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Sodium Chloride API Manufacturers & Suppliers
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Commercial-scale Suppliers
Distributor
Produced in
Germany|
Employees: 50+
|
Audit Report:
Certifications:
GMP
|
MSDS|
BSE/TSE|
ISO 9001|
CoAAll certificates
GMP
MSDS
BSE/TSE
ISO 9001
CoA
Producer
Produced in
Japan|
Employees: 2400+
|
Audit Report:
Certifications:
GMP
|
MSDS|
BSE/TSE|
ISO9001|
CoAAll certificates
GMP
MSDS
BSE/TSE
ISO9001
CoA
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Producer
Produced in
Austria|
Employees: 500+
|
Audit Report:
Certifications:
GMP
|
CEP|
USDMF|
ISO9001|
coaAll certificates
GMP
CEP
USDMF
ISO9001
coa
WC
WHO-GMP
Distributor
Produced in
World|
Employees: 50
|
Audit Report:
Certifications:
GMP
|
MSDS|
CoA|
ISO9001All certificates
GMP
MSDS
CoA
ISO9001
Distributor
Produced in
Switzerland|
Employees: 135+
|
Audit Report:
Certifications:
GMP
|
MSDS|
CoAAll certificates
GMP
MSDS
CoA
Distributor
Produced in
Singapore|
Employees: 50+
|
Audit Report:
Certifications:
GMP
|
FDA|
CEP|
USDMF|
EDMF/ASMFAll certificates
GMP
FDA
CEP
USDMF
EDMF/ASMF
MSDS
BSE/TSE
ISO9001
JDMF
WC
KDMF
CoA
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€399,-
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Distributor
Produced in
Unknown|
Employees: 275+
|
Audit Report:
Certifications:
GMP
|
MSDS|
BSE/TSE|
ISO9001|
CoAAll certificates
GMP
MSDS
BSE/TSE
ISO9001
CoA
Producer
Produced in
Netherlands|
Audit Report:
Certifications:
GMP
|
MSDS|
BSE/TSE|
CoAAll certificates
GMP
MSDS
BSE/TSE
CoA
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€399,-
All Sodium Chloride data. Full access. Full negotiation power
Producer
Produced in
Denmark|
Audit Report:
Certifications:
GMP
|
FDA|
CEP|
USDMF|
coaAll certificates
GMP
FDA
CEP
USDMF
coa
Producer
Produced in
Switzerland|
Audit Report:
Certifications:
CEP
|
coaAll certificates
CEP
coa
Producer
Produced in
Germany|
Audit Report:
Certifications:
GMP
|
CEP|
CoAAll certificates
GMP
CEP
CoA
Producer
Produced in
Germany|
Audit Report:
Certifications:
GMP
|
FDA|
CEP|
coaAll certificates
GMP
FDA
CEP
coa
Get full market intelligence report
€399,-
All Sodium Chloride data. Full access. Full negotiation power
Producer
Produced in
Japan|
Audit Report:
Certifications:
coa
All certificates
coa
Producer
Produced in
India|
Audit Report:
Certifications:
USDMF
|
CoAAll certificates
USDMF
CoA
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Sodium chloride | CAS No: 7647-14-5 | GMP-certified suppliers
A medication that provides essential electrolytes for hydration in adults and pediatric patients and supports compatible intravenous drug administration as a reliable diluent.
Therapeutic categories
Alimentary Tract and MetabolismBlood and Blood Forming OrgansBlood Substitutes and Perfusion SolutionsChloridesChlorine CompoundsDiluents
Generic name
Sodium chloride
Molecule type
small molecule
CAS number
7647-14-5
DrugBank ID
DB09153
Approval status
Approved drug, Vet_approved drug
ATC code
B05XA03
Primary indications
- This intravenous solution is indicated for use in adults and pediatric patients as a source of electrolytes and water for hydration
- Also, designed for use as a diluent and delivery system for intermittent intravenous administration of compatible drug additives
Product Snapshot
- This product is a widely used parenteral and multi-route formulation of sodium chloride, primarily supplied as injectable and irrigating solutions
- It is used for hydration, electrolyte replacement, and as a diluent or carrier for compatible intravenous drug products
- It is approved for human and veterinary use in the US and Canada
Clinical Overview
Sodium chloride (CAS 7647-14-5) is an inorganic alkali metal chloride widely used in clinical practice as a fundamental electrolyte component. In parenteral formulations, it functions as a source of sodium and chloride to support hydration in adults and pediatric patients and serves as a diluent for compatible intravenous drug additives. It is also present in many irrigation and perfusion solutions and appears on the World Health Organization Model List of Essential Medicines.
Its pharmacological activity reflects the physiological roles of its constituent ions. Sodium is the predominant extracellular cation responsible for regulating water distribution, osmotic pressure, and fluid balance. It also contributes to acid-base equilibrium through interactions with chloride and bicarbonate. Chloride, the major extracellular anion, mirrors sodium handling and influences acid-base status by adjusting to changes in bicarbonate concentrations. Together, these ions maintain extracellular volume and support blood pressure homeostasis.
Absorption, distribution, and elimination depend on the route of administration and the individual’s fluid status. Intravenous administration delivers immediate availability in the extracellular space. Sodium and chloride undergo renal regulation, with excretion rates linked to glomerular filtration and tubular reabsorption mechanisms. Neither ion undergoes metabolic transformation.
Safety considerations are primarily related to volume status, electrolyte balance, and renal function. Excessive administration may cause hypernatremia, fluid overload, or acid-base disturbances, while rapid shifts in serum sodium can lead to neurological complications. Sodium chloride solutions should be used cautiously in patients with heart failure, renal impairment, or conditions requiring sodium restriction. Common clinical formulations include isotonic (0.9 percent) and hypertonic saline, selected based on therapeutic need.
For API procurement, sourcing should prioritize material produced under appropriate GMP controls, with attention to sterility assurance when intended for parenteral use and tight specifications for elemental impurities, particulate matter, and microbial limits to support global regulatory compliance.
Its pharmacological activity reflects the physiological roles of its constituent ions. Sodium is the predominant extracellular cation responsible for regulating water distribution, osmotic pressure, and fluid balance. It also contributes to acid-base equilibrium through interactions with chloride and bicarbonate. Chloride, the major extracellular anion, mirrors sodium handling and influences acid-base status by adjusting to changes in bicarbonate concentrations. Together, these ions maintain extracellular volume and support blood pressure homeostasis.
Absorption, distribution, and elimination depend on the route of administration and the individual’s fluid status. Intravenous administration delivers immediate availability in the extracellular space. Sodium and chloride undergo renal regulation, with excretion rates linked to glomerular filtration and tubular reabsorption mechanisms. Neither ion undergoes metabolic transformation.
Safety considerations are primarily related to volume status, electrolyte balance, and renal function. Excessive administration may cause hypernatremia, fluid overload, or acid-base disturbances, while rapid shifts in serum sodium can lead to neurological complications. Sodium chloride solutions should be used cautiously in patients with heart failure, renal impairment, or conditions requiring sodium restriction. Common clinical formulations include isotonic (0.9 percent) and hypertonic saline, selected based on therapeutic need.
For API procurement, sourcing should prioritize material produced under appropriate GMP controls, with attention to sterility assurance when intended for parenteral use and tight specifications for elemental impurities, particulate matter, and microbial limits to support global regulatory compliance.
Identification & chemistry
| Generic name | Sodium chloride |
|---|---|
| Molecule type | Small molecule |
| CAS | 7647-14-5 |
| UNII | 451W47IQ8X |
| DrugBank ID | DB09153 |
Pharmacology
| Summary | This formulation provides sodium and chloride ions that support extracellular fluid volume, osmotic balance, and acid‑base regulation. Its pharmacologic effects reflect the role of sodium as the primary extracellular cation and chloride as the principal anion, which together influence water distribution and electrolyte homeostasis. It is used to supply electrolytes and water for hydration and to serve as a diluent for compatible intravenous drug additives. |
|---|---|
| Mechanism of action | Sodium and chloride — major electrolytes of the fluid compartment outside of cells (i.e., extracellular) — work together to control extracellular volume and blood pressure. Disturbances in sodium concentrations in the extracellular fluid are associated with disorders of water balance. |
| Pharmacodynamics | Sodium, the major cation of the extracellular fluid, functions primarily in the control of water distribution, fluid balance, and osmotic pressure of body fluids. Sodium is also associated with chloride and bicarbonate in the regulation of the acid-base equilibrium of body fluid. Chloride, the major extracellular anion, closely follows the metabolism of sodium, and changes in the acid-base balance of the body are reflected by changes in the chloride concentration. |
ADME / PK
| Absorption | Absorption of sodium in the small intestine plays an important role in the absorption of chloride, amino acids, glucose, and water. Chloride, in the form of hydrochloric acid (HCl), is also an important component of gastric juice, which aids the digestion and absorption of many nutrients. |
|---|---|
| Half-life | 17 minutes |
| Protein binding | Sodium is not bound by plasma proteins. |
| Metabolism | The salt that is taken in to gastro intestinal tract remains for the most part unabsorbed as the liquid contents pass through the stomach and small bowel. On reaching the colon this salt, together with the water is taken in to the blood. As excesses are absorbed the kidney is constantly excreting sodium chloride, so that the chloride level in the blood and tissues remains fairly constant.Further more, if the chloride intake ceases, the kidney ceases to excrete chlorides. Body maintains an equilibrium retaining the 300gm of salt dissolved in the blood and fluid elements of the tissue dissociated into sodium ions and chloride ions. |
| Route of elimination | Substantially excreted by the kidneys. |
| Volume of distribution | The volume of distribution is 0.64 L/kg. |
Formulation & handling
- Highly water‑soluble inorganic small molecule suitable for simple aqueous formulations across parenteral, inhalation, irrigation, oral, and topical routes.
- Chemically stable in solution with minimal degradation pathways; primary handling considerations relate to controlling concentration, osmolarity, and sterility for parenteral and ophthalmic use.
- Not sensitive to food or physiologic enzymes; formulation focus is on achieving appropriate tonicity and compatibility with device materials.
Regulatory status
| Lifecycle | Most U.S. patents for the API expired between 2017 and 2023, indicating a mature intellectual‑property stage. With products marketed in the United States and Canada, the ingredient is positioned in a late‑lifecycle market environment. |
|---|
| Markets | Canada, US |
|---|
Supply Chain
| Supply chain summary | Sodium chloride solutions are produced by multiple manufacturers, with no single originator dominating this mature therapeutic area. The listed branded formulations are available in North American markets, and similar electrolyte and dextrose–saline products are widely supplied globally. All cited U.S. patents have expired, indicating an established environment for broad generic production and ongoing multi‑supplier competition. |
|---|
Safety
| Toxicity | The rare inadvertent intravascular administration or rapid intravascular absorption of hypertonic sodium chloride can cause a shift of tissue fluids into the vascular bed, resulting in hypervolemia, electrolyte disturbances, circulatory failure, pulmonary embolism, or augmented hypertension. |
|---|
High Level Warnings:
- Risk of hypervolemia and electrolyte displacement may arise from inadvertent intravascular misadministration or rapid absorption of hypertonic sodium chloride
- Excessive intravascular fluid shifts can precipitate circulatory overload, augmented hypertension, or pulmonary complications
- Monitor for conditions associated with osmotic imbalance, as rapid vascular expansion can exacerbate underlying cardiovascular stressors
Sodium Chloride is a type of Electrolytes
Electrolytes are a crucial category of pharmaceutical active pharmaceutical ingredients (APIs) that play a vital role in maintaining the balance of essential ions in the body. These ions include sodium, potassium, calcium, magnesium, and chloride, among others. Electrolytes are responsible for maintaining proper hydration, regulating nerve and muscle function, and supporting various physiological processes.
In the pharmaceutical industry, electrolytes are widely utilized in the formulation of oral rehydration solutions, intravenous fluids, and dialysis solutions. These medications are employed to treat conditions such as dehydration, electrolyte imbalances, and renal dysfunction.
The availability of high-quality electrolyte APIs is of utmost importance to ensure the efficacy and safety of these pharmaceutical products. Pharmaceutical manufacturers rely on reputable suppliers who adhere to stringent quality control measures and comply with Good Manufacturing Practices (GMP) to produce electrolyte APIs of consistent quality.
To meet regulatory requirements, electrolyte APIs undergo rigorous testing to confirm their identity, purity, and potency. This includes analysis using advanced techniques such as high-performance liquid chromatography (HPLC), mass spectrometry (MS), and atomic absorption spectroscopy (AAS).
In conclusion, electrolytes are a vital category of pharmaceutical APIs used to maintain the balance of essential ions in the body. They are extensively employed in various medications aimed at treating dehydration, electrolyte imbalances, and renal dysfunction. Pharmaceutical manufacturers prioritize the use of high-quality electrolyte APIs to ensure the safety and efficacy of their products, and adherence to stringent regulatory standards is crucial in their production and testing processes.
Sodium Chloride API manufacturers & distributors
Compare qualified Sodium Chloride API suppliers worldwide. We currently have 14 companies offering Sodium Chloride API, with manufacturing taking place in 10 different countries. Use the table below to review supplier type, countries of origin, certifications, product portfolio and GMP audit availability.
| Supplier | Type | Country | Product origin | Certifications | Portfolio |
|---|---|---|---|---|---|
| Acta minerals | Producer | Netherlands | Netherlands | BSE/TSE, CoA, GMP, MSDS | 67 products |
| Akzo Nobel Salt | Producer | Denmark | Denmark | CEP, CoA, FDA, GMP, USDMF | 2 products |
| Apollo Healthcare Resourc... | Distributor | Singapore | Singapore | BSE/TSE, CEP, CoA, EDMF/ASMF, FDA, GMP, ISO9001, JDMF, KDMF, MSDS, USDMF, WC | 200 products |
| AXXO GmbH | Distributor | Germany | World | CoA, GMP, GDP, MSDS | 243 products |
| Caesar & Loretz GmbH (CAE... | Distributor | Germany | Unknown | BSE/TSE, CoA, GMP, ISO9001, MSDS | 211 products |
| Duchefa Farma B.V. | Distributor | Netherlands | Germany | BSE/TSE, CoA, GMP, ISO9001, MSDS | 170 products |
| ESCO Salt | Producer | Germany | Germany | CEP, CoA, FDA, GMP | 1 products |
| Fujifilm Wako Pure Chemic... | Producer | Japan | Japan | BSE/TSE, CoA, GMP, ISO9001, MSDS | 55 products |
| Hänseler AG | Distributor | Switzerland | Switzerland | CoA, GMP, MSDS | 174 products |
| NANDU CHEMICAL | Producer | India | India | CoA, USDMF | 3 products |
| Salinen Austria AG | Producer | Austria | Austria | CEP, CoA, GMP, ISO9001, USDMF, WC, WHO-GMP | 1 products |
| Schweizer Salinen | Producer | Switzerland | Switzerland | CEP, CoA | 1 products |
| Südwestdeutsche Salzwerke | Producer | Germany | Germany | CEP, CoA, GMP | 1 products |
| Tomita Pharmaceutical | Producer | Japan | Japan | CoA | 10 products |
When sending a request, specify which Sodium Chloride API quality you need: for example EP (Ph. Eur.), USP, JP, BP, or another pharmacopoeial standard, as well as the required grade (base, salt, micronised, specific purity, etc.).
Use the list above to find high-quality Sodium Chloride API suppliers. For example, you can select GMP, FDA or ISO certified suppliers. Visit our help page to learn more about sourcing APIs via Pharmaoffer.
Frequently asked questions about Sodium Chloride API
Sourcing
What matters most when sourcing GMP-grade Sodium Chloride?
Key considerations include confirming GMP compliance and alignment with U.S. and Canadian regulatory requirements. Suppliers should provide clear documentation of quality, traceability, and testing standards. In this mature, multi‑supplier market, consistent specifications and a reliable supply chain are essential for ensuring uninterrupted availability.
Which documents are typically required when sourcing Sodium Chloride API?
Request the core API documentation set: CoA (14 companies), GMP (11 companies), MSDS (7 companies), CEP (6 companies), ISO9001 (5 companies). Confirm versions and validity dates match the destination market to avoid delays in qualification.
Which manufacturers are known to produce Sodium Chloride API?
Known or reported manufacturers for Sodium Chloride: Duchefa Farma B.V., Caesar & Loretz GmbH (CAELO), Fujifilm Wako Pure Chemical Corporation, Hänseler AG, Apollo Healthcare Resources (Singapore), Acta minerals, Salinen Austria AG, AXXO GmbH. Evaluate their GMP history, scale, and regional coverage before requesting dossiers or allocating demand.
How can I request quotes for Sodium Chloride API from GMP suppliers?
Submit quote requests through the supplier listings with your specs and required documents (specifications, target volume, delivery timeline, and destination). Providing consistent details upfront speeds comparable offers and clarifies technical feasibility.
Is a GMP audit report available for Sodium Chloride manufacturers?
Audit reports may be requested for Sodium Chloride: 2 GMP audit reports available. Confirm the scope and recency of any audit before relying on it for qualification decisions.
How many suppliers offer Sodium Chloride API on Pharmaoffer?
Reported supplier count for Sodium Chloride: 14 verified suppliers. Filter listings by certifications, regions, and delivery options to match your qualification plan.
Which countries are known to manufacture Sodium Chloride API?
Production countries reported for Sodium Chloride: Germany (3 producers), Japan (2 producers), Switzerland (2 producers). Knowing the manufacturing geography helps anticipate logistics lead times and import compliance needs.
Which certifications do suppliers of Sodium Chloride usually hold?
Common certifications for Sodium Chloride suppliers: CoA (14 companies), GMP (11 companies), MSDS (7 companies), CEP (6 companies), ISO9001 (5 companies). Always verify issuing authorities and expiry dates when reviewing audit packages.
Technical
What is Sodium Chloride (CAS 7647-14-5) used for?
Sodium Chloride is used as an essential electrolyte component in parenteral, irrigation, and perfusion solutions to maintain extracellular fluid balance and support osmotic and acid‑base regulation. In intravenous formulations, it provides sodium and chloride for hydration and serves as a diluent for compatible drug additives. It is also included in many clinical saline preparations, such as isotonic and hypertonic solutions, for routine therapeutic use.
Which therapeutic class does Sodium Chloride fall into?
Sodium Chloride belongs to the following therapeutic categories: Alimentary Tract and Metabolism, Blood and Blood Forming Organs, Blood Substitutes and Perfusion Solutions, Chlorides, Chlorine Compounds. This positioning helps teams compare alternative APIs, anticipate pharmacology expectations, and align early research priorities.
What conditions is Sodium Chloride mainly prescribed for?
The primary indications for Sodium Chloride: This intravenous solution is indicated for use in adults and pediatric patients as a source of electrolytes and water for hydration, Also, designed for use as a diluent and delivery system for intermittent intravenous administration of compatible drug additives. These use cases frame the target patient populations and help prioritize formulation and safety evaluations.
How does Sodium Chloride work?
Sodium and chloride — major electrolytes of the fluid compartment outside of cells (i.e., extracellular) — work together to control extracellular volume and blood pressure. Disturbances in sodium concentrations in the extracellular fluid are associated with disorders of water balance.
What should someone know about the safety or toxicity profile of Sodium Chloride?
Sodium Chloride is generally well tolerated, but safety concerns relate to dosing, volume status, and renal function. Excess or rapid administration, particularly of hypertonic solutions, can cause hypervolemia, electrolyte displacement, hypernatremia, or acid‑base disturbances, and may precipitate circulatory overload or pulmonary complications. Rapid shifts in serum sodium may also lead to neurological effects. Use requires caution in patients with heart failure, renal impairment, or conditions requiring sodium restriction, with close monitoring for osmotic imbalance.
What are important formulation and handling considerations for Sodium Chloride as an API?
Important considerations include controlling concentration and osmolarity, as Sodium Chloride is highly water‑soluble and used to achieve appropriate tonicity in many dosage forms. For parenteral, ophthalmic, and irrigation products, sterility and particulate control are essential. The compound is chemically stable, so formulation focus is primarily on solution quality and compatibility with container and device materials.
Is Sodium Chloride a small molecule?
Sodium Chloride is classified as a small molecule. That classification shapes process design, impurity profiling, and analytical control strategies.
Are there special stability concerns for oral Sodium Chloride?
Oral Sodium Chloride is chemically stable and does not undergo meaningful degradation in simple aqueous formulations. It is not sensitive to food or physiologic enzymes, so no special stability concerns arise during gastrointestinal transit. Formulation considerations mainly involve maintaining the intended concentration and tonicity.
Regulatory
Where is Sodium Chloride approved or in use globally?
Sodium Chloride is reported as approved in the following major regions: Canada, US. Understanding geographic coverage informs regulatory filings, supply planning, and risk assessments before escalating procurement.
What’s the regulatory and patent landscape for Sodium Chloride right now?
Sodium Chloride is an established, non‑proprietary API with longstanding acceptance in both the United States and Canada. In these markets, it is included in compendial standards and is regulated as a well‑characterized ingredient. Because it is not a novel compound, it is not subject to active patent protection. Regulatory oversight focuses on compliance with quality and purity specifications rather than exclusivity.
Pharmaoffer
How does Pharmaoffer’s Smart Sourcing Service help with Sodium Chloride procurement?
Pharmaoffer's Smart Sourcing Service coordinates compliant suppliers, documentation, and competitive quotes for Sodium Chloride. It centralizes outreach, follow-ups, and document validation to shorten procurement timelines.
Is Sodium Chloride included in the PRO Data Insights coverage?
PRO Data Insights coverage for Sodium Chloride: 776 verified transactions across 280 suppliers and 261 buyers worldwide. Use the dataset to benchmark suppliers and monitor regulatory activity where available.
Where can I access the API market report for Sodium Chloride?
Market report availability for Sodium Chloride: Report Available. The report highlights demand trends, pricing drivers, and supplier landscape insights for procurement planning.
