Last Updated: June 9, 2026

Suppliers and packagers for POTASSIUM CHLORIDE 10MEQ


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POTASSIUM CHLORIDE 10MEQ

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

Applicant Tradename Generic Name Dosage NDA NDA/ANDA Supplier Package Code Package Marketing Start
Fresenius Kabi Usa POTASSIUM CHLORIDE 10MEQ potassium chloride INJECTABLE;INJECTION 211087 ANDA Fresenius Kabi USA, LLC 65219-004-01 60 BAG in 1 CARTON (65219-004-01) / 50 mL in 1 BAG (65219-004-00) 2021-06-25
Fresenius Kabi Usa POTASSIUM CHLORIDE 10MEQ potassium chloride INJECTABLE;INJECTION 211087 ANDA Fresenius Kabi USA, LLC 65219-006-01 50 BAG in 1 CARTON (65219-006-01) / 100 mL in 1 BAG (65219-006-00) 2021-06-25
Fresenius Kabi Usa POTASSIUM CHLORIDE 10MEQ potassium chloride INJECTABLE;INJECTION 211087 ANDA Fresenius Kabi USA, LLC 65219-008-51 60 BAG in 1 CARTON (65219-008-51) / 50 mL in 1 BAG (65219-008-50) 2021-06-25
>Applicant >Tradename >Generic Name >Dosage >NDA >NDA/ANDA >Supplier >Package Code >Package >Marketing Start

Suppliers for Potassium Chloride 10 mEq (API and Finished Dosage)

Last updated: May 2, 2026

Potassium chloride 10 mEq is a widely used electrolyte replacement product. Supply splits into (1) active pharmaceutical ingredient (API) and (2) finished dosage forms sold to healthcare systems and distributors. The supplier set depends on whether you source API (for formulation) or finished product (for dispensing).

What does “Potassium Chloride 10 mEq” map to in products?

“10 mEq” typically labels an amount of potassium (K+) delivered, not a tablet strength in milligrams. Market listings commonly translate to oral solid forms (tablets, extended-release tablets, capsules) and oral liquids depending on the brand.

Typical US label equivalence often uses:

  • 10 mEq K+ delivered per dose unit (brand-dependent)
  • Composition may list potassium chloride as the salt with a strength that corresponds to the 10 mEq potassium content (varies by formulation)

Because “10 mEq” is a labeling convention rather than a single standardized “API grade,” supplier qualification is usually handled at the finished product level (NDC/strength/form) or at the API level (USP/EP grade, particle size, water content, trace metals).

Who supplies the finished product (oral potassium chloride 10 mEq)?

Finished product suppliers for “potassium chloride 10 mEq” generally come from:

  • US brand manufacturers for specific NDCs and label strengths
  • Authorized generics from large generic plants
  • Wholesale-distributor channel supply (multiple manufacturers per SKU)

At the level of the “10 mEq” strength, the supplier list is NDC-specific. Without the target market (US vs EU vs LATAM) and without the exact dosage form (immediate-release vs extended-release vs liquid), a complete supplier list cannot be produced accurately.

Who supplies the potassium chloride API used for dosing?

Potassium chloride API sourcing is more standardized because it is the salt itself. API supply commonly comes from:

  • Global chemical-pharma producers supplying USP/EP-grade potassium chloride
  • Bulk producers that sell through pharmaceutical distribution channels after compliance qualification
  • Specialty API suppliers that support tighter specs (impurities, particle size distribution, moisture control)

The practical procurement approach for potassium chloride API is to source against:

  • Pharmacopoeial grade (USP or EP)
  • Manufacturing compliance (GMP status, DMF/CEP/CoA support depending on region)
  • Specifications relevant to oral solid/liquid formulations (water content, sulfate/chloride impurities, heavy metals, insoluble matter)

Procurement reality: which supply route matters for “10 mEq”?

Supply decisions differ sharply:

If you need finished “10 mEq” product

You buy against:

  • Dosage form (tablet vs capsule vs extended-release vs liquid)
  • Release profile (immediate vs extended)
  • Regulatory listing (NDC, market authorization ID, local registration)
  • Packaging (bottles, blister packs, unit-of-use packs)

If you need potassium chloride API for your own formulation

You buy against:

  • API grade and quality system
  • Analytical release and CoA frequency
  • Stability and impurity profile suitability for your dosage form

Quality and regulatory criteria used to qualify suppliers

For potassium chloride used in oral medicines, supplier qualification typically covers:

API qualification checklist

  • Pharmacopoeial compliance (USP or EP)
  • Impurity limits (heavy metals, sulfate, insoluble matter)
  • Water content / drying specifications
  • Particle size (especially for tablets and granules)
  • Stability under your expected storage conditions
  • GMP compliance and documentation package (CoA, DMF/CEP as applicable)

Finished product qualification checklist

  • GMP manufacturing site and inspection status (region-specific)
  • Stability data for the exact formulation
  • Bioequivalence requirements (where applicable)
  • Labeling match for “10 mEq” and salt equivalence
  • Lot release controls and adverse event complaint handling

Commercial supply patterns

Across electrolyte replacements, supply is characterized by:

  • Multiple interchangeable manufacturers for the same dose strength when the dosage form and release profile match
  • Channel dominance by distributors with broad pharmaceutical portfolios
  • Contract manufacturing for certain label presentations (brand ownership changes at the finished-product level)

What can be stated with precision from the request?

The request specifies: “Suppliers for the pharmaceutical drug: POTASSIUM CHLORIDE 10MEQ.”
It does not specify:

  • region/market
  • dosage form (IR vs ER vs liquid)
  • whether the supplier target is API or finished product
  • target packaging or regulatory status (NDC, EU MA, etc.)

Because supplier rosters are NDC- and form-specific at the finished-product level, and because API grade qualification depends on intended pharmacopoeial compliance, a complete and accurate supplier list cannot be produced from the provided input alone.


Key Takeaways

  • “Potassium chloride 10 mEq” is a dose-labeling convention; the exact supplier set depends on dosage form and release profile.
  • For finished product, supplier identification is SKU/NDC-specific and cannot be derived from “10 mEq” alone.
  • For API, sourcing is based on pharmacopoeial grade and GMP compliance, not the “10 mEq” label.
  • Procurement and supplier qualification hinge on region, dosage form (IR vs ER), and regulatory listing requirements.

FAQs

  1. Is “10 mEq potassium chloride” the same across all brands?
    It is a label equivalent for delivered potassium (K+) per dose, but formulation and tablet strength in mg can differ by brand and release profile.

  2. Should I source potassium chloride as API or buy finished “10 mEq” products?
    API sourcing fits formulation/manufacturing needs; finished product sourcing fits dispensing or procurement with established labeling and regulatory status.

  3. What quality attributes matter most for potassium chloride used in oral medicines?
    Pharmacopoeial compliance, impurity limits, heavy metals, insoluble matter, moisture/water content, and (for solids) particle size and flow properties.

  4. Do API suppliers guarantee the “10 mEq” dosage strength?
    No. API suppliers provide potassium chloride meeting specs; “10 mEq” strength is determined by your dosage formulation and tablet/liquid composition.

  5. What determines whether a supplier can be used in a specific market?
    Regional regulatory listing, GMP inspection status, and documentation package (CoA plus relevant registration dossiers such as DMF/CEP depending on region).


References

No sources were provided in the request, and no external supplier roster or regulatory listing was supplied; therefore no cited materials can be provided.

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