Last updated: May 28, 2026
Urocit-K suppliers (potassium citrate) and who manufactures it for brands, wholesalers, and contract users
Urocit-K is an established potassium citrate brand used for urinary alkalinization. Supplier coverage in the US market is primarily through the brand manufacturer(s) and their contract manufacturing network for solid oral extended-release products, with downstream distribution handled by national wholesalers and specialty pharmacies.
Who manufactures Urocit-K (potassium citrate) in the US?
Answer: Urocit-K is supplied by the brand holder’s manufacturing and contracted manufacturing operations that produce the marketed potassium citrate tablets/capsules (including extended-release formulations), then distributed through standard pharmaceutical channels (national wholesalers, specialty distributors, and retail pharmacy supply chains).
How to map “supplier” to real-world supply chain roles
- Brand manufacturer (drug substance/product): Responsible for commercial manufacturing of the finished dose that is packaged and released for sale under the Urocit-K label.
- Contract manufacturing organization (CMO): Can produce tablets/capsules or perform packaging and release testing on behalf of the label holder.
- Distributors/wholesalers: Source Urocit-K from the label holder and service retail chains, mail order, hospitals, and clinics.
- Contract packagers: Provide bottle/blister packing and labeling if outsourced.
Product form impacts supplier mapping
Supplier identification often differs by dosage form and strength (including extended-release versus immediate-release, if marketed). For Urocit-K specifically, the commercial listing typically tracks the approved dosage form and strength under the brand.
What wholesalers supply Urocit-K to US pharmacies and hospitals?
Answer: Urocit-K is distributed through the same national pharmaceutical wholesaling network that covers most branded oral generics and older brands. In practice, pharmacies and institutions obtain stock via one of the top US distributors, which procure inventory from the brand’s upstream supply.
Typical US distributor routes used for established oral brands
- Retail and mail order pharmacies: via major wholesalers that carry branded inventory and fulfill pharmacy distribution requests.
- Hospitals and health systems: via wholesaler-administered purchasing systems and group purchasing networks.
- Specialty channels: less common for older oral urinary alkalinizers, but specialty distribution can apply where inventory is handled through specialty stocking programs.
Which companies supply the active ingredient potassium citrate used in Urocit-K?
Answer: Potassium citrate is a commodity chemical intermediate with multiple industrial suppliers worldwide. The relevant supplier for Urocit-K is the brand holder’s qualified drug-substance sources, which may include several chemical manufacturers supplying potassium citrate for formulation into the finished oral product.
Drug-substance supplier structure for branded potassium citrate
- The brand’s quality system qualifies drug substance vendors.
- The qualified vendor list can include different sources depending on supply continuity and batch qualification.
Do generic potassium citrate brands compete with Urocit-K from the same suppliers?
Answer: Generics and authorized equivalents often come from different CMO networks and different packaging labels, even when the underlying chemical is the same. Finished-dose manufacturing and packaging are the distinguishing “supplier” layer.
Supplier comparison: brand vs. generic
- Brand Urocit-K: Uses the label holder’s manufacturing and packaging supply chain.
- Generic potassium citrate: Uses one or more generic manufacturers’ own supply chains or their contracted CMOs.
- Consequence for “supplier” due diligence: Even if drug substance suppliers overlap, finished-dose manufacturing and QA release are separate.
What contract manufacturing and packaging suppliers make Urocit-K?
Answer: Urocit-K’s commercial finished dose can be manufactured and packaged by third-party facilities, but identifying the specific plant and CMO requires linking the label’s manufacturing site(s) and the FDA-approved listing for the marketed product.
Where contract manufacturing evidence typically appears
- FDA labeling for the approved product lists manufacturing and packaging facilities for the marketed strengths.
- Patent and submission documentation can sometimes identify facility-level manufacturing responsibilities, but “supplier” claims in litigation or marketing materials rarely map cleanly to plant owners.
What does Orange Book data say about who supplies Urocit-K?
Answer: Orange Book listings identify the approved product(s), label holder(s), and related application(s), but they do not always enumerate every commercial-day upstream supplier. The most actionable supplier mapping comes from the combination of:
- Orange Book product/application record,
- FDA labeling manufacturing/packaging site information,
- and patent-holder/manufacturer alignment tied to the listed NDA holder.
Timeline: when supplier transitions affect Urocit-K availability?
Answer: Supplier transitions occur when the label holder changes manufacturing site(s), scales capacity, or requalifies a backup facility. For established oral brands, such transitions usually show up as:
- changes in manufacturing/packaging site addresses in labeling,
- batch-level lot trace updates,
- and sometimes supply continuity adjustments visible in wholesaler availability patterns.
Key Takeaways
- Urocit-K is supplied through the brand label holder’s manufacturing and packaging network, which may include contract manufacturing sites and contract packagers.
- In the US, retail and hospital supply is routed primarily through national pharmaceutical wholesalers and standard distribution channels.
- Potassium citrate drug substance is supplied by multiple industrial manufacturers globally; Urocit-K specifically uses qualified drug-substance vendors feeding the approved finished-dose manufacturing network.
- For due diligence on “who supplies Urocit-K,” the most probative sources are FDA label manufacturing/packaging site information plus the Orange Book/NDA record for the marketed product.
FAQs
- How can I identify the manufacturing site for Urocit-K by strength and dosage form?
- Which distributors typically stock Urocit-K in the US retail and hospital channels?
- Is Urocit-K manufactured by the same facilities that produce generic potassium citrate ER tablets?
- How do supply chain changes show up for Urocit-K during manufacturer or packaging site transitions?
- What Orange Book fields help map Urocit-K to the NDA holder and approved product listings used for supplier due diligence?
References
- FDA. Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations. (Urocit-K listing and application records). https://www.accessdata.fda.gov/scripts/cder/daf/
- FDA. Drugs@FDA: Urocit-K (NDA record and labeling). https://www.accessdata.fda.gov/scripts/cder/daf/
