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Suppliers and packagers for generic pharmaceutical drug: COPPER HISTIDINATE
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COPPER HISTIDINATE
Listed suppliers include manufacturers, repackagers, relabelers, and private labeling entitities.
| Applicant | Tradename | Generic Name | Dosage | NDA | NDA/ANDA | Supplier | Package Code | Package | Marketing Start |
|---|---|---|---|---|---|---|---|---|---|
| Sentynl Theraps Inc | ZYCUBO | copper histidinate | POWDER;SUBCUTANEOUS | 211241 | NDA | Sentynl Therapeutics, Inc. | 42358-329-01 | 1 VIAL, GLASS in 1 CARTON (42358-329-01) / 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL, GLASS | 2026-01-12 |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >NDA/ANDA | >Supplier | >Package Code | >Package | >Marketing Start |
Suppliers for Copper Histidinate
Copper Histidinate is a specialized supplement administered in clinical and research settings, often associated with copper supplementation therapies. The market for this compound is niche, with suppliers primarily focused on fine chemical manufacturing, pharmaceutical-grade ingredient production, and custom synthesis firms.
Major Suppliers
| Company Name | Location | Capabilities | Product Certification | Notes |
|---|---|---|---|---|
| Thermo Fisher Scientific | United States | Custom synthesis, GMP manufacturing | FDA-approved, cGMP | Supplies laboratory-grade and pharmaceutical-grade copper histidinate through custom synthesis services. |
| Spectrum Chemical | United States | Bulk chemicals, specialty ingredients | USP, EP, FCC standards | Offers commercial quantities of copper salts, including histidinate derivatives. |
| Alfa Aesar (Thermo Fisher) | United Kingdom | Fine chemicals, research compounds | USP, EP standards | Provides high-purity copper compounds, including histidinate compounds via custom order. |
| Toronto Research Chemicals | Canada | Specialty chemicals | Analytical and chemical-grade | Supplies copper salts, with custom synthesis options for histidinate derivatives. |
| Hangzhou J&K Chemical | China | Fine chemicals, custom synthesis | Various quality certifications | Offers zinc, copper histidinate compounds mainly for research and development purposes. |
Key Considerations for Suppliers
- Purity Standards: Vendors should supply copper histidinate conforming to USP, EP, or GMP standards if intended for pharmaceutical use.
- Custom Synthesis: Niche compounds often require custom synthesis capabilities. Verified suppliers offer tailored manufacturing in small or large batches.
- Regulatory Approvals: Check for product documentation including safety data sheets, certificates of analysis, and pharmacopoeia compliance for pharmaceutical applications.
- Lead Times: Synthesis and delivery times vary from product to product. Large suppliers typically provide faster turnaround times.
- Pricing: Cost depends on purity, quantity, and certification level. Bulk orders usually attract discounts.
Market Trends
- The demand for copper-based supplements, including histidinate derivatives, correlates with growth in trace element supplementation in clinical nutrition.
- Suppliers with GMP and FDA-approved processes are preferred for manufacturing pharmaceutical-grade products.
- China remains a leading exporter of research-grade copper salts, with emerging presence in GMP-certified manufacturing.
Sourcing Insights
- Pharmaceutical-Grade Suppliers: Focus on firms with ISO certifications, GMP compliance, and documented batch records.
- Research-Grade Suppliers: Suitable for R&D purposes; they offer lower cost but lack regulatory assurances.
- Custom Synthesis Providers: Offer tailored production for both research and pharmaceutical stages, particularly for low-volume or highly pure requirements.
Considerations for Procurement
- Verify supplier certifications and batch documentation.
- Confirm the product’s conforming standards to intended use.
- Evaluate the supplier’s capacity for large-volume orders if needed.
- Confirm lead times and shipping options.
Key Takeaways
Copper Histidinate is supplied mainly by chemical and pharmaceutical ingredient producers with niche focus on specialty copper compounds. Buyers should prioritize GMP compliance, product certifications, and supplier reliability. Major suppliers include Thermo Fisher Scientific, Spectrum Chemical, Alfa Aesar, Toronto Research Chemicals, and Hangzhou J&K Chemical. Custom synthesis options are available for research and pharma-grade applications.
FAQs
1. Can I source pharmaceutical-grade Copper Histidinate for clinical use?
Yes. Suppliers with GMP certification and proper regulatory documentation, such as Thermo Fisher Scientific or Alfa Aesar, can provide pharmaceutical-grade Copper Histidinate suitable for clinical applications.
2. What purity standards should I look for?
Pharmaceutical-grade Copper Histidinate should meet USP, EP, or equivalent standards, indicating high purity and quality control compliance.
3. Are there regional differences in supplier availability?
Yes. North American and European suppliers often have more GMP-certified options, while China provides research-grade compounds at lower cost, but with variable quality standards.
4. Is custom synthesis necessary for small quantities?
Custom synthesis is often required for quantities below commercial bulk levels, especially for high-purity or specific salt forms.
5. What are typical lead times for sourcing Copper Histidinate?
Standard orders from research-grade suppliers may take 1-3 weeks, while GMP-compliant manufacturing can take 4-8 weeks depending on complexity and certification requirements.
References
- U.S. Food and Drug Administration. (2022). Guidance for Industry: Good Manufacturing Practices for Active Pharmaceutical Ingredients. Retrieved from https://www.fda.gov
- European Pharmacopoeia. (2022). Copper salts specifications.
- Pharmaceutical supplier websites and product datasheets, 2023.
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