Last updated: May 26, 2026
Suppliers of KLOR-CON (potassium chloride oral products) break into two lanes: (1) finished-dose manufacturers that sell KLOR-CON-labeled drug product into the U.S. market, and (2) upstream ingredient and packaging/material suppliers used for potassium chloride manufacturing and oral-solid formulation. The KLOR-CON brand is a potassium chloride (KCl) portfolio in multiple extended-release formats, and the supply chain varies by strength and dosage form.
Which companies supply KLOR-CON drug product in the U.S.?
Finished-dose “supplier” for KLOR-CON in practice means the labeled manufacturer (and, where different, the packager/labeler) that appears on the U.S. prescription packaging and FDA labeling, plus the drug product manufacturing sites that appear in regulatory filings (e.g., FDA facility listings and drug product descriptions).
What is the typical KLOR-CON manufacturing/labeler structure?
KLOR-CON is a brand line where:
- the “applicant/labeler” may be distinct from the “manufacturer” of the finished dosage form,
- extended-release tablets often involve specialized excipient systems and coating/pressing steps that are handled at specific sites, and
- packaging and labeling can be consolidated even when drug product is made elsewhere.
What active ingredient and dosage forms define KLOR-CON supply?
KLOR-CON products are potassium chloride for electrolyte replacement and arrhythmia prophylaxis support, sold as oral dosage forms including extended-release tablets and powder/capsule presentations depending on the specific NDC. Supply partners therefore include:
- KCl ingredient suppliers (chemical grade and pharmaceutical-grade),
- excipient suppliers (matrix formers, binders, coatings, colorants),
- tablet processing and coating subcontractors (when used),
- and packaging suppliers (bottles, blister packs, desiccant, induction seals).
Who supplies the potassium chloride API used to make KLOR-CON?
For potassium chloride oral solids, the upstream supplier set is generally split between:
- producers of pharmaceutical-grade potassium chloride (meeting compendial specifications and impurity limits), and
- ingredient distributors that supply finished API lots to tablet manufacturers under GMP controls.
What API specifications matter for oral KCl products?
KLOR-CON supply chain design is constrained by:
- assay and impurity profiles (sulfate, chloride, heavy metals, water content),
- particle size and flow properties (affect tablet pressability and uniformity),
- stability considerations (hygroscopic behavior and moisture control).
What types of suppliers participate?
In the KCl ecosystem, suppliers typically fall into:
- global inorganic chemical makers that produce KCl at scale,
- pharmaceutical ingredient specialists that grade-select, mill, dry, and certificate lots, and
- contract sourcing/distribution groups that manage regulatory documentation.
Which excipient and coating suppliers support KLOR-CON extended-release tablets?
Extended-release KLOR-CON tablets rely on excipient systems that control dissolution and tablet erosion. These can include:
- hydrophilic or insoluble matrix formers,
- binders for wet granulation or direct compression,
- film-coating materials,
- colorants and opacifiers,
- and overcoats that manage moisture and appearance.
What excipient categories show up most in extended-release KCl tablets?
Common functional excipient categories for ER oral solids that can be part of Klor-Con-style designs include:
- matrix-forming polymers or waxy/insoluble components,
- dissolution modifiers,
- glidants and lubricants (for tablet uniformity and ejection),
- and coating/film components.
How do excipient suppliers affect supply continuity?
Supply risk can come from:
- single-source polymer/coating materials,
- higher-cost excipients with limited capacity,
- and packaging components that require moisture barriers.
Which packaging suppliers are used for KLOR-CON oral products?
Packaging for oral potassium chloride products is typically:
- HDPE bottles with child-resistant closures,
- blister packaging where applicable by NDC presentation,
- induction seals and desiccant packs depending on bottle design.
What packaging components drive vendor selection?
For KLOR-CON, manufacturers generally require suppliers that can provide:
- consistent closure torque and sealing performance,
- moisture barrier performance for hygroscopic API mixtures,
- and compliance documentation for GMP and regulatory audits.
How do KLOR-CON supply partners differ by dosage form and strength?
KLOR-CON spans multiple presentations, and supply partners shift with:
- tablet strength and ER layer design,
- whether the ER system is matrix-based or coated-microstructure-based,
- and the manufacturing line configuration used by the finished-dose supplier.
What is the operational impact on suppliers?
If a manufacturer runs only one ER line, then:
- NDC-level sourcing can change when the product is transferred to another line/site,
- and procurement may require separate vendor qualification for each NDC.
What company supplies KLOR-CON in the distribution chain?
In the U.S. market, “supplier” in commercial terms is often:
- the labeler of record on the FDA listing,
- the marketing authorization holder (brand owner),
- and the wholesale distributor network used by that holder.
KLOR-CON is widely stocked, but vendor responsibility at the point of sale remains tied to labeler/manufacturer assignment and the NDC packaging listed with wholesalers.
What patent and litigation context affects KLOR-CON sourcing?
KLOR-CON is not a typical biologic exclusivity case. The practical sourcing implications come from:
- whether the specific KLOR-CON presentation is still within market exclusivity for a given formulation or method,
- and whether generics with bioequivalence have entered for certain NDCs.
For potassium chloride oral products, multiple authorized generics exist for many strengths and release profiles, which changes the supply landscape: the brand supplier must compete on availability and logistics, not only on IP.
Key Takeaways
- KLOR-CON sourcing is a multi-tier chain: finished-dose manufacturers (site-specific), potassium chloride API suppliers (grade/spec-driven), excipient/coating suppliers (release control), and packaging suppliers (moisture barrier and closure performance).
- Supply partners vary by KLOR-CON NDC because extended-release technology and line/site configuration differ by strength and presentation.
- The U.S. “supplier” that matters for procurement is the labeled manufacturer/labeler on the product’s FDA listing and packaging, complemented by the known manufacturing sites behind that labeler.
FAQs
- Which NDCs map to which KLOR-CON manufacturing sites?
- Are there single-source excipients that pose capacity risk for extended-release potassium chloride tablets?
- Do KLOR-CON suppliers change during NDC transfer or manufacturing site relocation?
- What packaging formats (bottle vs blister) are used across KLOR-CON strengths, and who typically supplies closures and seals?
- How does generic entry for potassium chloride ER affect KLOR-CON brand supplier procurement and lead times?
References
- FDA. Drugs@FDA. Labeling and product details for KLOR-CON (accessed via Drugs@FDA search).
- FDA. Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations (KLOR-CON listings and related product entries).
- FDA. NDC Directory and SPL data elements (NDC mapping and labeler/manufacturer fields).
