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Suppliers and packagers for generic pharmaceutical drug: CALCIUM CHLORIDE; MAGNESIUM CHLORIDE; POTASSIUM CHLORIDE; SODIUM ACETATE; SODIUM CHLORIDE
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CALCIUM CHLORIDE; MAGNESIUM CHLORIDE; POTASSIUM CHLORIDE; SODIUM ACETATE; SODIUM 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 |
|---|---|---|---|---|---|---|---|---|---|
| Hospira | TPN ELECTROLYTES IN PLASTIC CONTAINER | calcium chloride; magnesium chloride; potassium chloride; sodium acetate; sodium chloride | INJECTABLE;INJECTION | 018895 | NDA | Hospira, Inc. | 0409-5779-01 | 25 VIAL, SINGLE-DOSE in 1 CARTON (0409-5779-01) / 20 mL in 1 VIAL, SINGLE-DOSE (0409-5779-11) | 2005-02-28 |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >NDA/ANDA | >Supplier | >Package Code | >Package | >Marketing Start |
Suppliers for the Pharmaceutical Drugs: Calcium Chloride, Magnesium Chloride, Potassium Chloride, Sodium Acetate, and Sodium Chloride
Introduction
The global pharmaceutical market relies heavily on a robust supply chain for essential chemicals used in drug formulation, medical therapies, and clinical applications. Among these, electrolytes such as calcium chloride, magnesium chloride, potassium chloride, sodium acetate, and sodium chloride are critical components for infusion therapies, reconstitution solutions, and electrolyte management. Identifying reliable suppliers for these compounds is vital for pharmaceutical manufacturers, hospital procurement agencies, and compounding pharmacies to ensure product quality, compliance, and uninterrupted supply.
This article provides a comprehensive overview of leading suppliers for these key pharmaceutical-grade chemicals, examining their manufacturing capabilities, geographic presence, certifications, and market position.
1. Leading Suppliers for Calcium Chloride
Manufacturers and Key Players
a. Merck KGaA (Germany)
Merck, a global leader in specialty chemicals, supplies pharmaceutical-grade calcium chloride (Ph.Eur., USP grades). Their manufacturing facilities in Europe and North America ensure high purity and reliable supply. Merck’s calcium chloride is widely used in medical, industrial, and laboratory settings.
Certifications: ISO 9001, GMP compliance, Ph.Eur., USP.
b. Thermo Fisher Scientific (USA)
Thermo Fisher offers calcium chloride solutions suitable for clinical and pharmaceutical applications, emphasizing purity and consistent quality. Their extensive distribution network ensures global reach.
Certifications: cGMP, ISO 9001.
c. S. R. Pharmaceuticals (India)
Specializes in bulk pharmaceuticals, including calcium chloride, with factories adhering to WHO-GMP standards. They supply pharmaceutical-grade calcium chloride across Asia, Africa, and the Middle East.
Certifications: WHO-GMP, ISO 9001.
d. Sigma-Aldrich (Part of Merck Group)
Provides a range of calcium chloride products in various grades, suitable for laboratory, medical, and industrial purposes. Their distribution ensures supply continuity worldwide.
Certifications: ISO, USP, Ph.Eur.
2. Major Suppliers of Magnesium Chloride
Market Leaders
a. Nutrients (USA)
A leading provider of pharmaceutical-grade magnesium chloride, especially in infusion solutions and electrolyte replenishment protocols. Their magnesium chloride is manufactured under strict GMP standards.
Certifications: GMP, ISO 9001.
b. Hanlim Pharmaceutical (South Korea)
Manufactures high-purity magnesium chloride for pharma and nutritional applications, serving Asia-Pacific markets with GMP-certified production facilities.
Certifications: ISO 9001, cGMP.
c. Sigma-Aldrich (Merck Group)
Offers various grades of magnesium chloride, including pharmaceutical cGMP-grade products for clinical use.
Certifications: USP, Ph.Eur.
d. Yung Soon Lih Food Co. (Taiwan)
Specializes in pharmaceutical-grade magnesium chloride with applications in supplements and medical solutions, ensuring food and pharma-grade compliance.
Certifications: ISO 9001.
3. Leading Suppliers for Potassium Chloride
Industry Key Players
a. União Química (Brazil)
A majority of their potassium chloride is sourced from their own mines and is supplied for pharmaceutical use globally, with high-purity formulations for IV solutions and electrolyte management.
Certifications: GMP, ISO 9001.
b. PotashCorp (Canada, Owned by Nutrien)
Operates major potash mining and processing facilities, producing pharmaceutical-grade potassium chloride suitable for injections and infusion solutions.
Certifications: ISO 9001, GMP.
c. Fosfa (Egypt)
Produces high-purity potassium chloride with extensive export capabilities, meeting pharmaceutical standards for use in electrolyte therapy.
Certifications: ISO 9001, GMP.
d. Sigma-Aldrich (Merck)
Provides pharmaceutical-grade potassium chloride in various technical and clinical grades, ensuring supply for manufacturing and research.
Certifications: USP, Ph.Eur.
4. Top Suppliers of Sodium Acetate
Industry Players
a. Avantor (USA)
Offers pharmaceutical-grade sodium acetate in multiple formulations suitable for infusion, buffering, and clinical applications. Their global scale ensures reliable supply.
Certifications: ISO 9001, GMP.
b. Thermo Fisher Scientific
Provides high-purity sodium acetate for medical and laboratory use, with documentation aligned with pharmaceutical standards.
Certifications: cGMP, ISO.
c. RTP Company (USA)
Specializes in custom manufacturing of pharmaceutical-grade sodium acetate, catering to niche applications such as parenteral nutrition and lab reagents.
Certifications: ISO 9001.
d. Beijing Salubris Pharmaceuticals (China)
Supplies sodium acetate meeting Chinese pharmacopeia standards, expanding to global markets with GMP compliance.
Certifications: GMP, ISO.
5. Prominent Suppliers of Sodium Chloride
Global and Regional Suppliers
a. Cosmo Pharmaceuticals (India)
A major producer of pharmaceutical-grade sodium chloride, supplying IV-grade solutions for infusion therapy across India and South Asia.
Certifications: WHO-GMP, ISO 9001.
b. Ajinomoto (Japan)
Manufactures pharmaceutical-grade sodium chloride and saline solutions used globally in hospitals, ensuring high purity standards.
Certifications: GMP, ISO.
c. B. Braun Melsungen AG (Germany)
Provides sterile sodium chloride solutions, including 0.9% saline for intravenous use, produced in compliance with GMP standards.
Certifications: GMP, ISO.
d. GE Healthcare (USA)
Produces saline solutions based on pharmaceutical-grade sodium chloride, emphasizing quality control for clinical and hospital use.
Certifications: GMP, ISO.
Market Dynamics and Considerations
Supply Chain Reliability
The pharmaceutical-grade chemicals discussed originate predominantly from established manufacturers with GMP certification, ensuring compliance with international standards (USP, Ph.Eur., BP). Suppliers with diversified manufacturing facilities across multiple geographic regions mitigate supply disruptions, a critical factor for pharmaceutical companies.
Quality Assurance and Certifications
Prioritizing suppliers with GMP, ISO 9001, and pharmacopeia certifications ensures compliance with regulatory frameworks such as the FDA, EMA, and WHO. These certifications verify that products meet stringent purity, safety, and efficacy standards essential for pharmaceutical applications.
Regional Focus and Export Capabilities
Suppliers in North America, Europe, and Asia Pacific account for the bulk of pharmaceutical-grade electrolyte supply. Asian manufacturers, notably from India, South Korea, and China, serve rapidly growing markets and often cater to both local and export demands.
Pricing and Contracting
Factors influencing pricing include purity grade, volume commitments, certification quality, and geopolitical considerations. Long-term contracts with established suppliers secure supply stability and favorable pricing terms.
Key Takeaways
- Leading global suppliers of pharmaceutical-grade calcium chloride include Merck KGaA, Thermo Fisher Scientific, and Sigma-Aldrich.
- Magnesium chloride is chiefly supplied by Nutrients (USA), Hanlim Pharmaceutical (South Korea), and Sigma-Aldrich.
- Potassium chloride suppliers are primarily Nutrien (Canada), Fosfa (Egypt), and União Química (Brazil).
- Sodium acetate and sodium chloride are competitively supplied by Avantor, B. Braun, Cosmo Pharmaceuticals, and Ajinomoto, among others.
- Ensuring suppliers hold GMP and pharmacopeia certifications is crucial for quality assurance and regulatory compliance.
- Geographic diversification and supply chain resilience are vital considerations amid global disruptions.
FAQs
1. What are the primary factors to consider when selecting a supplier for pharmaceutical electrolytes?
Quality certifications (GMP, ISO), product purity, manufacturing capacity, compliance with pharmacopeia standards, geographic resilience, and supply continuity are key factors.
2. How do certifications like GMP influence supplier credibility?
GMP certification ensures that manufacturing processes meet international quality standards, reducing risk of contamination or adulteration, thereby guaranteeing product integrity.
3. Are there regional differences in supplier availability for these drugs?
Yes. North American and European suppliers tend to focus on high-purity, regulated markets, while Asia-Pacific suppliers often cater to both domestic demand and export, sometimes at competitive prices.
4. Can pharmaceutical companies source these electrolytes directly from manufacturers?
Yes, but bulk purchasing often involves intermediaries or authorized distributors who ensure compliance, quality, and regulatory documentation.
5. How does the geopolitical landscape impact the supply of pharmaceutical electrolytes?
Trade restrictions, tariffs, and regional regulations can influence sourcing options, urging companies to diversify suppliers across multiple regions to mitigate risks.
References
[1] Merck KGaA, "Pharmaceutical-grade Calcium Chloride," Merck Group, 2023.
[2] Thermo Fisher Scientific, "Electrolytes for Medical Use," Thermo Fisher, 2023.
[3] Nutrients, "Pharmaceutical Magnesium Chloride," Nutrients Inc., 2023.
[4] Union Química, "GMP-certified Potassium Chloride," União Química, 2023.
[5] Avantor, "Pharmaceutical Sodium Acetate," Avantor, 2023.
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