Register entry
- Registered sites
- 3
- Active NDC listings
- 31
- Labeller names
- 2
- Live patents
- 0
- Countries
- 2
- Base
- United States
Authorisation
Registered operations
Analytical testing3Active ingredient (API) manufacture2Labelling1Finished drug manufacture3Packaging1Relabelling1Repackaging1sterilize1
Sites
Registered establishments
3| Establishment | Address | Registered for | FEI / DUNS |
|---|---|---|---|
| REGENERON IRELAND DESIGNATED ACTIVITY COMPANYRegistrant: Regeneron Pharmaceuticals, Inc. | Raheen Business Park, LIMERICK, , Ireland (IRL) | Analytical testing, Active ingredient (API) manufacture, Finished drug manufacture | 3011684330986063166 |
| Regeneron Pharmaceuticals, Inc. | 350 Tempel Ln, East Greenbush, New York (NY) 12061, United States (USA) | Analytical testing, Labelling, Finished drug manufacture, Packaging, Relabelling, Repackaging, sterilize | 3015581066118205659 |
| Regeneron Pharmaceuticals, Inc. | 81 Columbia Turnpike, Rensselaer, New York (NY) 12144, United States (USA) | Analytical testing, Active ingredient (API) manufacture, Finished drug manufacture | 1000514603945589711 |
Catalogue
Drug listings by form and route
3131 active NDC listings: 19 drug for further processing, 12 human prescription drug. By marketing category: DRUG FOR FURTHER PROCESSING 20, BLA 11.
| Dosage form | NDCs |
|---|---|
| injection, solution | 24 |
| solution | 4 |
| injection | 1 |
| injection, powder, lyophilized, for solution | 1 |
| injection, solution, concentrate | 1 |
| Route | NDCs |
|---|---|
| intravenous | 5 |
| intravitreal | 3 |
| subcutaneous | 3 |
| intracochlear | 1 |
| Labeller name on the listing | NDCs |
|---|---|
| regeneron pharmaceuticals, inc. | 23 |
| regeneron pharmaceuticals, inc | 8 |
Catalogue
Marketed products
31| Brand | Generic name | Form / route | NDC |
|---|---|---|---|
| - | Alirocumab | injection, solution | 61755-921DRUG FOR FURTHER PROCESSING |
| - | Dupilumab | injection, solution | 61755-940DRUG FOR FURTHER PROCESSING |
| - | Dupilumab | injection, solution | 61755-941DRUG FOR FURTHER PROCESSING |
| EYLEA | aflibercept | injection, solution, intravitreal | 61755-005BLA |
| EYLEA HD | aflibercept | injection, solution, intravitreal | 61755-050BLA |
| EYLEA HD | aflibercept | injection, solution, intravitreal | 61755-051BLA |
| - | Evinacumab | solution | 61755-910DRUG FOR FURTHER PROCESSING |
| Inmazeb | atoltivimab, maftivimab, and odesivimab-ebgn | injection, solution, intravenous | 61755-018BLA |
| Inmazeb | atoltivimab, maftivimab, and odesivimab-ebgn | injection, solution, intravenous | 61755-019BLA |
| LIBTAYO | cemiplimab-rwlc | injection, intravenous | 61755-008BLA |
| OTARMENI | lunsotogene parvec-cwha | injection, solution, intracochlear | 61755-062BLA |
| Pasatru | garetosmab-grts | injection, solution, concentrate, intravenous | 61755-012BLA |
| - | Pozelimab | injection, solution | 61755-914DRUG FOR FURTHER PROCESSING |
| Praluent | alirocumab | injection, solution, subcutaneous | 61755-020BLA |
| Praluent | alirocumab | injection, solution, subcutaneous | 61755-021BLA |
| - | Sarilumab | injection, solution | 61755-923DRUG FOR FURTHER PROCESSING |
| - | Sarilumab | injection, solution | 61755-924DRUG FOR FURTHER PROCESSING |
| VEOPOZ | Pozelimab | injection, solution, intravenous, subcutaneous | 61755-014BLA |
| - | aflibercept | injection, solution | 61755-905DRUG FOR FURTHER PROCESSING |
| - | aflibercept | injection, solution | 61755-930DRUG FOR FURTHER PROCESSING |
| - | aflibercept | injection, solution | 61755-950DRUG FOR FURTHER PROCESSING |
| - | atoltivimab | injection, solution | 61755-960DRUG FOR FURTHER PROCESSING |
| - | atoltivimab | injection, solution | 61755-963DRUG FOR FURTHER PROCESSING |
| - | cemiplimab | solution | 61755-908DRUG FOR FURTHER PROCESSING |
| - | cemiplimab | solution | 61755-909DRUG FOR FURTHER PROCESSING |
| - | linvoseltamab | solution | 61755-954DRUG FOR FURTHER PROCESSING |
| - | maftivimab | injection, solution | 61755-961DRUG FOR FURTHER PROCESSING |
| - | maftivimab | injection, solution | 61755-964DRUG FOR FURTHER PROCESSING |
| - | odesivimab | injection, solution | 61755-962DRUG FOR FURTHER PROCESSING |
| - | odesivimab | injection, solution | 61755-965DRUG FOR FURTHER PROCESSING |
| - | rilonacept | injection, powder, lyophilized, for solution | 61755-931DRUG FOR FURTHER PROCESSING |
Neighbours
Registered in the same town
1- Curia India Private LimitedRensselaer, NY
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Enquiry
Common questions
- Is Regeneron Pharmaceuticals, Inc. FDA approved?
- Regeneron Pharmaceuticals, Inc. holds 3 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 Regeneron Pharmaceuticals, Inc.'s drugs manufactured?
- At registered sites in Ireland, the United States. The FDA register lists Raheen Business Park; East Greenbush, NY; Rensselaer, NY. Registered operations: analytical testing, active ingredient (API) manufacture, labelling, finished drug manufacture, packaging, relabelling, repackaging, sterilize.
- What drugs does Regeneron Pharmaceuticals, Inc. make?
- 31 products are listed under Regeneron Pharmaceuticals, 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.