Register entry
Genzyme Corporation
- Registered sites
- 5
- Drug products
- 45
- Live patents
- 20
- Countries
- 4
- 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 manufacturePackagingRelabellingRepackagingsterilize
Sites
Facilities
5| Site | Location | Operations | FEI |
|---|---|---|---|
| Genzyme Flanders | GeelBelgium | Analytical testing, Active ingredient (API) manufacture, Finished drug manufacture | 3003623839 |
| SANOFI WINTHROP INDUSTRIE | LyonFrance | Analytical testing, Active ingredient (API) manufacture, Finished drug manufacture | 3009194033 |
| Genzyme Ireland Limited | WaterfordIreland | Analytical testing, Labelling, Finished drug manufacture, Packaging, Relabelling, Repackaging, sterilize | 3003809840 |
| Genzyme Corporation | Framingham, MAUnited States | Analytical testing, Active ingredient (API) manufacture, Finished drug manufacture | 1220423 |
| Genzyme Corporation | Northborough, MAUnited States | Analytical testing, Labelling, Packaging, Relabelling, Repackaging | 3009389940 |
Exclusivity
Patents
20Unexpired Orange Book patents where this company is the application holder.
| Product | Active ingredient | Expiry |
|---|---|---|
| CAPRELSA | VANDETANIB | Aug 2028 |
| CERDELGA | ELIGLUSTAT TARTRATE | Nov 2030 |
| CERDELGA | ELIGLUSTAT TARTRATE | Jan 2031 |
| CERDELGA | ELIGLUSTAT TARTRATE | Jun 2032 |
| CERDELGA | ELIGLUSTAT TARTRATE | Dec 2038 |
| QFITLIA | FITUSIRAN SODIUM | Mar 2033 |
| QFITLIA | FITUSIRAN SODIUM | Mar 2033 |
| QFITLIA | FITUSIRAN SODIUM | Dec 2036 |
| RENVELA | SEVELAMER CARBONATE | Dec 2030 |
| WAYRILZ | RILZABRUTINIB | Mar 2033 |
| WAYRILZ | RILZABRUTINIB | Sept 2033 |
| WAYRILZ | RILZABRUTINIB | Oct 2040 |
| WAYRILZ | RILZABRUTINIB | Feb 2041 |
Catalogue
Marketed products
45Showing 45 of 45.
| Brand | Generic name | Form | Category |
|---|---|---|---|
| - | AGALSIDASE BETA | INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION | DRUG FOR FURTHER PROCESSING |
| ALDURAZYME | laronidase | INJECTION, SOLUTION, CONCENTRATE | BLA |
| - | AVALGLUCOSIDASE ALFA | INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION | DRUG FOR FURTHER PROCESSING |
| - | Alglucosidase alfa | SOLUTION | DRUG FOR FURTHER PROCESSING |
| Aubagio | teriflunomide | TABLET, FILM COATED | NDA |
| Aubagio | teriflunomide | TABLET, FILM COATED | NDA |
| - | Avalglucosidase alfa | SOLUTION | DRUG FOR FURTHER PROCESSING |
| CAPRELSA | Vandetanib | TABLET, FILM COATED | NDA |
| CAPRELSA | Vandetanib | TABLET, FILM COATED | NDA |
| Cablivi | caplacizumab | KIT | BLA |
| Campath | ALEMTUZUMAB | INJECTION | BLA |
| Cerdelga | eliglustat | CAPSULE | NDA |
| Cerezyme | IMIGLUCERASE | INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION | BLA |
| - | Dupilumab | SOLUTION | DRUG FOR FURTHER PROCESSING |
| - | Dupilumab | SOLUTION | DRUG FOR FURTHER PROCESSING |
| Fabrazyme | AGALSIDASE BETA | INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION | BLA |
| Fabrazyme | AGALSIDASE BETA | INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION | BLA |
| - | IMIGLUCERASE | INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION | DRUG FOR FURTHER PROCESSING |
| - | LAPINE T-LYMPHOCYTE IMMUNE GLOBULIN | INJECTION, POWDER, FOR SOLUTION | DRUG FOR FURTHER PROCESSING |
| LEMTRADA | ALEMTUZUMAB | INJECTION, SOLUTION, CONCENTRATE | BLA |
| Lumizyme | ALGLUCOSIDASE ALFA | INJECTION, POWDER, FOR SOLUTION | BLA |
| Nexviazyme | avalglucosidase alfa-ngpt | INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION | BLA |
| Qfitlia | fitusiran | INJECTION, SOLUTION | NDA |
| Qfitlia | fitusiran | INJECTION, SOLUTION | NDA |
| Renvela | SEVELAMER CARBONATE | POWDER, FOR SUSPENSION | NDA |
| Renvela | SEVELAMER CARBONATE | POWDER, FOR SUSPENSION | NDA |
| Renvela | SEVELAMER CARBONATE | TABLET, FILM COATED | NDA |
| - | THYROTROPIN ALFA | INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION | DRUG FOR FURTHER PROCESSING |
| Thymoglobulin | Anti-thymocyte Globulin (Rabbit) | INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION | BLA |
| Thyrogen | THYROTROPIN ALFA | INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION | BLA |
| WAYRILZ | rilzabrutinib | TABLET, FILM COATED | NDA |
| XENPOZYME | olipudase alfa-rpcp | INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION | BLA |
| XENPOZYME | olipudase alfa-rpcp | INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION | BLA |
| - | efanesoctocog alfa | POWDER, FOR SOLUTION | DRUG FOR FURTHER PROCESSING |
| - | efanesoctocog alfa | POWDER, FOR SOLUTION | DRUG FOR FURTHER PROCESSING |
| - | efanesoctocog alfa | POWDER, FOR SOLUTION | DRUG FOR FURTHER PROCESSING |
| - | efanesoctocog alfa | POWDER, FOR SOLUTION | DRUG FOR FURTHER PROCESSING |
| - | efanesoctocog alfa | POWDER, FOR SOLUTION | DRUG FOR FURTHER PROCESSING |
| - | efanesoctocog alfa | POWDER, FOR SOLUTION | DRUG FOR FURTHER PROCESSING |
| - | efanesoctocog alfa | POWDER, FOR SOLUTION | DRUG FOR FURTHER PROCESSING |
| - | efanesoctocog alfa | POWDER, FOR SOLUTION | DRUG FOR FURTHER PROCESSING |
| - | efanesoctocog alfa | POWDER, FOR SOLUTION | DRUG FOR FURTHER PROCESSING |
| - | efanesoctocog alfa | POWDER, FOR SOLUTION | DRUG FOR FURTHER PROCESSING |
| - | efanesoctocog alfa | POWDER, FOR SOLUTION | DRUG FOR FURTHER PROCESSING |
| - | efanesoctocog alfa | POWDER, FOR SOLUTION | DRUG FOR FURTHER PROCESSING |
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.