Last Updated: June 13, 2026

Suppliers and packagers for generic pharmaceutical drug: SODIUM ACETATE


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SODIUM 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
Amneal SODIUM ACETATE sodium acetate SOLUTION;INTRAVENOUS 218469 ANDA Amneal Pharmaceuticals Private Limited 80830-2436-2 25 VIAL, PHARMACY BULK PACKAGE in 1 CARTON (80830-2436-2) / 50 mL in 1 VIAL, PHARMACY BULK PACKAGE (80830-2436-1) 2025-08-12
Amneal SODIUM ACETATE sodium acetate SOLUTION;INTRAVENOUS 218469 ANDA Amneal Pharmaceuticals Private Limited 80830-2437-2 10 VIAL, PHARMACY BULK PACKAGE in 1 CARTON (80830-2437-2) / 100 mL in 1 VIAL, PHARMACY BULK PACKAGE (80830-2437-1) 2025-08-12
Fresenius Kabi Usa SODIUM ACETATE sodium acetate SOLUTION;INTRAVENOUS 206687 ANDA Fresenius Kabi USA, LLC 63323-032-00 20 VIAL, PHARMACY BULK PACKAGE in 1 TRAY (63323-032-00) / 100 mL in 1 VIAL, PHARMACY BULK PACKAGE (63323-032-04) 2017-10-30
Hikma SODIUM ACETATE sodium acetate SOLUTION;INTRAVENOUS 216920 ANDA Hikma Pharmaceuticals USA Inc. 0641-6261-01 1 VIAL in 1 CARTON (0641-6261-01) / 20 mL in 1 VIAL 2024-05-20
Hikma SODIUM ACETATE sodium acetate SOLUTION;INTRAVENOUS 216920 ANDA Hikma Pharmaceuticals USA Inc. 0641-6262-01 1 VIAL in 1 CARTON (0641-6262-01) / 50 mL in 1 VIAL 2024-05-20
>Applicant >Tradename >Generic Name >Dosage >NDA >NDA/ANDA >Supplier >Package Code >Package >Marketing Start

Suppliers for Sodium Acetate (Pharmaceutical-Grade)

Last updated: April 23, 2026

Who supplies sodium acetate used in pharmaceutical manufacturing?

Sodium acetate is widely sourced from global fine-chemical and specialty-chemical suppliers. In practice, pharmaceutical users qualify suppliers through controlled documentation (GMP, DMF/CEP where applicable, CoA, impurity profile, and traceability for grade and lot). The supplier set below covers the major, repeatedly listed manufacturers and distributors for sodium acetate and sodium acetate solutions used in industrial and pharma contexts.

Manufacturers (common global supply sources)

Supplier / Company Market presence Typical product forms seen in trade Notes for pharmaceutical qualification
Merck (Sigma-Aldrich) Global Sodium acetate (anhydrous), sodium acetate trihydrate Often sold in multiple grades; pharma use requires the appropriate grade and documentation.
TCI Chemicals Global Sodium acetate (anhydrous, trihydrate) Provides CoA and specification-linked catalogs; pharma users must qualify the exact grade.
J.T. Baker / Avantor Global distribution Sodium acetate solutions and solids Large distributor network; pharma qualification depends on the specific manufactured grade.
Fisher Chemical (Thermo Scientific) Global Sodium acetate (anhydrous, trihydrate) Grade-specific compliance documents; users must match to pharma requirements.
Zhejiang Hisoar (China) API and intermediate supplier profile Sodium acetate (industrial and higher-purity listings) Requires grade verification, impurity specs, and manufacturing controls for pharma use.
Shanghai Aladdin Biochemical Technology Fine chemicals Sodium acetate Often provides analytical-grade variants; pharma use depends on qualified quality system.
Nippon Chemical (and related Asian chemical producers, category suppliers) Asian industrial chemicals Sodium acetate and derivatives Pharma-grade qualification is grade- and site-dependent.
Global chemical distributors (multiple regions) Multi-lingual distribution Solids and solutions Useful for lead times; pharmaceutical qualification focuses on supplier-of-record and manufacturing site.

Distributor vs. manufacturer reality for pharma procurement

  • Direct purchase from manufacturer is usually the fastest path to strong paper flow (GMP evidence, site details, batch traceability).
  • Purchases from lab/chemical distributors can still work if the distributor supplies a qualified grade, with documentation that traces to the manufacturing site and batch.

What grades and documentation do pharmaceutical buyers demand for sodium acetate?

Pharmaceutical manufacturers typically control sodium acetate by grade, impurity limits, and traceability. The supplier must provide (for the exact product/grade sold) at least:

  • CoA for each lot: assay, loss on drying (if applicable), residue on ignition (if applicable), water content (for hydrates), and impurity testing.
  • Impurity statement / specification sheet aligned to intended use.
  • Microbial limits if used in aqueous pharmaceutical formulations or sterile processes.
  • TSE/BSE and animal-origin statements if relevant to the user’s supply chain policy.
  • Manufacturing site information and batch traceability.
  • Quality system evidence:
    • GMP statement for pharmaceutical use (where applicable)
    • DMF/CEP where the user requires it (varies by region and product form)

What are common sourcing forms (and why it matters)?

Sodium acetate is supplied as:

  • Sodium acetate anhydrous
  • Sodium acetate trihydrate
  • Aqueous sodium acetate solutions (strength depends on supplier listing)

Procurement impact: pharma buyers often qualify per form because impurity and water content profiles differ materially between anhydrous, trihydrate, and solutions. Even when the active substance is the same salt, quality specifications and handling requirements are not identical.

Which regions dominate sodium acetate supply for pharma use?

Supply is global, with strong manufacturing bases in:

  • China (high-volume chemical salt and specialty chemicals supply)
  • Europe (fine chemical and GMP-enabled routes depending on producer)
  • North America (distribution strength plus select producers)
  • India and Southeast Asia (industrial-grade and some higher-purity listings)

For pharma qualification, the procurement target is not “the region,” it is the site and the grade.

How to short-list suppliers for sodium acetate for pharmaceutical manufacturing

Sodium acetate short-listing is usually driven by evidence and lot-level assurance:

  1. Match the exact form (anhydrous vs trihydrate vs solution) to the manufacturing use.
  2. Lock the impurity spec set (heavy metals, chloride/sulfate, organic impurities) used by the buyer.
  3. Require batch traceability and consistent CoA format across lots.
  4. Confirm regulatory support if required by the buyer’s region and dossier strategy (GMP statement, DMF/CEP if applicable).
  5. Perform incoming quality checks and stability/compatibility evaluation for the intended dosage form or process step.

Key decision points: “pharma grade” is not a single label

For sodium acetate, “pharmaceutical grade” procurement typically hinges on:

  • Supplier quality system scope for the manufacturing site
  • Specification alignment to buyer’s internal quality standards
  • Documentation package that supports regulatory and audit needs
  • Consistency across forms (especially for solutions)

Key Takeaways

  • Sodium acetate is supplied by major global chemical brands (e.g., Merck, TCI, Thermo Fisher, Avantor) and by higher-volume chemical manufacturers across Asia and Europe.
  • Pharma procurement must qualify by exact product form and grade, not by the generic name “sodium acetate.”
  • Short-list suppliers by site traceability, CoA rigor, impurity profile, and quality system documentation tied to the purchased grade.

FAQs

  1. Is sodium acetate available directly from major chemical brands for pharmaceutical use?
    Yes, major brands sell sodium acetate in multiple grades; pharma use depends on the specific grade and the documentation tied to that grade and manufacturing site.

  2. What product form is usually required for pharma workflows: anhydrous, trihydrate, or solution?
    It depends on the process and formulation requirements. Buyers typically qualify each form separately because water content and impurity profiles differ.

  3. Do distributors qualify sodium acetate for pharma, or is it strictly the manufacturer?
    Both matter. Distributors can be acceptable if the documentation traces to the manufacturing site and supports the buyer’s quality and regulatory needs.

  4. What are the most important quality documents to request from suppliers?
    Lot CoA, specification sheet for the exact grade, impurity/contaminant limits, batch traceability, and quality system statements for the manufacturing site.

  5. Which regions produce most sodium acetate globally?
    Large volumes come from Asia, especially China, with additional supply from Europe and North America through a mix of producers and distributors. For pharma, qualification targets the supplier site and grade.


References (APA)

[1] Merck. (n.d.). Sodium acetate (product listings). Merck. https://www.sigmaaldrich.com/
[2] TCI Chemicals. (n.d.). Sodium acetate (product listings). TCI Chemicals. https://www.tcichemicals.com/
[3] Thermo Fisher Scientific. (n.d.). Sodium acetate (Fisher Chemical product listings). Thermo Fisher Scientific. https://www.thermofisher.com/
[4] Avantor. (n.d.). J.T. Baker sodium acetate (product listings). Avantor. https://avantorsciences.com/
[5] Aladdin. (n.d.). Sodium acetate (product listings). Aladdin. https://www.aladdinz.com/

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