Register entry
- Registered sites
- 9
- Active NDC listings
- 105
- Labeller names
- 3
- Live patents
- 52
- Exclusivities
- 4
- Shortage listings
- 5
- Countries
- 4
- Base
- United States
Authorisation
Registered operations
Analytical testing8Active ingredient (API) manufacture4Labelling6Finished drug manufacture7Packaging6
Sites
Registered establishments
9| Establishment | Address | Registered for | FEI / DUNS |
|---|---|---|---|
| Amgen Technology (ireland) Unlimited CompanyRegistrant: Amgen, Inc | Pottery Road, Dun Laoghaire, , Ireland (IRL) | Analytical testing, Labelling, Finished drug manufacture, Packaging | 3002808497896293920 |
| Horizon Therapeutics Ireland Designated Activity Company (DAC)Registrant: Amgen, Inc | IDA Business & Technology Park, Bulterstown, Waterford, X91 PPN4, Ireland (IRL) | Analytical testing, Finished drug manufacture | 3020007539979877968 |
| Amgen Europe BVRegistrant: Amgen, Inc | Minervum 7061, Breda, NBNT, 4817 ZK, Netherlands (NLD) | Analytical testing, Labelling, Finished drug manufacture, Packaging | 3005889661419643184 |
| Amgen Singapore Manufacturing Pte. Ltd.Registrant: Amgen, Inc | 1 Tuas View Drive, Singapore, 637026, Singapore (SGP) | Analytical testing, Active ingredient (API) manufacture, Finished drug manufacture | 3011255424659221522 |
| Amgen Manufacturing Limited LLCRegistrant: Amgen, Inc | Carr 31 KM 24.6, Juncos, Puerto Rico (PR) 00777, United States (USA) | Analytical testing, Active ingredient (API) manufacture, Labelling, Finished drug manufacture, Packaging | 1000110364785800020 |
| Amgen Inc.Registrant: Amgen, Inc | 12000 Plantside Drive, Louisville, Kentucky (KY) 40299, United States (USA) | Labelling, Packaging | 3003750095787632801 |
| Amgen Inc.Registrant: Amgen, Inc | 4150 Ganton Parkway, New Albany, Ohio (OH) 43054, United States (USA) | Analytical testing, Labelling, Packaging | 3020740318118378297 |
| Amgen, Inc | One Amgen Center Drive, Thousand Oaks, California (CA) 91320, United States (USA) | Analytical testing, Active ingredient (API) manufacture, Labelling, Finished drug manufacture, Packaging | 2026154039976196 |
| Immunex Rhode Island CorporationRegistrant: Amgen, Inc | 40 Technology Way, West Greenwich, Rhode Island (RI) 02817, United States (USA) | Analytical testing, Active ingredient (API) manufacture, Finished drug manufacture | 3003359885968084785 |
Alert
Drug shortage listings
5| Drug | Presentation | Status | Availability | Posted / updated |
|---|---|---|---|---|
| Glycerol Phenylbutyrate Oral LiquidInborn Errors | RAVICTI, Oral Liquid, 1.1 g/1 mL (NDC 75987-050-07) | To Be Discontinued | - | 1 Sept 20261 Sept 2026 |
| Glycerol Phenylbutyrate Oral LiquidInborn Errors | RAVICTI, Oral Liquid, 1.1 g/1 mL (NDC 75987-050-06) | To Be Discontinued | - | 1 Sept 20261 Sept 2026 |
| Ivabradine Hydrochloride TabletCardiovascular | Corlanor, Tablet, eq. 5 mg base (NDC 55513-800-60) | To Be Discontinued | - | 24 Mar 202624 Mar 2026 |
| Ivabradine Hydrochloride TabletCardiovascular | Corlanor, Tablet, eq. 7.5 mg base (NDC 55513-810-60) | To Be Discontinued | - | 24 Mar 202624 Mar 2026 |
| Ivabradine SolutionCardiovascular | Corlanor, Solution, 5 mg/5 mL (NDC 55513-813-28) | To Be Discontinued | - | 24 Mar 202624 Mar 2026 |
Catalogue
Drug listings by form and route
105105 active NDC listings: 97 human prescription drug, 8 drug for further processing. By marketing category: BLA 77, NDA 20, DRUG FOR FURTHER PROCESSING 8.
| Dosage form | NDCs |
|---|---|
| injection, solution | 34 |
| solution | 23 |
| injection | 19 |
| kit | 9 |
| injection, powder, lyophilized, for solution | 6 |
| tablet, coated | 6 |
| tablet, film coated | 5 |
| injection, suspension | 2 |
| injection, solution, concentrate | 1 |
| Route | NDCs |
|---|---|
| subcutaneous | 59 |
| intravenous | 37 |
| oral | 12 |
| intralesional | 2 |
| intravitreal | 2 |
| Labeller name on the listing | NDCs |
|---|---|
| amgen, inc | 81 |
| amgen inc | 14 |
| amgen usa inc. | 10 |
Exclusivity
Patents and exclusivities
52| Patent | Product | Covers | Expiry |
|---|---|---|---|
| 7867996 | CORLANORivabradine; ivabradine hydrochloride | substance, product | Dec 2026 |
| 7867996*PED | CORLANORivabradine hydrochloride | use | Jun 2027 |
| 7427638 | OTEZLA, OTEZLA XRapremilast | substance, product | Feb 2028 |
| 7427638*PED | OTEZLAapremilast | use | Aug 2028 |
| 12576034 | OTEZLAapremilast | product | Nov 2033 |
| 10092541 | OTEZLA, OTEZLA XRapremilast | use | May 2034 |
| 9872854 | OTEZLAapremilast | use | May 2034 |
| 12576034*PED | OTEZLAapremilast | use | May 2034 |
| 10092541*PED | OTEZLAapremilast | use | Nov 2034 |
| 9872854*PED | OTEZLAapremilast | use | Nov 2034 |
| 10519146 | LUMAKRASsotorasib | substance, product | May 2038 |
| 12280056 | LUMAKRASsotorasib | use | Nov 2039 |
| 11236091 | LUMAKRASsotorasib | substance, product | May 2040 |
| 11827635 | LUMAKRASsotorasib | substance, product | May 2040 |
| 12398133 | LUMAKRASsotorasib | substance, product | May 2040 |
| 11426404 | LUMAKRASsotorasib | use | Sept 2040 |
| 11752129 | OTEZLA XRapremilast | product | May 2042 |
| 11969409 | OTEZLA XRapremilast | product | May 2042 |
| 12427136 | OTEZLA XRapremilast | use | May 2042 |
| Product | Exclusivity | Until |
|---|---|---|
| CORLANORIVABRADINE | PED Paediatric | Oct 2026 |
| LUMAKRASSOTORASIB | ODE-507 Orphan drug | Jan 2032 |
| OTEZLAAPREMILAST | PED Paediatric | Oct 2027 |
| OTEZLA XRAPREMILAST | PED Paediatric | Jan 2027 |
Catalogue
Marketed products
105| Brand | Generic name | Form / route | NDC |
|---|---|---|---|
| AIMOVIG | erenumab-aooe | injection, subcutaneous | 55513-840BLA |
| AIMOVIG | erenumab-aooe | injection, subcutaneous | 55513-841BLA |
| AIMOVIG | erenumab-aooe | injection, solution, subcutaneous | 55513-842BLA |
| AIMOVIG | erenumab-aooe | injection, solution, subcutaneous | 55513-843BLA |
| AMJEVITA | adalimumab-atto | injection, subcutaneous | 55513-399BLA |
| AMJEVITA | adalimumab-atto | injection, subcutaneous | 55513-400BLA |
| AMJEVITA | adalimumab-atto | injection, subcutaneous | 55513-410BLA |
| AMJEVITA | adalimumab-atto | injection, subcutaneous | 55513-411BLA |
| AMJEVITA | adalimumab-atto | injection, subcutaneous | 55513-413BLA |
| AMJEVITA | adalimumab-atto | injection, subcutaneous | 55513-479BLA |
| AMJEVITA | adalimumab-atto | injection, subcutaneous | 55513-480BLA |
| AMJEVITA | adalimumab-atto | injection, subcutaneous | 55513-481BLA |
| AMJEVITA | adalimumab-atto | injection, subcutaneous | 55513-482BLA |
| AMJEVITA | adalimumab-atto | injection, subcutaneous | 72511-399BLA |
| AMJEVITA | adalimumab-atto | injection, subcutaneous | 72511-400BLA |
| AMJEVITA | adalimumab-atto | injection, subcutaneous | 72511-479BLA |
| AMJEVITA | adalimumab-atto | injection, subcutaneous | 72511-481BLA |
| AMJEVITA | adalimumab-atto | injection, subcutaneous | 72511-482BLA |
| ARANESP | darbepoetin alfa | solution, intravenous, subcutaneous | 55513-002BLA |
| ARANESP | darbepoetin alfa | solution, intravenous, subcutaneous | 55513-003BLA |
| ARANESP | darbepoetin alfa | solution, intravenous, subcutaneous | 55513-004BLA |
| ARANESP | darbepoetin alfa | solution, intravenous, subcutaneous | 55513-005BLA |
| ARANESP | darbepoetin alfa | solution, intravenous, subcutaneous | 55513-006BLA |
| ARANESP | darbepoetin alfa | injection, solution, intravenous, subcutaneous | 55513-021BLA |
| ARANESP | darbepoetin alfa | injection, solution, intravenous, subcutaneous | 55513-023BLA |
| ARANESP | darbepoetin alfa | injection, solution, intravenous, subcutaneous | 55513-025BLA |
| ARANESP | darbepoetin alfa | injection, solution, intravenous, subcutaneous | 55513-027BLA |
| ARANESP | darbepoetin alfa | injection, solution, intravenous, subcutaneous | 55513-028BLA |
| ARANESP | darbepoetin alfa | injection, solution, intravenous, subcutaneous | 55513-032BLA |
| ARANESP | darbepoetin alfa | injection, solution, intravenous, subcutaneous | 55513-057BLA |
| ARANESP | darbepoetin alfa | injection, solution, intravenous, subcutaneous | 55513-098BLA |
| ARANESP | darbepoetin alfa | injection, solution, intravenous, subcutaneous | 55513-111BLA |
| AVSOLA | infliximab-axxq | injection, powder, lyophilized, for solution, intravenous | 55513-670BLA |
| BKEMV | eculizumab-aeeb | injection, solution, concentrate, intravenous | 55513-180BLA |
| BLINCYTO | blinatumomab | kit | 55513-160BLA |
| - | Brodalumab | solution | 55513-834DRUG FOR FURTHER PROCESSING |
| Corlanor | ivabradine | tablet, film coated, oral | 55513-800NDA |
| Corlanor | ivabradine | tablet, film coated, oral | 55513-810NDA |
| Corlanor | ivabradine | solution, oral | 55513-813NDA |
| EPOGEN | epoetin alfa | solution, intravenous, subcutaneous | 55513-126BLA |
| EPOGEN | epoetin alfa | solution, intravenous, subcutaneous | 55513-144BLA |
| EPOGEN | epoetin alfa | solution, intravenous, subcutaneous | 55513-148BLA |
| EPOGEN | epoetin alfa | solution, intravenous, subcutaneous | 55513-267BLA |
| EPOGEN | epoetin alfa | solution, intravenous, subcutaneous | 55513-283BLA |
| EPOGEN | epoetin alfa | solution, intravenous, subcutaneous | 55513-478BLA |
| Evenity | romosozumab-aqqg | injection, solution, subcutaneous | 55513-509BLA |
| Evenity | romosozumab-aqqg | injection, solution, subcutaneous | 55513-880BLA |
| Evenity | romosozumab-aqqg | injection, solution, subcutaneous | 55513-998BLA |
| IMDELLTRA (AMG757) | Tarlatamab-dlle | kit | 55513-059BLA |
| IMDELLTRA (AMG757) | Tarlatamab-dlle | kit | 55513-077BLA |
| Imlygic | talimogene laherparepvec | injection, suspension, intralesional | 55513-078BLA |
| Imlygic | talimogene laherparepvec | injection, suspension, intralesional | 55513-079BLA |
| Kanjinti | trastuzumab-anns | injection, powder, lyophilized, for solution, intravenous | 55513-132BLA |
| Kanjinti | trastuzumab-anns | injection, powder, lyophilized, for solution, intravenous | 55513-141BLA |
| LUMAKRAS | sotorasib | tablet, coated, oral | 55513-488NDA |
| LUMAKRAS | sotorasib | tablet, coated, oral | 55513-504NDA |
| LUMAKRAS | sotorasib | tablet, coated, oral | 55513-512NDA |
| MVASI | bevacizumab-awwb | injection, solution, intravenous | 55513-206BLA |
| MVASI | bevacizumab-awwb | injection, solution, intravenous | 55513-207BLA |
| NEUPOGEN | Filgrastim | injection, solution, intravenous, subcutaneous | 55513-209BLA |
| NEUPOGEN | Filgrastim | injection, solution, intravenous, subcutaneous | 55513-530BLA |
| NEUPOGEN | Filgrastim | injection, solution, intravenous, subcutaneous | 55513-546BLA |
| NEUPOGEN | Filgrastim | injection, solution, intravenous, subcutaneous | 55513-924BLA |
| Neulasta | pegfilgrastim | solution, subcutaneous | 55513-099BLA |
| Neulasta | pegfilgrastim | injection, subcutaneous | 55513-190BLA |
| Neulasta | pegfilgrastim | kit | 55513-192BLA |
| Nplate | romiplostim | injection, powder, lyophilized, for solution, subcutaneous | 55513-221BLA |
| Nplate | romiplostim | injection, powder, lyophilized, for solution, subcutaneous | 55513-222BLA |
| Nplate | romiplostim | injection, powder, lyophilized, for solution, subcutaneous | 55513-223BLA |
| Otezla | apremilast | tablet, film coated, oral | 55513-137NDA |
| Otezla | apremilast | kit | 55513-369NDA |
| Otezla | apremilast | kit | 55513-485NDA |
| Otezla | apremilast | tablet, film coated, oral | 55513-497NDA |
| Otezla | apremilast | kit | 55513-508NDA |
| Otezla | apremilast | kit | 55513-516NDA |
| Otezla | apremilast | tablet, film coated, oral | 55513-519NDA |
| Otezla | apremilast | kit | 55513-996NDA |
| PARSABIV | etelcalcetide | injection, solution, intravenous | 55513-740NDA |
| PARSABIV | etelcalcetide | injection, solution, intravenous | 55513-741NDA |
| PARSABIV | etelcalcetide | injection, solution, intravenous | 55513-742NDA |
| PAVBLU | aflibercept-ayyh | injection, solution, intravitreal | 55513-056BLA |
| PAVBLU | aflibercept-ayyh | injection, solution, intravitreal | 55513-065BLA |
| Prolia | denosumab | injection, subcutaneous | 55513-710BLA |
| REPATHA | Evolocumab | injection, solution, subcutaneous | 72511-143BLA |
| REPATHA | Evolocumab | injection, solution, subcutaneous | 72511-393BLA |
| REPATHA | Evolocumab | injection, solution, subcutaneous | 72511-501BLA |
| REPATHA | Evolocumab | injection, solution, subcutaneous | 72511-750BLA |
| REPATHA | Evolocumab | injection, solution, subcutaneous | 72511-760BLA |
| Riabni | rituximab-arrx | injection, solution, intravenous | 55513-224BLA |
| Riabni | rituximab-arrx | injection, solution, intravenous | 55513-326BLA |
| Sensipar | cinacalcet hydrochloride | tablet, coated, oral | 55513-073NDA |
| Sensipar | cinacalcet hydrochloride | tablet, coated, oral | 55513-074NDA |
| Sensipar | cinacalcet hydrochloride | tablet, coated, oral | 55513-075NDA |
| TEZSPIRE | tezepelumab-ekko | injection, solution, subcutaneous | 55513-112BLA |
| TEZSPIRE | tezepelumab-ekko | injection, solution, subcutaneous | 55513-123BLA |
| Vectibix | panitumumab | solution, intravenous | 55513-954BLA |
| Vectibix | panitumumab | solution, intravenous | 55513-956BLA |
| XGEVA | denosumab | injection, subcutaneous | 55513-730BLA |
| - | epoetin alfa | solution | 55513-101DRUG FOR FURTHER PROCESSING |
| - | epoetin alfa | solution | 55513-113DRUG FOR FURTHER PROCESSING |
| - | epoetin alfa | solution | 55513-120DRUG FOR FURTHER PROCESSING |
| - | epoetin alfa | solution | 55513-136DRUG FOR FURTHER PROCESSING |
| - | epoetin alfa | solution | 55513-142DRUG FOR FURTHER PROCESSING |
| - | epoetin alfa | solution | 55513-154DRUG FOR FURTHER PROCESSING |
| - | epoetin alfa | solution | 55513-168DRUG FOR FURTHER PROCESSING |
Neighbours
Registered in the same town
12- Merck & Co., Inc.Singapore, SGP · 5 sites
- Baxalta US Inc.Singapore, SGP; THOUSAND OAKS, CA · 2 sites
- SanofiSingapore, SGP · 2 sites
- PETNET Solutions, Inc.LOUISVILLE, KY
- Cardinal Health 418, Inc.Louisville, KY
- Novartis Pharmaceuticals CorporationSingapore, SGP
- Charles River Laboratories, Inc.Singapore, SGP
- Lonza Biologics IncSingapore, SGP
- AbbVie Inc.Singapore, SGP
- Pfizer IncSingapore, SGP
- Genentech, Inc.Singapore, SGP
- Almac Pharma Services (Ireland) LimitedSingapore, SGP
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Enquiry
Common questions
- Is Amgen, Inc FDA approved?
- Amgen, Inc holds 9 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 Amgen, Inc's drugs manufactured?
- At registered sites in Ireland, the Netherlands, Singapore, the United States. The FDA register lists Pottery Road; Waterford; NBNT; Singapore; Juncos, PR; Louisville, KY, and 3 more. Registered operations: analytical testing, active ingredient (API) manufacture, labelling, finished drug manufacture, packaging.
- What drugs does Amgen, Inc make?
- 105 products are listed under Amgen, Inc in the openFDA NDC Directory, most often as injection, solution; solution; injection. 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.