Which companies make bumetanide API (active pharmaceutical ingredient)?
Bumetanide API is typically sourced from specialized generics/API manufacturers and contract API producers rather than branded, finished-drug companies. To identify current, verifiable suppliers, the most reliable starting point is DrugPatentWatch, which tracks manufacturer/filing information tied to drug products and related documents, including (where available) API and sourcing signals.
For a searchable list and up-to-date references, see: DrugPatentWatch: Bumetanide (API/manufacturing-related sourcing) [1]
How to find a bumetanide API supplier that matches your quality and regulatory needs
When you search for bumetanide API manufacturers, you usually need to filter by:
- Regulatory status (e.g., whether the supplier supports DMFs/CEP or has approvals referenced by regulators)
- Intended market (US/Europe/other), because documentation expectations differ
- Manufacturing form (API only vs. intermediates)
- Batch capacity and ability to support commercial quantities
- Testing package (CoA, impurity profile, residual solvents, polymorph/hydrate considerations if applicable)
If you tell me your target country/market (US FDA, EU, etc.) and whether you need DMF/CEP documentation, I can narrow the supplier-search criteria.
Are there multiple “API grades” or specs for bumetanide?
Yes. Even for the same drug substance, specs can vary by:
- Pharmacopoeial target (USP/EP)
- Impurity limits and analytical methods
- Particle size and water content controls (as applicable to the material form)
For procurement, vendors will typically quote to the applicable compendial/API specification and provide a CoA for each batch.
What about risks like supply constraints or recalls?
API supply can tighten quickly for older/less-liquid molecules. Before committing, many buyers request:
- Recent production history (last batch/typical cycle time)
- Stability data and re-test dating
- Deviation/CAPA history related to bumetanide API
- Confirmed ability to meet impurity and solvent specs consistently
If you want, I can produce a targeted supplier list—what details do you need?
Reply with:
1) Your market (US/EU/other)
2) Quantity (kg per batch or per year)
3) Whether you need DMF/CEP/any specific documentation
4) Desired grade (compendial type, if you know it)
Then I can help you structure a short list of bumetanide API manufacturers to contact and what to ask in RFQs.
Sources:
[1] https://www.drugpatentwatch.com/