Register entry
Guerbet LLC
- Registered sites
- 2
- Drug products
- 14
- Live patents
- 27
- Countries
- 1
- Base
- France
Authorisation
Registered operations
What the FDA has registered these sites to do. This is the regulatory record, not a marketing claim.
Analytical testingActive ingredient (API) manufacture
Sites
Facilities
2| Site | Location | Operations | FEI |
|---|---|---|---|
| GUERBET | LanesterFrance | Analytical testing, Active ingredient (API) manufacture | 3002807063 |
| SIMAFEX | MaransFrance | Active ingredient (API) manufacture | 1000238384 |
Exclusivity
Patents
27Unexpired Orange Book patents where this company is the application holder.
| Product | Active ingredient | Expiry |
|---|---|---|
| ELUCIREM | GADOPICLENOL | May 2032 |
| ELUCIREM | GADOPICLENOL | Aug 2039 |
| ELUCIREM | GADOPICLENOL | Jan 2040 |
Catalogue
Marketed products
14Showing 14 of 14.
| Brand | Generic name | Form | Category |
|---|---|---|---|
| DOTAREM | gadoterate meglumine | INJECTION | NDA |
| DOTAREM | gadoterate meglumine | INJECTION | NDA |
| DOTAREM | gadoterate meglumine | INJECTION | NDA |
| ELUCIREM | gadopiclenol | INJECTION | NDA |
| ELUCIREM | gadopiclenol | INJECTION | NDA |
| ELUCIREM | gadopiclenol | INJECTION | NDA |
| ELUCIREM | gadopiclenol | INJECTION | NDA |
| ELUCIREM | gadopiclenol | INJECTION | NDA |
| ELUCIREM | gadopiclenol | INJECTION | NDA |
| ELUCIREM | gadopiclenol | INJECTION | NDA |
| ELUCIREM | gadopiclenol | INJECTION | NDA |
| ELUCIREM | gadopiclenol | INJECTION | NDA |
| - | Ioversol | POWDER | BULK INGREDIENT |
| LIPIODOL | ethiodized oil | INJECTION | NDA |
Provenance
Facility and operations data from the FDA Drug Establishments Current Registration Site. Product data from the openFDA National Drug Code Directory. Patent and exclusivity data from the FDA Orange Book. Shortage data from the FDA drug shortage database. Contact details the FDA publishes for registered establishments are deliberately not reproduced here. This entry is compiled from public records and has not been claimed by the company.