Drug
Who makes gadobutrol?
5 companies list gadobutrol as a human prescription drug, including under the names Gadavist. Forms: injection. Routes: intravenous.
Labellers from the openFDA NDC Directory. A labeller is the firm named on the label, not necessarily the site that made the product, and a listing is not an FDA approval. Data as of 24 Sept 2026. Methodology
Companies listing gadobutrol
| Company | Forms | Application | NDCs | Registered sites |
|---|---|---|---|---|
| Slate Run Pharmaceuticals, LLCUnited States | injection | ANDAANDA217480 | 6 | 1 |
| Fresenius Kabi USA, LLCUnited States | injection | ANDAANDA215061, ANDA216081 | 3 | 6 |
| Viwit Pharmaceutical Co., Ltd.China | injection | ANDAANDA219287 | 3 | 3 |
| Zydus Pharmaceuticals USA Inc.India | injection | ANDAANDA219287 | 3 | 1 |
| Bayer Healthcare Manufacturing SrlGermany | injection | NDANDA201277 | 1 | 13 |
Bulk ingredient listings
- Hainan Poly Pharm. Co., Ltd.China · 1 NDC
- Jiangsu Hengrui Pharmaceuticals Co., Ltd.China · 1 NDC
Enquiry
Common questions
- Who makes gadobutrol?
- 5 companies list gadobutrol as a human prescription drug in the openFDA NDC Directory, led by Slate Run Pharmaceuticals, LLC, Fresenius Kabi USA, LLC, Viwit Pharmaceutical Co., Ltd., Zydus Pharmaceuticals USA Inc., Bayer Healthcare Manufacturing Srl. Each is the labeller, the firm named on the label; the product may be made at a site registered to another company.
- Is there a generic Gadavist?
- 4 companies list gadobutrol under an abbreviated new drug application (ANDA), the application type used for generics, and 1 under an NDA or BLA. Listing status is from the NDC Directory; it is not a statement of availability.
- Who supplies gadobutrol active ingredient?
- 2 companies list gadobutrol as a bulk ingredient, including Hainan Poly Pharm. Co., Ltd., Jiangsu Hengrui Pharmaceuticals Co., Ltd..