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Suppliers and packagers for generic pharmaceutical drug: ZINC SULFATE
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ZINC SULFATE
Listed suppliers include manufacturers, repackagers, relabelers, and private labeling entitities.
| Applicant | Tradename | Generic Name | Dosage | NDA | NDA/ANDA | Supplier | Package Code | Package | Marketing Start |
|---|---|---|---|---|---|---|---|---|---|
| Am Regent | ZINC SULFATE | zinc sulfate | SOLUTION;INTRAVENOUS | 209377 | NDA | American Regent, Inc. | 0517-6101-25 | 25 VIAL in 1 TRAY (0517-6101-25) / 10 mL in 1 VIAL (0517-6101-01) | 2020-05-18 |
| Am Regent | ZINC SULFATE | zinc sulfate | SOLUTION;INTRAVENOUS | 209377 | NDA | American Regent, Inc. | 0517-6103-25 | 25 VIAL in 1 TRAY (0517-6103-25) / 10 mL in 1 VIAL (0517-6103-01) | 2019-10-01 |
| Am Regent | ZINC SULFATE | zinc sulfate | SOLUTION;INTRAVENOUS | 209377 | NDA | American Regent, Inc. | 0517-8005-25 | 25 VIAL in 1 TRAY (0517-8005-25) / 5 mL in 1 VIAL (0517-8005-01) | 2019-10-01 |
| Apotex | ZINC SULFATE | zinc sulfate | SOLUTION;INTRAVENOUS | 218059 | ANDA | Apotex Corp | 60505-6260-5 | 25 VIAL in 1 CARTON (60505-6260-5) / 5 mL in 1 VIAL (60505-6260-0) | 2024-08-01 |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >NDA/ANDA | >Supplier | >Package Code | >Package | >Marketing Start |
Suppliers for the Pharmaceutical Drug: Zinc Sulfate
Introduction
Zinc sulfate is a widely used pharmaceutical compound recognized for its therapeutic properties, primarily as a dietary supplement to address zinc deficiency and as an ingredient in topical formulations for skin conditions. Its demand spans across manufacturers of over-the-counter medications, nutritional supplements, and pharmaceutical formulations worldwide. Identifying reliable suppliers of zinc sulfate is crucial for pharmaceutical companies, distributors, and healthcare providers aiming to ensure quality, consistent supply, and regulatory compliance. This analysis provides a comprehensive overview of the leading suppliers of zinc sulfate globally, their capabilities, geographic strengths, and market positioning.
Global Market Overview of Zinc Sulfate Suppliers
The global zinc sulfate market is characterized by a mixture of regional producers and multinational chemical conglomerates. The supply landscape spans Asia, Europe, North America, and other regions, with Asia-Pacific emerging as a dominant source owing to its extensive chemical manufacturing infrastructure and cost advantages.
Key suppliers primarily produce zinc sulfate with pharmaceutical-grade purity, conforming to pharmacopeial standards such as USP, EP, or JP, essential for pharmaceutical applications.
Major Suppliers of Zinc Sulfate
1. EverZinc
Overview:
EverZinc is a leading global producer of zinc compounds, including zinc sulfate, with headquarters in Belgium. The company offers pharmaceutical-grade zinc sulfate solutions tailored for medicinal and nutritional applications.
Capabilities:
- Production of zinc sulfate monohydrate and heptahydrate, both suitable for pharmaceutical use.
- Strict adherence to international quality standards such as GMP, USP, and EP.
- Customization options for supply quantities.
Strengths:
- Extensive R&D capabilities ensuring product quality and stability.
- Global distribution network ensuring timely supply across continents.
- Certification compliance enhances suitability for medicinal applications.
2. Shanxi Weihua Zinc Industry Co., Ltd.
Overview:
Based in China, Shanxi Weihua Zinc Industry Co. specializes in zinc chemicals, including high-purity zinc sulfate grades suitable for pharmaceutical applications.
Capabilities:
- Manufacturing of zinc sulfate monohydrate and other forms.
- Focus on purity levels compliant with pharmacopeial standards.
- Export capabilities to global markets.
Strengths:
- Competitive pricing resulting from integrated production processes.
- Robust supply chain infrastructure to support large-volume orders.
- Certifications aligning with international standards.
3. Omega Chemicals & Minerals
Overview:
An Indian-based manufacturer and exporter of industrial and pharmaceutical-grade zinc compounds, Omega Chemicals & Minerals supplies zinc sulfate globally.
Capabilities:
- Production of high-purity zinc sulfate for medicinal use.
- Focused on meeting WHO guidelines and pharmaceutical industry specifications.
- Flexible manufacturing sizes suitable for both small and bulk orders.
Strengths:
- Strategic geographic location facilitating shipments across Asia, Europe, and Africa.
- Good reputation for quality control and regulatory compliance.
4. Lisen Chemical
Overview:
Headquartered in China, Lisen Chemical is a notable producer of zinc sulfate for several applications, including pharmaceuticals, agriculture, and industrial use.
Capabilities:
- Production of zinc sulfate monohydrate and anhydrous forms.
- Emphasis on purity and consistency for medicinal applications.
- Certification compliance for pharmaceutical standards.
Strengths:
- Cost-effective manufacturing processes.
- Extensive export experience.
5. TIB Chemicals
Overview:
TIB Chemicals is a German specialty chemicals supplier, with integrated capabilities to produce pharmaceutical-grade zinc sulfate.
Capabilities:
- Manufacturing aligned with stringent European pharmaceutical standards.
- Product customization and technical support.
Strengths:
- High compliance and quality assurance.
- Well-established distribution channels in Europe and North America.
Regional Focus and Market Trends
Asia-Pacific Region
Dominant producers in China, India, and South Korea supply the majority of zinc sulfate globally. Their competitive pricing and large capacity make them the primary suppliers for companies seeking cost-effective options.
Europe and North America
Suppliers in Germany, Belgium, and the United States emphasize premium quality and regulatory compliance, often serving pharmaceutical-grade zinc sulfate markets with stringent standards like USP and EP.
Quality and Regulatory Considerations
For pharmaceutical applications, suppliers must adhere to rigorous quality standards. Confirmed certification in GMP, ISO, USP, EP, or JP guidelines is essential. Additionally, suppliers should provide full documentation, including Certificates of Analysis (CoA), Material Safety Data Sheets (MSDS), and stability data, to ensure compliance with regulatory bodies like the FDA and EMA.
Supply Chain and Logistics
Given the critical nature of pharmaceutical zinc sulfate, reliable suppliers maintain robust logistics capabilities, including:
- Inventory management aligned with demand forecasts.
- Efficient shipping routes to minimize transit times.
- Transparency about sourcing and manufacturing practices.
Choosing suppliers with proven track records minimizes risks related to supply disruptions and quality inconsistencies.
Pricing and Contracting
Pricing varies depending on purity grade, volume, and contractual terms. Long-term contracts with reputable suppliers often include quality assurance clauses, supply contingencies, and compliance guarantees, which are vital for pharmaceutical manufacturing stability.
Conclusion
The landscape of zinc sulfate suppliers for pharmaceutical use is diverse, with regional strengths influencing the supply chain dynamics. Suppliers such as EverZinc, Shanxi Weihua Zinc Industry, Omega Chemicals & Minerals, Lisen Chemical, and TIB Chemicals stand out due to their capacity, quality standards, and global reach. Pharmaceutical companies should prioritize suppliers with demonstrated compliance to international pharmaceutical standards, robust quality assurance protocols, and reliable logistics. Strategic sourcing from verified suppliers ensures regulatory adherence, supply continuity, and product safety, supporting the overarching goal of delivering safe and effective medicinal products.
Key Takeaways
- Regulatory compliance is paramount: Always verify supplier adherence to GMP, USP, EP, or other relevant standards.
- Regional considerations impact sourcing: Asia-Pacific provides cost advantages, while Europe and North America emphasize quality and compliance.
- Long-term partnerships mitigate risks: Contracts incorporating quality assurance and contingency clauses stabilize supply chains.
- Quality documentation is critical: Certificates of Analysis and other documentation ensure integrity and compliance.
- Vendor evaluation should include logistics and capacity: Ensuring suppliers can meet demand fluctuations is essential for uninterrupted pharmaceutical production.
Frequently Asked Questions
Q1: What are the primary quality standards to look for in pharmaceutical-grade zinc sulfate suppliers?
A1: Suppliers should meet standards such as USP, EP, JP, or GMP certifications. These standards ensure purity, stability, and safety suitable for medicinal use.
Q2: How does regional origin influence zinc sulfate pricing?
A2: Suppliers from Asia often offer lower prices due to manufacturing efficiencies and lower operational costs, whereas European and North American suppliers may command higher premiums reflecting stricter regulatory compliance and quality assurance.
Q3: Can zinc sulfate suppliers provide custom formulations for specific pharmaceutical needs?
A3: Yes. Many suppliers, especially those with R&D capabilities, can modify forms (monohydrate, heptahydrate), purities, and packaging to meet individual client specifications.
Q4: What logistical factors are critical when sourcing zinc sulfate for pharmaceuticals?
A4: Critical factors include lead times, supply chain transparency, inventory management, transportation security, and the ability to meet regulatory documentation requirements during shipment.
Q5: What are the risks associated with poor-quality zinc sulfate suppliers?
A5: Risks include substandard purity affecting drug efficacy, regulatory non-compliance leading to legal issues, supply disruptions, and potential safety hazards for patients.
Sources
- [1] MarketsandMarkets, "Zinc Sulfate Market by Grade, Application, and Region," 2022.
- [2] EverZinc official website, "Product Portfolio," accessed 2023.
- [3] China Chemical Industry Association, "Zinc Compounds Production Data," 2021.
- [4] World Health Organization (WHO), "Guidelines for the Quality Control of Pharmaceutical Products," 2020.
- [5] European Pharmacopoeia, "Zinc Sulfate Monohydrate," 2023.
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