Register entry
Samsung Biologics Co., Ltd.
- Registered sites
- 2
- Drug products
- 57
- Live patents
- 0
- Countries
- 2
- Base
- United States
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) manufactureLabellingFinished drug manufacturePackaging
Sites
Facilities
2| Site | Location | Operations | FEI |
|---|---|---|---|
| Samsung Biologics Co., Ltd. | 22032South Korea | Analytical testing, Active ingredient (API) manufacture, Labelling, Finished drug manufacture, Packaging | 3010479596 |
| Human Genome Sciences, Inc. | Rockville, MDUnited States | Analytical testing, Active ingredient (API) manufacture | 3003782237 |
Catalogue
Marketed products
57Showing 57 of 57.
| Brand | Generic name | Form | Category |
|---|---|---|---|
| - | Adalimumab | LIQUID | BULK INGREDIENT |
| - | Adalimumab | LIQUID | BULK INGREDIENT |
| - | Durvalumab | LIQUID | BULK INGREDIENT |
| - | Emicizumab | SOLUTION | DRUG FOR FURTHER PROCESSING |
| - | Emicizumab | SOLUTION | DRUG FOR FURTHER PROCESSING |
| - | Emicizumab | SOLUTION | DRUG FOR FURTHER PROCESSING |
| - | Emicizumab | SOLUTION | DRUG FOR FURTHER PROCESSING |
| - | Infliximab | INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION | DRUG FOR FURTHER PROCESSING |
| - | Infliximab | LIQUID | BULK INGREDIENT |
| - | Ipilimumab | LIQUID | BULK INGREDIENT |
| - | Nivolumab | LIQUID | BULK INGREDIENT |
| - | Perflutren | INJECTION, SUSPENSION | DRUG FOR FURTHER PROCESSING |
| - | Rilonacept | LIQUID | BULK INGREDIENT |
| - | Rituximab | LIQUID | BULK INGREDIENT |
| - | THROMBIN ALFA | LIQUID | BULK INGREDIENT |
| - | Telavancin | INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION | DRUG FOR FURTHER PROCESSING |
| - | adalimumab | INJECTION | DRUG FOR FURTHER PROCESSING |
| - | aflibercept-yszy | LIQUID | BULK INGREDIENT |
| - | amivantamab | LIQUID | BULK INGREDIENT |
| - | bamlanivimab | LIQUID | BULK INGREDIENT |
| - | belatacept | LIQUID | BULK INGREDIENT |
| - | belimumab | LIQUID | BULK INGREDIENT |
| - | belimumab | LIQUID | BULK INGREDIENT |
| - | bevacizumab | INJECTION | DRUG FOR FURTHER PROCESSING |
| - | bevacizumab-bvzr | LIQUID | BULK INGREDIENT |
| - | bimekizumab | LIQUID | BULK INGREDIENT |
| - | cosibelimab | LIQUID | BULK INGREDIENT |
| - | cosibelimab | INJECTION | DRUG FOR FURTHER PROCESSING |
| - | daratumumab | LIQUID | BULK INGREDIENT |
| - | denosumab | INJECTION, SOLUTION | DRUG FOR FURTHER PROCESSING |
| - | denosumab | LIQUID | BULK INGREDIENT |
| - | donanemab | LIQUID | BULK INGREDIENT |
| - | eculizumab | INJECTION, SOLUTION | DRUG FOR FURTHER PROCESSING |
| - | emicizumab | INJECTION, SOLUTION | DRUG FOR FURTHER PROCESSING |
| - | emicizumab | INJECTION, SOLUTION | DRUG FOR FURTHER PROCESSING |
| - | etesevimab | LIQUID | BULK INGREDIENT |
| - | ibalizumab | SOLUTION | DRUG FOR FURTHER PROCESSING |
| - | ibalizumab | LIQUID | BULK INGREDIENT |
| - | infliximab | INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION | DRUG FOR FURTHER PROCESSING |
| - | infliximab | LIQUID | BULK INGREDIENT |
| - | ipilimumab | SOLUTION | DRUG FOR FURTHER PROCESSING |
| - | ipilimumab | SOLUTION | DRUG FOR FURTHER PROCESSING |
| - | ipilimumab | SOLUTION | DRUG FOR FURTHER PROCESSING |
| - | lebrikizumab | LIQUID | BULK INGREDIENT |
| - | mepolizumab | LIQUID | BULK INGREDIENT |
| - | mirvetuximab | LIQUID | BULK INGREDIENT |
| - | nirsevimab | LIQUID | BULK INGREDIENT |
| - | rituximab | LIQUID | BULK INGREDIENT |
| - | rozanolixizumab | LIQUID | BULK INGREDIENT |
| - | sacituzumab | LIQUID | BULK INGREDIENT |
| - | sotatercept | LIQUID | BULK INGREDIENT |
| - | tildrakizumab | LIQUID | BULK INGREDIENT |
| - | tocilizumab | LIQUID | BULK INGREDIENT |
| - | trastuzumab | LIQUID | BULK INGREDIENT |
| - | trastuzumab | LIQUID | BULK INGREDIENT |
| - | ublituximab | SOLUTION | DRUG FOR FURTHER PROCESSING |
| - | ublituximab | LIQUID | BULK INGREDIENT |
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.