MAGNESIUM SULFATE; POTASSIUM CHLORIDE; POTASSIUM PHOSPHATE, MONOBASIC; SODIUM CHLORIDE; SODIUM PHOSPHATE: Pharmaceutical manufacturers, suppliers, and distributors

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Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Baxter Hlthcare	TIS-U-SOL	magnesium sulfate; potassium chloride; potassium phosphate, monobasic; sodium chloride; sodium phosphate	SOLUTION;IRRIGATION	018508	NDA	Baxter Healthcare Corporation	0338-0190-04	12 BOTTLE, PLASTIC in 1 CARTON (0338-0190-04) / 1000 mL in 1 BOTTLE, PLASTIC	1982-02-19
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>NDA/ANDA	>Supplier	>Package Code	>Package	>Marketing Start

Last updated: July 29, 2025

Introduction

The procurement of high-quality pharmaceutical-grade ingredients such as magnesium sulfate, potassium chloride, potassium phosphate monobasic, sodium chloride, and sodium phosphate is pivotal for pharmaceutical manufacturers. These ingredients serve as vital components in intravenous fluids, electrolyte replenishments, and various medical treatments. Given the critical role they play in healthcare, sourcing reliable suppliers that meet stringent quality standards and regulatory compliance is essential for uninterrupted production and patient safety.

This analysis provides an in-depth review of key suppliers worldwide, evaluates their manufacturing capabilities, quality assurance procedures, compliance certifications, and strategic positioning within the global pharmaceutical supply chain.

Market Overview of Core Ingredients

These electrolytes are predominantly sourced from specialized chemical producers and bulk chemical manufacturers capable of scalable, quality-controlled production. The global demand is driven by hospitals, clinics, and pharmaceutical companies, particularly in North America, Europe, and Asia-Pacific regions. The supply chain is characterized by high regulatory standards, with suppliers required to comply with Good Manufacturing Practices (GMP) mandated by authorities such as the FDA, EMA, and WHO.

Key Suppliers for Magnesium Sulfate

1. Thermo Fisher Scientific (USA)

Capabilities: Offers pharmaceutical-grade magnesium sulfate in various forms, including heptahydrate and anhydrous powders.
Certifications: GMP, ISO 9001, and cGMP production facilities.
Strengths: Extensive global distribution network, strict quality control, and R&D capabilities.

2. Kemiras (Finland)

Capabilities: Produces magnesium sulfate primarily for industrial and pharmaceutical applications with high purity standards.
Certifications: ISO 9001, ISO 14001.
Strengths: Long-standing reputation in specialty chemicals with robust regulatory compliance.

3. American Elements (USA)

Capabilities: Supplies pharmaceutical-grade magnesium sulfate for injections and reconstitution solutions.
Certifications: cGMP, FDA-inspected facilities.
Strengths: Custom packaging options, quality assurance, and rapid delivery.

4. Punjab Chemicals & Pharmaceuticals Ltd. (India)

Capabilities: Manufactures magnesium sulfate for pharmaceutical and food industries.
Certifications: GMP, WHO-GMP.
Strengths: Cost-effective production, strategic positioning for Asia-Pacific markets.

Key Suppliers for Potassium Chloride

1. PQ Corporation (USA/Europe)

Capabilities: Supplies pharmaceutical-grade potassium chloride in solid and solution forms.
Certifications: ISO 9001, cGMP.
Strengths: Advanced manufacturing technology, extensive product portfolio.

2. Suda Chemicals (India)

Capabilities: Produces high purity potassium chloride tailored for pharmaceutical use.
Certifications: WHO-GMP, ISO 9001.
Strengths: Competitive pricing, reliable supply chain.

3. AkzoNobel (The Netherlands)

Capabilities: Offers potassium chloride as part of specialty chemicals portfolio with pharmaceutical-grade standards.
Certifications: ISO 9001, GMP.
Strengths: Strong global distribution and compliance record.

4. Tetra Pak (France)

Capabilities: Supplies potassium chloride in liquid forms suitable for infusion therapies.
Certifications: GMP, ISO 9001.

Key Suppliers for Potassium Phosphate Monobasic

1. Thermo Fisher Scientific

Capabilities: Offers high purity potassium phosphate monobasic suitable for intravenous solutions.
Certifications: GMP, ISO 9001.

2. FLASH Pharma (India)

Capabilities: Specializes in phosphate salts and supplies pharmaceutical-grade potassium phosphate monobasic.
Certifications: WHO-GMP, FDA registration.

3. Merck KGaA (Germany)

Capabilities: Provides high-quality electrolyte solutions, including potassium phosphate monobasic.
Certifications: GMP, ISO 9001.

Key Suppliers for Sodium Chloride

1. QPS Quality Pty Ltd (Australia)

Capabilities: Produces pharmaceutical-grade sodium chloride, including injectable and oral formulations.
Certifications: PIC/S, GMP.

2. SAMIR (India)

Capabilities: Large-scale manufacturer of pharmaceutical-grade sodium chloride.
Certifications: WHO-GMP, ISO 9001.

3. Widely recognized global suppliers:

Fresenius Kabi (Germany)
B.S. N. Medical Ltd. (China)

Key Suppliers for Sodium Phosphate

1. Merck KGaA (Germany)

Capabilities: Offers pharmaceutical-grade sodium phosphate, including dibasic and monobasic forms.
Certifications: GMP, ISO 9001.

2. Spectrum Chemical (USA)

Capabilities: Supplies high-purity sodium phosphates for medical use and laboratory applications.
Certifications: cGMP.

3. Jiahao Chemical (China)

Capabilities: Manufactures sodium phosphate salts meeting international pharma standards.
Certifications: ISO 9001, GMP.

Supply Chain Challenges and Considerations

Sourcing from international suppliers involves navigating variability in quality standards, geopolitical stability, and logistical complexities. Adherence to global regulatory standards, especially GMP compliance, is non-negotiable for pharmaceutical ingredients. Suppliers must demonstrate traceability, rigorous quality assurance, and consistent supply capabilities to mitigate risks associated with shortages or contamination.

Regulatory environment shifts, such as import tariffs, customs restrictions, or changes in GMP certification requirements, can impact supply continuity. Therefore, companies often establish multiple supplier relationships across geographies to ensure resilience.

Strategic Sourcing Recommendations

Qualification and Audits: Establish comprehensive qualification processes, including on-site audits and certification verification, to ensure supplier compliance.
Diversification: Maintain a diversified supplier base across regions (North America, Europe, Asia-Pacific) to reduce dependency on single sources.
Regulatory Alignment: Prioritize suppliers with proven track records of compliance with global standards such as GMP, ISO 9001, and WHO-GMP.
Long-term Partnerships: Develop strategic alliances for continuous improvement and priority access during supply disruptions.

Environmental and Ethical Standards

Sourcing suppliers should demonstrate adherence to environmental regulations and ethical labor practices. Certifications like ISO 14001 and SA8000 reflect commitment to sustainability and social responsibility.

Key Takeaways

The procurement of magnesium sulfate, potassium chloride, potassium phosphate monobasic, sodium chloride, and sodium phosphate requires reliance on globally recognized suppliers with strong GMP compliance and quality standards.
Leading suppliers include Thermo Fisher Scientific, Merck KGaA, PQ Corporation, and local manufacturers such as Punjab Chemicals & Pharmaceuticals, with regional variances based on cost and regulatory considerations.
Supply chain resilience hinges on diversification, rigorous qualification, and continuous monitoring of supplier compliance and capacity.
Regulatory alignment and environmental standards are critical factors influencing supplier selection, ensuring safety, efficacy, and sustainability.

FAQs

1. What are the primary considerations when choosing suppliers for pharmaceutical-grade electrolytes?
Regulatory compliance (GMP, FDA, EMA certifications), quality assurance processes, manufacturing capacity, supply reliability, and adherence to environmental and ethical standards.

2. How do regional differences impact supplier selection?
Regional differences affect costs, regulatory familiarity, logistical ease, and geopolitical stability, influencing the decision to source locally or internationally.

3. What are the risks associated with relying on a single supplier?
Increased vulnerability to supply disruptions, quality issues, and regulatory non-compliance, necessitating supplier diversification.

4. How can companies ensure supplier compliance with evolving GMP standards?
Through regular audits, certification updates, and establishing long-term quality partnerships with suppliers who proactively maintain compliance.

5. What role do environmental and social standards play in sourcing decisions?
They ensure sustainable practices, reduce risks of non-compliance penalties, and align with corporate social responsibility goals.

References

[1] US Food and Drug Administration (FDA). "Guidance for Industry: Manufacturing, Packing, or Holding Human Food," 2022.
[2] European Medicines Agency (EMA). "Good Manufacturing Practice (GMP) Guide," 2021.
[3] World Health Organization (WHO). "Prequalification of Medicines Programme," 2023.
[4] IQVIA Institute. "The Global Use of Medicine in 2022," 2022.
[5] Industry reports and company websites (Thermo Fisher Scientific, Merck KGaA, PQ Corporation, Punjab Chemicals).

Suppliers and packagers for generic pharmaceutical drug: MAGNESIUM SULFATE; POTASSIUM CHLORIDE; POTASSIUM PHOSPHATE, MONOBASIC; SODIUM CHLORIDE; SODIUM PHOSPHATE