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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 and packagers for generic pharmaceutical drug: CALCIUM CHLORIDE; MAGNESIUM CHLORIDE; POTASSIUM CHLORIDE; SODIUM ACETATE; SODIUM CHLORIDE
Who Supplies Calcium Chloride, Magnesium Chloride, Potassium Chloride, Sodium Acetate, and Sodium Chloride to Pharma?
Pharma-grade supply for the five listed salts is dominated by commodity chemical suppliers with GMP-capable manufacturing and documented quality controls. The practical supplier set falls into two tiers: (1) large global chemical producers that supply regulated markets and (2) specialty distributors that package and qualify salts for pharmaceutical and sterile use.
Which companies supply calcium chloride (pharmaceutical-grade)?
Typical supplier set used for regulated markets includes manufacturers of bulk CaCl2 and operators that provide GMP documentation, controlled particle specs, and audited traceability.
Common supplier sources
- Otsuka Chemical (calcium chloride product lines for regulated end uses; check site-specific GMP capabilities)
- Tata Chemicals (chemical-grade to pharma-adjacent supply; qualification required per use case)
- Merck KGaA / MilliporeSigma (branded lab/industrial salt supply; qualification per pharmaceutical specification)
- VWR / Avantor (distribution of branded and manufacturer-sourced CaCl2)
- Fisher Scientific / Thermo Fisher (distribution of branded CaCl2)
Route-to-market reality
- For injectables and sterile formulations, buyers typically qualify:
- the specific manufacturing site
- the grade (USP/EP where applicable)
- and documentation package (CoA format, impurity profile, endotoxin approach if relevant to use)
Which companies supply magnesium chloride (pharmaceutical-grade)?
Common supplier sources
- Merck KGaA / MilliporeSigma
- Fisher Scientific / Thermo Fisher
- Avantor / VWR
- DAD (distribution) and pharma chemical distributors with site-level GMP/DMF support depending on end use
- Global salt and brine chemical manufacturers that can provide controlled-grade MgCl2
Qualification focus
- MgCl2 specs vary widely by hydration state and impurity tolerance. Pharmaceutical use typically drives additional controls for:
- sulfate, calcium, heavy metals
- water content / hydration form
- particle size if used for sterile manufacturing steps
Which companies supply potassium chloride (pharmaceutical-grade)?
Common supplier sources
- Fresenius Kabi procurement channels for KCl-related needs (if sourcing for internal use; public supplier lists vary)
- Merck KGaA / MilliporeSigma
- Thermo Fisher Scientific
- Avantor / VWR
- Major inorganic chemical producers with USP or EP-oriented grades depending on market
Common compliance expectations
- Buyers often standardize on USP/EP compliance for excipient or formulation compatibility.
- For parenteral contexts, buyers typically require additional controls and documentation aligned to sterile supply chains.
Which companies supply sodium acetate (pharmaceutical-grade)?
Sodium acetate supply is often routed through chemical producers with high-volume fermentation or synthesis supply chains and then qualified to pharmacopeial specs (USP/EP grade variants depending on intended use).
Common supplier sources
- Merck KGaA / MilliporeSigma
- Thermo Fisher Scientific / Fisher Chemical
- Avantor / VWR
- Global inorganic/commodity chemical manufacturers producing sodium acetate as a bulk chemical with pharmacopeial-grade offerings
Qualification focus
- Buffering agents and pH adjusters require tighter control of:
- acetic acid residuals (where applicable)
- heavy metals
- clarity/color and conductivity-type controls used in downstream formulation
Which companies supply sodium chloride (pharmaceutical-grade)?
Sodium chloride is the most widely supplied of the five salts due to extensive use in:
- oral formulations,
- saline preparation workflows,
- and excipient supply chains.
Common supplier sources
- Merck KGaA / MilliporeSigma
- Thermo Fisher Scientific / Fisher Chemical
- Avantor / VWR
- Large salt producers and brine processors supplying USP/EP grades
Typical supplier segmentation
- Bulk industrial grade suppliers: suitable only if buyer’s quality system accepts non-pharma grade documentation (rare for regulated drug products).
- Pharma-qualified suppliers: provide pharmacopeial grade CoAs and controlled impurity ranges.
Supplier short-list by salt (high-probability regulated-market sources)
| Salt | High-probability regulated-market supplier types | Example supplier names (common in pharma procurement/distribution) |
|---|---|---|
| Calcium chloride | Global chemical producers + branded distributors | Merck KGaA / MilliporeSigma; Thermo Fisher (Fisher); Avantor (VWR); Otsuka Chemical; Tata Chemicals |
| Magnesium chloride | Global chemical producers + branded distributors | Merck KGaA / MilliporeSigma; Thermo Fisher; Avantor; qualification via site/grade documentation |
| Potassium chloride | Global chemical producers + branded distributors | Merck KGaA / MilliporeSigma; Thermo Fisher; Avantor; pharma-grade KCl variants |
| Sodium acetate | Chemical producers with USP/EP-grade options + branded distributors | Merck KGaA / MilliporeSigma; Thermo Fisher; Avantor |
| Sodium chloride | Large salt/brine processors + branded distributors | Merck KGaA / MilliporeSigma; Thermo Fisher; Avantor; major salt producers |
What determines whether a supplier qualifies for pharma use?
For each salt, the business-critical evaluation points are the same. Buyers generally require:
- Pharmacopeial grade alignment (USP and/or EP) for excipient or processing use.
- Manufacturing site qualification and documented control strategy.
- Impurity specification matching the drug product dossier needs (heavy metals, sulfate, calcium, insolubles, and other salt-specific residues).
- CoA format and traceability tied to batch identity, lot-to-lot variability controls, and repeatable test methods.
- Supply-chain compliance where sterile processing or parenteral contact is implicated.
Key Takeaways
- Regulated supply for calcium chloride, magnesium chloride, potassium chloride, sodium acetate, and sodium chloride is typically handled by large inorganic chemical manufacturers plus branded distributors that provide pharmacopeial-grade variants and quality documentation.
- The most actionable supplier starting points are Merck KGaA / MilliporeSigma, Thermo Fisher (Fisher Chemical), and Avantor (VWR), then extending to major salt/chemical producers by grade and manufacturing site qualification.
- Qualification is driven less by “which company” and more by the grade, manufacturing site, impurity profile, and documentation package tied to the exact use case.
FAQs
1) What supplier category is fastest to qualify for these salts?
Branded distributors tied to pharmacopeial-grade products are usually the fastest entry route, because they provide consistent documentation and well-defined product grades.
2) Are these salts commonly supplied in USP and EP grades?
Yes. These excipient salts are widely offered in pharmacopeial-grade variants, with grade selection dependent on intended regulatory use.
3) Do hydration state and particle specs matter for all five salts?
They matter most when used in filtration/sterile workflows, pH-adjustment-sensitive buffers, or when solid-state properties affect dissolution or clarity.
4) Can the same supplier support multiple salts in one procurement?
Often yes through broad inorganic chemical portfolios and distributor packaging systems, but buyers still qualify by product grade and manufacturing site.
5) What documentation is typically required for GMP excipient qualification?
A batch-specific CoA aligned to pharmacopeial specifications, plus impurity control and traceability documentation consistent with the buyer’s quality system.
References
[1] Merck. “Merck MilliporeSigma Products: Calcium Chloride / Magnesium Chloride / Potassium Chloride / Sodium Acetate / Sodium Chloride.” (Product catalog pages).
[2] Thermo Fisher Scientific. “Fisher Chemical: Calcium Chloride / Magnesium Chloride / Potassium Chloride / Sodium Acetate / Sodium Chloride.” (Product pages).
[3] Avantor (VWR). “VWR/Avantor Chemicals: Calcium Chloride / Magnesium Chloride / Potassium Chloride / Sodium Acetate / Sodium Chloride.” (Product pages).
[4] Otsuka Chemical. “Otsuka Chemical Inorganic Chemicals: Calcium Chloride (product information pages).”
[5] Tata Chemicals. “Tata Chemicals: Inorganic chemical product listings including calcium chloride (site pages).”
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