sodium chloride: Pharmaceutical manufacturers, suppliers, and packagers

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Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
B Braun	SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER	sodium chloride	INJECTABLE;INJECTION	019635	NDA	B. Braun Medical Inc.	0264-5802-00	12 CONTAINER in 1 CASE (0264-5802-00) / 1000 mL in 1 CONTAINER	1998-03-09
B Braun	SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER	sodium chloride	INJECTABLE;INJECTION	019635	NDA	B. Braun Medical Inc.	0264-5802-10	24 CONTAINER in 1 CASE (0264-5802-10) / 500 mL in 1 CONTAINER	1998-03-09
B Braun	SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER	sodium chloride	INJECTABLE;INJECTION	019635	NDA	B. Braun Medical Inc.	0264-5804-00	12 CONTAINER in 1 CASE (0264-5804-00) / 1000 mL in 1 CONTAINER	1988-03-09
B Braun	SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER	sodium chloride	INJECTABLE;INJECTION	019635	NDA	B. Braun Medical Inc.	0264-7800-09	12 CONTAINER in 1 CASE (0264-7800-09) / 1000 mL in 1 CONTAINER	2013-12-31
B Braun	SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER	sodium chloride	INJECTABLE;INJECTION	019635	NDA	B. Braun Medical Inc.	0264-7800-00	12 CONTAINER in 1 CASE (0264-7800-00) / 1000 mL in 1 CONTAINER	2013-12-31
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>NDA/ANDA	>Supplier	>Package Code	>Package	>Marketing Start

Last updated: May 23, 2026

Suppliers for Sodium Chloride (Pharmaceutical Grade) in the US and Global Market

Executive summary: Sodium chloride is a high-volume commodity input used across sterile injectables, oral solids, ophthalmics, dialysis, and medical devices. Supplier ecosystems cluster by (1) sterile saline contract manufacturing and sterile fill-finish, (2) bulk saline solution production, (3) bulk API/salt supply (including vacuum salt, brine extraction, and purification), and (4) specialty grades (USP/EP, low-endotoxin targets, and packaging formats). The most material “supplier” decision points are whether you need USP/EP-grade sodium chloride, sterile saline (0.9% NaCl, unit-dose, IV bags/vials), or GMP bulk for formulation.

Who are the top suppliers of pharmaceutical grade sodium chloride (USP/EP)

Featured snippet answer: Major supply comes from large chemical producers (salt and specialty brine processing) and sterile contract manufacturers that make 0.9% saline and related strengths under GMP.

Supply segments that matter commercially

Bulk sodium chloride (USP/EP) for oral/solid dosage, extemporaneous compounding, and non-sterile formulations
Sterile saline (0.9% NaCl) for IV and irrigation use, typically made by sterile fill-finish operators
Low-bioburden/low-endotoxin sodium chloride grades for sterile and ophthalmic workflows
Packaged saline formats: IV bags, bottles, mini-bags, vials, irrigation bottles, and unit-dose containers

Common sourcing geographies

North America: large chemical/salt producers plus sterile injectables manufacturers with regional distribution
Europe: salt producers and major sterile manufacturers aligned to EU GMP and EP monographs
Asia: scale sodium chloride and brine processing, with many suppliers tied to international sterile fill-finish networks

Which companies supply 0.9% sodium chloride (sterile saline) IV bags and vials

Featured snippet answer: Sterile saline supply is concentrated among injectables manufacturers with sterile filling lines, not just commodity salt producers.

Typical supplier categories

Sterile fill-finish manufacturers producing 0.9% NaCl in bags and vials
OEM/contract sterile packagers supplying private label distributors and hospital networks
Integrated injectable firms that both purify sodium chloride and run sterile finishing

Where procurement risk shows up

Sterility assurance capacity (fill-finish line constraints)
Container system supply (bag films, rubber stoppers, vial closures)
Endotoxin/particulate specifications and batch release speed
Raw brine/salt purification capacity during seasonal demand spikes

What certifications and pharmacopeial grades do sodium chloride suppliers offer

Featured snippet answer: Pharmaceutical buyers screen for USP and EP compliance, with sterile suppliers also meeting sterility assurance and endotoxin limits under validated manufacturing.

Common buyer requirements

USP–NF sodium chloride monograph compliance
EP compliance for Europe-facing portfolios
Certificate of Analysis (CoA) per batch
GMP compliance for manufacturing and packaging
For sterile saline: sterility assurance level (SAL) claims, environmental monitoring, endotoxin limits, and particulate testing per release specs

Material traceability

Lot-level traceability from salt/brine source to purification step to packaging
Controlled change management for filtration media, sterilization cycles, and container suppliers

How to evaluate sodium chloride suppliers for sterile drug product use

Featured snippet answer: The evaluation hinges on whether the supplier makes sterile finished sodium chloride versus shipping non-sterile bulk.

Sterile use screening checklist

Sterile fill-finish: line clearance and aseptic process validation documented
Endotoxin control: release endotoxin specification aligned to intended route of administration
Particulate controls: sub-visible particle limits (for injectables)
Container closure integrity testing for bags and vials
Stability data for the specific container system and storage condition
Change control transparency for purification chemistry and sterilization programs

Operational constraints

Some suppliers can provide bulk material but not sterile finished dosage forms
Some sterile suppliers need controlled raw inputs for endotoxin performance, tightening acceptable bulk sources

What patent or exclusivity issues affect sodium chloride supply

Featured snippet answer: Sodium chloride itself is a widely used excipient and commodity; exclusivity typically attaches to specific branded formulations, dosage forms, or sterile manufacturing processes, not to the salt ingredient in general.

Where IP shows up in practice

Sterile manufacturing process patents (rarely the primary sourcing constraint for a commodity feedstock)
Container/closure or delivery system innovations for branded saline products
Tender-specific labeling and packaging requirements, sometimes coupled to supply agreements

Commercial implication

Competitive supply is generally broad unless a tender specifies a particular finished product spec, container system, or manufacturer qualification.

What generic entry risks exist for sodium chloride

Featured snippet answer: Generic entry risk is low at the ingredient level; risk shifts to finished sterile supply availability and qualified supplier status.

Where shortages can occur

Sterile line downtime, filter/sterilant supply disruption, or container shortages
Concentrated market share among a small number of sterile fill-finish operators for specific container sizes or unit-dose SKUs

How does the sodium chloride supplier landscape differ for excipient vs IV saline

Featured snippet answer: Excipient sourcing focuses on grade compliance and impurity profile, while IV saline sourcing focuses on sterility assurance, container systems, and batch release performance.

Excipient-grade sodium chloride (non-sterile)

Focus: impurity profile (heavy metals, insoluble matter), moisture/particle size, microbial limits where relevant
Typical use cases: tablets, oral liquids, compounding, formulation buffering and tonicity adjustment

Sterile saline (0.9%)

Focus: aseptic processing, endotoxin, particulate, container closure integrity, stability in final packaging
Typical use cases: IV infusion, irrigation, wound care where sterile spec is mandatory

Which sodium chloride product specs drive supplier selection

Featured snippet answer: The product spec set usually determines which supplier qualifies, not merely “USP sodium chloride.”

Spec dimensions

Concentration: typically 0.9% for sterile saline; other strengths for specialized uses
Route: IV, ophthalmic, irrigation, inhalation systems (if applicable)
Container: PVC-free bags, dual chamber bags, glass vs plastic vials
Micro limits: endotoxin and bioburden targets for sterile use
Residuals: sterilization residual controls and extraction limits for certain polymers/closures

How many sodium chloride suppliers can qualify for a qualified tender

Featured snippet answer: Many suppliers can meet USP grade at the ingredient level; fewer qualify at the sterile finished-product level due to GMP and release testing requirements.

Supplier universe practical sizing

Bulk sodium chloride: broad global universe
Sterile 0.9% saline: constrained by sterile manufacturing capacity and packaging system supply

What supply agreements and distribution models are typical for sodium chloride

Featured snippet answer: Buyers commonly use (1) distributor channels for excipient-grade salt and (2) manufacturer-to-hospital or manufacturer-to-distributor arrangements for sterile saline.

Common commercial structures

Panel procurement: multiple manufacturers qualified to cover demand swings
Long-term supply contracts: for hospital systems and national distributors
Private label arrangements: distributor-branded saline products sourced from qualified sterile finishers
Tender-specific qualification: container format and labeling requirements drive award outcomes

Key constraints that limit sodium chloride supplier substitution

Featured snippet answer: Substitution risk is highest for sterile finished products due to validated process and container compatibility, not the sodium chloride identity.

Substitution blockers

Container/closure system differences that affect stability and extractables
Sterile process differences affecting endotoxin and particle release
Labeling and regulatory listing differences for finished dosage forms
Qualified supplier status for hospitals and group purchasing organizations

Key Takeaways

Sodium chloride supply splits into bulk excipient and sterile finished saline; supplier choice depends on which one you need.
Ingredient-grade sodium chloride has a broad supplier universe; sterile 0.9% saline supply is more concentrated due to sterile fill-finish and packaging constraints.
The decisive criteria are USP/EP grade compliance for bulk and aseptic processing, endotoxin/particulate release, and container closure integrity for sterile products.
IP/exclusivity is not a major constraint for sodium chloride as an ingredient; supply availability and qualification requirements are the main commercial risks.

FAQs

Which suppliers provide USP sodium chloride powder for pharmaceutical formulation?

Bulk USP sodium chloride is typically supplied by chemical and salt processors that can provide GMP-grade CoAs and impurity profiles appropriate for formulation use.

Can the same supplier provide both bulk sodium chloride and sterile saline?

Some groups can, but sterile saline qualification generally requires sterile fill-finish capability, so many buyers maintain separate sourcing for excipient and finished sterile dosage forms.

What container formats most affect sodium chloride sterile supply qualification?

IV bag films, vial type, and closure systems can materially affect stability and extractables; they often determine whether a supplier can be substituted.

What quality tests are most important for sterile sodium chloride release?

Endotoxin and particulate testing, sterility assurance, and container closure integrity are typically the highest-impact release tests.

Is there a risk of shortage for sterile saline compared with bulk sodium chloride?

Yes. Bulk sodium chloride can be produced broadly, while sterile saline depends on sterile line capacity and container systems, which can tighten during disruption periods.

References

U.S. Pharmacopeia and National Formulary (USP–NF). Sodium Chloride monograph.
European Pharmacopoeia (Ph. Eur.). Sodium chloride monograph.
FDA. Sterile Drug Products Produced by Aseptic Processing (Guidance for Industry) and associated sterile manufacturing expectations.