Last updated: June 2, 2026
KLOR-CON M10 Suppliers: Who Manufactures Potassium Chloride Extended-Release M10 and Related Supply Chain Players?
Executive summary: Klor-Con M10 is a potassium chloride extended-release (ER) tablet product. The supplier landscape breaks into (1) the potassium chloride (API) supply chain and (2) the finished-dose manufacturing/labeling supply chain. The available public record for “KLOR-CON M10” in FDA product filings and commercial listings is not sufficient in this feed to identify, with patent-grade precision, the specific API vendors and finished-dose manufacturing suppliers tied to this exact strength and dosage form.
What is KLOR-CON M10 and which companies supply it?
Direct answer: Klor-Con M10 is an ER oral potassium chloride tablet intended to treat potassium deficiency and prevent recurrence in patients needing sustained potassium replacement. Market supply is typically provided through (a) contract manufacturing and (b) API procurement, with product distribution under the brand’s FDA labeler.
Which labeler is associated with KLOR-CON M10?
Featured-snippet style: The FDA labeler and dosage form for Klor-Con M10 determine the “finished-dose supplier” entry point for regulatory traceability.
What is typically sourced for ER potassium chloride tablets?
- Potassium chloride API
- ER matrix excipients and tablet coating system
- Release-modifying film coating and tablet imprinting/packaging components
Who are the API suppliers for potassium chloride ER products like KLOR-CON M10?
Direct answer: Potassium chloride API is commercially available from multiple global suppliers, but the specific API source(s) used for KLOR-CON M10 are not identifiable from the limited information in this feed.
How do you identify the API supplier for a specific brand/strength?
In practice, API provenance for an individual brand is traced through:
- FDA drug master file (DMF) cross-references (where publicly indexable)
- Site-level inspections and manufacturing establishment lists (for finished dose vs. API)
- Labeler’s supply-chain disclosures in quality submissions (not usually public at supplier granularity)
Which finished-dose manufacturers supply KLOR-CON M10 to the U.S. market?
Direct answer: Finished-dose manufacturing and packaging for Klor-Con products can be performed by internal or contract sites, but the exact manufacturing/packaging establishment for the specific strength “M10” is not determinable from the available information in this feed.
How to map “supplier” to FDA manufacturing establishments
A defensible mapping requires:
- FDA “Drug Establishment Registration and Listing” identifiers tied to the specific dosage form
- Strength-specific site attribution in the label and application metadata
What does Orange Book listing for KLOR-CON M10 indicate about suppliers?
Direct answer: Orange Book listings indicate patent and exclusivity status, not supplier identity. For supply-chain decisions, Orange Book data is a proxy only for regulatory lifecycle timing.
Does Orange Book identify manufacturing sites or API sources?
No. Orange Book does not list API suppliers or contract manufacturing suppliers. It lists active ingredients, dosage forms, application numbers, and associated patents/exclusivities.
What generic or AB-rated equivalents compete with KLOR-CON M10 and who supplies them?
Direct answer: Potassium chloride ER tablet strengths have AB-rated generics, but the supplier identities for those exact products are not determinable from this feed.
What supplier risk exists when buying “equivalent” potassium chloride ER?
Procurement risk concentrates in:
- ER release profile equivalence
- Matrix/coating system differences
- Lot-to-lot dissolution and stability variation
- Counterfeit and diversion exposure if sourcing is not controlled
How does KLOR-CON M10 supply chain sourcing differ by strength (M10 vs other Klor-Con ER strengths)?
Direct answer: Different Klor-Con ER strengths can use different manufacturing lots, component specifications, or release system parameters. Supplier identity can change at the site level even when the active ingredient is the same.
Where supplier changes typically appear
- ER film-coating vendor changes (technical qualification required)
- Compression tooling and tablet geometry specifications
- Packaging line assignment and blister/bottle sourcing
What manufacturing/IP barriers affect suppliers of KLOR-CON M10?
Direct answer: For supply, the barriers are usually quality-system and regulatory compliance rather than IP, unless product-specific patents extend to formulations or manufacturing methods. Patent-scope and litigation status are not provided here, so barriers cannot be linked with specificity to KLOR-CON M10 in this feed.
Which barriers usually matter for ER tablets
- cGMP capability for ER release
- Validated dissolution profile controls
- Stability qualification for matrix/coating
- Batch record controls and change management
Key Takeaways
- “Supplier” for KLOR-CON M10 can mean API vendors and finished-dose manufacturing sites, but those identities cannot be established to the required precision from the information available in this feed.
- Orange Book data is not a supplier directory. FDA listings that identify labeler and establishments are the starting point, but exact mapping to the “M10” strength supplier requires product- and site-specific regulatory data not present here.
- For procurement and continuity planning, supply risk for ER potassium chloride concentrates in the ER system and cGMP execution, not just API availability.
FAQs
- Who is the FDA labeler for KLOR-CON M10?
- Are there AB-rated generic equivalents to KLOR-CON M10 and how do they differ in release characteristics?
- What excipients and ER matrix components are typically used in potassium chloride ER tablets?
- How do you verify the manufacturing site for a specific KLOR-CON M10 lot?
- What regulatory pathway do generic potassium chloride ER tablets typically use in the U.S.?
References
- FDA Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations. U.S. Food and Drug Administration. https://www.accessdata.fda.gov/scripts/cder/ob/
- FDA Drug Establishment Registration and Listing (DERL). U.S. Food and Drug Administration. https://www.fda.gov/drugs/drug-establishment-registration-and-listing/
