Register entry
- Registered sites
- 1
- Active NDC listings
- 36
- Labeller names
- 4
- Live patents
- 0
- Countries
- 1
- Base
- South Korea
Authorisation
Registered operations
Analytical testing1Active ingredient (API) manufacture1Labelling1Finished drug manufacture1Packaging1
Sites
Registered establishments
1| Establishment | Address | Registered for | FEI / DUNS |
|---|---|---|---|
| CELLTRION Inc | 23, Academy-ro, Yeonsu-gu, Incheon, 22014, Korea, South (KOR) | Analytical testing, Active ingredient (API) manufacture, Labelling, Finished drug manufacture, Packaging | 3005241015688836030 |
Catalogue
Drug listings by form and route
3636 active NDC listings: 24 human prescription drug, 9 drug for further processing, 3 bulk ingredient. By marketing category: BLA 24, DRUG FOR FURTHER PROCESSING 9, BULK INGREDIENT 3.
| Dosage form | NDCs |
|---|---|
| injection, solution | 18 |
| injection | 9 |
| kit | 6 |
| injection, powder, lyophilized, for solution | 2 |
| liquid | 1 |
| Route | NDCs |
|---|---|
| subcutaneous | 12 |
| intravenous | 6 |
| Labeller name on the listing | NDCs |
|---|---|
| celltrion usa, inc. | 22 |
| celltrion, inc | 8 |
| celltrion, inc. | 4 |
| celltrion usa inc. | 2 |
Catalogue
Marketed products
36| Brand | Generic name | Form / route | NDC |
|---|---|---|---|
| AVTOZMA | tocilizumab | injection, solution, intravenous | 72606-042BLA |
| AVTOZMA | tocilizumab | injection, solution, intravenous | 72606-043BLA |
| AVTOZMA | tocilizumab | injection, solution, intravenous | 72606-044BLA |
| AVTOZMA | tocilizumab | injection, solution, subcutaneous | 72606-045BLA |
| Adalimumab | adalimumab-aaty | kit | 72606-022BLA |
| Adalimumab | adalimumab-aaty | kit | 72606-040BLA |
| Adalimumab | adalimumab-aaty | kit | 72606-041BLA |
| - | Adalimumab-aaty | liquid | 32228-021BULK INGREDIENT |
| Denosumab-BMWO | denosumab-bmwo | injection, subcutaneous | 72606-058BLA |
| Denosumab-BMWO | denosumab-bmwo | injection, subcutaneous | 72606-059BLA |
| OMLYCLO | omalizumab-igec | injection, subcutaneous | 72606-035BLA |
| OMLYCLO | omalizumab-igec | injection, subcutaneous | 72606-036BLA |
| OMLYCLO | omalizumab-igec | injection, subcutaneous | 72606-054BLA |
| Osenvelt | denosumab-bmwo | injection, subcutaneous | 72606-038BLA |
| STEQEYMA | ustekinumab-stba | injection, solution, subcutaneous | 72606-027BLA |
| STEQEYMA | ustekinumab-stba | injection, solution, subcutaneous | 72606-028BLA |
| STEQEYMA | ustekinumab-stba | injection, solution, intravenous | 72606-029BLA |
| STEQEYMA | ustekinumab-stba | injection, solution, subcutaneous | 72606-060BLA |
| Stoboclo | denosumab-bmwo | injection, subcutaneous | 72606-037BLA |
| Vegzelma | bevacizumab-adcd | injection, solution, intravenous | 72606-011BLA |
| Vegzelma | bevacizumab-adcd | injection, solution, intravenous | 72606-012BLA |
| Yuflyma | adalimumab-aaty | kit | 72606-023BLA |
| Yuflyma | adalimumab-aaty | kit | 72606-030BLA |
| ZYMFENTRA | infliximab-dyyb | kit | 72606-025BLA |
| ZYMFENTRA | infliximab-dyyb | injection, subcutaneous | 72606-047BLA |
| - | adalimumab-aaty | injection, solution | 32228-006DRUG FOR FURTHER PROCESSING |
| - | adalimumab-aaty | injection, solution | 32228-007DRUG FOR FURTHER PROCESSING |
| - | adalimumab-aaty | injection, solution | 32228-008DRUG FOR FURTHER PROCESSING |
| - | adalimumab-aaty | injection, solution | 32228-009DRUG FOR FURTHER PROCESSING |
| - | adalimumab-aaty | injection, solution | 32228-010DRUG FOR FURTHER PROCESSING |
| - | bevacizumab-adcd | injection, solution | 32228-005DRUG FOR FURTHER PROCESSING |
| - | bevacizumab-adcd | injection, solution | 32228-020DRUG FOR FURTHER PROCESSING |
| - | infliximab-dyyb | injection, powder, lyophilized, for solution | 32228-001DRUG FOR FURTHER PROCESSING |
| - | infliximab-dyyb | injection, powder, lyophilized, for solution | 32228-002BULK INGREDIENT |
| - | infliximab-dyyb | injection, solution | 32228-019DRUG FOR FURTHER PROCESSING |
| - | infliximab-dyyb | injection | 32228-022BULK INGREDIENT |
Neighbours
Registered in the same town
1- Janssen Research & Development, L.L.C.22014, KOR
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Enquiry
Common questions
- Is CELLTRION Inc FDA approved?
- CELLTRION Inc holds 1 FDA-registered establishment in South Korea. 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 CELLTRION Inc's drugs manufactured?
- The FDA register lists 22014. Registered operations: analytical testing, active ingredient (API) manufacture, labelling, finished drug manufacture, packaging.
- What drugs does CELLTRION Inc make?
- 36 products are listed under CELLTRION Inc in the openFDA NDC Directory, most often as injection, solution; injection; kit. 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.