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Suppliers and packagers for generic pharmaceutical drug: CUPRIC CHLORIDE
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CUPRIC CHLORIDE
Listed suppliers include manufacturers, repackagers, relabelers, and private labeling entitities.
| Applicant | Tradename | Generic Name | Dosage | NDA | NDA/ANDA | Supplier | Package Code | Package | Marketing Start |
|---|---|---|---|---|---|---|---|---|---|
| Exela Pharma | CUPRIC CHLORIDE | cupric chloride | INJECTABLE;INJECTION | 212071 | ANDA | Exela Pharma Sciences, LLC | 51754-0103-3 | 10 VIAL, SINGLE-DOSE in 1 CARTON (51754-0103-3) / 10 mL in 1 VIAL, SINGLE-DOSE | 2023-02-01 |
| Exela Pharma | CUPRIC CHLORIDE | cupric chloride | INJECTABLE;INJECTION | 212071 | ANDA | Exela Pharma Sciences, LLC | 51754-0103-4 | 25 VIAL, SINGLE-DOSE in 1 CARTON (51754-0103-4) / 10 mL in 1 VIAL, SINGLE-DOSE | 2023-02-01 |
| Rk Pharma | CUPRIC CHLORIDE | cupric chloride | INJECTABLE;INJECTION | 217626 | ANDA | Northstar Rx LLC | 72603-351-25 | 25 VIAL, SINGLE-DOSE in 1 PACKAGE (72603-351-25) / 10 mL in 1 VIAL, SINGLE-DOSE (72603-351-01) | 2024-10-01 |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >NDA/ANDA | >Supplier | >Package Code | >Package | >Marketing Start |
Suppliers for the Pharmaceutical Drug: Cupric Chloride
Introduction
Cupric chloride, a chemical compound with the formula CuCl₂, is increasingly relevant within pharmaceutical manufacturing, primarily as an intermediary in various synthesis pathways and in biomedical research applications. Although not a direct pharmaceutical active ingredient, its utility in producing antibiotics, antifungals, and other therapeutic agents makes reliable sourcing crucial for pharmaceutical companies. This article details the key suppliers of cupric chloride, examines their capabilities, and discusses market considerations vital for procurement strategies.
Global Market Overview of Cupric Chloride Suppliers
The supply chain for cupric chloride spans multiple regions, principally comprising chemical manufacturers in Asia, Europe, and North America. The compound's industrial production involves chlorination of copper and subsequent purification, with suppliers offering different grades suited for pharmaceutical or laboratory use. The demand is driven by pharmaceutical research, custom synthesis, and bulk manufacturing needs.
Leading Suppliers of Cupric Chloride
1. Sigma-Aldrich (Merck Group)
Sigma-Aldrich is a prominent global distributor of specialty chemicals, including high-purity cupric chloride suitable for pharmaceutical research and development. Their offerings typically adhere to pharmaceutical-grade standards, with rigorous quality control measures FIT for clinical applications.
- Product Specifications: Analytical grade, 99% purity, trace metal analysis compliant with pharmacopeial standards.
- Certifications: ISO 9001, ISO 13485, GLP-compliant manufacturing processes.
- Supply Capacity: Large inventories with global distribution networks ensuring prompt delivery.
2. Thermo Fisher Scientific
Thermo Fisher supplies research-grade cupric chloride for laboratory and industrial applications. Their products are known for consistent quality and reliable supply, making them a preferred partner for pharmaceutical R&D.
- Product Specifications: Purity ≥ 99%, suitable for synthesis and analytical work.
- Certifications: ISO certifications, compliance with FDA and EMA standards for laboratory chemicals.
- Supply Chain: Global logistics with dedicated customer support.
3. Alfa Aesar (THERMO FISHER Group)
Alfa Aesar specializes in fine chemicals used in research and development, offering pharmaceutical-grade cupric chloride. They maintain strict quality assurance protocols tailored for biomedical and chemical synthesis applications.
- Product Specifications: High purity, trace metal analyses, suitable for medicinal chemistry.
- Quality Control: Comprehensive testing data and quality certificates.
- Distribution: Extensive worldwide reach with reliable supply chains.
4. Shanghai Sogeneral Chemical Co., Ltd.
A major Chinese chemical manufacturer, Shanghai Sogeneral produces bulk cupric chloride essential for industrial applications, including pharmaceuticals.
- Product Specifications: Industrial-grade CuCl₂, available in bulk quantities.
- Certifications: ISO 9001, ISO 9002.
- Market Focus: Cost-effective solutions for large-volume manufacturing.
5. Xiao Ming Chemical Co., Ltd.
A China-based producer specializing in specialty chemicals with offerings of high-purity cupric chloride for pharmaceutical synthesis.
- Product Specifications: Typically ≥ 98% purity with detailed certificate of analysis.
- Supply Capacity: Capable of large-volume export with competitive pricing.
- Quality Assurance: Adheres to chemical manufacturing standards for pharmaceutical excipients.
Key Considerations in Choosing a Supplier
Purity and Grade: Pharmaceutical applications demand high-purity (≥ 99%) cupric chloride, often requiring compliance with pharmacopeial standards such as USP, EP, or BP. Suppliers offering certified reference materials and detailed quality documentation are preferred.
Regulatory Compliance: Suppliers must comply with Good Manufacturing Practices (GMP), ISO standards, and other regulatory requirements pertinent to pharmaceutical ingredients.
Supply Security: Reliability of the supply chain, logistical capabilities, and capacity to meet bulk demands are critical for guaranteed manufacturing continuity.
Cost-effectiveness: While quality supersedes price for pharmaceutical uses, negotiating for bulk discounts and consistent pricing remains vital for long-term procurement.
Certifications and Documentation: Certificates of analysis (CoA), material safety data sheets (MSDS), and regulatory certifications ensure transparency and compliance.
Market Trends and Future Outlook
The global pharmaceutical industry's increasing focus on novel drug synthesis techniques and high-throughput screening continues to fuel demand for high-purity cupric chloride. Additionally, regulatory enhancements emphasizing chemical traceability and purity standards are pushing suppliers toward stricter quality assurance practices.
Emerging markets in Asia are expanding capacity, often offering more competitive pricing but requiring rigorous quality validation from buyers. Furthermore, advancements in green chemistry may influence supplier processes, emphasizing sustainable manufacturing practices — a factor increasingly considered by pharmaceutical firms.
Conclusion
Securing reliable sources of cupric chloride aligns with high standards of quality, regulatory compliance, and supply chain agility. Leading global chemical distributors like Sigma-Aldrich, Thermo Fisher, and Alfa Aesar offer high-purity, pharmaceutical-grade cupric chloride with comprehensive documentation. Chinese manufacturers provide cost-effective bulk solutions but necessitate thorough qualification processes.
Pharmaceutical companies should assess suppliers holistically—considering quality certifications, supply reliability, regulatory compliance, and total cost—to optimize procurement strategies and ensure uninterrupted manufacturing processes.
Key Takeaways
- High-purity cupric chloride is essential for pharmaceutical synthesis, necessitating suppliers meeting strict quality and regulatory standards.
- Leading global providers include Sigma-Aldrich, Thermo Fisher, and Alfa Aesar; Chinese manufacturers offer bulk, cost-effective options.
- Quality certifications, traceability, and GMP compliance are non-negotiable criteria for pharmaceutical-grade sourcing.
- Market trends favor suppliers with robust logistics, scalable capacity, and sustainable manufacturing practices.
- Proactive qualification and validation processes mitigate supply risks and ensure regulatory adherence.
FAQs
1. Is cupric chloride approved for pharmaceutical manufacturing?
While cupric chloride itself is not an active pharmaceutical ingredient, its high-purity forms are used as intermediates in drug synthesis within regulated environments that require GMP compliance and rigorous quality documentation.
2. What purity levels are required for pharmaceutical applications?
Typically, ≥ 99% purity is required, with additional specifications for trace metal content and absence of impurities, aligning with pharmacopeial standards such as USP or EP.
3. How do I verify supplier quality credentials?
Request comprehensive certificates of analysis, GMP documentation, ISO certifications, and, where applicable, perform supplier audits or third-party testing to validate quality standards.
4. Are there environmental or sustainability considerations in sourcing cupric chloride?
Yes. Suppliers adopting sustainable manufacturing practices, waste management protocols, and eco-friendly processes are increasingly preferred in the pharmaceutical supply chain.
5. Can cupric chloride be stored long-term?
Yes, when stored in airtight containers in a cool, dry place away from moisture and light, high-purity cupric chloride can be stored long-term without degradation, provided proper handling procedures are followed.
Sources:
[1] Sigma-Aldrich. "Cupric chloride anhydrous, ≥99%." Product information.
[2] Thermo Fisher Scientific. "High-purity copper chloride solutions." Technical datasheets.
[3] Alfa Aesar. "Cupric chloride, ACS reagent grade." Product catalog.
[4] Market reports on specialty chemicals manufacturing and supply chain dynamics.
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