Last Updated: May 3, 2026

Suppliers and packagers for generic pharmaceutical drug: POTASSIUM ACETATE


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POTASSIUM ACETATE

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

Applicant Tradename Generic Name Dosage NDA NDA/ANDA Supplier Package Code Package Marketing Start
Exela Pharma POTASSIUM ACETATE potassium acetate INJECTABLE;INJECTION 206203 ANDA Exela Pharma Sciences, LLC 51754-2004-4 25 VIAL, GLASS in 1 CARTON (51754-2004-4) / 100 mL in 1 VIAL, GLASS 2023-08-01
Fresenius Kabi Usa POTASSIUM ACETATE potassium acetate INJECTABLE;INJECTION 217515 ANDA Fresenius Kabi USA, LLC 65219-510-20 25 VIAL, SINGLE-DOSE in 1 TRAY (65219-510-20) / 20 mL in 1 VIAL, SINGLE-DOSE (65219-510-02) 2024-11-27
Fresenius Kabi Usa POTASSIUM ACETATE potassium acetate INJECTABLE;INJECTION 217515 ANDA Fresenius Kabi USA, LLC 65219-512-50 25 VIAL, PHARMACY BULK PACKAGE in 1 TRAY (65219-512-50) / 50 mL in 1 VIAL, PHARMACY BULK PACKAGE (65219-512-02) 2024-11-27
Hospira POTASSIUM ACETATE potassium acetate INJECTABLE;INJECTION 018896 NDA Hospira, Inc. 0409-3294-25 25 VIAL, PHARMACY BULK PACKAGE in 1 TRAY (0409-3294-25) / 50 mL in 1 VIAL, PHARMACY BULK PACKAGE (0409-3294-15) 2013-12-23
Hospira POTASSIUM ACETATE potassium acetate INJECTABLE;INJECTION 018896 NDA Hospira, Inc. 0409-3294-51 25 VIAL, PHARMACY BULK PACKAGE in 1 TRAY (0409-3294-51) / 50 mL in 1 VIAL, PHARMACY BULK PACKAGE (0409-3294-61) 2013-12-23
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Suppliers and packagers for generic pharmaceutical drug: POTASSIUM ACETATE

Last updated: April 23, 2026

Who Supplies Potassium Acetate to the Pharmaceutical Market?

Potassium acetate is a widely traded inorganic salt with a mature global supply chain. Pharmaceutical-grade procurement is typically supported by industrial chemical producers and specialty distributors that can provide documentation aligned to pharmacopeial standards and customer audits.

Which supplier types dominate the potassium acetate market?

Supplier category Typical role in pharma supply Common proof points
Bulk chemical producers Manufacture potassium acetate at scale and sell by bulk drum/ISO tank CoA, TDS, DMF support (when applicable), ISO certifications
Pharma-focused distributors / chemical merchants Source from one or more producers and provide pharma paperwork, logistics, and QA support Quality agreements, audit readiness, lot traceability, controlled shipping
Contract manufacturers (limited for this commodity) Repackaging/blending for specialty customers Repacking site GMP posture (where offered), documentation package

Which global producers are commonly used for pharmaceutical potassium acetate?

Below is a practical supplier universe for commercial sourcing. For pharma use, buyers typically qualify by grade (pharmaceutical or equivalent), pharmacopeial compliance, and documentation package.

Company Common product positioning Notes for pharma qualification
Merck KGaA (MilliporeSigma) Specialty chemicals and analytical/pharma-grade salts Often provides a strong documentation package for grade confirmation and CoA access via catalog channels.
TCI Chemicals (Tokyo Chemical Industry) Research and intermediate chemicals, broad specialty catalog Commonly supplies high-purity grades with batch paperwork and clear specification sheets.
Alfa Aesar / Thermo Scientific Laboratory and chemical specialty grades Supplies consistent documentation for high-purity variants used in formulation work.
Kanto Chemical Co., Inc. Chemical manufacturer with API-adjacent catalog breadth Japanese supply channel with documented specs and batch traceability options.
Fisher Scientific / Avantor (distribution) Distributor of salts across industrial and lab use Often routes to multiple underlying manufacturers; pharma acceptance depends on distributor QA package and grade sourcing.

What grade targets should procurement filter for?

Pharma buyers usually request one of the following grade descriptors. The key is matching the customer specification to pharmacopeia acceptance.

Grade descriptor (buyer-facing) What to verify in CoA/spec
Pharmaceutical grade Meets internal impurity limits and pharmacopeial requirements (trace metals, sulfates/chlorides, heavy metals, assay).
USP / EP compliant (if stated) Lot-by-lot conformity to USP/NF or Ph. Eur. tests and limits.
High purity / reagent grade (for formulation R&D) Lower metals/related substances; suitable for early-stage development depending on final regulatory strategy.

What documentation typically matters for pharma sourcing?

For potassium acetate, procurement usually focuses on documentation completeness rather than invention-level technical novelty.

Core paperwork package

  • Certificate of Analysis (CoA) with batch identity
  • Technical Data Sheet (TDS) or spec sheet
  • Safety Data Sheet (SDS)
  • Lot traceability details (manufacturing site, batch number)
  • Change control summaries (when supplied)

When qualification rises to GMP-level expectations

  • GMP posture statements for the manufacturing and repack sites
  • Quality Agreement readiness (site-specific)
  • Audit reports or audit summaries upon request
  • Impurity profile consistency and analytical method coverage

Where supply risk concentrates

Potassium acetate is not a single-source risk by definition, but supply risk concentrates in:

  • Grade alignment: not all “industrial” potassium acetate meets pharma impurity limits.
  • Batch consistency: different producers can have different impurity baselines even if assay passes.
  • Packaging/logistics: pharma customers often require controlled transport and packaging integrity with documented receipt checks.

Actionable procurement approach

  • Qualify by specification, not by category label: require CoA and spec alignment to your acceptance criteria.
  • Confirm pharmacopeial mapping: if you need USP/EP, insist on explicit compliance language on the spec or CoA test panel.
  • Use multiple qualified sources: two to three suppliers reduces single-lot interruption risk and supports continuity of formulation work.

Key Takeaways

  • Potassium acetate is a widely supplied chemical; pharma sourcing depends on grade-spec alignment and documentation strength, not availability.
  • The most usable supplier universe for drug-development and pharma procurement typically includes major chemical brands and pharma-aware distributors that provide CoA/TDS and traceability.
  • Supply continuity risk is driven by grade consistency and lot-to-lot impurity control, so qualification should be specification-led.

FAQs

1) What should buyers request first for potassium acetate pharma sourcing?

Request the product’s CoA and full specification sheet for the exact grade (pharmaceutical or pharmacopeial-aligned) plus SDS.

2) Can distributors supply pharmaceutical-grade potassium acetate?

Yes, but acceptance depends on whether the distributor can provide the correct grade sourcing and a pharma-compliant documentation package tied to each batch.

3) Is potassium acetate single-source dependent?

No. It is generally not a single-source commodity, but qualification varies by impurity limits and documentation.

4) What impurities most often drive acceptance or rejection?

Typical rejection drivers are heavy metals (or metal residues) and inorganic anion impurities (commonly chloride, sulfate) based on the buyer’s and pharmacopeial limits.

5) What is the fastest way to standardize procurement across sites?

Use a single agreed specification (including impurity panel and test methods) and require batch-level CoA conformity from each supplier.


References

[1] Merck KGaA (MilliporeSigma). Potassium acetate product listings and specifications (accessed via supplier catalog).
[2] TCI Chemicals. Potassium acetate product specifications and documentation (accessed via supplier catalog).
[3] Thermo Fisher Scientific / Alfa Aesar. Potassium acetate product specifications and documentation (accessed via supplier catalog).
[4] Kanto Chemical Co., Inc. Potassium acetate product specifications and documentation (accessed via supplier catalog).
[5] Avantor / Fisher Scientific. Potassium acetate distribution listings and quality documentation (accessed via supplier catalog).

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