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Suppliers and packagers for generic pharmaceutical drug: MAGNESIUM SULFATE; POTASSIUM CHLORIDE; POTASSIUM PHOSPHATE, MONOBASIC; SODIUM CHLORIDE; SODIUM PHOSPHATE
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MAGNESIUM SULFATE; POTASSIUM CHLORIDE; POTASSIUM PHOSPHATE, MONOBASIC; SODIUM CHLORIDE; SODIUM PHOSPHATE
Listed suppliers include manufacturers, repackagers, relabelers, and private labeling entitities.
| 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 |
Suppliers and packagers for generic pharmaceutical drug: MAGNESIUM SULFATE; POTASSIUM CHLORIDE; POTASSIUM PHOSPHATE, MONOBASIC; SODIUM CHLORIDE; SODIUM PHOSPHATE
Suppliers for Magnesium Sulfate, Potassium Chloride, Potassium Phosphate (Monobasic), and Sodium Chloride / Sodium Phosphate for Pharmaceutical Use
Key supply conclusion: magnesium sulfate, potassium chloride, potassium phosphate monobasic, sodium chloride, and sodium phosphate are commodity-style salts with broad vendor availability across API-grade and USP/NF reagent-grade tiers, plus finished-dose injectables from multiple FDA-licensed manufacturers. Sourcing risk typically concentrates in (1) sterile injectable capacity, (2) regulatory compliance for USP/NF and DMF/ASMF dossiers, (3) quality system alignment with hospital and GPO expectations, and (4) logistics for high-volume distribution.
Who supplies magnesium sulfate for pharmaceutical production and injection?
Magnesium sulfate supply splits into two common procurement lanes: (a) bulk/API or reagent-grade salts for compounding, and (b) finished sterile injectables for hospital and institutional distribution.
Which companies supply magnesium sulfate bulk or reagent-grade
Common global suppliers for magnesium sulfate (non-sterile) include large chemical producers and specialty ingredient distributors. Typical product coverage includes USP-grade and food/pharma-grade variants depending on buyer requirements.
Which companies supply magnesium sulfate sterile injectable (finished dosage)
Sterile injectable magnesium sulfate is supplied by manufacturers with FDA-registered drug establishments and commercially distributed NDC products. These manufacturers are usually also active in other parenteral electrolytes, giving them manufacturing scale advantages.
What forms are typically sourced
- Magnesium sulfate heptahydrate (MgSO4·7H2O) for bulk compounding
- Magnesium sulfate solution for injection (concentration varies by label)
- Magnesium sulfate powder for IV admixture workflows
Who supplies potassium chloride (KCl) for pharmaceutical formulations and IV use?
Potassium chloride has deep vendor penetration for both bulk salts and sterile injections. Procurement is often driven by dose concentration, container configuration, and sterile manufacturing track record.
Which companies supply potassium chloride bulk or reagent-grade
Bulk KCl is widely supplied by multi-category chemical companies and ingredient distributors that can provide CoA and grade compliance documentation.
Which companies supply potassium chloride sterile injectable (finished dosage)
Finished potassium chloride IV products are supplied by FDA-licensed sterile manufacturers. Sourcing often depends on whether buyers require:
- USP compendial compliance
- specific concentration ranges
- glass versus plastic container preference
- packaging and cold-chain needs (if applicable)
What product specs matter for buyers
- Elemental K purity and chloride content
- Particle size and solubility behavior for admixtures
- Sterility assurance and endotoxin limits (sterile dosage only)
- Container and stopper material compatibility
Who supplies potassium phosphate, monobasic for pharmaceutical production?
Potassium phosphate monobasic is commonly sourced as a laboratory/chemical grade ingredient and as a compounding-grade salt for buffer and electrolyte formulations.
Which suppliers provide potassium phosphate, monobasic for pharma use
Supply comes from chemical producers that supply monobasic potassium phosphate as:
- bulk powder (pharma grade options)
- solutions where applicable
- compendial grades used in manufacturing of buffer systems
What delivery forms are typically used
- Monobasic potassium phosphate powder for solid or liquid formulation
- Buffer components in oral and injectable supportive therapies (depending on end product)
Who supplies sodium chloride for pharmaceutical compounding and sterile injection?
Sodium chloride is one of the most supplied pharmaceutical excipients and active electrolyte salts. Buyers typically source it as bulk salt (for compounding and formulation) or as sterile injectables (0.9% saline and other concentrations).
Which companies supply sodium chloride bulk or reagent-grade
Bulk NaCl is available from multiple global chemical producers and distribution partners, typically with pharma-grade options and documentation packages.
Which companies supply sodium chloride sterile injectable (finished dosage)
Sterile saline injectables are supplied by major parenteral manufacturers. The supplier landscape typically includes firms that produce multiple IV electrolyte solutions, creating manufacturing redundancy.
What specs determine sourcing
- USP/NF-grade status
- sterility assurance level and endotoxin testing approach
- container format (bag, vial) and label concentration
- distribution lane readiness (GPO and hospital supply contracts)
Who supplies sodium phosphate for pharmaceutical use?
“Sodium phosphate” is a family term; most buyers differentiate between monosodium phosphate and disodium phosphate depending on formulation pH, buffer system, and dosing profile. Your specified item is “sodium phosphate,” so procurement should map to the exact pharmacopeial form used by the target formulation.
Which suppliers provide sodium phosphate
Multiple chemical producers supply sodium phosphate as compounding-grade salts. Availability is typically strongest for common pharmacopeial forms used in buffer and electrolyte systems.
What forms matter most
- Monosodium phosphate (for acidic buffering systems)
- Disodium phosphate (for neutral to alkaline buffering)
- Mixed phosphate salts where a specific buffer profile is required
How do supplier tiers differ: commodity salts vs FDA-sterile products?
Tier 1: Bulk chemical producers
- Provide bulk salts: MgSO4, KCl, KH2PO4 (monobasic), NaCl, Na phosphate forms.
- Documentation: CoA, grade specs, contamination controls.
- Typical fit: manufacturing and compounding where sterility is not required.
Tier 2: Pharma ingredient distributors
- Package and distribute from Tier 1 producers.
- Provide documentation and supply continuity through inventory and logistics.
- Typical fit: formulators needing quick access to verified lots.
Tier 3: Finished-dose sterile injectable manufacturers
- Provide IV solutions and ready-to-use products.
- Heavily dependent on sterile manufacturing capacity and regulatory compliance.
- Typical fit: hospitals, alternate-site infusion centers, and wholesalers.
What sourcing and quality requirements are most commonly demanded?
For bulk salts and excipients
- USP/NF grade or defined internal spec
- Impurity profile controls (heavy metals, sulfate or chloride tolerance depending on salt)
- Traceability of production lots
- Change control and notification commitments
For sterile injectables
- FDA-registered facility manufacturing under CGMP
- Batch-level sterility and endotoxin testing
- Container closure integrity and leachables/extractables controls (as required)
- Labeling and distribution compliance
How do you reduce supply risk when sourcing these electrolyte salts?
Diversify by manufacturing lane
- Keep at least two qualified suppliers per ingredient grade tier (bulk or sterile).
- Separate qualifications for “chemical grade” vs “pharma compendial grade” vs “sterile injectable.”
Qualification focus
- Raw material impurity and spec adherence
- CoA consistency across lots
- Analytical method alignment to customer specs
- Packaging configuration consistency for sterile products
Key Takeaways
- Magnesium sulfate, potassium chloride, potassium phosphate monobasic, sodium chloride, and sodium phosphate are broadly sourced commodity salts, but sourcing complexity increases sharply for sterile injectable finished dosage forms.
- Supplier selection should be split by procurement lane: bulk salt/ingredient vs sterile injectable manufacturer.
- The highest practical supply risks are capacity-constrained sterile production, qualification delays across lot/spec changes, and regulatory compliance expectations for pharma-grade documentation.
FAQs
- Which grades of magnesium sulfate are typically accepted for USP-compliant formulations?
- What impurity specs matter most for potassium chloride lots used in sterile compounding?
- How should buyers map “sodium phosphate” to monosodium vs disodium phosphate for buffer formulations?
- What container and packaging formats dominate sodium chloride IV shortages and procurement?
- Which qualification steps differ most between bulk electrolyte salts and sterile injectable electrolytes?
References
- U.S. Food and Drug Administration. Orange Book / Drug Products (accessed via FDA drug product pages).
- U.S. Food and Drug Administration. Current Good Manufacturing Practice (CGMP) regulations for drugs (21 CFR Parts 210 and 211).
- United States Pharmacopeia (USP). USP-NF monographs for relevant salts and injectable requirements.
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