Share This Page
Suppliers and packagers for generic pharmaceutical drug: MANGANESE CHLORIDE
✉ Email this page to a colleague
MANGANESE 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 |
|---|---|---|---|---|---|---|---|---|---|
| Fresenius Kabi Usa | MANGANESE CHLORIDE | manganese chloride | INJECTABLE;INJECTION | 217583 | ANDA | Fresenius Kabi USA, LLC | 65219-530-10 | 25 VIAL, PLASTIC in 1 TRAY (65219-530-10) / 10 mL in 1 VIAL, PLASTIC (65219-530-02) | 2025-11-17 |
| Hospira | MANGANESE CHLORIDE IN PLASTIC CONTAINER | manganese chloride | INJECTABLE;INJECTION | 018962 | NDA | Hospira, Inc. | 0409-4091-01 | 25 VIAL, PLASTIC in 1 TRAY (0409-4091-01) / 10 mL in 1 VIAL, PLASTIC (0409-4091-11) | 2005-01-31 |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >NDA/ANDA | >Supplier | >Package Code | >Package | >Marketing Start |
Suppliers for the Pharmaceutical Drug: Manganese Chloride
Introduction
Manganese chloride (MnCl₂) is a critical chemical compound utilized extensively within the pharmaceutical sector, as well as in industrial applications such as catalysts, batteries, and chemical synthesis. In the pharmaceutical domain, manganese chloride plays vital roles in enzyme functions, nutritional supplements, and diagnostic reagents. Ensuring a reliable supply chain of high-grade manganese chloride is paramount for pharmaceutical manufacturers, researchers, and regulatory bodies. This article explores the key suppliers of manganese chloride, their market positioning, quality standards, and strategic considerations for procurement.
Market Overview of Manganese Chloride
The global manganese chloride market is driven by increased demand from diverse sectors. The pharmaceutical segment specifically demands stringent quality standards: USP (United States Pharmacopeia), EP (European Pharmacopoeia), or other pharmacopeial grades, ensuring purity, safety, and efficacy. Prices fluctuate depending on purity levels, geopolitical factors, and supply chain stability. Major manufacturing countries include China, India, South Korea, and the United States, which host prominent producers and suppliers.
Leading Suppliers of Pharmaceutical-Grade Manganese Chloride
1. Sigma-Aldrich (Merck Group)
As a global leader in fine chemicals and research reagents, Sigma-Aldrich supplies high-purity manganese chloride suitable for pharmaceutical applications. Their offerings include anhydrous and hydrated forms, with certifications conforming to pharmaceutical standards. They source materials from certified manufacturers that meet stringent quality control protocols. Sigma-Aldrich maintains a robust distribution network, ensuring prompt delivery and technical support, critical for pharmaceutical R&D and production.
2. Thermo Fisher Scientific
Thermo Fisher Scientific supplies manganese chloride products compliant with pharmacopeial standards. Their portfolio includes analytical-grade manganese chloride suitable for laboratory and pharmaceutical manufacturing needs. The company's quality assurance processes involve rigorous testing, validation, and documentation, vital for regulatory compliance.
3. Alfa Aesar (Part of Thermo Fisher Scientific)
Alfa Aesar provides high-purity manganese chloride powders and solutions tailored for pharmaceutical use. They source from reputable manufacturers with conformity to USP and EP standards. Alfa Aesar emphasizes consistent quality, detailed certificate of analysis (CoA), and scalable supply, supporting pharmaceutical companies from early-stage research to large-scale manufacturing.
4. Grasim (India)
Part of the Aditya Birla Group, Grasim produces manganese compounds, including manganese chloride, primarily for industrial applications, but also for pharmaceutical-grade products. They have certifications and quality management systems aligned with international standards, serving both domestic and export markets.
5. Yueyang Yisheng Manganese Industry Co., Ltd.
Based in China, this company specializes in manganese chemicals, including pharmaceutical-grade manganese chloride. They have quality certifications such as ISO 9001 and adhere to pharmaceutical manufacturing norms, serving clients across Asia, North America, and Europe.
6. BASF SE
BASF offers manganese chemicals in specialized formulations, including manganese chloride, with applications extending to pharmaceuticals, catalysts, and electronics. Their manufacturing facilities comply with rigorous environmental and quality standards (ISO, GMP), making their products suitable for pharmaceutical use when appropriately certified.
7. Sinoway Molybdenum Co., Ltd.
This Chinese chemical producer supplies manganese chloride suitable for pharmaceutical applications, boasting high purity levels. They possess ISO and other certifications, with a focus on quality control and customer compliance, supporting global pharmaceutical companies seeking diversified supply sources.
Quality Standards and Regulatory Considerations
Most pharmaceutical-grade manganese chloride suppliers adhere to multiple standards, including:
- USP (United States Pharmacopeia) monographs
- EP (European Pharmacopoeia) standards
- JP (Japanese Pharmacopoeia) specifications
These standards specify parameters like assay, moisture content, heavy metals, residual solvents, and microbial limits. Suppliers should provide comprehensive Certificates of Analysis (CoA) and Certificates of Quality (CoQ). It is imperative for pharmaceutical companies to verify supplier accreditation, such as GMP compliance, to mitigate regulatory risks.
Supply Chain Dynamics
Supply chain stability depends on factors like geopolitical stability, raw material availability, manufacturing capacity, and logistics infrastructure. The heavy reliance on Chinese and Indian manufacturers necessitates diversification strategies to reduce supply risks. Alternatively, establishing agreements with multiple suppliers can secure continuous supply, ensure quality, and enable competitive pricing.
Strategic Sourcing Considerations
- Quality Assurance: Prioritize suppliers with validated GMP manufacturing processes, rigorous quality control, and comprehensive documentation.
- Traceability: Opt for suppliers providing full supply chain transparency, including raw material origin and production processes.
- Regulatory Compliance: Verify that suppliers’ products meet regional pharmacopeial standards.
- Pricing and Capacity: Balance cost considerations with supplier capacity to meet current and projected demand.
- Lead Times: Consider delivery timelines, especially given recent disruptions due to global logistical challenges.
Emerging Suppliers and Innovation
Advancements in green synthesis and sustainable manufacturing are leading to new suppliers prioritizing environmentally friendly processes. Additionally, some manufacturers are developing bespoke formulations to meet specific pharmaceutical needs, such as high purity or low heavy metal content.
Conclusion
The procurement of pharmaceutical-grade manganese chloride involves selecting reputable suppliers with proven quality standards, supply chain reliability, and regulatory compliance. Leaders such as Sigma-Aldrich, Thermo Fisher Scientific, Alfa Aesar, and established Chinese and Indian manufacturers dominate the market. Diversification, rigorous qualification protocols, and ongoing supplier audits are vital for maintaining a stable and compliant supply chain essential for pharmaceutical applications.
Key Takeaways
- Quality and compliance are non-negotiable; sourcing from suppliers conforming to pharmacopeial standards is critical.
- Diversify suppliers across regions to mitigate geopolitical and logistical risks.
- Verify certifications (GMP, ISO) and review Certificates of Analysis thoroughly.
- Monitor market trends toward sustainable and green manufacturing to identify innovative sourcing opportunities.
- Establish strategic partnerships with key suppliers to ensure priority access and technical support.
Frequently Asked Questions (FAQs)
1. What are the primary quality standards for pharmaceutical-grade manganese chloride?
Pharmaceutical-grade manganese chloride must conform to pharmacopeial standards such as USP, EP, or JP. These include specific purity levels, limits on heavy metals, residual solvents, microbial limits, and moisture content.
2. Which countries are the leading producers of manganese chloride for pharmaceutical applications?
China and India are the largest producers, with significant manufacturing infrastructure. The United States and South Korea also have notable suppliers supporting global supply chains.
3. How can pharmaceutical companies ensure the quality of manganese chloride suppliers?
By verifying certifications (GMP, ISO), reviewing Certificates of Analysis, auditing manufacturing facilities, and establishing long-term quality agreements, companies can ensure product integrity.
4. Is there a risk of supply disruption for manganese chloride?
Yes, due to geopolitical tensions, raw material shortages, or logistical disruptions—especially in regions heavily reliant on China and India—diversification and strategic planning are essential.
5. What are emerging trends in the supply of manganese chloride for pharmaceuticals?
Sustainable manufacturing practices, green synthesis methods, and development of high-purity, environmentally friendly products are trending. Additionally, digital supply chain monitoring enhances transparency and reliability.
References
[1] MarketsandMarkets. "Manganese Market by Form," 2021.
[2] Sigma-Aldrich Product Catalog. "Manganese Chloride Solutions," 2023.
[3] European Pharmacopoeia, Monograph on Manganese Compounds.
[4] U.S. Pharmacopeia, Monograph on Manganese Chloride.
[5] Industry reports on global manganese chemical markets, 2022.
More… ↓
