Last updated: June 3, 2026
Bumex (bumetanide) Suppliers: Who Manufactures Bumetanide and Bumex in the US and Worldwide
Bumex is the brand name for bumetanide, a loop diuretic. Supplier coverage depends on (1) the US distributor/marketer listed on the FDA label and (2) the manufacturing sites and API producers behind the NDA/ANDA supply chain. Without the specific product presentation (oral tablets vs injection) and the relevant market (US vs EU vs other geographies), a complete supplier list cannot be produced accurately.
Who supplies Bumex (bumetanide) in the US?
Short answer: The US supply chain for Bumex is anchored by the NDA holder/labeler and the approved manufacturers for each dosage form (tablets and injection). Those approved manufacturing entities are typically shown on FDA labeling and in FDA drug listing records tied to the National Drug Code (NDC).
What does “supplier” mean for Bumex (NDC-based supply chain)?
For practical procurement and IP diligence, suppliers usually break into:
- Labeler/marketer (the company responsible for the product under the NDA)
- Drug product manufacturers (tablet or injection manufacturing sites)
- API (bumetanide) manufacturers (active pharmaceutical ingredient supply)
- Contract manufacturers (finish and packaging if different from product manufacturer)
- Distributors/wholesalers (commercial channel, not manufacturing)
Which companies manufacture Bumex tablets vs Bumex injection?
Short answer: Different presentations can have different manufacturing sites and sometimes different labeler coverage, even if the same API is used. A complete supplier split requires mapping each Bumex presentation to its specific NDC(s) and FDA label manufacturing statements.
Dosage form matters for supplier mapping
- Oral tablets often have different packaging and site approvals from
- Injection (which can be more sensitive to sterile manufacturing constraints)
Who supplies bumetanide API used to make Bumex?
Short answer: API supply for bumetanide is global and can involve multiple producers, including both general chemical suppliers and companies focused on sterile and non-sterile finished dose manufacturing. A definitive API supplier roster requires listing the approved suppliers tied to marketed finished doses (via FDA data and label manufacturing sections) and then cross-checking commercial API sources.
How to structure an API supplier map for bumetanide
A supplier map should be built as:
- Finished dose labeler and NDC
- Approved drug product manufacturing sites
- API source statements where available
- Cross-confirmation through GMP inspection exposure and documented procurement relationships
What is the FDA regulatory status of Bumex that drives its supplier approvals?
Short answer: Bumex is an FDA-approved drug product (NDA) with defined manufacturing approvals per dosage form. Those approvals limit which facilities can lawfully produce the drug product under that application.
How FDA labeling connects to “approved suppliers”
Drug labels list:
- The NDA holder (labeler)
- Manufacturing information and contact details
- Sometimes the manufacturing site(s) for the product
Is Bumex subject to generic competition that changes suppliers?
Short answer: Bumetanide (the active) is widely generically available. That generally increases the number of suppliers for bumetanide-containing products, but it does not change the specific approved manufacturing sites tied to the branded Bumex presentation.
Branded vs generic supplier dynamics
- Brand (Bumex): fewer labeled SKUs and typically fewer manufacturing statements
- Generics: multiple ANDA holders and multiple manufacturers, often with more supply diversification
How does manufacturing geography affect Bumex supplier availability?
Short answer: Sterility and quality systems for injection, plus packaging and distribution constraints, typically create regional bottlenecks. For tablets, supply can be more globally diversified.
What to look for in supplier screening
- GMP compliance record of the relevant manufacturing sites
- Capacity concentration (single-site risk)
- Sterile manufacturing lines for injections
- Sourcing continuity for bumetanide API
What supplier risks exist for bumetanide branded supply (Bumex)?
Short answer: The key risks for branded diuretics usually come from:
- Concentration of manufacturing approvals in limited sites
- API supply disruptions (rate-limiting synthesis steps and intermediates)
- Quality events that force temporary holds across product lines
Key Takeaways
- “Suppliers for Bumex” must be defined by presentation (tablets vs injection) and by geography, then mapped to NDC-specific FDA-labeled manufacturing entities.
- Bumex is tied to approved NDA manufacturing sites; generic bumetanide availability can increase market supply but does not automatically change Bumex-specific manufacturing approvals.
- A defensible supplier list requires NDC-level mapping of each Bumex product presentation to its labeled manufacturer(s) and the underlying API supply chain.
FAQs
- Which NDCs identify Bumex (bumetanide) tablets and injection in the US?
- Do Bumex tablets and Bumex injection share the same manufacturing sites?
- Who supplies bumetanide API to finished-dose manufacturers for branded and generic products?
- Can a generic bumetanide supplier be substituted for Bumex from a procurement standpoint?
- What manufacturing-site changes trigger FDA label or listing updates for Bumex?
References
- FDA. Orange Book and labeling/manufacturer listings (accessed via FDA drug databases).
- FDA. National Drug Code (NDC) Directory and Drug Listing data (accessed via FDA databases).
