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Suppliers and packagers for generic pharmaceutical drug: zinc chloride
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zinc 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 | ZINC CHLORIDE | zinc chloride | INJECTABLE;INJECTION | 212007 | ANDA | Exela Pharma Sciences,LLC | 51754-0102-4 | 25 VIAL in 1 CARTON (51754-0102-4) / 10 mL in 1 VIAL | 2021-08-27 |
| Somerset | ZINC CHLORIDE | zinc chloride | INJECTABLE;INJECTION | 216152 | ANDA | Somerset Therapeutics, LLC | 70069-526-25 | 25 VIAL, PLASTIC in 1 CARTON (70069-526-25) / 10 mL in 1 VIAL, PLASTIC (70069-526-01) | 2024-10-16 |
| Hospira | ZINC CHLORIDE IN PLASTIC CONTAINER | zinc chloride | INJECTABLE;INJECTION | 018959 | NDA | Hospira, Inc. | 0409-4090-01 | 25 VIAL, PLASTIC in 1 TRAY (0409-4090-01) / 10 mL in 1 VIAL, PLASTIC (0409-4090-11) | 1990-09-30 |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >NDA/ANDA | >Supplier | >Package Code | >Package | >Marketing Start |
Suppliers for the Pharmaceutical Drug: Zinc Chloride
Introduction
Zinc chloride (ZnCl₂) is a chemical compound extensively used in various pharmaceutical applications, including topical antiseptics, astringents, and as a component in dental cements. Its importance in medicinal formulations underscores the need for reliable suppliers that can deliver high-quality, pharmaceutical-grade zinc chloride. This article provides a comprehensive overview of the leading suppliers in the market, their offerings, and key considerations for pharmaceutical companies seeking sourcing options.
Market Overview of Zinc Chloride Supplies
The global market for zinc chloride caters to multiple industries, with pharmaceuticals representing a significant segment owing to the compound's antiseptic properties. The demand persists across North America, Europe, Asia-Pacific, and other emerging markets. Suppliers are primarily categorized into chemical manufacturers capable of producing pharmaceutical-grade zinc chloride conforming to stringent quality standards like USP, EP, or JP.
Leading Suppliers of Pharmaceutical-Grade Zinc Chloride
1. Sigma-Aldrich (Merck Group)
Overview:
Sigma-Aldrich, a division of Merck KGaA, is a prominent supplier of laboratory chemicals, including pharmaceutical-grade zinc chloride. Known for its extensive product catalog, Sigma-Aldrich offers zinc chloride with high purity suitable for medicinal and laboratory applications.
Product Specifications:
- Purity: ≥99% or as specified
- Grade: Pharmaceutical, Reagent Grade
- Packaging: Bulk quantities, retail bottles, custom packaging options
Certifications & Quality:
- Complies with USP, EP, and JP standards
- Offers Material Safety Data Sheets (MSDS), COAs, and GMP documentation
Application Areas:
- Antiseptics in wound care
- Dental formulations
- Laboratory research
Supply Capacity & Reach:
- Global distribution network with robust logistics infrastructure
- Ability to deliver large bulk orders and smaller quantities for research or clinical use
2. Samchun Chemicals
Overview:
South Korea-based Samchun Chemicals produces pharmaceutical and industrial-grade chemicals, including high-purity zinc chloride. The company emphasizes quality control and compliance with international standards.
Product Specifications:
- Purity: ≥99.5%
- Grade: Pharmaceutical Grade, Reagent Grade
- Packaging: Drum, container, customized options
Certifications & Quality Control:
- ISO 9001, GMP compliance
- Meets USP, EP standards
Application Areas:
- Medical antiseptics
- Dental cements and adhesives
- Chemical synthesis in pharmaceuticals
Supply Capacity & Regional Focus:
- Strong presence in Asia-Pacific markets
- Reliable supply chain with flexible logistics arrangements
3. Lianyungang Chemwell Pharmaceuticals
Overview:
A Chinese pharmaceutical-grade chemical manufacturer with a focus on zinc salts, including zinc chloride. The company adheres to internationally recognized standards and offers competitive pricing.
Product Specifications:
- Purity: ≥98%
- Grade: Pharmaceutical, Laboratory, Reagent
Certifications & Quality:
- GMP, ISO 9001 certified manufacturing facilities
- Meets USP and EP standards
Application Areas:
- Disinfectants and antiseptics
- Dental materials
- Laboratory reagent solutions
Supply Capacity & Distribution:
- Capable of large-scale manufacturing
- Export-focused with global shipping capabilities
4. Pan Genomic Technologies (PDT)
Overview:
Specialized in high-purity chemical intermediates for pharmaceuticals, PDT supplies zinc chloride tailored for research, testing, and therapeutic applications.
Product Specifications:
- Purity: ≥99%
- Grade: Pharmaceutical, Analytical Reagent
Certifications & Quality:
- ISO 13485, GMP standards maintained
- Comprehensive documentation for regulatory compliance
Application Areas:
- Use in antiseptic formulations
- Chemical synthesis for drug development
Supply & Customization:
- Flexible order quantities to support clinical trials and commercialization
5. Merck KGaA
Overview:
Beyond Merck Millipore (Sigma-Aldrich), Merck KGaA produces specialty chemicals, including zinc chloride, with a focus on pharma-grade specifications.
Product Details:
- Purity: ≥99% or tailored as per customer needs
- Grade: Pharma and laboratory
Certifications & Compliance:
- Meets international pharmacopoeia standards
- Extensive regulatory documentation
Distribution & Availability:
- Global supply chain with robust logistics channels
- Long-term supply agreements available
Key Factors in Selecting Zinc Chloride Suppliers
Quality and Compliance
Pharmaceutical-grade zinc chloride must adhere to stringent purity and quality standards such as USP, EP, or JP. Suppliers should provide comprehensive certification, batch testing reports, and GMP compliance documentation.
Certifications and Regulatory Support
Ensure suppliers hold relevant certifications (ISO, GMP) and are capable of offering regulatory support for documentation required in different markets.
Supply Reliability and Capacity
Assess suppliers’ production capacity, lead times, and their ability to fulfill bulk and small-volume orders consistently.
Pricing and Terms
Competitive pricing must be balanced against quality assurances. Long-term partnerships may benefit from volume discounts, flexible payment terms, and logistical arrangements.
Regional Presence and Logistics
Selecting suppliers with strategic regional presence simplifies import procedures, reduces shipping times, and mitigates supply chain risks.
Emerging Trends and Challenges
- Regulatory Stringency: Increasing regulatory oversight heightens the importance of verified certifications and rigorous batch quality controls.
- Supply Chain Disruptions: Political, logistical, or environmental factors continue to impact global chemical supply chains. Diversification of suppliers mitigates risks.
- Sustainability & Environmental Impact: Growing emphasis on environmentally sustainable manufacturing practices influences supplier qualification processes.
Conclusion
Securing a reliable supply of pharmaceutical-grade zinc chloride requires careful evaluation of supplier credentials, product quality, and logistical capabilities. The companies highlighted—Sigma-Aldrich (Merck), Samchun Chemicals, Lianyungang Chemwell, Pan Genomic Technologies, and Merck KGaA—are industry leaders known for their adherence to quality standards, regulatory certifications, and global distribution networks.
Partnerships with established suppliers ensure consistent product quality essential for pharmaceutical applications, supporting regulatory compliance and patient safety.
Key Takeaways
- Prioritize Certification: Confirm suppliers provide products meeting USP, EP, or JP standards with comprehensive documentation.
- Assess Capacity & Reliability: Choose suppliers with proven production scales and supply chain robustness to prevent disruptions.
- Regulatory Compatibility: Ensure supplier compliance with local and international regulatory frameworks.
- Diversify Suppliers: Reduce risks by engaging multiple qualified suppliers, especially for large-scale or continuous procurement.
- Monitor Regulatory Trends: Stay updated on evolving pharmaceutical manufacturing standards and environmental regulations.
FAQs
1. What are the primary applications of zinc chloride in pharmaceuticals?
Zinc chloride serves as an antiseptic in wound care, astringent in dermatological treatments, part of dental cements, and a reagent in various drug synthesis processes.
2. How do I verify the quality of zinc chloride from a new supplier?
Request Certificates of Analysis (COA), Good Manufacturing Practice (GMP) compliance documentation, and conduct independent testing if necessary to verify purity and conformity.
3. What certifications should a pharmaceutical-grade zinc chloride supplier have?
Key certifications include USP (United States Pharmacopeia), EP (European Pharmacopoeia), JP (Japanese Pharmacopoeia), GMP (Good Manufacturing Practices), and ISO standards.
4. Can zinc chloride suppliers provide tailored packaging for specific pharmaceutical needs?
Yes, reputable suppliers offer customizable packaging solutions, from bulk drums for manufacturing to smaller bottles for research or clinical purposes.
5. How are supply chain disruptions affecting the zinc chloride market?
Global disruptions, including geopolitical issues and pandemics, challenge steady supply. Diversifying sourcing and maintaining strategic inventories mitigate potential risks.
Sources:
- Merck KGaA, Sigma-Aldrich Product Catalog.
- Samchun Chemicals Corporate Brochure.
- Lianyungang Chemwell Pharmaceuticals Product Data Sheets.
- Pan Genomic Technologies Supply Chain Overview.
- International Pharmacopoeia Standards and Regulations.
More… ↓
