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Suppliers and packagers for generic pharmaceutical drug: COPPER
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COPPER
Listed suppliers include manufacturers, repackagers, relabelers, and private labeling entitities.
| Applicant | Tradename | Generic Name | Dosage | NDA | NDA/ANDA | Supplier | Package Code | Package | Marketing Start |
|---|---|---|---|---|---|---|---|---|---|
| Sebela Womens Hlth | MIUDELLA | copper | SYSTEM;INTRAUTERINE | 218201 | NDA | Sebela Women's Health Inc. | 82686-300-01 | 1 TRAY in 1 BOX, UNIT-DOSE (82686-300-01) / 1 INTRAUTERINE DEVICE in 1 TRAY | 2025-10-01 |
| Coopersurgical | PARAGARD T 380A | copper | SYSTEM;INTRAUTERINE | 018680 | NDA | CooperSurgical, Inc. | 59365-5128-1 | 1 POUCH in 1 CARTON (59365-5128-1) / 1 INTRAUTERINE DEVICE in 1 POUCH | 2017-11-02 |
| Coopersurgical | PARAGARD T 380A | copper | SYSTEM;INTRAUTERINE | 018680 | NDA | CooperSurgical, Inc. | 59365-5129-1 | 1 POUCH in 1 CARTON (59365-5129-1) / 1 INTRAUTERINE DEVICE in 1 POUCH | 2024-08-15 |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >NDA/ANDA | >Supplier | >Package Code | >Package | >Marketing Start |
Suppliers for the Pharmaceutical Drug: Copper
Introduction
Copper, a vital trace mineral, plays essential roles in enzymatic reactions and cellular functions. While not classified as a traditional pharmaceutical drug, copper compounds are used therapeutically in medical formulations, including topical antiseptics, wound dressings, and nutritional supplements. The procurement of pharmaceutical-grade copper and its compounds requires a reliable, high-quality supply chain. This article evaluates the primary suppliers of pharmaceutical-grade copper, highlighting their market standing, certification standards, and significance within the industry to support decision-making by pharmaceutical manufacturers, healthcare providers, and investors.
Overview of Copper in Pharmaceuticals
Copper's biomedical applications include antimicrobial agents in wound care, copper-based biocidal textiles, and nutritional supplements. The quality of copper used for such purposes mandates strict compliance with pharmacopoeial standards, such as USP (United States Pharmacopeia), EP (European Pharmacopoeia), or JP (Japanese Pharmacopoeia). These standards stipulate purity levels, contaminant limits, and composition criteria necessary for pharmaceutical use.
Types of Copper and Relevant Specifications
- Copper Metal: Typically supplied in forms such as sheets, rods, or powders, intended for compounding or manufacturing processes.
- Copper Salts: Such as copper sulfate (CuSO₄), used in wound dressings and supplements.
- Copper Complexes: Including chelated forms used in nutritional or therapeutic applications.
The key requirement across all these forms involves high purity (generally 99.9% or higher), minimal heavy metal contamination, and compliance with pharmacopeial standards.
Major Suppliers of Pharmaceutical-Grade Copper
1. Balinit (Part of John Crane/Borealis Solutions)
Overview: A global supplier known for high-quality metal powders, Balinit offers copper powders compliant with pharmaceutical standards. Their supply chain emphasizes purity and traceability, meeting industry regulatory requirements.
Strengths:
- Proven track record within pharmaceutical manufacturing sectors.
- Compliance certifications including ISO 9001:2015 and GMP standards.
- Customizable particle sizes suitable for medical formulations.
2. Umicore
Overview: A Belgian materials technology group specializing in metal products, including high-purity copper powders and compounds. Umicore’s pharmaceutical-grade copper materials are used in sterilization and supplement manufacturing.
Strengths:
- Industry-leading purity levels suitable for pharmaceutical applications.
- Robust supply chains spanning Europe, Asia, and North America.
- Certification adherence to pharmaceutical GMP and food-grade standards.
3. American Elements
Overview: A global leader in advanced materials, American Elements supplies high-purity copper products, including powders, wires, and salts, tailored for biomedical use.
Strengths:
- Extensive product catalog with strict quality control.
- Compliance with USP, EP, and other pharmacopeial standards.
- U.S.-based manufacturing ensures responsiveness and traceability.
4. Atlantic Copper
Overview: A major copper producer based in Spain, Atlantic Copper specializes in cathodes and refined copper suitable for pharmaceutical processing. Their products meet rigorous international standards.
Strengths:
- Certified for pharmaceutical-grade purity.
- Long-standing reputation with established supply chains.
- Ability to supply large bulk quantities necessary for industrial-scale manufacturing.
5. Glencore
Overview: As one of the world’s largest commodity trading and mining companies, Glencore offers copper concentrates, cathodes, and refined copper with pharmaceutical-grade options. Their extensive vertical integration ensures quality and supply stability.
Strengths:
- Global footprint with diversified sourcing.
- Supply chain reliability backed by massive production capacity.
- High transparency and compliance with international standards.
Emerging Suppliers and Niche Providers
In response to increasing demand for specialized copper compounds, numerous niche suppliers and startups focus on high-purity copper salts and complexes, especially for cutting-edge biomedical applications. These suppliers often target niche markets such as wound care devices, antimicrobial textiles, and nutraceuticals.
Quality Assurance and Regulatory Compliance
Suppliers of pharmaceutical copper must adhere to stringent quality assurance protocols, including ISO certifications, Good Manufacturing Practices (GMP), and pharmacopoeial compliance. Traceability, contaminant control, and purity verification tests (inductively coupled plasma mass spectrometry - ICP-MS, for example) are critical in qualifying suppliers for pharmaceutical use.
Market Dynamics and Supply Chain Considerations
The global copper market faces volatility driven by geopolitical factors, environmental regulations, and demand dynamics in renewable energy and electronics sectors, indirectly affecting pharmaceutical-grade copper supplies. Ensuring supplier diversification and inventory management strategies are pivotal for pharmaceutical companies.
Environmental and Ethical Sourcing
Sustainability and responsible sourcing are increasingly critical. Suppliers with verified ethical mining practices, environmental stewardship, and compliance with regulations such as the OECD Due Diligence Guidance offer strategic advantages. Certifications like Responsible Minerals Initiative (RMI) are increasingly valued in procurement processes.
Conclusion
The supply chain for pharmaceutical-grade copper hinges on high purity, regulatory compliance, and reliable delivery. Major players such as Umicore, American Elements, Atlantic Copper, and Glencore provide established, certified sources suitable for pharmaceutical applications. Emerging suppliers and niche providers offer tailored solutions for specialized needs. Companies must prioritize quality assurance, traceability, and sustainability in vendor selection to mitigate risks and meet global regulatory standards.
Key Takeaways
- High-purity copper suppliers for pharmaceuticals include Umicore, American Elements, Atlantic Copper, and Glencore, each with proven quality and compliance credentials.
- Ensuring supplier adherence to pharmacopeial standards, GMP, and environmental regulations is crucial.
- Supply chain diversification mitigates risks due to market volatility and geopolitical factors.
- Transparency, traceability, and ethical sourcing practices are increasingly important in supplier evaluation.
- Buyers should consider future market trends, including sustainability initiatives and technological innovations in copper processing.
FAQs
1. What are the standard purity requirements for pharmaceutical-grade copper?
Pharmaceutical-grade copper typically requires a purity of 99.9% or higher, with strict limits on heavy metals and contaminants as specified by pharmacopeial standards such as USP or EP.
2. How do suppliers verify compliance with pharmaceutical standards?
Suppliers provide certificates of analysis (COA), GMP compliance documentation, and third-party testing reports (e.g., ICP-MS analysis) to verify purity and contaminant levels.
3. Is recycled copper suitable for pharmaceutical applications?
Recycled copper can be used if it adheres to strict purification and testing standards consistent with pharmacopeial requirements. Certification processes ensure recycled materials meet quality benchmarks.
4. What role does sustainability play in copper sourcing for pharmaceuticals?
Sustainability is increasingly emphasized, with suppliers being evaluated for responsible mining practices, environmental impact, and adherence to supply chain due diligence standards like the OECD guidelines.
5. Are there regional differences in supply chain considerations for copper?
Yes; geopolitical stability, trade policies, and local regulations influence availability and cost. European, North American, and Asian suppliers have distinct advantages and challenges depending on the buyer's location.
Sources:
[1] USP. United States Pharmacopeia. Copper Standards.
[2] European Pharmacopoeia. Copper Compounds.
[3] International Copper Association. Market Reports.
[4] Responsible Minerals Initiative. Supply Chain Sustainability.
[5] Glencore Annual Reports. Mining and Supply Chain.
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