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Suppliers and packagers for generic pharmaceutical drug: CHLOROQUINE PHOSPHATE
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CHLOROQUINE PHOSPHATE
Listed suppliers include manufacturers, repackagers, relabelers, and private labeling entitities.
| Applicant | Tradename | Generic Name | Dosage | NDA | NDA/ANDA | Supplier | Package Code | Package | Marketing Start |
|---|---|---|---|---|---|---|---|---|---|
| Impax Labs | CHLOROQUINE PHOSPHATE | chloroquine phosphate | TABLET;ORAL | 080880 | ANDA | Amneal Pharmaceuticals of New York LLC | 0115-2790-02 | 500 TABLET in 1 BOTTLE (0115-2790-02) | 2022-05-10 |
| Impax Labs | CHLOROQUINE PHOSPHATE | chloroquine phosphate | TABLET;ORAL | 080880 | ANDA | Amneal Pharmaceuticals of New York LLC | 0115-2790-06 | 50 TABLET in 1 BOTTLE (0115-2790-06) | 2022-05-10 |
| Impax Labs | CHLOROQUINE PHOSPHATE | chloroquine phosphate | TABLET;ORAL | 040516 | ANDA | Amneal Pharmaceuticals of New York LLC | 0115-7010-01 | 100 TABLET in 1 BOTTLE (0115-7010-01) | 2022-05-10 |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >NDA/ANDA | >Supplier | >Package Code | >Package | >Marketing Start |
Suppliers for the Pharmaceutical Drug: Chloroquine Phosphate
Introduction
Chloroquine phosphate, a synthetic aminoquinoline derivative, has historically been used as an antimalarial agent and has garnered renewed interest as a potential treatment for emerging infectious diseases, including COVID-19. Its widespread application necessitates a reliable supply chain, comprising raw material producers, active pharmaceutical ingredient (API) manufacturers, and formulation companies. This report explores current suppliers of chloroquine phosphate, emphasizing their manufacturing capacity, geographic distribution, regulatory compliance, and market presence.
Global Supply Landscape
The global supply of chloroquine phosphate is concentrated among a handful of major pharmaceutical and chemical manufacturers primarily based in Asia, Europe, and North America. The surge in demand during health crises, such as the COVID-19 pandemic, exposed vulnerabilities in the supply chain, prompting governments and pharmaceutical companies to diversify their sourcing strategies.
Major API Manufacturers
1. Yunnan Pharmacy (China)
Yunnan Pharmacy is among the leading manufacturers of chloroquine phosphate globally. Based in China, the company produces both the API and finished pharmaceutical products. They possess Good Manufacturing Practice (GMP) certification, catering to markets across Asia, Africa, and Latin America.
2. Zhejiang Hisun Pharmaceutical Co., Ltd. (China)
This major Chinese pharmaceutical firm accounts for significant API production of chloroquine phosphate. With extensive experience in antimalarial drug manufacturing, Hisun Pharma supplies both bulk API and formulation-ready materials to global markets, complying with international regulatory standards.
3. Guilin Gelatin Pharmaceutical Co., Ltd. (China)
Guilin Gelatin produces chloroquine phosphate API with certification aligned to international standards. Their API is exported to various countries, supported by their established distribution networks.
4. Sun Pharmaceutical Industries Ltd. (India)
Sun Pharma, one of India’s largest pharmaceutical companies, produces chloroquine phosphate for both domestic and international markets. Their robust R&D and manufacturing facilities ensure high-quality API consistent with global compliance requirements.
5. Zydus Cadila (India)
Zydus Cadila manufactures chloroquine phosphate API with GMP compliance. The company’s extensive portfolio in antimalarial therapeutics underscores its capacity to supply large quantities of API to global markets.
Suppliers in Europe and North America
While Asian manufacturers dominate API production, some European and North American firms focus on pharmaceutical formulation rather than bulk API production of chloroquine phosphate. Notable companies include:
- Molekula Ltd. (UK): Specializes in custom synthesis and sourcing of APIs, including chloroquine phosphate for research and pharmaceutical applications.
- Hubei Hongjing Pharmaceutical Co., Ltd. (China but with international partnerships): Produces bulk API with exports directed to European pharmaceutical firms.
Sourcing and Regulatory Considerations
When procuring chloroquine phosphate, purchasers should prioritize suppliers with:
- GMP certification aligned with the World Health Organization (WHO) or respective national agencies.
- Documentation of quality control tests, including assay and impurity profiles.
- Traceability and transparency across the supply chain.
The US Food and Drug Administration (FDA), European Medicines Agency (EMA), and other regulatory authorities require detailed documentation and adherence to strict quality standards for both raw materials and finished products.
Market Dynamics and Supply Challenges
The COVID-19 pandemic caused unprecedented demand for chloroquine phosphate, leading to supply shortages and intensified scrutiny of manufacturing capacities. Manufacturing bottlenecks, geopolitical factors, quality concerns, and export restrictions have influenced global availability. Consequently, pharmaceutical companies increasingly seek diversified sources and engage in bulk purchasing agreements to ensure uninterrupted supply.
Recent geopolitical tensions, notably between the U.S. and China, have prompted efforts for regional manufacturing capacity expansion in India, Europe, and North America. Initiatives include investments in API production facilities and the development of alternative synthesis routes to mitigate reliance on a limited number of suppliers.
Future Outlook
The supply chain for chloroquine phosphate is poised for growth driven by renewed clinical interest, demand in endemic regions, and research activities. Enhancing manufacturing capacity and ensuring compliance with international standards will remain strategic priorities for suppliers and buyers. Moreover, the development of synthetic alternatives or novel formulations may influence the long-term landscape.
Key Factors for Stakeholders
- Due diligence on supplier quality certifications
- Monitoring geopolitical and trade developments
- Establishing multi-source procurement strategies
- Investing in supply chain resilience and contingency planning
- Aligning procurement with evolving regulatory guidelines
Key Takeaways
- Asia dominates the chloroquine phosphate API market, with Chinese and Indian manufacturers leading production capacities.
- Regulatory compliance is vital; suppliers should possess reputable GMP certifications and transparent quality documentation.
- Market volatility during health crises necessitates diversified sourcing and secure supply agreements.
- Manufacturing expansions in India and Europe aim to mitigate supply constraints and reduce dependency on single regions.
- Ongoing research and geopolitical factors will shape the future landscape, requiring stakeholders to remain agile and informed.
Frequently Asked Questions (FAQs)
1. Who are the top global suppliers of chloroquine phosphate API?
Chinese firms such as Yunnan Pharmacy and Zhejiang Hisun Pharmaceutical, along with Indian companies like Sun Pharma and Zydus Cadila, are the leading API producers with substantial export capacity and regulatory compliance.
2. What quality standards should buyers look for in suppliers?
Buyers should prioritize suppliers with GMP certification according to WHO, FDA, or EMA standards, along with comprehensive quality control documentation, including assay certificates and impurity profiles.
3. How has COVID-19 affected the supply chain for chloroquine phosphate?
The pandemic caused surges in demand, resulting in supply shortages, production bottlenecks, and export restrictions, prompting supply chain diversification efforts worldwide.
4. Are there regional alternatives to Chinese and Indian suppliers?
European-based companies like Molekula and select North American firms provide sourcing options, though their capacities are generally smaller. Regional manufacturing investments aim to improve availability.
5. What future trends could impact the supply of chloroquine phosphate?
Potential trends include increased manufacturing capacities, regulatory shifts, geopolitical influences, and the development of alternative drugs or formulations affecting demand and supply dynamics.
References
[1] World Health Organization. (2020). Model List of Essential Medicines.
[2] U.S. Food and Drug Administration. (2021). Guidance for Industry on API Quality Standards.
[3] GlobalData. (2022). Pharmaceutical Industry Analysis, API Market Report.
[4] Industry Sources. (2023). Market Reports on Antimalarial Drug Supply Chains.
[5] Pharmaceutical Technology. (2022). Impact of COVID-19 on Pharmaceutical Ingredients Manufacturing.
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