Register entry
- Registered sites
- 4
- Active NDC listings
- 53
- Labeller names
- 2
- Live patents
- 0
- Countries
- 2
- Base
- United States
Authorisation
Registered operations
Labelling1Finished drug manufacture3Packaging1
Sites
Registered establishments
4| Establishment | Address | Registered for | FEI / DUNS |
|---|---|---|---|
| GRIFOLS WORLDWIDE OPERATIONS LIMITEDRegistrant: GRIFOLS WORLDWIDE OPERATIONS LTD. | GRANGE CASTLE BUSINESS PARK, CLONDALKIN, D22 K2R3, Ireland (IRL) | Labelling, Packaging | 3010767759985528524 |
| Grifols Biologicals LLC | 13111 Temple Ave., City of Industry, California (CA) 91746, United States (USA) | Finished drug manufacture | 2077802121076871 |
| Grifols Therapeutics LLC | 8368 Clayton Blvd, Clayton, North Carolina (NC) 27520, United States (USA) | Finished drug manufacture | 1050373611019113 |
| Grifols Biologicals LLC | 5555 Valley Blvd., Los Angeles, California (CA) 90032, United States (USA) | Finished drug manufacture | 2080769092694538 |
Catalogue
Drug listings by form and route
5353 active NDC listings: 53 plasma derivative. By marketing category: BLA 53.
| Dosage form | NDCs |
|---|---|
| kit | 29 |
| injection, solution | 10 |
| solution | 9 |
| injection | 5 |
| Route | NDCs |
|---|---|
| intravenous | 33 |
| intramuscular | 8 |
| subcutaneous | 2 |
| infiltration | 1 |
| topical | 1 |
| Labeller name on the listing | NDCs |
|---|---|
| grifols usa, llc | 52 |
| grifols usa llc | 1 |
Catalogue
Marketed products
53| Brand | Generic name | Form / route | NDC |
|---|---|---|---|
| ALBUTEIN | ALBUMIN (HUMAN) | injection, solution, intravenous | 68516-5214BLA |
| ALBUTEIN | ALBUMIN (HUMAN) | injection, solution, intravenous | 68516-5215BLA |
| ALBUTEIN | ALBUMIN (HUMAN) | injection, solution, intravenous | 68516-5216BLA |
| ALBUTEIN | ALBUMIN (HUMAN) | injection, solution, intravenous | 68516-5218BLA |
| ALBUTEIN | ALBUMIN (HUMAN) | injection, solution, intravenous | 68516-5219BLA |
| AlphaNine SD | COAGULATION FACTOR IX (HUMAN) | kit, intravenous | 68516-3607BLA |
| AlphaNine SD | COAGULATION FACTOR IX (HUMAN) | kit, intravenous | 68516-3608BLA |
| AlphaNine SD | COAGULATION FACTOR IX (HUMAN) | kit, intravenous | 68516-3609BLA |
| AlphaNine SD | COAGULATION FACTOR IX (HUMAN) | kit, intravenous | 68516-3610BLA |
| AlphaNine SD | COAGULATION FACTOR IX (HUMAN) | kit, intravenous | 68516-3611BLA |
| AlphaNine SD | COAGULATION FACTOR IX (HUMAN) | kit, intravenous | 68516-3612BLA |
| Alphanate | Antihemophilic Factor/von Willebrand Factor Complex (Human) | kit, intravenous | 68516-4611BLA |
| Alphanate | Antihemophilic Factor/von Willebrand Factor Complex (Human) | kit, intravenous | 68516-4612BLA |
| Alphanate | Antihemophilic Factor/von Willebrand Factor Complex (Human) | kit, intravenous | 68516-4613BLA |
| Alphanate | Antihemophilic Factor/von Willebrand Factor Complex (Human) | kit, intravenous | 68516-4614BLA |
| Alphanate | Antihemophilic Factor/von Willebrand Factor Complex (Human) | kit, intravenous | 68516-4615BLA |
| Alphanate | Antihemophilic Factor/von Willebrand Factor Complex (Human) | kit, intravenous | 68516-4616BLA |
| Alphanate | Antihemophilic Factor/von Willebrand Factor Complex (Human) | kit, intravenous | 68516-4617BLA |
| Alphanate | Antihemophilic Factor/von Willebrand Factor Complex (Human) | kit, intravenous | 68516-4618BLA |
| Alphanate | Antihemophilic Factor/von Willebrand Factor Complex (Human) | kit, intravenous | 68516-4619BLA |
| Alphanate | Antihemophilic Factor/von Willebrand Factor Complex (Human) | kit, intravenous | 68516-4620BLA |
| FESILTY | fibrinogen, human-chmt | kit | 13533-502BLA |
| Flebogamma DIF | Immune Globulin (Human) | injection, solution, intravenous | 61953-0004BLA |
| GAMASTAN | IMMUNE GLOBULIN (HUMAN) | injection, solution, intramuscular | 13533-635BLA |
| GamaSTAN | immune globulin (human) | injection, solution, intramuscular | 13533-335BLA |
| Gamunex-C | Immune Globulin (Human) | injection, intravenous, subcutaneous | 13533-800BLA |
| Gamunex-C | Immune Globulin (Human) | injection, intravenous | 13533-805BLA |
| HUMAN ALBUMIN GRIFOLS | ALBUMIN (HUMAN) | solution, intravenous | 61953-0001BLA |
| HYPERHEP B | HEPATITIS B IMMUNE GLOBULIN (HUMAN) | injection, intramuscular | 13533-636BLA |
| HYPERRAB S/D | RABIES IMMUNE GLOBULIN (HUMAN) | injection, intramuscular | 13533-618BLA |
| HYPERRHO FULL DOSE | RHO(D) IMMUNE GLOBULIN (HUMAN) | solution, intramuscular | 13533-631BLA |
| HYPERRHO MINI-DOSE | RHO(D) IMMUNE GLOBULIN (HUMAN) | solution, intramuscular | 13533-661BLA |
| HyperRAB | Rabies Immune Globulin (Human) | injection, solution, infiltration, intramuscular | 13533-318BLA |
| HyperTET | Tetanus Immune Globulin (Human) | injection, intramuscular | 13533-634BLA |
| PROLASTIN-C | ALPHA-1-PROTEINASE INHIBITOR (HUMAN) | kit | 13533-700BLA |
| PROLASTIN-C | ALPHA-1-PROTEINASE INHIBITOR (HUMAN) | kit | 13533-703BLA |
| PROLASTIN-C | ALPHA-1-PROTEINASE INHIBITOR (HUMAN) | kit | 13533-706BLA |
| Plasbumin | Albumin (Human) | solution, intravenous | 13533-690BLA |
| Plasbumin | Albumin (Human) | solution, intravenous | 13533-691BLA |
| Plasbumin | Albumin (Human) | solution, intravenous | 13533-692BLA |
| Plasmanate | Plasma Protein Fraction (Human) | solution, intravenous | 13533-613BLA |
| Profilnine | factor ix complex | kit, intravenous | 68516-3210BLA |
| Profilnine | factor ix complex | kit, intravenous | 68516-3211BLA |
| Profilnine | factor ix complex | kit, intravenous | 68516-3212BLA |
| Prolastin-C Liquid | Alpha1-Proteinase Inhibitor (Human) | injection, solution, intravenous | 13533-705BLA |
| THROMBATE III | ANTITHROMBIN III (HUMAN) | kit | 13533-602BLA |
| THROMBATE III | ANTITHROMBIN III (HUMAN) | kit | 13533-603BLA |
| THROMBATE III | ANTITHROMBIN III (HUMAN) | kit | 13533-606BLA |
| VISTASEAL | human fibrinogen, human thrombin | kit | 61953-0011BLA |
| VISTASEAL | human fibrinogen, human thrombin | kit | 61953-0012BLA |
| VISTASEAL | human fibrinogen, human thrombin | kit | 61953-0014BLA |
| VISTASEAL | Human fibrinogen, human thrombin | solution, topical | 61953-0020BLA |
| XEMBIFY | immune globulin subcutaneous, human-klhw | solution, subcutaneous | 13533-810BLA |
Neighbours
Registered in the same town
12- Baxalta US Inc.LOS ANGELES, CA
- Pharmalogic Holdings Corp.Los Angeles, CA
- Novo Nordisk Inc.Clayton, NC
- Sotera Health LLCLos Angeles, CA
- Ecolab Inc.City of Industry, CA
- Calox IncLos Angeles, CA
- Alexso, IncLos Angeles, CA
- Hyland's Consumer Health IncLos Angeles, CA
- MADISON ONE ACME INCLOS ANGELES, CA
- Morning Star OTCLos Angeles, CA
- Super Care, LLCCity of Industry, CA
- XSEER PHARMACEUTICALS INC.Los Angeles, CA
Compare
Comparable companies in United States
- Hikma Pharmaceuticals USA Inc.4 sites · 763 NDC
- Church & Dwight Co., Inc.4 sites · 157 NDC
- Sterling Pharmaceutical Services, LLC4 sites · 104 NDC
- Bausch & Lomb Ireland Limited4 sites · 92 NDC
- Gilead Sciences, Inc.4 sites · 51 NDC
- Nice-Pak Products, LLC4 sites · 48 NDC
- HOVIONE FARMACIENCIA, S.A.4 sites · 47 NDC
- Pacific Medical Industries Ltd4 sites · 41 NDC
- United Therapeutics Corporation4 sites · 40 NDC
- Avantor Performance Materials, LLC4 sites · 33 NDC
Enquiry
Common questions
- Is Grifols Therapeutics LLC FDA approved?
- Grifols Therapeutics LLC holds 4 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 Grifols Therapeutics LLC's drugs manufactured?
- At registered sites in Ireland, the United States. The FDA register lists CLONDALKIN; City of Industry, CA; Clayton, NC; Los Angeles, CA. Registered operations: labelling, finished drug manufacture, packaging.
- What drugs does Grifols Therapeutics LLC make?
- 53 products are listed under Grifols Therapeutics LLC 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.