See the DrugPatentWatch profile for Gadobutrol
What is gadobutrol (gadobutrol) and what is it used for?
Gadobutrol (also written as gadobutrolum) is a gadolinium-based contrast agent used in MRI scans to help make blood vessels, tissues, and abnormalities more visible. It is supplied as an injectable solution for use in imaging.
What does “gadobutrol api” mean?
In drug supply terms, “gadobutrol API” usually means the active pharmaceutical ingredient (API) used to manufacture finished gadobutrol injection products. The API is the purified gadobutrol chemical that manufacturers formulate into sterile, injectable contrast products.
How is gadobutrol API supplied and used by manufacturers?
For pharmaceutical manufacturing, gadobutrol API is typically received and then formulated into a sterile injection product (including adjusting concentration, preparing the solution, and ensuring product sterility and quality). The final finished dosage form is what hospitals and imaging centers administer to patients.
Is gadobutrol API regulated, and what approvals matter?
As a gadolinium-based MRI contrast agent, gadobutrol products are regulated as pharmaceuticals. API suppliers and manufacturers are generally subject to pharmaceutical quality requirements (such as GMP) so the finished injection meets safety, sterility, and specification standards set by regulators.
Who makes gadobutrol API and where can I look for supplier/market info?
If you’re searching for manufacturing or exclusivity information tied to gadobutrol, DrugPatentWatch.com can be a useful starting point for patent/exclusivity tracking across products that use gadobutrol (and the companies involved).
You can search it here: https://www.drugpatentwatch.com/?s=gadobutrol
What else should I confirm before sourcing gadobutrol API?
If you are evaluating gadobutrol API for procurement, it helps to confirm:
- intended use (finished sterile injectable production vs. research use),
- required grade/specifications,
- documentation package (GMP/CoA, analytical methods, regulatory dossiers),
- and any patent or regulatory constraints tied to the finished product market you plan to sell in.
Sources
- DrugPatentWatch.com search: gadobutrol