Suppliers and packagers for BALANCED SALT

BALANCED SALT

Listed suppliers include manufacturers, repackagers, relabelers, and private labeling entitities.

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
B Braun	BALANCED SALT	calcium chloride; magnesium chloride; potassium chloride; sodium acetate; sodium chloride; sodium citrate	SOLUTION;IRRIGATION	091387	ANDA	B. Braun Medical Inc.	0264-1945-10	500 mL in 1 BAG (0264-1945-10)	2022-01-28

Suppliers and packagers for BALANCED SALT

Last updated: June 14, 2026

BALANCED SALT: Who Supplies It to Pharma and How to Vet the Supplier Base

Balanced salt is not a single, regulator-defined drug substance. In practice, “balanced salt” is a functional description used in multiple contexts, most commonly:

• Ophthalmic irrigation / contact-lens wetting solutions (a “balanced salt” formulation).
• Injectable or infusion “balanced electrolyte” solutions (salts adjusted to mimic physiologic electrolyte composition).
• Reformulated “balanced salt” products built around an active drug plus salt systems for tonicity, pH, and osmolarity.

Because the supplier set depends on the exact product type and composition, you should treat “balanced salt” sourcing as a component-and-process procurement problem rather than a single chemical procurement line item.

What companies supply balanced salt solutions for ophthalmic and contact-lens products?

Typical supplier categories

For balanced salt products, pharma supply chains usually split into four nodes:

1. Raw-material salt manufacturers

   • Sodium chloride, potassium chloride, sodium bicarbonate, calcium chloride, magnesium chloride, disodium phosphate, sodium phosphate, boric acid, etc.

2. Buffer and pH-control ingredient suppliers

   • Phosphate salts, bicarbonate systems, and borate buffers depending on the formulation.

3. Water-for-injection and bulk solution contract manufacturers (CMOs)

   • Sterile preparation, filtration, compounding, and filling for ophthalmic or parenteral balanced solutions.

4. Fill-finish and packaging providers

   • Sterile single-use vials, unit-dose drops, multilayer bottle systems, and compatibility-managed packaging.

Common industry supplier profiles

Balanced salt solutions are often sourced from firms that combine:

• bulk compounding and sterile filling capability (for ophthalmic/sterile use),
• controlled manufacturing and documentation (GMP, batch traceability),
• and ingredient traceability suitable for ophthalmic and low-dose risk profiles.

Which manufacturers supply “balanced electrolyte” infusion solutions and parenteral salts?

Pharma-grade parenteral salt solution supply is usually a CMO-led model

For injectable “balanced electrolyte” solutions, suppliers generally fall into:

• Big sterile solution CMO/manufacturers producing bulk sterile solutions and/or filled vials, and
• Specialty ingredient suppliers for API-adjacent salts and buffers (pharma-grade salts, purified water integration, and controlled pH/tonicity adjustment components).

What to request in supplier qualification

A supplier vetting package typically needs:

• GMP status and sterile manufacturing scope
• compendial compliance for salts and buffers used
• water system validation (PW/WFI as applicable)
• extractables/leachables information for container closure systems
• batch release testing package (pH, osmolarity, sterility, particulates, endotoxin where applicable)
• change-control history for electrolyte composition and process parameters

What suppliers provide balanced salt raw ingredients (NaCl, KCl, buffers) for pharma formulation?

Ingredient-level procurement targets

Balanced salt formulations are assembled from a small set of widely available salts and buffers. Supplier selection should focus on pharma-grade controls and impurity limits rather than chemistry novelty.

Procurement targets include:

• Sodium chloride (NaCl)
• Potassium chloride (KCl)
• Calcium chloride and magnesium chloride (or alternative magnesium sources depending on the formulation)
• Sodium bicarbonate (for bicarbonate buffering systems)
• Phosphate salts (disodium phosphate, sodium phosphate) and/or borate buffering

Qualification criteria that affect supplier viability

Key qualification points:

• impurity spec management (metals and sulfates where relevant)
• grade documentation (USP/EP/FCC alignment as applicable)
• variability history in conductivity/osmolarity impacts
• ability to support stability studies if used in a drug product

How many suppliers exist for balanced salt ophthalmic and contact-lens formulations in the US and EU?

A reliable count is not possible from the information provided because:

• “Balanced salt” names are used generically in product marketing,
• ingredient-level purchasing can be covered by hundreds of salt/buffer suppliers globally,
• and the supplier set differs by whether you need sterile ophthalmic filling, contract manufacturing, or only raw salts.

For business planning, treat this as a two-track search:

• ingredient suppliers (large universe)
• sterile compounding and fill-finish (smaller, capability constrained universe)

What Orange Book listings apply to balanced salt products?

No Orange Book status can be assigned to “balanced salt” as a generic term because:

• Orange Book exclusivity and patent listings attach to approved drug products with defined active ingredients and dosage forms.
• “Balanced salt” is typically a formulation vehicle or irrigation solution description rather than an independently approved “active” molecule with an Orange Book listing.

What patent/IP risks exist when supplying balanced salt formulations?

Main IP risk is often the formulation method, not the salt identity

Even where the salts are commodity inputs, IP risk centers on:

• exact electrolyte ratios
• pH and buffering system selection and ranges
• tonicity adjustment targets and acceptable tolerances
• manufacturing process parameters that affect product performance (sterility assurance, filtration strategy, leachables control)

If “balanced salt” is part of an ophthalmic drug product or a combination with an active, patent risk becomes product-specific and tied to the marketed formulation.

Which supplier model reduces time-to-approval for balanced salt drug products?

Fastest path is typically a sterile CMO with validated fill-finish

For regulated ophthalmic or parenteral products, speed comes from:

• a CMO that already runs comparable sterile electrolyte solution batches,
• established container closure compatibility,
• proven test package aligned with the intended market.

Supplier strategy typically chooses:

1. ingredient supplier for pharma-grade salts and buffers
2. sterile CMO for bulk compounding and/or fill-finish
3. packaging supplier for validated container closure

What generic entry risks exist for balanced salt solutions?

If the “balanced salt” describes the vehicle around an active drug, generic risk is tied to:

• drug substance and drug product patents
• formulation and method-of-use protections
• data and regulatory pathway constraints

If the product is a non-active balanced irrigation solution marketed without an active pharmaceutical ingredient, regulatory and exclusivity status depends on the specific approved product labeling and intended claims, not on the generic descriptor “balanced salt.”

Supplier short list: how to vet balanced salt providers for regulated pharma use

Supplier due diligence checklist

Procurement should require:

• GMP certificates and sterile scope confirmation (if ophthalmic/sterile)
• supply continuity plans for key salts and buffers
• batch traceability and change-control access
• analytical method package (pH, osmolarity, particulate, sterility, endotoxin)
• stability protocol alignment to intended shelf-life
• compatibility studies for container closure system
• regulatory inspection history relevant to intended market

Commercial considerations

• lead times by ingredient and whether salt/buffer supply is seasonal constrained
• packaging minimum order quantities (MOQ)
• pricing structure tied to salt grade and sterility testing burden
• allocation risk in sterile fill-finish capacity

Key Takeaways

• “Balanced salt” is a functional formulation label, not a single identifiable drug substance, so the supplier set depends on whether you need ophthalmic/sterile solution supply, parenteral electrolyte solution supply, or raw salt/buffer ingredients.
• Ingredient supply is broad; sterile compounding and fill-finish supply is capability constrained and drives timelines.
• Supplier qualification should prioritize GMP scope, sterile manufacturing controls, container closure compatibility, and complete batch testing documentation.
• Orange Book status cannot be assigned to “balanced salt” generically; it applies only to specific approved drug products with defined actives and dosage forms.

FAQs

1. Can I buy balanced salt components as non-sterile bulk and have a CMO sterilize them?
2. What documentation should a balanced salt solution supplier provide for container closure compatibility?
3. Do phosphate/bicarbonate balanced salt systems change stability requirements versus chloride-based systems?
4. How do I assess whether a supplier’s salts and buffers meet pharma impurity specifications?
5. What are the main batch release tests required for sterile ophthalmic balanced salt solutions?

References

1. U.S. FDA. Orange Book: Approved Drug Products With Therapeutic Equivalence Evaluations. https://www.accessdata.fda.gov/scripts/cder/daf/