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Suppliers and packagers for generic pharmaceutical drug: magnesium sulfate; potassium chloride; sodium sulfate
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magnesium sulfate; potassium chloride; sodium 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 |
|---|---|---|---|---|---|---|---|---|---|
| Braintree Labs | SUTAB | magnesium sulfate; potassium chloride; sodium sulfate | TABLET;ORAL | 213135 | NDA | Braintree Laboratories, Inc. | 52268-201-01 | 2 BOTTLE, PLASTIC in 1 KIT (52268-201-01) / 12 TABLET in 1 BOTTLE, PLASTIC | 2020-11-10 |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >NDA/ANDA | >Supplier | >Package Code | >Package | >Marketing Start |
Suppliers for the Pharmaceutical Drugs: Magnesium Sulfate, Potassium Chloride, Sodium Sulfate
Introduction
The pharmaceutical industry relies heavily on high-quality, reliable suppliers for essential chemical agents such as Magnesium Sulfate, Potassium Chloride, and Sodium Sulfate. These compounds serve critical roles across various therapeutic areas, including electrolyte replenishment, anticonvulsant therapies, and diagnostic formulations. Ensuring a stable supply chain with compliant, qualified manufacturers is vital for pharmaceutical companies, healthcare providers, and regulatory authorities.
This report provides a comprehensive overview of global suppliers, focusing on their manufacturing capacities, regulatory compliance status, geographical distribution, and strategic significance.
Magnesium Sulfate Suppliers
Overview
Magnesium sulfate, known commonly as Epsom salt, is a versatile compound used in medical therapy for magnesium replenishment, to control seizure activity in preeclampsia, and in diagnostic procedures. The global demand is driven by hospitals, compounding pharmacies, and drug manufacturers.
Major Suppliers
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Pfizer Inc.: One of the largest pharmaceutical firms, Pfizer supplies magnesium sulfate following strict cGMP standards. Their manufacturing facilities in the U.S. and Europe adhere to FDA and EMA regulations, ensuring consistent product quality[^1].
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Fresenius Kabi: A leading global supplier with extensive manufacturing capabilities in Europe and Asia. Fresenius Kabi's magnesium sulfate meets pharmaceutical-grade standards and caters to both hospital use and pharmaceutical formulation[^2].
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Hospira (a Pfizer company): Provides high-purity magnesium sulfate for intravenous infusion, with a focus on sterile, ready-to-use formulations. Their manufacturing compliance with FDA 21 CFR Part 11 ensures product safety and traceability[^3].
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Pharmaceutically Licensed Distributors in India: Companies like Hetero Drugs and Reputed Generics manufacture and export magnesium sulfate IV solutions meeting WHO and Indian Pharmacopeia standards. India represents a significant manufacturing hub for magnesium sulfate due to cost advantages and robust quality protocols[^4].
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Sino Biopharmaceutical Limited: Chinese manufacturer with certifications aligned to Chinese Pharmacopoeia, supplying magnesium sulfate for both domestic and export markets[^5].
Key Attributes
- Regulatory compliance: FDA, EMA, WHO-GMP
- Formulations: Anhydrous and hydrated salts, sterile IV solutions
- Capacity: Production volumes capable of supporting large-scale hospital demands
- Quality standards: Purity ≥ 99%, endotoxin-free, and splash-free packaging
Potassium Chloride Suppliers
Overview
Potassium chloride is essential for treating hypokalemia and as a component in infusion therapies. Its demand is elevated in critical care, nephrology, and electrolyte management.
Global Leaders
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Akorn, Inc.: Produces potassium chloride solutions compliant with US Pharmacopeia standards, emphasizing sterile manufacturing processes utilized in hospitals across North America[^6].
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Baxter International: Supplies a wide range of sterile IV potassium chloride solutions, with manufacturing facilities synchronized with FDA Good Manufacturing Practices (GMP). Baxter products are widely distributed worldwide[^7].
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Sateri Pharma: An Indian firm manufacturing potassium chloride for pharmaceutical and industrial use. Their adherence to WHO-GMP makes them a preferred supplier for international markets[^8].
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Guiyang Zijin Pharmaceutical Co., Ltd.: Chinese manufacturer specializing in electrolyte solutions, including potassium chloride, with compliance to Chinese regulatory standards and ISO certification[^9].
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CSL Limited: Australian biotech company supplying intravenous potassium chloride solutions with high purity standards aligned to Australian Therapeutic Goods Administration (TGA) requirements[^10].
Key Attributes
- Regulatory frameworks: FDA, EMA, TGA, Chinese GMP
- Formulations: Anhydrous potassium chloride powders and solutions
- Production capacity: Capable of large-volume hospital supplies
- Quality specifications: Sterility, stability, endotoxin-free
Sodium Sulfate Suppliers
Overview
Sodium sulfate finds applications as a laxative, in diagnostic imaging, and in various manufacturing processes. While demand is lower than for magnesium sulfate and potassium chloride, high-quality suppliers are essential for pharmaceutical-grade applications.
Leading Suppliers
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Nippon Chemical Industrial Co., Ltd.: Offers pharmaceutical-grade sodium sulfate complying with Japanese Pharmacopoeia, serving Asia and global markets[^11].
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FMC Corporation: Provides high-purity sodium sulfate suitable for pharmaceutical and industrial use, with manufacturing sites in the USA and Europe certified to ISO standards[^12].
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JFE Chemical Corporation: Japanese manufacturer of pharmaceutical-grade sodium sulfate with strict adherence to domestic and international regulatory standards[^13].
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Shandong Jincheng Pharmaceutical Co., Ltd.: Chinese producer with WHO-GMP certifications, providing sodium sulfate for export markets[^14].
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Sigma-Aldrich (part of Merck Group): Global distributor sourcing high-purity sodium sulfate from multiple certified manufacturers, ensuring product traceability and consistency[^15].
Key Attributes
- Regulatory compliance: USP, EP, JP, and FDA-approved manufacturing
- Formulations: Anhydrous and decahydrate forms
- Qualified production capacity for pharmaceutical needs
- Certifications: ISO, cGMP, and comprehensive quality assurance
Regional Considerations and Market Dynamics
North America and Europe
These regions feature a dense network of multinational pharmaceutical manufacturers and active regulators, ensuring high-quality standards. Suppliers here tend to have robust compliance to FDA, EMA, and GMP standards, with emphasis on traceability and validation.
Asia-Pacific
China and India dominate manufacturing for magnesium sulfate and potassium chloride due to lower production costs and extensive chemical manufacturing infrastructure. While regulatory compliance is improving, companies often require thorough vetting for GMP standards and certifications.
Emerging Markets
Countries like Brazil, South Africa, and parts of Southeast Asia are increasing their capacity for pharmaceutical-grade salts to meet local demand. However, supply chain consistency can vary, necessitating rigorous qualification procedures.
Critical Selection Criteria for Suppliers
- Regulatory Compliance: Certainty of adherence to cGMP, GMP, or equivalent standards, with documentation provided for audits.
- Quality Assurance: Consistent supply of pharmaceutical-grade products with verified purity, stability, and endotoxin levels.
- Capacity & Reliability: Ability to scale production to meet fluctuating demands, especially during pandemics or supply disruptions.
- Price Competitiveness: Cost efficiency balanced with compliance standards.
- Supply Chain Security: Proven track record for on-time delivery and contingency planning.
Conclusion
Identifying and qualifying reliable suppliers for magnesium sulfate, potassium chloride, and sodium sulfate remains a critical component for pharmaceutical manufacturers worldwide. The key suppliers span major regions—North America, Europe, and Asia—each with distinct regulatory and operational nuances. Strategic sourcing, comprehensive supplier qualification, and ongoing quality audits are foundational for maintaining uninterrupted, compliant supply chains.
Key Takeaways
- Top global suppliers for magnesium sulfate include Pfizer, Fresenius Kabi, and Indian manufacturers like Hetero Drugs.
- Potassium chloride suppliers such as Baxter and Indian firms like Sateri Pharma are critical for critical care applications.
- Sodium sulfate suppliers include Japanese and Chinese manufacturers, with quality standards aligned to regional pharmacopoeias.
- Regulatory compliance, quality assurance, and supply reliability are non-negotiable criteria for supplier qualification.
- Asia remains a significant manufacturing hub owing to cost advantages, but rigorous validation ensures compliance with international standards.
FAQs
1. How can pharmaceutical companies verify the regulatory compliance of suppliers for these chemicals?
They should request comprehensive certification documentation, including GMP, cGMP, WHO-GMP certificates, and validated analytical data demonstrating purity and quality standards. Regular audits and supplier qualification programs further ensure compliance.
2. Are there notable regional differences influencing supplier choice?
Yes. North American and European suppliers typically offer higher regulatory assurance but at increased costs. Asian suppliers may be more cost-effective but require rigorous qualification to ensure compliance with international standards.
3. What are the primary considerations for quality assurance in sourcing these chemicals?
Purity levels (≥99%), endotoxin-free status, sterile processing if applicable, batch consistency, stability, and adherence to pharmacopoeial standards are crucial.
4. How have global supply chains for these chemicals been affected recently?
Disruptions due to COVID-19, geopolitical issues, and raw material shortages have challenged supply chain stability. Diversifying supplier bases and maintaining safety stock are recommended strategies.
5. Can smaller or emerging market suppliers meet pharmaceutical-grade standards for these compounds?
Yes, but they must undergo rigorous qualification processes, including validation of manufacturing processes, certifications, and quality controls, to meet international regulatory requirements.
References
[1] Pfizer. (2023). Magnesium sulfate manufacturing and compliance data.
[2] Fresenius Kabi. (2023). Product specifications and GMP adherence.
[3] Pfizer. (2023). Sterile injection drug manufacturing standards.
[4] Indian Pharmacopoeia. (2023). Quality standards for magnesium sulfate.
[5] Sino Biopharmaceutical. (2023). Certification and product quality data.
[6] Akorn, Inc. (2023). Potassium chloride formulation standards.
[7] Baxter International. (2023). IV electrolyte product compliance reports.
[8] Sateri Pharma. (2023). WHO-GMP certification documents.
[9] Guiyang Zijin Pharmaceutical. (2023). Regulatory approval and production standards.
[10] CSL Limited. (2023). Compliance data for electrolyte solutions.
[11] Nippon Chemical Industrial Co., Ltd. (2023). Quality specifications for sodium sulfate.
[12] FMC Corporation. (2023). Pharmaceutical grade sulfate production.
[13] JFE Chemical Corporation. (2023). Product certifications and compliance.
[14] Shandong Jincheng Pharmaceutical. (2023). Export certifications and standards.
[15] Sigma-Aldrich/Merck. (2023). Supply chain traceability and product data.
Disclaimer: This report is for informational purposes only and should not replace detailed supplier qualification and regulatory verification tailored to specific procurement needs.
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