Register entry
- Registered sites
- 3
- Active NDC listings
- 28
- Labeller names
- 6
- Live patents
- 0
- Countries
- 2
- Base
- Italy
Authorisation
Registered operations
Active ingredient (API) manufacture1Labelling1Finished drug manufacture2Packaging1
Sites
Registered establishments
3| Establishment | Address | Registered for | FEI / DUNS |
|---|---|---|---|
| Kedrion S.p.A. | Via Giovanni Pascoli, Barga, Lucca 55051, Italy (ITA) | Active ingredient (API) manufacture | 3009166014434338887 |
| Kedrion S.p.A. | Via Di Fondovalle, Bolognana, Lucca 55027, Italy (ITA) | Labelling, Finished drug manufacture, Packaging | 3008919567339096023 |
| Kedrion Biopharma Inc. | 155 Duryea Road, Melville, New York (NY) 11747, United States (USA) | Finished drug manufacture | 3003683714080452111 |
Catalogue
Drug listings by form and route
2828 active NDC listings: 27 plasma derivative, 1 human prescription drug. By marketing category: BLA 28.
| Dosage form | NDCs |
|---|---|
| kit | 18 |
| injection, solution | 4 |
| solution | 4 |
| injection | 1 |
| injection, powder, lyophilized, for solution | 1 |
| Route | NDCs |
|---|---|
| intravenous | 23 |
| intramuscular | 2 |
| subcutaneous | 1 |
| Labeller name on the listing | NDCs |
|---|---|
| kedrion biopharma, inc. | 22 |
| kedrion biopharma inc | 2 |
| kedrion biopharma inc. | 1 |
| kedrion biopharma, inc. | 1 |
| kedrion s.p.a | 1 |
| kedrion s.p.a. | 1 |
Catalogue
Marketed products
28| Brand | Generic name | Form / route | NDC |
|---|---|---|---|
| Albuked | Albumin (Human) | solution, intravenous | 76125-790BLA |
| Albuked | Albumin (Human) | solution, intravenous | 76125-791BLA |
| Albuked | Albumin (Human) | solution, intravenous | 76125-792BLA |
| GAMMAKED | Immune Globulin (Human) | injection, intravenous, subcutaneous | 76125-900BLA |
| KEDBUMIN | Albumin (Human) | injection, solution, intravenous | 76179-025BLA |
| KEDRAB | HUMAN RABIES VIRUS IMMUNE GLOBULIN | injection, solution, intramuscular | 76125-150BLA |
| Koate | Antihemophilic Factor (Human) | kit | 76125-250BLA |
| Koate | Antihemophilic Factor (Human) | kit, intravenous | 76125-253BLA |
| Koate | ANTIHEMOPHILIC FACTOR (HUMAN) | kit, intravenous | 76125-256BLA |
| Koate | ANTIHEMOPHILIC FACTOR (HUMAN) | kit, intravenous | 76125-257BLA |
| Koate | Antihemophilic Factor (Human) | kit, intravenous | 76125-258BLA |
| Koate | ANTIHEMOPHILIC FACTOR (HUMAN) | kit, intravenous | 76125-259BLA |
| Koate | Antihemophilic Factor (Human) | kit, intravenous | 76125-661BLA |
| Koate | Antihemophilic Factor (Human) | kit, intravenous | 76125-662BLA |
| Koate | ANTIHEMOPHILIC FACTOR (HUMAN) | kit, intravenous | 76125-663BLA |
| Koate | ANTIHEMOPHILIC FACTOR (HUMAN) | kit, intravenous | 76125-665BLA |
| Koate | Antihemophilic Factor (Human) | kit | 76125-667BLA |
| Koate | ANTIHEMOPHILIC FACTOR (HUMAN) | kit, intravenous | 76125-668BLA |
| Koate | Antihemophilic Factor (Human) | kit | 76125-672BLA |
| Koate | Antihemophilic Factor (Human) | kit, intravenous | 76125-674BLA |
| Koate | Antihemophilic Factor (Human) | kit, intravenous | 76125-675BLA |
| Koate | ANTIHEMOPHILIC FACTOR (HUMAN) | kit, intravenous | 76125-676BLA |
| Koate | ANTIHEMOPHILIC FACTOR (HUMAN) | kit, intravenous | 76125-678BLA |
| Koate | ANTIHEMOPHILIC FACTOR (HUMAN) | kit, intravenous | 76125-679BLA |
| QIVIGY kthm | human immunoglobulin g | injection, solution, intravenous | 76179-010BLA |
| RhoGAM Ultra-Filtered PLUS | HUMAN RHO(D) IMMUNE GLOBULIN | injection, solution, intramuscular | 0562-7805BLA |
| Ryplazim | plasminogen | injection, powder, lyophilized, for solution, intravenous | 70573-099BLA |
| YIMMUGO | immune globulin intravenous, human - dira | solution, intravenous | 70573-605BLA |
Neighbours
Registered in the same town
2- Certified Laboratories, LLCMelville, NY
- Fougera Pharmaceuticals, LLCMelville, NY
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Enquiry
Common questions
- Is Kedrion Biopharma Inc. FDA approved?
- Kedrion Biopharma Inc. holds 3 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 Kedrion Biopharma Inc.'s drugs manufactured?
- At registered sites in Italy, the United States. The FDA register lists Barga; Bolognana; Melville, NY. Registered operations: active ingredient (API) manufacture, labelling, finished drug manufacture, packaging.
- What drugs does Kedrion Biopharma Inc. make?
- 28 products are listed under Kedrion Biopharma Inc. in the openFDA NDC Directory, most often as kit; 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.