Register entry
- Registered sites
- 2
- Active NDC listings
- 8
- Labeller names
- 3
- Live patents
- 0
- Countries
- 2
- Base
- United Kingdom
Authorisation
Registered operations
Analytical testing2Labelling2Finished drug manufacture2Packaging2sterilize2
Sites
Registered establishments
2| Establishment | Address | Registered for | FEI / DUNS |
|---|---|---|---|
| Terumo BCT LtdRegistrant: Terumo BCT, Inc | Old Belfast Road, Millbrook, Larne, BT40 2SH, United Kingdom (GBR) | Analytical testing, Labelling, Finished drug manufacture, Packaging, sterilize | 3002545766233649834 |
| Terumo BCT Vietnam Co., Ltd.Registrant: Terumo BCT Ltd | Long Duc Industrial Park, Binh An Commune, Dong Nai 76208, Vietnam (VNM) | Analytical testing, Labelling, Finished drug manufacture, Packaging, sterilize | 3011720361555361198 |
Catalogue
Drug listings by form and route
88 active NDC listings: 8 human prescription drug. By marketing category: ANDA 6, NDA 2.
| Dosage form | NDCs |
|---|---|
| injection, solution | 5 |
| solution | 3 |
| Route | NDCs |
|---|---|
| intravenous | 8 |
| Labeller name on the listing | NDCs |
|---|---|
| terumo bct, ltd | 6 |
| terumo bct ltd | 1 |
| terumo bct, ltd. | 1 |
Catalogue
Marketed products
8| Brand | Generic name | Form / route | NDC |
|---|---|---|---|
| ACD A | Citric Acid Monohydrate, Dextrose Monohydrate, and Trisodium Citrate Dihydrate | injection, solution, intravenous | 14537-810ANDA |
| ACD A | Citric Acid Monohydrate, Dextrose Monohydrate, and Trisodium Citrate Dihydrate | injection, solution, intravenous | 14537-817ANDA |
| ACD A | Dextrose Monohydrate, Sodium Citrate, and Citric Acid Monohydrate | injection, solution, intravenous | 14537-967ANDA |
| Additive Formula 3 | Dextrose Monohydrate, TRISODIUM CITRATE DIHYDRATE, Sodium Chloride, SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE, Citric Acid Monohydrate, and Adenine | solution, intravenous | 14537-832NDA |
| Additive Formula 3 | Dextrose Monohydrate, TRISODIUM CITRATE DIHYDRATE, Sodium Chloride, SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE, Citric Acid Monohydrate, and Adenine | solution, intravenous | 14537-833NDA |
| Anticoagulant Citrate Dextrose (ACD-A) | Dextrose Monohydrate, sodium citrate, unspecified form, and Citric Acid Monohydrate | solution, intravenous | 14537-820ANDA |
| Sodium Citrate 4% w/v Anticoagulant | TRISODIUM CITRATE DIHYDRATE | injection, solution, intravenous | 14537-881ANDA |
| Sodium Citrate w/v Anticoagulant | TRISODIUM CITRATE DIHYDRATE | injection, solution, intravenous | 14537-883ANDA |
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- DSM Nutritional Products France SAS3 sites · 30 NDC
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Enquiry
Common questions
- Is Terumo BCT, Inc FDA approved?
- Terumo BCT, Inc 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 Terumo BCT, Inc's drugs manufactured?
- At registered sites in the United Kingdom, Vietnam. The FDA register lists Larne; Binh An Commune. Registered operations: analytical testing, labelling, finished drug manufacture, packaging, sterilize.
- What drugs does Terumo BCT, Inc make?
- 8 products are listed under Terumo BCT, Inc in the openFDA NDC Directory, most often as injection, solution; 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.