Register entry
- Registered sites
- 2
- Active NDC listings
- 65
- Labeller names
- 3
- Live patents
- 99
- Exclusivities
- 3
- Countries
- 2
- Base
- Belgium
Authorisation
Registered operations
Analytical testing2Active ingredient (API) manufacture2Labelling2Finished drug manufacture2Packaging2Relabelling2Repackaging2sterilize1
Sites
Registered establishments
2| Establishment | Address | Registered for | FEI / DUNS |
|---|---|---|---|
| UCB Pharma S.A.Registrant: UCB, Inc. | Chemin du Foriest, Braine-l'Alleud, 1420, Belgium (BEL) | Analytical testing, Active ingredient (API) manufacture, Labelling, Finished drug manufacture, Packaging, Relabelling, Repackaging | 3003909356400112724 |
| UCB Farchim S.A.Registrant: UCB, Inc. | Z.I. de Planchy 10, Chemin de Croix-Blanche, Bulle, 1630, Switzerland (CHE) | Analytical testing, Active ingredient (API) manufacture, Labelling, Finished drug manufacture, Packaging, Relabelling, Repackaging, sterilize | 3005023799481797603 |
Catalogue
Drug listings by form and route
6565 active NDC listings: 45 human prescription drug, 17 drug for further processing, 3 bulk ingredient. By marketing category: NDA 34, DRUG FOR FURTHER PROCESSING 17, BLA 11, BULK INGREDIENT 3.
| Dosage form | NDCs |
|---|---|
| tablet, film coated | 26 |
| injection, solution | 14 |
| patch, extended release | 6 |
| solution | 4 |
| tablet, film coated, extended release | 4 |
| powder | 3 |
| kit | 2 |
| injection | 1 |
| injection, solution, concentrate | 1 |
| injection, suspension | 1 |
| powder, for solution | 1 |
| spray | 1 |
| tablet, extended release | 1 |
| Route | NDCs |
|---|---|
| oral | 20 |
| subcutaneous | 13 |
| transdermal | 6 |
| intravenous | 3 |
| nasal | 1 |
| Labeller name on the listing | NDCs |
|---|---|
| ucb, inc. | 45 |
| ucb pharma s.a. | 13 |
| ucb pharma sa | 7 |
Exclusivity
Patents and exclusivities
99| Patent | Product | Covers | Expiry |
|---|---|---|---|
| 8246979 | NEUPROrotigotine | product | Sept 2027 |
| 8217033 | NAYZILAMmidazolam | product | Jan 2028 |
| 8809322 | NAYZILAMmidazolam | product | Jan 2028 |
| 9289432 | NAYZILAMmidazolam | product | Jan 2028 |
| 9687495 | NAYZILAMmidazolam | product | Jan 2028 |
| 7858122 | KEPPRA XRlevetiracetam | product | Sept 2028 |
| 10729653 | BRIVIACTbrivaracetam | product | Apr 2030 |
| 10130589 | NEUPROrotigotine | product | Dec 2030 |
| 10350174 | NEUPROrotigotine | product | Dec 2030 |
| 8802142 | KEPPRAlevetiracetam | product | Jun 2031 |
| 8802142*PED | KEPPRAlevetiracetam | use | Dec 2031 |
| 9925150 | NEUPROrotigotine | product | Mar 2032 |
| 10478441 | FINTEPLAfenfluramine hydrochloride | use | May 2033 |
| 10478442 | FINTEPLAfenfluramine hydrochloride | use | May 2033 |
| 12097206 | FINTEPLAfenfluramine hydrochloride | use | May 2033 |
| 9549909 | FINTEPLAfenfluramine hydrochloride | use | May 2033 |
| 9603814 | FINTEPLAfenfluramine hydrochloride | use | May 2033 |
| 9603815 | FINTEPLAfenfluramine hydrochloride | use | May 2033 |
| 9610260 | FINTEPLAfenfluramine hydrochloride | use | May 2033 |
| 10478441*PED | FINTEPLAfenfluramine hydrochloride | use | Nov 2033 |
| 10478442*PED | FINTEPLAfenfluramine hydrochloride | use | Nov 2033 |
| 12097206*PED | FINTEPLAfenfluramine hydrochloride | use | Nov 2033 |
| 9549909*PED | FINTEPLAfenfluramine hydrochloride | use | Nov 2033 |
| 9603814*PED | FINTEPLAfenfluramine hydrochloride | use | Nov 2033 |
| 9603815*PED | FINTEPLAfenfluramine hydrochloride | use | Nov 2033 |
| 9610260*PED | FINTEPLAfenfluramine hydrochloride | use | Nov 2033 |
| 10106579 | ZILBRYSQzilucoplan sodium | substance, product | Jun 2035 |
| 10208089 | ZILBRYSQzilucoplan sodium | substance | Jun 2035 |
| 10435438 | ZILBRYSQzilucoplan sodium | substance | Jun 2035 |
| 10562934 | ZILBRYSQzilucoplan sodium | substance | Jun 2035 |
| 10835574 | ZILBRYSQzilucoplan sodium | product | Jun 2035 |
| 11014965 | ZILBRYSQzilucoplan sodium | substance | Jun 2035 |
| 11535650 | ZILBRYSQzilucoplan sodium | product | Jun 2035 |
| 11752190 | ZILBRYSQzilucoplan sodium | product | Jun 2035 |
| 11965040 | ZILBRYSQzilucoplan sodium | product | Jun 2035 |
| 10471087 | KYGEVVIdoxecitine; doxribtimine | use | Aug 2036 |
| 10947183 | FINTEPLAfenfluramine hydrochloride | substance, product | Dec 2036 |
| 10947183*PED | FINTEPLAfenfluramine hydrochloride | use | Jun 2037 |
| 10603290 | FINTEPLAfenfluramine hydrochloride | use | Aug 2037 |
| 11040018 | FINTEPLAfenfluramine hydrochloride | use | Aug 2037 |
| 11406606 | FINTEPLAfenfluramine hydrochloride | use | Aug 2037 |
| 11759440 | FINTEPLAfenfluramine hydrochloride | use | Aug 2037 |
| 11786487 | FINTEPLAfenfluramine hydrochloride | use | Aug 2037 |
| 10603290*PED | FINTEPLAfenfluramine hydrochloride | use | Feb 2038 |
| 11040018*PED | FINTEPLAfenfluramine hydrochloride | use | Feb 2038 |
| 11406606*PED | FINTEPLAfenfluramine hydrochloride | use | Feb 2038 |
| 11759440*PED | FINTEPLAfenfluramine hydrochloride | use | Feb 2038 |
| 11786487*PED | FINTEPLAfenfluramine hydrochloride | use | Feb 2038 |
| 10452815*PED | FINTEPLAfenfluramine hydrochloride | use | Dec 2038 |
| 11649259 | KYGEVVIdoxecitine; doxribtimine | product | Aug 2040 |
| Product | Exclusivity | Until |
|---|---|---|
| FINTEPLAFENFLURAMINE HYDROCHLORIDE | PED Paediatric | Sept 2029 |
| KYGEVVIDOXECITINE; DOXRIBTIMINE | NCE New chemical entity | Nov 2030 |
| ZILBRYSQZILUCOPLAN SODIUM | ODE-446 Orphan drug | Oct 2030 |
Catalogue
Marketed products
65| Brand | Generic name | Form / route | NDC |
|---|---|---|---|
| - | BRIVARACETAM | tablet, film coated | 36998-3700DRUG FOR FURTHER PROCESSING |
| - | BRIVARACETAM | tablet, film coated | 36998-3800DRUG FOR FURTHER PROCESSING |
| - | BRIVARACETAM | tablet, film coated | 36998-3900DRUG FOR FURTHER PROCESSING |
| - | BRIVARACETAM | tablet, film coated | 36998-4000DRUG FOR FURTHER PROCESSING |
| - | BRIVARACETAM | tablet, film coated | 36998-4100DRUG FOR FURTHER PROCESSING |
| Bimzelx | bimekizumab | injection, solution, subcutaneous | 50474-780BLA |
| Bimzelx | bimekizumab | injection, solution, subcutaneous | 50474-781BLA |
| Bimzelx | bimekizumab | injection, solution, subcutaneous | 50474-782BLA |
| Bimzelx | bimekizumab | injection, solution, subcutaneous | 50474-783BLA |
| Briviact | brivaracetam | tablet, film coated, oral | 50474-370NDA |
| Briviact | brivaracetam | tablet, film coated, oral | 50474-470NDA |
| Briviact | brivaracetam | tablet, film coated, oral | 50474-570NDA |
| Briviact | brivaracetam | tablet, film coated, oral | 50474-670NDA |
| Briviact | brivaracetam | tablet, film coated, oral | 50474-770NDA |
| Briviact | brivaracetam | solution, oral | 50474-870NDA |
| Briviact | brivaracetam | injection, suspension, intravenous | 50474-970NDA |
| Cimzia | certolizumab pegol | kit | 50474-700BLA |
| Cimzia | certolizumab pegol | injection, solution, subcutaneous | 50474-710BLA |
| Cimzia | certolizumab pegol | injection, solution, subcutaneous | 50474-750BLA |
| Fintepla | fenfluramine | solution, oral | 43376-322NDA |
| KYGEVVI | doxecitine and doxribtimine | powder, for solution, oral | 50474-350NDA |
| Keppra | levetiracetam | solution, oral | 50474-001NDA |
| Keppra | levetiracetam | injection, solution, concentrate, intravenous | 50474-002NDA |
| Keppra | levetiracetam | tablet, film coated, oral | 50474-594NDA |
| Keppra | levetiracetam | tablet, film coated, oral | 50474-595NDA |
| Keppra | levetiracetam | tablet, film coated, oral | 50474-596NDA |
| Keppra | levetiracetam | tablet, film coated, oral | 50474-597NDA |
| Keppra XR | levetiracetam | tablet, film coated, extended release, oral | 50474-598NDA |
| Keppra XR | levetiracetam | tablet, film coated, extended release, oral | 50474-599NDA |
| Nayzilam | midazolam | spray, nasal | 50474-500NDA |
| Neupro | rotigotine | patch, extended release, transdermal | 50474-801NDA |
| Neupro | rotigotine | patch, extended release, transdermal | 50474-802NDA |
| Neupro | rotigotine | patch, extended release, transdermal | 50474-803NDA |
| Neupro | rotigotine | patch, extended release, transdermal | 50474-804NDA |
| Neupro | rotigotine | patch, extended release, transdermal | 50474-805NDA |
| Neupro | rotigotine | patch, extended release, transdermal | 50474-806NDA |
| Neupro | rotigotine | kit | 50474-808NDA |
| RYSTIGGO | ROZANOLIXIZUMAB | injection, solution, subcutaneous | 50474-980BLA |
| RYSTIGGO | ROZANOLIXIZUMAB | injection, solution, subcutaneous | 50474-981BLA |
| RYSTIGGO | ROZANOLIXIZUMAB | injection, solution, subcutaneous | 50474-982BLA |
| RYSTIGGO | ROZANOLIXIZUMAB | injection, solution, subcutaneous | 50474-983BLA |
| Vimpat | lacosamide | injection, intravenous | 0131-1810NDA |
| Vimpat | lacosamide | tablet, film coated, oral | 0131-2477NDA |
| Vimpat | lacosamide | tablet, film coated, oral | 0131-2478NDA |
| Vimpat | lacosamide | tablet, film coated, oral | 0131-2479NDA |
| Vimpat | lacosamide | tablet, film coated, oral | 0131-2480NDA |
| Vimpat | lacosamide | solution, oral | 0131-5410NDA |
| ZILBRYSQ | zilucoplan | injection, solution, subcutaneous | 50474-990NDA |
| ZILBRYSQ | zilucoplan | injection, solution, subcutaneous | 50474-991NDA |
| ZILBRYSQ | zilucoplan | injection, solution, subcutaneous | 50474-992NDA |
| - | brivaracetam | powder | 36998-0118BULK INGREDIENT |
| - | cetirizine hydrochloride and pseudoephedrine hydrochloride | tablet, extended release | 36998-9550DRUG FOR FURTHER PROCESSING |
| - | lacosamide | powder | 36998-0119BULK INGREDIENT |
| - | lacosamide | injection, solution | 36998-1810DRUG FOR FURTHER PROCESSING |
| - | lacosamide | tablet, film coated | 36998-2477DRUG FOR FURTHER PROCESSING |
| - | lacosamide | tablet, film coated | 36998-2478DRUG FOR FURTHER PROCESSING |
| - | lacosamide | tablet, film coated | 36998-2479DRUG FOR FURTHER PROCESSING |
| - | lacosamide | tablet, film coated | 36998-2480DRUG FOR FURTHER PROCESSING |
| - | levetiracetam | powder | 36998-0117BULK INGREDIENT |
| - | levetiracetam | tablet, film coated | 36998-5940DRUG FOR FURTHER PROCESSING |
| - | levetiracetam | tablet, film coated | 36998-5950DRUG FOR FURTHER PROCESSING |
| - | levetiracetam | tablet, film coated | 36998-5960DRUG FOR FURTHER PROCESSING |
| - | levetiracetam | tablet, film coated | 36998-5970DRUG FOR FURTHER PROCESSING |
| - | levetiracetam | tablet, film coated, extended release | 36998-5980DRUG FOR FURTHER PROCESSING |
| - | levetiracetam | tablet, film coated, extended release | 36998-5990DRUG FOR FURTHER PROCESSING |
Compare
Comparable companies in Belgium
- Benechim1 site · 5 NDC
- Institut National des Radioelements1 site · 4 NDC
- Minakem High Potent1 site · 4 NDC
- argenx BV1 site · 3 NDC
- Henogen1 site · 1 NDC
- Kaneka Eurogentec SA1 site · 1 NDC
- Purna Pharmaceuticals NV1 site · 1 NDC
- Ajinomoto OmniChem N.V.4 sites · 14 NDC
Enquiry
Common questions
- Is UCB, Inc. FDA approved?
- UCB, Inc. holds 2 FDA-registered establishments across 2 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 UCB, Inc.'s drugs manufactured?
- At registered sites in Belgium, Switzerland. The FDA register lists Braine-l'Alleud; Bulle. Registered operations: analytical testing, active ingredient (API) manufacture, labelling, finished drug manufacture, packaging, relabelling, repackaging, sterilize.
- What drugs does UCB, Inc. make?
- 65 products are listed under UCB, Inc. in the openFDA NDC Directory, most often as tablet, film coated; injection, solution; patch, extended release. 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.