Register entry
Rentschler Biopharma SE
- Registered sites
- 2
- Drug products
- 8
- Live patents
- 0
- Countries
- 2
- Base
- Germany
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) manufactureFinished drug manufacture
Sites
Facilities
2| Site | Location | Operations | FEI |
|---|---|---|---|
| Rentschler Biopharma SE | LaupheimGermany | Analytical testing, Active ingredient (API) manufacture, Finished drug manufacture | 1000291122 |
| Rentschler Biopharma Inc. | Milford, MAUnited States | Analytical testing, Active ingredient (API) manufacture | 3003282293 |
Catalogue
Marketed products
8Showing 8 of 8.
| Brand | Generic name | Form | Category |
|---|---|---|---|
| - | Antihemophilic Factor (recombinant), Porcine Sequence | INJECTION, SOLUTION | BULK INGREDIENT FOR HUMAN PRESCRIPTION COMPOUNDING |
| - | Bimzelx | INJECTION, SOLUTION | BULK INGREDIENT FOR HUMAN PRESCRIPTION COMPOUNDING |
| - | Lanadelumab-flyo | INJECTION, SOLUTION | BULK INGREDIENT FOR HUMAN PRESCRIPTION COMPOUNDING |
| - | Mepsevii | INJECTION | BULK INGREDIENT FOR HUMAN PRESCRIPTION COMPOUNDING |
| - | Pivekimab Sunirine-pvzy | INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION | BULK INGREDIENT FOR HUMAN PRESCRIPTION COMPOUNDING |
| - | Velmanase Alfa-tycv | INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION | BULK INGREDIENT |
| - | epcoritamab-bysp | INJECTION | BULK INGREDIENT |
| - | ustekinumab-aauz | INJECTION | 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.