Register entry
- Registered sites
- 2
- Active NDC listings
- 14
- Live patents
- 28
- Exclusivities
- 1
- Countries
- 1
- Base
- France
Authorisation
Registered operations
Analytical testing1Active ingredient (API) manufacture2
Sites
Registered establishments
2| Establishment | Address | Registered for | FEI / DUNS |
|---|---|---|---|
| GUERBETRegistrant: Guerbet LLC | ZONE INDUSTRIELLE DE KERPONT 705 RUE DENIS PAPIN, Lanester, 56600, France (FRA) | Analytical testing, Active ingredient (API) manufacture | 3002807063503171949 |
| SIMAFEXRegistrant: Guerbet LLC | 16, avenue des Fours � Chaux, Marans, 17230, France (FRA) | Active ingredient (API) manufacture | 1000238384381108273 |
Catalogue
Drug listings by form and route
1414 active NDC listings: 13 human prescription drug, 1 bulk ingredient. By marketing category: NDA 13, BULK INGREDIENT 1.
| Dosage form | NDCs |
|---|---|
| injection | 13 |
| powder | 1 |
| Route | NDCs |
|---|---|
| intravenous | 12 |
| intra-arterial | 1 |
| intralymphatic | 1 |
| intrauterine | 1 |
| Labeller name on the listing | NDCs |
|---|---|
| guerbet llc | 14 |
Exclusivity
Patents and exclusivities
28| Patent | Product | Covers | Expiry |
|---|---|---|---|
| 8114863 | ELUCIREMgadopiclenol | substance, product | May 2032 |
| 10973934 | ELUCIREMgadopiclenol | substance | Aug 2039 |
| 11590246 | ELUCIREMgadopiclenol | product | Jan 2040 |
| 12064487 | ELUCIREMgadopiclenol | use | Jan 2040 |
| Product | Exclusivity | Until |
|---|---|---|
| ELUCIREMGADOPICLENOL | NPP New patient population | Feb 2029 |
Catalogue
Marketed products
14| Brand | Generic name | Form / route | NDC |
|---|---|---|---|
| DOTAREM | gadoterate meglumine | injection, intravenous | 67684-2000NDA |
| DOTAREM | gadoterate meglumine | injection, intravenous | 67684-2001NDA |
| DOTAREM | gadoterate meglumine | injection, intravenous | 67684-3001NDA |
| ELUCIREM | gadopiclenol | injection, intravenous | 67684-4230NDA |
| ELUCIREM | gadopiclenol | injection, intravenous | 67684-4231NDA |
| ELUCIREM | gadopiclenol | injection, intravenous | 67684-4232NDA |
| ELUCIREM | gadopiclenol | injection, intravenous | 67684-4233NDA |
| ELUCIREM | gadopiclenol | injection, intravenous | 67684-4240NDA |
| ELUCIREM | gadopiclenol | injection, intravenous | 67684-4241NDA |
| ELUCIREM | gadopiclenol | injection, intravenous | 67684-4242NDA |
| ELUCIREM | gadopiclenol | injection, intravenous | 67684-4250NDA |
| ELUCIREM | gadopiclenol | injection, intravenous | 67684-4251NDA |
| - | Ioversol | powder | 67684-8777BULK INGREDIENT |
| LIPIODOL | ethiodized oil | injection, intra-arterial, intralymphatic, intrauterine | 67684-1901NDA |
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Enquiry
Common questions
- Is Guerbet LLC FDA approved?
- Guerbet LLC holds 2 FDA-registered establishments in France. Registration puts a site on the FDA's register and open to inspection; it is not an approval of the company. Approvals attach to individual drug applications.
- Where are Guerbet LLC's drugs manufactured?
- The FDA register lists Lanester; Marans. Registered operations: analytical testing, active ingredient (API) manufacture.
- What drugs does Guerbet LLC make?
- 14 products are listed under Guerbet LLC in the openFDA NDC Directory, most often as injection; powder. The full breakdown by dosage form and route is above. A listing count is not a sales figure.
Compiled from FDA establishment registrations, the openFDA NDC Directory, the Orange Book and the FDA drug shortage database. Not claimed by the company. Sources and methodology.