Register entry
- Registered sites
- 7
- Active NDC listings
- 12
- Labeller names
- 5
- Live patents
- 0
- Countries
- 5
- Base
- United States
Authorisation
Registered operations
Analytical testing6Active ingredient (API) manufacture6Finished drug manufacture2
Sites
Registered establishments
7| Establishment | Address | Registered for | FEI / DUNS |
|---|---|---|---|
| AGC Biologics GmbH | Czernyring 22, Heidelberg, Baden-Wuerttemberg 69115, Germany (DEU) | Analytical testing | 3003323027499129666 |
| AGC Biologics A/S | Vandtaarnsvej 83B, Soeborg, Copenhagen 2860, Denmark (DNK) | Analytical testing, Active ingredient (API) manufacture | 3004708748307169677 |
| AGC Biologics SPA | VIA ANTONIO MEUCCI 3, Bresso, Milan 20091, Italy (ITA) | Analytical testing, Active ingredient (API) manufacture, Finished drug manufacture | 3020270660428486752 |
| AGC Inc. | 10, Goikaigan, Ichihara, Chiba 290-8566, Japan (JPN) | Active ingredient (API) manufacture | 3003282601695073924 |
| AGC Biologics, Inc. | 21511 23rd Dr SE, Bothell, Washington (WA) 98021, United States (USA) | Analytical testing, Active ingredient (API) manufacture | 3000209996824771724 |
| AGC Biologics Inc. | 5550 Airport Blvd, Boulder, Colorado (CO) 80301-2340, United States (USA) | Analytical testing, Active ingredient (API) manufacture | 3018698628117594220 |
| AGC Biologics Inc. | 4000 Nelson Rd, Longmont, Colorado (CO) 80503-9004, United States (USA) | Analytical testing, Active ingredient (API) manufacture, Finished drug manufacture | 3020775398118317062 |
Catalogue
Drug listings by form and route
1212 active NDC listings: 10 drug for further processing, 2 bulk ingredient. By marketing category: DRUG FOR FURTHER PROCESSING 10, BULK INGREDIENT FOR HUMAN PRESCRIPTION COMPOUNDING 2.
| Dosage form | NDCs |
|---|---|
| solution | 11 |
| liquid | 1 |
| Route | NDCs |
|---|
| Labeller name on the listing | NDCs |
|---|---|
| agc biologics, inc. | 5 |
| agc biologics a/s | 4 |
| agc biologics inc. | 1 |
| agc inc. | 1 |
| agc, inc. | 1 |
Catalogue
Marketed products
12| Brand | Generic name | Form / route | NDC |
|---|---|---|---|
| - | AFLIBERCEPT | solution | 83277-004DRUG FOR FURTHER PROCESSING |
| - | ASPARAGINASE ERWINIA CHRYSANTHEMI | solution | 82507-001DRUG FOR FURTHER PROCESSING |
| - | AXATILIMAB | solution | 83277-005DRUG FOR FURTHER PROCESSING |
| - | COAGULATION FACTOR IX RECOMBINANT HUMAN | solution | 83277-001DRUG FOR FURTHER PROCESSING |
| - | ETUVETIDIGENE AUTOTEMCEL | solution | 83277-100DRUG FOR FURTHER PROCESSING |
| - | NOGAPENDEKIN ALFA | solution | 83277-003DRUG FOR FURTHER PROCESSING |
| - | Perfluorhexlyoctane | liquid | 75872-0002BULK INGREDIENT FOR HUMAN PRESCRIPTION COMPOUNDING |
| - | TEBENTAFUSP | solution | 82507-003DRUG FOR FURTHER PROCESSING |
| - | TEPLIZUMAB | solution | 83277-002DRUG FOR FURTHER PROCESSING |
| - | TEPROTUMUMAB | solution | 82507-002DRUG FOR FURTHER PROCESSING |
| - | Tafluprost | solution | 75872-0001BULK INGREDIENT FOR HUMAN PRESCRIPTION COMPOUNDING |
| - | Ustekinumab | solution | 82507-004DRUG FOR FURTHER PROCESSING |
Neighbours
Registered in the same town
10- Pfizer IncBothell, WA
- Bristol Myers Squibb CompanyBothell, WA
- KBI Biopharma, Inc.Boulder, CO
- Avista Pharma Solutions, Inc. dba CambrexLongmont, CO
- StateServ Medical LLCLongmont, CO
- Agilent Technologies, Inc.Boulder, CO
- Zealand Pharma A/SSoeborg, DNK
- Corden Pharma Colorado, Inc.Boulder, CO
- Seattle Children's HospitalBothell, WA
- Super Gas, Inc.Longmont, CO
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Enquiry
Common questions
- Is AGC Biologics, Inc. FDA approved?
- AGC Biologics, Inc. holds 7 FDA-registered establishments across 5 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 AGC Biologics, Inc.'s drugs manufactured?
- At registered sites in Germany, Denmark, Italy, Japan, the United States. The FDA register lists Heidelberg; Soeborg; Bresso; Ichihara; Bothell, WA; Boulder, CO, and 1 more. Registered operations: analytical testing, active ingredient (API) manufacture, finished drug manufacture.
- What drugs does AGC Biologics, Inc. make?
- 12 products are listed under AGC Biologics, Inc. in the openFDA NDC Directory, most often as solution; liquid. 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.