Register entry
- Registered sites
- 5
- Active NDC listings
- 21
- Labeller names
- 2
- Live patents
- 7
- Countries
- 4
- Base
- Denmark
Authorisation
Registered operations
Analytical testing2Active ingredient (API) manufacture2Labelling1Finished drug manufacture2Packaging1
Sites
Registered establishments
5| Establishment | Address | Registered for | FEI / DUNS |
|---|---|---|---|
| H. Lundbeck A/SRegistrant: Lundbeck Pharmaceuticals LLC | Oddenvej 182, Nykoebing Sj, 4500, Denmark (DNK) | Active ingredient (API) manufacture | 3002807184310613542 |
| H. Lundbeck A/SRegistrant: Lundbeck Pharmaceuticals LLC | Ottiliavej 9, Valby, 2500, Denmark (DNK) | Analytical testing, Finished drug manufacture, Packaging | 3002807185305238644 |
| ELAIAPHARMRegistrant: Lundbeck Pharmaceuticals LLC | ZI BOUILLIDES, Valbonne, Provence Alpes Cote 06560, France (FRA) | Analytical testing, Finished drug manufacture | 3005659648385593728 |
| Lundbeck Pharmaceuticals Italy SpARegistrant: Lundbeck Pharmaceuticals LLC | Zona Industriale Quarta Strada 2, Padova, 35129, Italy (ITA) | Active ingredient (API) manufacture | 3002808449431207075 |
| Lundbeck Pharmaceuticals LLC | Six Parkway North, Deerfield, Illinois (IL) 60015, United States (USA) | Labelling | 3004100593009582068 |
Catalogue
Drug listings by form and route
2121 active NDC listings: 11 human prescription drug, 10 drug for further processing. By marketing category: DRUG FOR FURTHER PROCESSING 10, NDA 10, BLA 1.
| Dosage form | NDCs |
|---|---|
| powder | 10 |
| tablet | 4 |
| capsule | 3 |
| injection | 1 |
| powder, for solution | 1 |
| suspension | 1 |
| tablet, film coated | 1 |
| Route | NDCs |
|---|---|
| oral | 10 |
| intravenous | 1 |
| Labeller name on the listing | NDCs |
|---|---|
| lundbeck pharmaceuticals llc | 11 |
| lundbeck pharmaceuticals italy s.p.a. | 10 |
Exclusivity
Patents and exclusivities
7| Patent | Product | Covers | Expiry |
|---|---|---|---|
| 9629797 | CARNEXIVcarbamazepine | use | Nov 2028 |
| 9770407 | CARNEXIVcarbamazepine | product | Nov 2028 |
| 7635773 | CARNEXIVcarbamazepine | product | Mar 2029 |
| 8410077 | CARNEXIVcarbamazepine | product | Mar 2029 |
| 9750822 | CARNEXIVcarbamazepine | product | Mar 2029 |
| 9493582 | CARNEXIVcarbamazepine | product | Feb 2033 |
| 11529357 | CARNEXIVcarbamazepine | product | Jan 2040 |
Catalogue
Marketed products
21| Brand | Generic name | Form / route | NDC |
|---|---|---|---|
| - | Argatroban | powder | 45562-1124DRUG FOR FURTHER PROCESSING |
| - | Clomipramine Hydrochloride | powder | 45562-1742DRUG FOR FURTHER PROCESSING |
| - | Dapsone | powder | 45562-1120DRUG FOR FURTHER PROCESSING |
| - | Desipramine Hydrochloride | powder | 45562-1736DRUG FOR FURTHER PROCESSING |
| - | Diazoxide | powder | 45562-1740DRUG FOR FURTHER PROCESSING |
| - | Imipramine Pamoate | powder | 45562-1127DRUG FOR FURTHER PROCESSING |
| - | Memantine Hydrochloride | powder | 45562-1122DRUG FOR FURTHER PROCESSING |
| - | Metoclopramide Hydrochloride | powder | 45562-1737DRUG FOR FURTHER PROCESSING |
| Northera | droxidopa | capsule, oral | 67386-820NDA |
| Northera | droxidopa | capsule, oral | 67386-821NDA |
| Northera | droxidopa | capsule, oral | 67386-822NDA |
| Onfi | clobazam | suspension, oral | 67386-313NDA |
| Onfi | clobazam | tablet, oral | 67386-314NDA |
| Onfi | clobazam | tablet, oral | 67386-315NDA |
| SABRIL | vigabatrin | tablet, film coated, oral | 67386-111NDA |
| SABRIL | vigabatrin | powder, for solution, oral | 67386-211NDA |
| - | Trimipramine Maleate | powder | 45562-1739DRUG FOR FURTHER PROCESSING |
| - | Vortioxetine Hydrobromide | powder | 45562-1135DRUG FOR FURTHER PROCESSING |
| Vyepti | eptinezumab-jjmr | injection, intravenous | 67386-130BLA |
| Xenazine | tetrabenazine | tablet, oral | 67386-421NDA |
| Xenazine | tetrabenazine | tablet, oral | 67386-422NDA |
Compare
Comparable companies in Denmark
- Xellia Pharmaceuticals ApS3 sites · 50 NDC
- Zealand Pharma A/S2 sites · 0 NDC
- Fertin Pharma A/S1 site · 25 NDC
- Pharmacosmos A/S1 site · 10 NDC
- A/S Orthana Kemisk Fabrik1 site · 1 NDC
- Chr. Olesen Synthesis A/S1 site · 1 NDC
- Danipharm A/S1 site · 1 NDC
- Mariager Salt Specialties A/S1 site · 1 NDC
- SmartPractice Denmark ApS1 site · 1 NDC
- Syntese A/S1 site · 1 NDC
Enquiry
Common questions
- Is Lundbeck Pharmaceuticals LLC FDA approved?
- Lundbeck Pharmaceuticals LLC holds 5 FDA-registered establishments across 4 countries. 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 Lundbeck Pharmaceuticals LLC's drugs manufactured?
- At registered sites in Denmark, France, Italy, the United States. The FDA register lists Nykoebing Sj; Valby; Valbonne; Padova; Deerfield, IL. Registered operations: analytical testing, active ingredient (API) manufacture, labelling, finished drug manufacture, packaging.
- What drugs does Lundbeck Pharmaceuticals LLC make?
- 21 products are listed under Lundbeck Pharmaceuticals LLC in the openFDA NDC Directory, most often as powder; tablet; capsule. 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.