Suppliers and packagers for POTASSIUM IODIDE

POTASSIUM IODIDE

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

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Mission Pharmacal	POTASSIUM IODIDE	potassium iodide	SOLUTION;ORAL	206211	ANDA	Mission Pharmacal Company	0178-0314-30	1 BOTTLE, DROPPER in 1 CARTON (0178-0314-30) / 30 mL in 1 BOTTLE, DROPPER	2016-05-15

POTASSIUM IODIDE: Supplier Landscape and Procurement Targets

Last updated: April 23, 2026

Who supplies potassium iodide for pharmaceutical use?

Potassium iodide (KI) is widely sourced from chemical and specialty-chemical manufacturers that produce iodide salts in bulk. Pharmaceutical-grade supply typically comes from companies that either (1) manufacture KI themselves under controlled specifications or (2) provide pharmaceutical-grade KI sourced from integrated chemical production.

Because supplier eligibility for “pharmaceutical use” depends on specific regulatory status (e.g., DMF/CEP, GMP manufacturing sites, compendial compliance, and controlled impurity profiles), procurement usually targets the subset of manufacturers that publish pharmaceutical-grade quality dossiers and support documentation for global registrations.

What supplier categories matter for procurement?

Procurement is usually split across four practical supplier types for KI:

• Bulk chemical manufacturers: Produce KI at scale and distribute to pharma distributors. Pricing is driven by iodide feedstock and crystallization capacity.
• Pharmaceutical ingredient specialists: Supply KI as an active ingredient or excipient-grade material with tighter impurity and documentation sets.
• GMP packagers/re-packers: Do not necessarily manufacture KI but perform packaging, relabeling, and documentation that fits pharma QA workflows.
• API distributors: Source from manufacturer networks and provide batch traceability, CoA, and regulatory documents.

For regulated pharma purchasing, the most defensible approach is to prioritize suppliers that can provide:

• GMP manufacturing statement for the site
• Batch CoA against pharmacopeial assays/limits
• DMF and/or CEP (where applicable) and validated impurity specifications
• Traceability to iodide-salt manufacturing batches and analytical methods

What product specifications drive supplier selection for KI?

Supplier qualification for potassium iodide typically revolves around pharmacopeial acceptance plus iodide-related impurity control. The key specs procurement teams screen include:

• Assay / identity: KI content and chromatographic/chemical identification
• Water content: Impacts stability and downstream blending
• Sulfate and heavy metals: Control of inorganic contaminants
• Reducing substances and iodate: Iodate control is important for iodide stability and equivalence in finished dosage forms
• Solubility: Impacts uniformity and processing behavior
• Particle/appearance: Relevant for direct compression or blending performance

Which supplier markets usually dominate availability?

KI supply is concentrated in established industrial chemical hubs. For global pharma procurement, the supplier pool typically includes:

• Europe: GMP chemical manufacturers and compounding salt suppliers with regulated documentation
• North America: Chemical producers with pharma-grade product lines and distributors
• Asia: High-volume iodide salt manufacturing with pharma-grade variants, supported by GMP and dossier packages

Concrete supplier shortlist (actionable procurement targets)

Below is a procurement-oriented shortlist of supplier entities that commonly appear in pharmaceutical chemical distribution channels for potassium iodide. These companies are standard targets for QA/regulatory document checks (CoA, GMP statements, DMF/CEP status, and site qualification for your exact market):

Supplier	Typical role	What to verify in procurement	Fit signals
Fisher Chemical (Thermo Fisher Scientific)	Distributor/retailer	GMP documentation for the specific grade and packaging configuration	Strong documentation workflow and fast logistics for small-to-mid pharma volumes
Sigma-Aldrich / Merck (MilliporeSigma)	Distributor/retailer	Pharma-grade designation, CoA contents, and regulatory support for your jurisdiction	Broad analytical catalog and batch documentation
TCI Chemicals	Distributor/retailer	Grade mapping to pharmacopeial limits and regulatory documents	Consistent availability and COA traceability
Beijing Tongrentang / regional pharma chemical distributors (China networks)	Distributor channel	Confirm GMP status of the underlying manufacturer and dossier coverage	Competitive pricing for pharma packaging volumes
Major industrial iodide salt producers (global chemical manufacturers)	Manufacturer	GMP site certification, DMF/CEP availability, impurity profile	Best option for direct supply contracts at scale

Procurement note that matters: many distributors carry multiple grades under one product name. QA should qualify the exact “pharmaceutical grade” SKU, not generic chemical grade.

What contract-ready documentation should suppliers provide for KI?

To lock KI into a pharma supply chain, procurement should require at least:

• CoA for each batch, including method references and test results for:
  • assay
  • identification
  • insoluble matter
  • iodate/relevant impurities (where specified)
  • heavy metals and sulfate
• GMP status of the manufacturing site
• Regulatory dossier references (DMF/CEP) if required by the target market
• Specification sheet for the exact grade (not a generic leaflet)

Supply risk factors for potassium iodide

KI is sensitive to upstream iodide availability and industrial capacity. The practical risk factors that shape supplier decisions include:

• Iodate/impurity variability due to upstream processing conditions
• Batch-to-batch impurity profile drift if a supplier changes crystallization or purification trains
• Packaging configuration constraints (bulk bags vs. pharma drums)
• Dossier alignment risk when suppliers switch grades or documentation packs

How to run supplier qualification for KI (fast track)

A fast, compliant qualification pathway typically includes:

1. Document qualification: GMP statement, CoA template, specification sheet, and dossier references.
2. Analytical equivalence: confirm key impurity limits and assay consistency against your internal spec.
3. Stability and handling: verify water content and flow characteristics meet blending needs.
4. Change control check: confirm supplier notifies packaging/grade/manufacturing changes with sufficient lead time.

Key Takeaways

• Potassium iodide is widely available, but pharmaceutical-grade procurement depends on the exact grade/SKU and dossier coverage, not the product name.
• Qualification should prioritize suppliers (or supplier sites behind distributors) that provide GMP statements, per-batch CoAs, and regulatory dossier support.
• The most actionable procurement work is grade mapping and documentation screening against pharmacopeial and impurity specs, with attention to iodate- and heavy-metal-related limits.

FAQs

1) Do distributors count as suppliers for pharmaceutical potassium iodide?

Yes, but procurement must qualify the manufacturing site behind the distributed grade and obtain the pharma documentation pack for that exact SKU.

2) What purity and impurity tests matter most for KI in pharma?

Focus on assay and identity, iodate and related oxidizing impurities, heavy metals, and sulfate, plus pharmacopeial limits for insolubles and water content.

3) Can the same potassium iodide name cover multiple grades?

Yes. “Potassium iodide” can span chemical-grade and multiple pharmacopeial or pharma-grade variants. QA must qualify the specific product grade.

4) What documentation is typically required for regulatory filing use?

Commonly GMP manufacturing statement, CoA and specification, and DMF or CEP references where required for the target market.

5) What are the main supply risks for potassium iodide?

Key risks include upstream iodide raw material variability, impurity profile drift, and grade or documentation changes tied to supplier transitions.

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References

[1] Thermo Fisher Scientific. Fisher Chemical product information for potassium iodide (KI).
[2] Merck (MilliporeSigma). Sigma-Aldrich product information for potassium iodide (KI).
[3] TCI Chemicals. TCI product information for potassium iodide (KI).