Register entry
- Registered sites
- 2
- Active NDC listings
- 6
- Live patents
- 0
- Countries
- 2
- Base
- United States
Authorisation
Registered operations
Analytical testing2Active ingredient (API) manufacture1Labelling2Finished drug manufacture2Packaging2particle size reduction1Relabelling1sterilize2
Sites
Registered establishments
2| Establishment | Address | Registered for | FEI / DUNS |
|---|---|---|---|
| Simtra Deutschland GmbHRegistrant: Bamboo US BidCo LLC | Kantstrasse 2, Halle/Westfalen, 33790, Germany (DEU) | Analytical testing, Active ingredient (API) manufacture, Labelling, Finished drug manufacture, Packaging, particle size reduction, sterilize | 3002806419344276063 |
| Simtra US LLCRegistrant: Bamboo US BidCo LLC | 927 South Curry Pike, Bloomington, Indiana (IN) 47403, United States (USA) | Analytical testing, Labelling, Finished drug manufacture, Packaging, Relabelling, sterilize | 1000115571604719430 |
Catalogue
Drug listings by form and route
66 active NDC listings: 5 vaccine, 1 drug for further processing. By marketing category: BLA 5, DRUG FOR FURTHER PROCESSING 1.
| Dosage form | NDCs |
|---|---|
| injection, suspension | 4 |
| injection, powder, lyophilized, for solution | 1 |
| injection, solution | 1 |
| Route | NDCs |
|---|---|
| intramuscular | 5 |
| subcutaneous | 2 |
| Labeller name on the listing | NDCs |
|---|---|
| bamboo us bidco llc | 6 |
Catalogue
Marketed products
6| Brand | Generic name | Form / route | NDC |
|---|---|---|---|
| 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, intramuscular | 83703-087BLA |
| 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, intramuscular | 83703-088BLA |
| HEPLISAV-B | Hepatitis B Vaccine (Recombinant) Adjuvanted | injection, solution, intramuscular | 83703-048BLA |
| RECOMBIVAX HB | Hepatitis B Vaccine (Recombinant) | injection, suspension, intramuscular, subcutaneous | 83703-085BLA |
| RECOMBIVAX HB | Hepatitis B Vaccine (Recombinant) | injection, suspension, intramuscular, subcutaneous | 83703-086BLA |
| - | choriogonadotropin alfa | injection, powder, lyophilized, for solution | 83703-001DRUG FOR FURTHER PROCESSING |
Neighbours
Registered in the same town
2- Cook IncorporatedBloomington, IN
- Catalent Indiana, LLCBloomington, IN
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Enquiry
Common questions
- Is Bamboo US BidCo LLC FDA approved?
- Bamboo US BidCo LLC holds 2 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 Bamboo US BidCo LLC's drugs manufactured?
- At registered sites in Germany, the United States. The FDA register lists Halle/Westfalen; Bloomington, IN. Registered operations: analytical testing, active ingredient (API) manufacture, labelling, finished drug manufacture, packaging, particle size reduction, relabelling, sterilize.
- What drugs does Bamboo US BidCo LLC make?
- 6 products are listed under Bamboo US BidCo LLC in the openFDA NDC Directory, most often as injection, suspension; injection, powder, lyophilized, for solution; injection, solution. 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.