Last Updated: May 10, 2026

Suppliers and packagers for POTASSIUM CITRATE


✉ Email this page to a colleague

« Back to Dashboard


POTASSIUM CITRATE

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

Applicant Tradename Generic Name Dosage NDA NDA/ANDA Supplier Package Code Package Marketing Start
Ani Pharms POTASSIUM CITRATE potassium citrate TABLET, EXTENDED RELEASE;ORAL 212779 ANDA ANI Pharmaceuticals, Inc. 62559-291-01 100 TABLET, EXTENDED RELEASE in 1 BOTTLE (62559-291-01) 2020-03-16
Ani Pharms POTASSIUM CITRATE potassium citrate TABLET, EXTENDED RELEASE;ORAL 212779 ANDA ANI Pharmaceuticals, Inc. 62559-292-01 100 TABLET, EXTENDED RELEASE in 1 BOTTLE (62559-292-01) 2020-03-16
Ani Pharms POTASSIUM CITRATE potassium citrate TABLET, EXTENDED RELEASE;ORAL 212779 ANDA Bryant Ranch Prepack 63629-1966-1 100 TABLET, EXTENDED RELEASE in 1 BOTTLE (63629-1966-1) 2020-03-16
Ani Pharms POTASSIUM CITRATE potassium citrate TABLET, EXTENDED RELEASE;ORAL 212779 ANDA Bryant Ranch Prepack 63629-1967-1 100 TABLET, EXTENDED RELEASE in 1 BOTTLE (63629-1967-1) 2020-03-16
Ani Pharms POTASSIUM CITRATE potassium citrate TABLET, EXTENDED RELEASE;ORAL 212779 ANDA REMEDYREPACK INC. 70518-3160-0 100 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (70518-3160-0) 2021-07-15
Ani Pharms POTASSIUM CITRATE potassium citrate TABLET, EXTENDED RELEASE;ORAL 212779 ANDA Bryant Ranch Prepack 71335-1967-1 30 TABLET, EXTENDED RELEASE in 1 BOTTLE (71335-1967-1) 2020-03-16
Ani Pharms POTASSIUM CITRATE potassium citrate TABLET, EXTENDED RELEASE;ORAL 212779 ANDA Bryant Ranch Prepack 72162-1758-1 100 TABLET, EXTENDED RELEASE in 1 BOTTLE (72162-1758-1) 2020-03-16
>Applicant >Tradename >Generic Name >Dosage >NDA >NDA/ANDA >Supplier >Package Code >Package >Marketing Start

Potassium Citrate Suppliers: Global Market Structure, Recipients, and Sourcing Paths

Last updated: April 25, 2026

Who supplies potassium citrate at scale?

Potassium citrate is supplied through three primary channels: (1) commodity chemical producers (bulk API/intermediates), (2) excipient-grade and pharmaceutical-grade producers (tablet and effervescent markets), and (3) distributors that carry multi-grade inventories and support regulatory documentation.

Market segmentation by grade (how suppliers typically position)

Grade used in practice Typical buyer Examples of supplier types
Food/animal (lower purity targets) Beverage, food additive Commodity chemical firms and regional distributors
USP/NF or pharmacopeial (higher purity; specs managed) Pharmaceutical manufacturers Pharma-grade chemical producers and excipient specialists
EP/BP-aligned (and “technical” variants) EU-oriented buyers Regional European chemical producers and distributors
Injection or ultra-high purity claims (limited segment) Specialized dosage forms Small set of higher-compliance suppliers

Which supplier categories matter to pharmaceutical procurement?

Pharma buyers usually select potassium citrate supply based on documentation, traceability, and compliance rather than only price.

Typical procurement requirements that narrow supplier lists

Requirement What it filters for
GMP manufacturing statement (and often DMF/ASMF availability) Limits to pharma-grade manufacturers
CoA per batch with controlled impurities Eliminates many commodity-only sources
Microbial/bioburden specs (as applicable to excipient use) Narrows to excipient-grade capable producers
Particle size or effervescence-relevant specs Narrows to “direct to tablet” suppliers
Packaging validation (e.g., multi-layer bags; drum liners) Filters logistics and material-handling capabilities

Which companies supply potassium citrate for pharmaceutical use?

The list below covers the major supplier and distribution landscape that repeatedly appears in pharma procurement workflows for potassium citrate (bulk and excipient grade). It is organized into (A) direct manufacturers and (B) distributors that provide regulatory-ready product documentation.

Direct manufacturers of potassium citrate (bulk/pharma grade)

Core global producers and excipient-grade suppliers

Company Common sourcing route Market role
Merck KGaA (MilliporeSigma) Distributor-anchored procurement (often via lab and pharma channels) Global chemical supply with pharmacopeial cataloging
TCI Chemicals Direct catalog supply and pharma-grade variants High-availability chemical producer and trader
Hangzhou Dayangchem Co., Ltd. Bulk chemical supply for downstream buyers Bulk manufacturing and export orientation
Anhui Kingsway Chemicals Co., Ltd. Bulk export and industrial-to-pharma grade transitions Scale producer for salts and citrate families
Zhejiang Wyncer Chemical Co., Ltd. Bulk chemical export Large-scale salt producer
Hubei Sun Shine Pharmaceutical Co., Ltd. Pharma-oriented salt/supply channel Regional pharma-aligned chemical manufacturer

Distributors that carry potassium citrate with pharma documentation

Distributor Sourcing value to pharma buyers Where they fit
Univar Solutions Multi-grade inventory and documentation handling Excipient sourcing and bundling
Fisher Scientific (Thermo Fisher) Regulatory documentation and standardized CoA flows Lab-to-plant transitioning
VWR (Avantor) Broad SKU coverage and compliance documentation EU and global procurement support
SFS Enterprises / J. T. Baker channel providers Catalog availability and batch documentation Routine reorders and spot fills
Brenntag Broad chemical portfolio, compliance services Industrial-to-pharma grade sourcing
AkzoNobel industrial chemical distributors (regional coverage varies) Regional availability and logistics Local procurement with documentation

Which sourcing paths reduce compliance risk?

Best-practice sourcing route map

  1. Direct manufacturer with GMP statement and pharmacopeial compliance
    • Best for long-term supply, consistent specs, and validation packages.
  2. Authorized distributor with consistent CoA format
    • Best for short lead times and stable reorder cycles.
  3. Tendering across at least two qualified suppliers
    • Best for continuity if specs tighten or impurity profiles shift.

How to screen suppliers for potassium citrate quickly

Procurement teams typically reduce cycle time by using a spec-based checklist.

Supplier qualification checklist (pharma-facing)

  • Pharmacopeial designation: USP, NF, EP, BP (as required by the formulation plan).
  • Impurity profile controls: common citrate-salt impurities and related ion limits.
  • Assay and moisture range: stable effervescence and dissolution performance depends on spec.
  • Microbiological limits: relevant when used as an excipient in oral dosage forms.
  • Packaging and labeling: lot traceability, tamper-evident options.
  • CoA and SDS availability: both in standardized formats and same-lot alignment.

Regulatory and documentation considerations that affect supplier choice

Potassium citrate used in pharmaceuticals often maps to an excipient or API-like salt specification depending on product role.

Typical documentation deliverables that drive selection

Document Why it matters
CoA (batch-specific) Confirms assay and impurities for each lot
SDS Required for EHS onboarding and storage controls
GMP statement or manufacturing compliance letters Required by QA for vendor qualification
Traceability evidence Supports audits and discrepancy investigations
Change control commitments Reduces risk of performance drift

Reference specs buyers often align to

Procurement teams usually align incoming control specs to the target pharmacopeia for potassium citrate.

Common alignment points (by pharmacopeia)

Spec category What buyers verify
Identity Confirmed by standard tests (e.g., citrate salt identity methods)
Assay Potassium citrate content range
Limit tests Insolubles, related substances, sulfate/chloride-type limits depending on pharmacopeia
Water content Critical for effervescence stability and handling
Microbial limits When relevant for excipients and oral formulations

Lead times and volume: where supply concentration shows up

Potassium citrate is widely produced, but procurement bottlenecks usually come from:

  • Pharma-grade inventory availability (not every producer holds pharmacopeial compliance stock continuously).
  • Batch-to-batch impurity profile stability (tight pharmacopeial limits reduce “free switching” among suppliers).
  • Packaging format constraints (drums vs bags; moisture-protective liners).

Pricing and contract structure signals that distinguish suppliers

Because potassium citrate is a commodity relative to complex APIs, contract structure matters more than marketing.

Supplier contracting patterns observed in market practice

Contract lever What it changes
Incoterms (FOB/CIF/DDP) Delivered cost and lead time reliability
Packaging options Breaks pricing bands (bulk bag vs drum vs lined bag)
Spec-driven pricing tiers Pharmacopeial vs technical grade spreads
Annual supply agreements Often reduce volatility for validated lots
Change-notice lead times Required when impurity or supplier site changes

Key Takeaways

  • Potassium citrate sourcing typically splits between commodity chemical producers and pharmacopeial/excipient-grade supply, with compliance documentation as the differentiator.
  • For pharmaceutical use, prioritize suppliers that provide pharmacopeial alignment (USP/NF and/or EP/BP), batch CoA consistency, and GMP or compliance statements.
  • Vendor qualification is usually won by documentation completeness, impurity-control stability, and packaging traceability, not just unit price.
  • Distributors can speed procurement, but long-term risk control favors direct manufacturers or distributors with stable pharma-grade inventory programs.

FAQs

  1. Is potassium citrate sourced as an API or excipient depending on the drug product?
    It can function as an excipient (salt/buffering agent) in oral formulations, and buyers often align controls to the relevant pharmacopeial standard for that intended use.

  2. What documentation do pharma buyers typically require for potassium citrate?
    Batch CoA, SDS, and GMP/manufacturing compliance statements aligned to the buyer’s quality system and pharmacopeial targets.

  3. Do all suppliers offer USP/NF or EP-compliant potassium citrate?
    No. Many producers manufacture commodity-grade citrate salts; pharmacopeial compliance is a narrower, spec-locked segment.

  4. How do packaging and moisture protection affect potassium citrate supply?
    Packaging format and liner choices influence moisture uptake and handling stability, which can affect dissolution behavior and specification pass rates.

  5. What is the fastest way to add a second source for potassium citrate?
    Qualify an alternative supplier already carrying the same pharmacopeial-grade designation and packaging format, using a document-first vendor onboarding to shorten audit cycles.

References

[1] Merck KGaA. MilliporeSigma. Potassium citrate product listing and specifications (catalog data).
[2] TCI Chemicals. Potassium citrate product listings and grade descriptions (catalog data).
[3] Univar Solutions. Chemical product catalog coverage for potassium citrate (distribution listings).
[4] Fisher Scientific. Potassium citrate product listing and documentation availability (catalog data).
[5] VWR (Avantor). Potassium citrate product listings (catalog data).

More… ↓

⤷  Start Trial

Make Better Decisions: Try a trial or see plans & pricing

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. We do not provide individual investment advice. This service is not registered with any financial regulatory agency. The information we publish is educational only and based on our opinions plus our models. By using DrugPatentWatch you acknowledge that we do not provide personalized recommendations or advice. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.