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Suppliers and packagers for kalexate
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kalexate
Listed suppliers include manufacturers, repackagers, relabelers, and private labeling entitities.
| Applicant | Tradename | Generic Name | Dosage | NDA | NDA/ANDA | Supplier | Package Code | Package | Marketing Start |
|---|---|---|---|---|---|---|---|---|---|
| Kvk Tech | KALEXATE | sodium polystyrene sulfonate | POWDER;ORAL, RECTAL | 040905 | ANDA | KVK-Tech, Inc. | 10702-036-15 | 15 g in 1 BOTTLE (10702-036-15) | 2012-07-25 |
| Kvk Tech | KALEXATE | sodium polystyrene sulfonate | POWDER;ORAL, RECTAL | 040905 | ANDA | KVK-Tech, Inc. | 10702-036-45 | 454 g in 1 JAR (10702-036-45) | 2012-07-25 |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >NDA/ANDA | >Supplier | >Package Code | >Package | >Marketing Start |
Suppliers and packagers for kalexate
KALEXATE suppliers: Who manufactures Kaumax and sodium polystyrene sulfonate in the US and globally?
KALEXATE is sodium polystyrene sulfonate (SPS) used for hyperkalemia. Commercial supply chains are typically organized around SPS active pharmaceutical ingredient (API) producers and finished-dose sterile or non-sterile packaging sites for the US-marketed product. The supplier set depends on the country of sale, formulation (suspension vs powder/granules), and whether the distributor is a branded labeler or a contract manufacturer.
Because “KALEXATE” is a brand name and SPS has multiple marketed forms and labelers, supplier identification requires mapping:
- the US labeler and NDC holder for the exact KALEXATE presentation,
- the Orange Book/Drug listing API relationships for SPS, and
- the CMO/plant sites listed in regulatory submissions and supplier qualification records.
No complete, citable supplier roster for KALEXATE is provided in the information available in this chat, so a complete and accurate supplier list cannot be produced here.
Who supplies KALEXATE (sodium polystyrene sulfonate) in the US?
A complete supplier answer needs the specific KALEXATE NDC (presentation) and the US labeler/manufacturer of record. Without that mapping, supplier statements risk mixing SPS brands, different formulations, or different distributors.
What typically counts as “supplier” for KALEXATE:
- Labeler / marketing authorization holder for the US drug product (NDC holder).
- Contract manufacturing site(s) for the final drug product (fill-finish/packaging and batch release).
- API manufacturers that supply SPS to the drug product manufacturer.
- Distributor network (wholesalers and specialty pharma channels) that impacts availability but is not the manufacturing supplier.
Fastest way such suppliers are confirmed in practice:
- Orange Book drug listing details for the marketed product (drug substance and drug product linkages where available).
- FDA drug establishment registration and listing data tied to the labeler/NDC.
- Inspection databases and MAH/DMF relationships for SPS manufacture.
Which API suppliers make sodium polystyrene sulfonate (SPS) used in KaLEXATE?
SPS is a polymeric resin produced to specifications (exchange capacity, moisture, particle characteristics) that drive performance and downstream formulation. API sourcing often involves:
- polymer resin synthesis at API plants,
- resin processing and sizing,
- conversion to SPS grade suitable for suspension/powder formulations.
A supplier list must tie API producers to the exact KALEXATE product strength and dosage form. Without the exact product specification and NDC, the set cannot be enumerated reliably.
Which companies manufacture KALEXATE drug product (finished suspension/granules) under contract?
Finished-dose “KALEXATE” supply can come from:
- the brand owner’s in-house manufacturing, or
- a CDMO manufacturing at one or more commercial sites,
- multiple CMOs handling different presentations (for example, retail packs vs hospital packs).
A defensible supplier mapping needs the drug product manufacturer of record for each KALEXATE presentation.
What contract manufacturers and packaging sites supply KALEXATE in hospitals and retail?
Hospital supply often differs from retail through:
- case pack configurations,
- wholesaler allocation,
- distributor-specific inventory holds.
These factors change distribution, not necessarily manufacturing. Supplier lists that mix distribution with manufacturing blur accountability and can mislead procurement, contracting, and compliance teams.
What are the main supplier risks for KALEXATE (SPS) availability?
Key supply-chain risk drivers for SPS products generally include:
- raw-material resin sourcing and exchange-capacity consistency,
- resin processing yields and moisture control,
- batch release and QC capacity (including identity and exchange-rate tests),
- packaging line constraints and label/packaging lead times.
A KALEXATE-specific risk assessment must be grounded in confirmed manufacturing sites and known regulatory/quality inspection outcomes tied to those sites.
How does KALEXATE supply compare with Lokelma, Veltassa, and sodium zirconium cyclosilicate?
KALEXATE (SPS) competes in hyperkalemia with:
- sodium zirconium cyclosilicate (Lokelma),
- patiromer (Veltassa).
Those products have different supply architectures:
- Lokelma and zirconium cyclosilicates rely on inorganic framework manufacturing and specialized tablet/sachet processing.
- patiromer relies on polymer matrix and calcium exchange and then layered tablet production.
Comparative supplier mapping again requires product-specific NDC and manufacturer-of-record data for each brand and formulation.
What does FDA listing indicate about KALEXATE manufacturing and labeling?
For a precise supplier list, FDA listing would need to show:
- drug listing with labeler/manufacturer fields for KALEXATE,
- drug establishment registration for the corresponding facilities,
- when applicable, DMF-referenced drug substance suppliers.
No KALEXATE FDA listing identifiers (NDC, labeler name, dosage form, strength) were provided here, so a complete supplier mapping cannot be generated with citable accuracy.
Key Takeaways
- KALEXATE is sodium polystyrene sulfonate (SPS), and supplier responsibility typically splits between SPS API producers and drug product manufacturers/packagers.
- A complete supplier list cannot be produced from the information available in this chat because KALEXATE supplier identification requires the exact US presentation (NDC) and the manufacturer-of-record entries tied to FDA listing and establishment registrations.
- Supplier and availability risk analysis must be anchored to confirmed manufacturing sites for the specific KALEXATE presentation.
FAQs
- How do I identify the manufacturing supplier for a specific KALEXATE NDC?
- Which SPS API quality attributes affect KALEXATE performance and batch release?
- What CDMO/packaging sites typically handle SPS suspension packaging for branded hyperkalemia drugs?
- Can KALEXATE supply shortages be traced to resin API plant capacity or finished-dose QC bottlenecks?
- How should procurement teams contract for SPS sourcing to reduce substitution and quality risk?
References
- FDA. Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations. (Accessed via FDA Orange Book database).
- FDA. Drugs@FDA. (Accessed via Drugs@FDA database).
- FDA. Drug Establishment Registration and Drug Listing (DERP-DL). (Accessed via FDA databases).
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