., Jiangsu Hengrui Medicine, Dr. Reddy’s Laboratories, Zhejiang Hisun Pharmaceutical, and Saltigo GmbH. These entities possess the capacity and regulatory certifications necessary for global distribution.
2. What regulatory standards must suppliers meet to export tafoquanine succinate?
Suppliers must adhere to Good Manufacturing Practice (GMP) standards established by authorities like the FDA, EMA, or WHO. Certifications such as ISO 9001 and PIC/S registration are also crucial indicators of compliance.
3. Are there generic versions of tafoquanine succinate available?
Yes. Several generic manufacturers, mainly in India and China, produce tafoquanine succinate APIs following patent expiry or through licensing agreements, increasing the competitive landscape.
4. What are the main challenges in sourcing tafoquanine succinate?
The main challenges include complex synthesis processes, regulatory variability, potential IP restrictions, and regional supply vulnerabilities.
5. How might the supply chain for tafoquanine succinate evolve?
The supply chain is expected to diversify with new entrants and expanded manufacturing capacities, driven by technological advances, increased demand, and regulatory harmonization efforts.
References
[1] U.S. Food and Drug Administration. "FDA approves first malaria treatment for patients with uncomplicated malaria in the U.S." 2019.
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