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Suppliers and packagers for DEXTROSE 5%, SODIUM CHLORIDE 0.2% AND POTASSIUM CHLORIDE 20MEQ
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DEXTROSE 5%, SODIUM CHLORIDE 0.2% AND POTASSIUM CHLORIDE 20MEQ
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 | DEXTROSE 5%, SODIUM CHLORIDE 0.2% AND POTASSIUM CHLORIDE 20MEQ | dextrose; potassium chloride; sodium chloride | INJECTABLE;INJECTION | 018037 | NDA | Baxter Healthcare Company | 0338-0663-04 | 1000 mL in 1 BAG (0338-0663-04) | 1979-02-02 |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >NDA/ANDA | >Supplier | >Package Code | >Package | >Marketing Start |
Who Supplies Dextrose 5% + Sodium Chloride 0.2% + Potassium Chloride 20 mEq?
What is this product formulation and how is it typically sold?
This is an IV admixture commonly marketed as an electrolyte-containing infusion with:
- Dextrose 5% (D5W)
- Sodium chloride 0.2% (NaCl)
- Potassium chloride 20 mEq (KCl), usually expressed as total potassium content per bag rather than a percentage
In the market, this mix is typically supplied in two ways:
- Ready-to-administer (premixed) IV bags manufactured under GMP by specialized sterile injectables producers.
- Hospital/outsourced compounding (3PL sterile compounding) using commercially sourced components, then dispensed as an individualized admixture under local regulatory frameworks.
Because “suppliers” can mean either manufacturers of the premix or component suppliers used in compounding, the actionable supplier universe below is organized to cover both.
Who supplies premixed “D5W + NaCl 0.2% + KCl 20 mEq” IV solutions?
Premix supply is typically limited to manufacturers that produce electrolyte + dextrose admixtures with potassium in a finished container. These products often appear under varying brand names and pack sizes and can change by country and tender cycle.
Supplier categories that reliably produce this type of admixture:
- Sterile injectables GMP manufacturers
- Regional IV admixture packagers with capacity for potassium-containing solutions
- Global hospital pharmacy outsourcing providers that prepare finished admixtures for direct distribution
Common procurement channels for premix (typical names seen in tenders and hospital purchasing):
- GMP sterile injectables companies (sell finished admixture bags)
- GPO-aligned sterile compounding networks (sell finished admixtures as “custom admixture” SKUs)
(If you are sourcing for a specific geography and pack size, supplier availability depends on those tender inputs and the exact labeling format.)
What sterile compounding providers can supply it as an IV admixture?
If you need assured supply at scale, hospitals commonly route through outsourced sterile compounding. These providers can prepare the final bag using standard component inputs (dextrose, NaCl, KCl) in controlled manufacturing conditions.
Key provider groups (outsourced sterile compounding and pharmacy services):
- Large sterile compounding networks supplying hospitals and long-term care through distribution hubs
- Regional 503A/503B compounding facilities (US framework) or equivalent licensed sterile sites (EU/UK/APAC frameworks)
- Third-party logistics (3PL) providers operating sterile manufacturing suites
These providers will generally list admixture SKUs or accept order parameters specifying:
- bag volume (for example, 250 mL / 500 mL / 1000 mL)
- dextrose concentration (D5W)
- sodium chloride concentration (0.2%)
- target potassium content (20 mEq per bag)
Which raw-material suppliers provide the components used to make the admixture?
In practice, most supply chains for this admixture trace back to suppliers of:
- Dextrose anhydrous or dextrose monohydrate
- Sodium chloride
- Potassium chloride
- Sterile diluent-grade water (or WFI process)
- Container systems (for compounding: infusion bags and tubing)
Component supplier types and typical sourcing structure:
- API and bulk chemical producers (dextrose, NaCl, KCl)
- IV-grade solution manufacturers supplying premade sterile bases (where permitted)
- Container and packaging suppliers for sterile fluid contact materials
This component chain is usually stable because dextrose, NaCl, and KCl are high-volume commodities with broad supplier redundancy.
How do you reduce supply risk when ordering this admixture?
Supply breaks typically come from one of three points: potassium stock constraints, sterile container availability, or manufacturing line capacity for electrolyte admixtures.
Mitigation practices that materially improve continuity of supply:
- Order by target mEq per bag rather than a single concentration spec that varies by volume.
- Use approved substitutes where permitted (same potassium mEq target with different bag volume, if label and protocol allow).
- Place multi-supplier purchase orders with both premix vendors and sterile compounding vendors.
What specific ordering specifications determine which suppliers can fulfill?
Suppliers can only quote if the order matches their manufacturing or compounding capability. The key inputs are:
- Bag size (total volume per infusion)
- Potassium specification as mEq per bag (not always interchangeable with % KCl)
- Electrolyte concentration basis (0.2% NaCl must align with supplier formulation conventions)
- Container type (polyolefin/other, compatible with potassium)
- Sterility assurance and release testing requirements tied to the destination market
If these specs do not match, suppliers may quote a different SKU that is not clinically or protocol equivalent.
Key Takeaways
- This admixture is commonly supplied either as a premixed sterile IV bag from GMP sterile injectables manufacturers or as a finished outsourced sterile compounding admixture prepared to order.
- Supplier selection depends on pack size and the potassium requirement expressed as 20 mEq per bag.
- For continuity, maintain a dual-source strategy spanning premix manufacturers and outsourced sterile compounding providers, and define tolerances around the clinically equivalent mEq target.
FAQs
1) Is “20 mEq potassium chloride” interchangeable with a KCl percentage specification?
No. mEq-per-bag dosing is the clinically relevant spec for potassium; % KCl depends on bag volume and can lead to dosing mismatch.
2) Can hospitals receive this as a custom compounded admixture?
Yes. Many hospitals use licensed outsourced sterile compounding providers to prepare electrolytes plus dextrose admixtures to a protocol-defined spec.
3) Why might premixed supply be inconsistent even when components are available?
Potassium-containing electrolyte admixtures are line- and container-sensitive, and capacity constraints can tighten even when bulk dextrose, NaCl, and KCl remain available.
4) What documentation should accompany the shipment?
Expect COA/batch release documentation, admixture label listing concentrations and total mEq, and sterile manufacturing release evidence aligned to the destination regulator.
5) How do I compare quotes across suppliers fairly?
Compare bag volume, NaCl concentration basis (0.2%), and total potassium (20 mEq per bag), then verify container compatibility and labeled dosing.
References (APA)
[1] U.S. Food and Drug Administration. (n.d.). FDA guidance and resources on sterile compounding and outsourcing facilities. FDA. https://www.fda.gov/
[2] World Health Organization. (n.d.). Guidelines for IV fluids and sterile preparations (reference materials and quality principles). WHO. https://www.who.int/
[3] European Medicines Agency. (n.d.). Guidelines related to good manufacturing practice and sterile medicinal products. EMA. https://www.ema.europa.eu/
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