Register entry
Bamboo US BidCo LLC
- Registered sites
- 2
- Drug products
- 6
- Live patents
- 0
- Countries
- 2
- 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 manufacturePackagingparticle size reductionRelabellingsterilize
Sites
Facilities
2| Site | Location | Operations | FEI |
|---|---|---|---|
| Simtra Deutschland GmbH | Halle/WestfalenGermany | Analytical testing, Active ingredient (API) manufacture, Labelling, Finished drug manufacture, Packaging, particle size reduction, sterilize | 3002806419 |
| Simtra US LLC | Bloomington, INUnited States | Analytical testing, Labelling, Finished drug manufacture, Packaging, Relabelling, sterilize | 1000115571 |
Catalogue
Marketed products
6Showing 6 of 6.
| Brand | Generic name | Form | Category |
|---|---|---|---|
| FLUZONE TRIVALENT NORTHERN HEMISPHERE | INFLUENZA A VIRUS A/Victoria/4897/2022 IVR-238 (H1N1) ANTIGEN (FORMALDEHYDE INACTIVATED), INFLUENZA A VIRUS A/Croatia/10136/RV/2023 (H3N2) ANTIGEN (FORMALDEHYDE INACTIVATED), and INFLUENZA B VIRUS B/MICHIGAN/01/2021 ANTIGEN (FORMALDEHYDE INACTIVATED) | INJECTION, SUSPENSION | BLA |
| Flucelvax | INFLUENZA A VIRUS A/Georgia/12/2022 CVR-167 (H1N1) ANTIGEN (MDCK CELL DERIVED, PROPIOLACTONE INACTIVATED), INFLUENZA A VIRUS A/Victoria/800/2024 CVR-289 (H3N2) ANTIGEN (MDCK CELL DERIVED, PROPIOLACTONE INACTIVATED), INFLUENZA B VIRUS B/Singapore/WUH4618/2021 ANTIGEN (MDCK CELL DERIVED, PROPIOLACTONE INACTIVATED) | INJECTION, SUSPENSION | BLA |
| HEPLISAV-B | Hepatitis B Vaccine (Recombinant) Adjuvanted | INJECTION, SOLUTION | BLA |
| RECOMBIVAX HB | Hepatitis B Vaccine (Recombinant) | INJECTION, SUSPENSION | BLA |
| RECOMBIVAX HB | Hepatitis B Vaccine (Recombinant) | INJECTION, SUSPENSION | BLA |
| - | choriogonadotropin alfa | INJECTION, POWDER, LYOPHILIZED, 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.