Register entry
- Registered sites
- 5
- Active NDC listings
- 45
- Labeller names
- 2
- Live patents
- 20
- Exclusivities
- 2
- Countries
- 4
- Base
- United States
Authorisation
Registered operations
Analytical testing5Active ingredient (API) manufacture3Labelling2Finished drug manufacture4Packaging2Relabelling2Repackaging2sterilize1
Sites
Registered establishments
5| Establishment | Address | Registered for | FEI / DUNS |
|---|---|---|---|
| Genzyme FlandersRegistrant: Genzyme Corporation | Cipalstraat 8, Geel, 2440, Belgium (BEL) | Analytical testing, Active ingredient (API) manufacture, Finished drug manufacture | 3003623839372153895 |
| SANOFI WINTHROP INDUSTRIERegistrant: Genzyme Corporation | 23 boulevard Chambaud de la Bruyere, Lyon, 69007, France (FRA) | Analytical testing, Active ingredient (API) manufacture, Finished drug manufacture | 3009194033280065724 |
| Genzyme Ireland LimitedRegistrant: Genzyme Corporation | Unit 701 IDA Industrial Park, Old Kilmeaden Road, Waterford, X91 TP27, Ireland (IRL) | Analytical testing, Labelling, Finished drug manufacture, Packaging, Relabelling, Repackaging, sterilize | 3003809840985127419 |
| Genzyme Corporation | 8 New York Avenue, Framingham, Massachusetts (MA) 01701-8806, United States (USA) | Analytical testing, Active ingredient (API) manufacture, Finished drug manufacture | 1220423117450412 |
| Genzyme Corporation | 11 Forbes Road, Northborough, Massachusetts (MA) 01532, United States (USA) | Analytical testing, Labelling, Packaging, Relabelling, Repackaging | 3009389940050424395 |
Catalogue
Drug listings by form and route
4545 active NDC listings: 24 human prescription drug, 21 drug for further processing. By marketing category: DRUG FOR FURTHER PROCESSING 21, BLA 13, NDA 11.
| Dosage form | NDCs |
|---|---|
| injection, powder, lyophilized, for solution | 12 |
| powder, for solution | 12 |
| tablet, film coated | 6 |
| solution | 4 |
| injection, powder, for solution | 2 |
| injection, solution | 2 |
| injection, solution, concentrate | 2 |
| powder, for suspension | 2 |
| capsule | 1 |
| injection | 1 |
| kit | 1 |
| Route | NDCs |
|---|---|
| intravenous | 11 |
| oral | 9 |
| subcutaneous | 2 |
| intramuscular | 1 |
| Labeller name on the listing | NDCs |
|---|---|
| genzyme corporation | 33 |
| genzyme ireland limited | 12 |
Exclusivity
Patents and exclusivities
20| Patent | Product | Covers | Expiry |
|---|---|---|---|
| 8067427 | CAPRELSAvandetanib | product | Aug 2028 |
| 11458119 | CERDELGAeliglustat tartrate | substance, product | Nov 2030 |
| 9095509 | RENVELAsevelamer carbonate | product | Dec 2030 |
| 10888547 | CERDELGAeliglustat tartrate | use | Jan 2031 |
| 12465586 | CERDELGAeliglustat tartrate | use | Jun 2032 |
| 9580427 | WAYRILZrilzabrutinib | substance, product | Mar 2033 |
| 9376680 | QFITLIAfitusiran sodium | substance, product | Mar 2033 |
| 9127274 | QFITLIAfitusiran sodium | substance, product | Mar 2033 |
| 8940744 | WAYRILZrilzabrutinib | substance, product | Sept 2033 |
| 9266895 | WAYRILZrilzabrutinib | substance, product | Sept 2033 |
| 9994576 | WAYRILZrilzabrutinib | substance, product | Sept 2033 |
| 11091759 | QFITLIAfitusiran sodium | use | Dec 2036 |
| 10888544 | CERDELGAeliglustat tartrate | use | Dec 2038 |
| 12178818 | WAYRILZrilzabrutinib | use | Oct 2040 |
| 11708370 | WAYRILZrilzabrutinib | substance | Feb 2041 |
| Product | Exclusivity | Until |
|---|---|---|
| QFITLIAFITUSIRAN SODIUM | ODE-510 Orphan drug | Mar 2032 |
| WAYRILZRILZABRUTINIB | ODE-552 Orphan drug | Aug 2032 |
Catalogue
Marketed products
45| Brand | Generic name | Form / route | NDC |
|---|---|---|---|
| - | AGALSIDASE BETA | injection, powder, lyophilized, for solution | 58468-5030DRUG FOR FURTHER PROCESSING |
| ALDURAZYME | laronidase | injection, solution, concentrate, intravenous | 58468-0070BLA |
| - | AVALGLUCOSIDASE ALFA | injection, powder, lyophilized, for solution | 58468-5011DRUG FOR FURTHER PROCESSING |
| - | Alglucosidase alfa | solution | 58468-5005DRUG FOR FURTHER PROCESSING |
| Aubagio | teriflunomide | tablet, film coated, oral | 58468-0210NDA |
| Aubagio | teriflunomide | tablet, film coated, oral | 58468-0211NDA |
| - | Avalglucosidase alfa | solution | 58468-5006DRUG FOR FURTHER PROCESSING |
| CAPRELSA | Vandetanib | tablet, film coated, oral | 58468-7820NDA |
| CAPRELSA | Vandetanib | tablet, film coated, oral | 58468-7840NDA |
| Cablivi | caplacizumab | kit | 58468-0225BLA |
| Campath | ALEMTUZUMAB | injection, intravenous | 58468-0357BLA |
| Cerdelga | eliglustat | capsule, oral | 58468-0220NDA |
| Cerezyme | IMIGLUCERASE | injection, powder, lyophilized, for solution, intravenous | 58468-4663BLA |
| - | Dupilumab | solution | 58468-5150DRUG FOR FURTHER PROCESSING |
| - | Dupilumab | solution | 58468-5151DRUG FOR FURTHER PROCESSING |
| Fabrazyme | AGALSIDASE BETA | injection, powder, lyophilized, for solution, intravenous | 58468-0040BLA |
| Fabrazyme | AGALSIDASE BETA | injection, powder, lyophilized, for solution, intravenous | 58468-0041BLA |
| - | IMIGLUCERASE | injection, powder, lyophilized, for solution | 58468-5010DRUG FOR FURTHER PROCESSING |
| - | LAPINE T-LYMPHOCYTE IMMUNE GLOBULIN | injection, powder, for solution | 58468-5025DRUG FOR FURTHER PROCESSING |
| LEMTRADA | ALEMTUZUMAB | injection, solution, concentrate, intravenous | 58468-0200BLA |
| Lumizyme | ALGLUCOSIDASE ALFA | injection, powder, for solution, intravenous | 58468-0160BLA |
| Nexviazyme | avalglucosidase alfa-ngpt | injection, powder, lyophilized, for solution, intravenous | 58468-0426BLA |
| Qfitlia | fitusiran | injection, solution, subcutaneous | 58468-0347NDA |
| Qfitlia | fitusiran | injection, solution, subcutaneous | 58468-0348NDA |
| Renvela | SEVELAMER CARBONATE | powder, for suspension, oral | 58468-0131NDA |
| Renvela | SEVELAMER CARBONATE | powder, for suspension, oral | 58468-0132NDA |
| Renvela | SEVELAMER CARBONATE | tablet, film coated, oral | 58468-0133NDA |
| - | THYROTROPIN ALFA | injection, powder, lyophilized, for solution | 58468-5015DRUG FOR FURTHER PROCESSING |
| Thymoglobulin | Anti-thymocyte Globulin (Rabbit) | injection, powder, lyophilized, for solution, intravenous | 58468-0080BLA |
| Thyrogen | THYROTROPIN ALFA | injection, powder, lyophilized, for solution, intramuscular | 58468-0030BLA |
| WAYRILZ | rilzabrutinib | tablet, film coated, oral | 58468-0251NDA |
| XENPOZYME | olipudase alfa-rpcp | injection, powder, lyophilized, for solution, intravenous | 58468-0050BLA |
| XENPOZYME | olipudase alfa-rpcp | injection, powder, lyophilized, for solution, intravenous | 58468-0051BLA |
| - | efanesoctocog alfa | powder, for solution | 83246-019DRUG FOR FURTHER PROCESSING |
| - | efanesoctocog alfa | powder, for solution | 83246-020DRUG FOR FURTHER PROCESSING |
| - | efanesoctocog alfa | powder, for solution | 83246-021DRUG FOR FURTHER PROCESSING |
| - | efanesoctocog alfa | powder, for solution | 83246-023DRUG FOR FURTHER PROCESSING |
| - | efanesoctocog alfa | powder, for solution | 83246-024DRUG FOR FURTHER PROCESSING |
| - | efanesoctocog alfa | powder, for solution | 83246-025DRUG FOR FURTHER PROCESSING |
| - | efanesoctocog alfa | powder, for solution | 83246-060DRUG FOR FURTHER PROCESSING |
| - | efanesoctocog alfa | powder, for solution | 83246-061DRUG FOR FURTHER PROCESSING |
| - | efanesoctocog alfa | powder, for solution | 83246-062DRUG FOR FURTHER PROCESSING |
| - | efanesoctocog alfa | powder, for solution | 83246-063DRUG FOR FURTHER PROCESSING |
| - | efanesoctocog alfa | powder, for solution | 83246-064DRUG FOR FURTHER PROCESSING |
| - | efanesoctocog alfa | powder, for solution | 83246-065DRUG FOR FURTHER PROCESSING |
Neighbours
Registered in the same town
8- Janssen Research & Development, L.L.C.Geel, BEL
- Amgen, IncWaterford, IRL
- Isomedix Operations IncNorthborough, MA
- LFB USA Inc.Framingham, MA
- West Pharmaceutical Services, Inc.Waterford, IRL
- Q1 Scientific LtdWaterford, IRL
- Replimune Group, Inc.Framingham, MA
- Eirgen Pharma LtdWaterford, IRL
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Enquiry
Common questions
- Is Genzyme Corporation FDA approved?
- Genzyme Corporation holds 5 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 Genzyme Corporation's drugs manufactured?
- At registered sites in Belgium, France, Ireland, the United States. The FDA register lists Geel; Lyon; Waterford; Framingham, MA; Northborough, MA. Registered operations: analytical testing, active ingredient (API) manufacture, labelling, finished drug manufacture, packaging, relabelling, repackaging, sterilize.
- What drugs does Genzyme Corporation make?
- 45 products are listed under Genzyme Corporation in the openFDA NDC Directory, most often as injection, powder, lyophilized, for solution; powder, for solution; tablet, film coated. 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.