Last updated: April 24, 2026
What are the key suppliers for KLOR-CON M15?
KLOR-CON M15 is a prescription potassium chloride (KCl) tablet product. The manufacturer and supplier chain for this product is anchored by the branded drug’s U.S. marketing authorization holder and the contract manufacturing network that produces solid oral dose forms.
Current U.S. product listing shows:
- Applicant / Market authorization holder: Bausch Health US, LLC (Bausch Health)
- Active ingredient: Potassium chloride
- Dosage form: Extended-release tablets (KLOR-CON M15)
- Strength: 15 mEq per tablet (M15)
Because KLOR-CON M15 is a branded solid oral product, the “supplier” category typically resolves to:
1) the marketing authorization holder (label applicant), and
2) the manufacturer(s) named on the product labeling (primary and alternate manufacturers).
Labeled manufacturer(s) are the definitive suppliers for production and packaging of the final drug product (as opposed to raw-material suppliers for KCl).
Which companies are listed as manufacturers or suppliers on KLOR-CON M15 labeling?
The branded labeling for KLOR-CON M15 identifies the companies responsible for manufacturing and/or distributing the marketed product. For business diligence, the manufacturer and distributor names on the FDA label are the authoritative supplier references used in procurement and quality audits.
Bausch Health US, LLC is the applicant/labeler for KLOR-CON M15 in the U.S. drug labeling context. The labeling also names the company responsible for the drug product manufacturing operations for the specific marketed presentation and NDC.
Who supplies raw materials (potassium chloride) versus who supplies the finished drug?
Pharma procurement typically separates:
- API/raw-material suppliers (potassium chloride)
- Drug product manufacturers (extended-release tablet manufacturing, granulation, coating, compression, and packaging)
- Label distributors (U.S. labeler/applicant)
For KLOR-CON M15, the labeler is Bausch Health US, LLC and the finished-drug supplier is the manufacturer(s) named on the FDA label for that NDC presentation. The raw-material KCl supplier is not usually disclosed in consumer-facing or standard FDA label text for branded potassium chloride tablets.
What supplier records matter for diligence (FDA, label, NDC)?
When identifying suppliers for KLOR-CON M15 for R&D sourcing, quality agreements, or distribution contracts, the actionable artifacts are:
- FDA drug listing and labeling record (labeler/applicant identity)
- NDC-specific label (to map to the correct manufacturing site and product configuration)
- CGMP manufacturing responsibility (manufacturer named on the label for the marketed product)
Supplier map for KLOR-CON M15 (U.S. context)
| Supplier role |
Entity |
Evidence basis |
| Labeler / Applicant (U.S.) |
Bausch Health US, LLC |
FDA drug listing and label applicant identity for KLOR-CON M15 |
| Active pharmaceutical ingredient |
Potassium chloride |
Product composition on labeling |
| Finished-dose manufacturer |
Manufacturer named on the KLOR-CON M15 label for the specific NDC |
FDA labeling manufacturer identification (primary/alternate manufacturers may vary by NDC) |
How should suppliers be evaluated for KLOR-CON M15 continuity?
For procurement and regulatory-facing due diligence, the supply risk pivots on:
- NDC-specific manufacturer assignment (alternate sites can change over time)
- Finished-dose release testing and packaging responsibility (often tied to the named manufacturer)
- Quality system alignment (CGMP compliance and inspection history for the named manufacturing site)
- Shelf-life and formulation integrity (extended-release tablet release characteristics depend on manufacturing controls)
Key Takeaways
- Bausch Health US, LLC is the U.S. labeler/applicant for KLOR-CON M15.
- The finished drug supplier is the manufacturer(s named on the KLOR-CON M15 FDA label for the relevant NDC.
- Raw-material (potassium chloride) suppliers are not the primary supplier identifiers for regulatory label compliance; the drug product manufacturer and labeler drive procurement and quality documentation for KLOR-CON M15.
FAQs
1) Who is the labeler for KLOR-CON M15 in the U.S.?
Bausch Health US, LLC.
2) What is KLOR-CON M15’s active ingredient?
Potassium chloride (KCl).
3) Is KLOR-CON M15 an immediate-release or extended-release product?
It is an extended-release tablet product.
4) How do I identify the drug product manufacturing supplier for KLOR-CON M15?
Use the manufacturer name(s on the KLOR-CON M15 FDA label tied to the specific NDC.
5) Are potassium chloride raw-material suppliers the same as the finished-dose suppliers?
No. Raw-material sourcing is separate from drug product manufacturing and packaging, which are tied to the label’s named manufacturer(s).
References (APA)
[1] U.S. Food and Drug Administration. (n.d.). Drug databases: KLOR-CON M15 (potassium chloride). FDA. https://www.accessdata.fda.gov/scripts/cder/daf/
[2] U.S. Food and Drug Administration. (n.d.). FDA label information for KLOR-CON M15. FDA. https://www.accessdata.fda.gov/
