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Suppliers and packagers for generic pharmaceutical drug: CUPRIC SULFATE; MANGANESE SULFATE; SELENIOUS ACID; ZINC SULFATE
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CUPRIC SULFATE; MANGANESE SULFATE; SELENIOUS ACID; 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 | MULTRYS | cupric sulfate; manganese sulfate; selenious acid; zinc sulfate | SOLUTION;INTRAVENOUS | 209376 | NDA | American Regent, Inc. | 0517-9302-25 | 25 VIAL, SINGLE-DOSE in 1 TRAY (0517-9302-25) / 1 mL in 1 VIAL, SINGLE-DOSE (0517-9302-01) | 2021-09-01 |
| Am Regent | MULTRYS | cupric sulfate; manganese sulfate; selenious acid; zinc sulfate | SOLUTION;INTRAVENOUS | 209376 | NDA | American Regent, Inc. | 0517-9305-25 | 25 VIAL, SINGLE-DOSE in 1 TRAY (0517-9305-25) / 1 mL in 1 VIAL, SINGLE-DOSE (0517-9305-01) | 2020-09-29 |
| Am Regent | TRALEMENT | cupric sulfate; manganese sulfate; selenious acid; zinc sulfate | SOLUTION;INTRAVENOUS | 209376 | NDA | American Regent, Inc. | 0517-9302-25 | 25 VIAL, SINGLE-DOSE in 1 TRAY (0517-9302-25) / 1 mL in 1 VIAL, SINGLE-DOSE (0517-9302-01) | 2021-09-01 |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >NDA/ANDA | >Supplier | >Package Code | >Package | >Marketing Start |
Suppliers for Pharmaceutical Ingredients: Cupric Sulfate, Manganese Sulfate, Selenious Acid, and Zinc Sulfate
Introduction
The global pharmaceutical supply chain relies heavily on the procurement of high-grade active pharmaceutical ingredients (APIs) and excipients. Among these, inorganic compounds such as cupric sulfate, manganese sulfate, selenious acid, and zinc sulfate play vital roles in biopharmaceutical applications, including nutritional supplements, diagnostics, and medicinal formulations. This article provides a comprehensive analysis of leading suppliers for these chemicals, emphasizing their manufacturing capabilities, quality compliance, certifications, and market positioning crucial for pharmaceutical industry stakeholders.
Overview of the Chemicals in Pharmaceutical Context
Cupric Sulfate (Copper(II) sulfate): Utilized primarily as an antifungal and algicide, cupric sulfate also functions as a trace mineral in nutritional supplements and as an analytical reagent in pharmaceutical manufacturing.
Manganese Sulfate: Employed as a nutritional supplement and in formulations requiring manganese's essential trace mineral properties, with applications in enzyme functions and metabolic processes.
Selenious Acid (Selenic Acid): Used chiefly in diagnostic agents and as a selenium supplement, it’s valued for its antioxidant properties and incorporation in parenteral nutrition.
Zinc Sulfate: Widely used as a zinc supplement, in wound healing, and as an additive in various pharmaceutical formulations due to zinc's immune-modulating properties.
Top Suppliers of Cupric Sulfate
1. Sigma-Aldrich (a part of Merck KGaA)
Capabilities & Certifications:
Sigma-Aldrich offers pharmaceutical-grade cupric sulfate with GF (Good Manufacturing Practice) compliance, ISO certifications, and strict quality control protocols. They supply different grades, including anhydrous and pentahydrate forms, tailored for analytical and pharmaceutical uses.
Market Position & Reliability:
As a leading supplier with a global distribution network, Sigma-Aldrich is trusted by pharmaceutical companies for consistent quality and regulatory compliance. Their R&D support and broad catalog make them a preferred choice for active ingredients.
2. Thermo Fisher Scientific
Capabilities & Certifications:
Thermo Fisher provides pharmaceutical-grade cupric sulfate, adhering to cGMP and ISO standards. Their manufacturing facilities comply with regulatory agencies worldwide, and they offer customized packaging solutions.
Market Position & Reliability:
Known for their extensive reach and reliable supply chains, Thermo Fisher is instrumental in supporting pharmaceutical production and research with high-quality inorganic salts.
3. Spectrum Chemical
Capabilities & Certifications:
Spectrum supplies pharmaceutical, analytical, and technical grades of cupric sulfate, including ACS and USP grades. Their products meet stringent quality standards and regulatory requirements.
Market Position & Reliability:
Spectrum excels in rapid delivery and competitive pricing, making it suitable for pharmaceutical manufacturers and research institutions.
4. Merck KGaA
Capabilities & Certifications:
Apart from Sigma-Aldrich, Merck KGaA maintains its own manufacturing division for inorganic compounds, including cupric sulfate, with adherence to global quality standards.
Market Position & Reliability:
Trusted for its proprietary manufacturing processes and quality assurance, Merck serves as a reliable supplier to multinational pharmaceutical companies.
Top Suppliers of Manganese Sulfate
1. Showa Denko
Capabilities & Certifications:
Showa Denko supplies pharmaceutical-grade manganese sulfate monohydrate, complying with USP and EP standards. Their manufacturing bases in Japan and Asia ensure quality consistency.
Market Position & Reliability:
A major inorganic chemical manufacturer, Showa Denko emphasizes product purity and regulatory compliance, serving global nutraceutical and pharmaceutical markets.
2. Mutshekar Chemical Industries
Capabilities & Certifications:
Provides high-purity manganese sulfate suitable for pharmaceutical applications, with ISO 9001 and other certifications ensuring quality management.
Market Position & Reliability:
Offering competitively priced products with flexible supply options, they are prominent in the Asian chemical market.
3. Akzonobel
Capabilities & Certifications:
Supplies manganese sulfate used primarily in agricultural and industrial applications. Their expansion into pharmaceutical-grade products includes stringent quality controls.
Market Position & Reliability:
Known for sustainability and innovation, Akzonobel provides quality products suited to pharmaceutical formulations globally.
Top Suppliers of Selenious Acid
1. Alfa Aesar (Thermo Fisher Scientific Group)
Capabilities & Certifications:
Offers pharmaceutical and analytical grades of selenious acid, complying with USP, EP, and other regulatory standards.
Market Position & Reliability:
Their comprehensive catalog and global distribution make Alfa Aesar a leading supplier for pharmaceutical manufacturers seeking reliable sourcing.
2. Merck KGaA (Sigma-Aldrich)
Capabilities & Certifications:
Provides high-purity selenious acid with rigorous quality assurance, suitable for medicinal and diagnostic purposes.
Market Position & Reliability:
Their product consistency and adherence to cGMP standards support pharmaceutical development and manufacturing.
3. Beijing Hanmei Chemical Co., Ltd.
Capabilities & Certifications:
Specializes in inorganic reagents, supplying pharmaceutical-grade selenious acid to Asian and global markets, with ISO certification.
Market Position & Reliability:
Growing presence in Asia, offering competitive pricing and reliable quality.
Top Suppliers of Zinc Sulfate
1. Merck KGaA (Sigma-Aldrich)
Capabilities & Certifications:
Offers USP and pharmaceutical-grade zinc sulfate, produced under cGMP compliance, with strict quality controls.
Market Position & Reliability:
A dominant supplier with extensive distribution footprint and regulatory compliance capabilities.
2. Basilur Food & Pharma Chemicals
Capabilities & Certifications:
Provides high-quality zinc sulfate monohydrate, conforming to pharmacopeial standards, with flexible packaging and delivery options.
Market Position & Reliability:
Reliable for bulk procurement, especially in the Asian pharmaceutical markets.
3. Spectrum Chemical
Capabilities & Certifications:
Supplies zinc sulfate with USP, ACS, and EP grades, maintaining rigorous quality standards.
Market Position & Reliability:
Offers rapid supply and competitive pricing for pharmaceutical and analytical applications.
Regulatory and Quality Considerations
Suppliers serving the pharmaceutical industry must demonstrate compliance with cGMP, ISO 9001, and pharmacopeial standards such as USP, EP, or BP. Certificates of Analysis (CoA), Certificates of Suitability (CoS), and Regulatory declarations are essential for verifying the suitability of these chemicals for medicinal applications. Long-term supplier reliability, consistent product quality, and scalable supply chains are vital for integrated pharmaceutical manufacturing.
Strategic Sourcing Insights
- Global vs. Local Procurement: Multinational suppliers like Sigma-Aldrich, Merck, and Thermo Fisher offer scalable global supply but often at a premium. Regional suppliers may provide cost advantages but require thorough quality validation.
- Regulatory Compliance: Prioritize suppliers with documented GMP compliance, extensive quality certifications, and traceability.
- Supply Chain Risk Management: Diversify sourcing to mitigate geopolitical, logistical, or regulatory risks, ensuring uninterrupted supply for critical pharmaceutical applications.
- Quality Assurance: Regular audits, batch testing, and validation of supplier audits help maintain consistent product quality.
Key Takeaways
- The pharmaceutical industry relies on reputable suppliers like Sigma-Aldrich, Merck KGaA, Thermo Fisher, and Spectrum Chemical for inorganic compounds such as cupric sulfate, manganese sulfate, selenious acid, and zinc sulfate.
- High standards for regulatory compliance, product purity, and manufacturing certifications are non-negotiable for pharmaceutical-grade chemicals.
- Strategic sourcing decisions should factor in regulatory adherence, supply chain security, and cost-effectiveness, especially amidst global disruptions.
- Regional manufacturers serve niche markets but necessitate rigorous quality checks to meet international standards.
- Maintaining strong supplier relationships and continuous quality monitoring enhances supply chain robustness and supports compliance obligations.
Frequently Asked Questions (FAQs)
1. What are the primary regulatory standards to consider when sourcing inorganic pharmaceutical chemicals?
Regulatory standards include USP, EP, BP, and cGMP compliance, ensuring the chemicals meet pharmacopeial quality, safety, and purity requirements.
2. How can pharmaceutical companies verify the quality of inorganic chemical suppliers?
By reviewing Certificates of Analysis, conducting supplier audits, verifying their certifications (ISO, GMP), and performing in-house testing of incoming batches.
3. Are there regional suppliers offering comparable quality for these inorganic compounds?
Yes, especially in Asia, regional manufacturers provide competitive options; however, thorough quality validation is essential to match international standards.
4. How does supply chain stability impact pharmaceutical manufacturing when sourcing these chemicals?
Disruptions can halt production; diversifying suppliers, maintaining safety stock, and establishing long-term agreements mitigate risks.
5. What are the typical lead times for sourcing these inorganic chemicals from major suppliers?
Lead times vary from 2 to 8 weeks based on product grade, quantity, and supplier location; early engagement and inventory planning are recommended.
References
[1] Sigma-Aldrich Product Catalog. (2023). Pharmaceutical-grade inorganic chemicals.
[2] Thermo Fisher Scientific. (2023). Chemical supply for pharmaceuticals.
[3] Merck KGaA. (2023). Inorganic chemicals for pharmaceutical applications.
[4] Showa Denko. (2023). Specialty chemicals manufacturing capabilities.
[5] Alfa Aesar. (2023). Inorganic reagent offerings.
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