Register entry
- Registered sites
- 12
- Active NDC listings
- 5
- Labeller names
- 2
- Live patents
- 0
- Countries
- 1
- Base
- United States
Authorisation
Registered operations
Finished drug manufacture1positron emission tomography drug production12
Sites
Registered establishments
12| Establishment | Address | Registered for | FEI / DUNS |
|---|---|---|---|
| SOFIE Co. dba SOFIE | 4447 Brass Way, Dallas, Texas (TX) 75236, United States (USA) | positron emission tomography drug production | 3008486071025600556 |
| SOFIE Co. dba SOFIE | 2300 N Edward St Ste 100, Decatur, Illinois (IL) 62526, United States (USA) | positron emission tomography drug production | 3009754344119476359 |
| SOFIE Co. dba SOFIE | 5900b Obata Way, Gilroy, California (CA) 95020, United States (USA) | positron emission tomography drug production | 3006246010832599976 |
| SOFIE Co. dba SOFIE | 8285 El Rio Suite 160, Houston, Texas (TX) 77054, United States (USA) | positron emission tomography drug production | 3003932395118258354 |
| SOFIE Co. dba SOFIE | 8614 NW 107th Terrace, Kansas City, Missouri (MO) 64153, United States (USA) | positron emission tomography drug production | 3008310003829109441 |
| SOFIE Co. dba SOFIE | 14324 Commerce Way 28, Miami Lakes, Florida (FL) 33016, United States (USA) | positron emission tomography drug production | 3032541011119364104 |
| SOFIE Co. dba SOFIE | 64 Medical Center Drive Rm B042, Morgantown, West Virginia (WV) 26506, United States (USA) | positron emission tomography drug production | 3005705842078623800 |
| SOFIE Co. dba SOFIE | 801 Forestwood Drive, Romeoville, Illinois (IL) 60446, United States (USA) | positron emission tomography drug production | 3008297570032324142 |
| SOFIE Co. dba SOFIE | 136 Commerce Way, Sanford, Florida (FL) 32771, United States (USA) | positron emission tomography drug production | 3008302967006320902 |
| SOFIE Co. dba SOFIE | 110 Clyde Road, Suite 1, Somerset, New Jersey (NJ) 08873, United States (USA) | positron emission tomography drug production | 3005705951008017970 |
| SOFIE Co. dba SOFIE | 100 Executive Drive, Suite 4 & 7, Sterling, Virginia (VA) 20166, United States (USA) | positron emission tomography drug production | 3004977184079854636 |
| SOFIE Co. dba SOFIE | 60D Commerce Way, Totowa, New Jersey (NJ) 07512, United States (USA) | Finished drug manufacture, positron emission tomography drug production | 3008415560117720207 |
Catalogue
Drug listings by form and route
55 active NDC listings: 5 human prescription drug. By marketing category: ANDA 5.
| Dosage form | NDCs |
|---|---|
| injection | 5 |
| Route | NDCs |
|---|---|
| intravenous | 5 |
| Labeller name on the listing | NDCs |
|---|---|
| sofie co. dba sofie | 3 |
| sofie co. | 2 |
Catalogue
Marketed products
5| Brand | Generic name | Form / route | NDC |
|---|---|---|---|
| Ammonia N 13 | AMMONIA N-13 | injection, intravenous | 49609-003ANDA |
| Ammonia N 13 | Ammonia N 13 | injection, intravenous | 73410-001ANDA |
| Fludeoxyglucose F 18 | Fludeoxyglucose F-18 | injection, intravenous | 49609-101ANDA |
| Fludeoxyglucose F 18 | Fludeoxyglucose F 18 | injection, intravenous | 73410-003ANDA |
| Sodium Fluoride F 18 | SODIUM FLUORIDE F-18 | injection, intravenous | 49609-102ANDA |
Neighbours
Registered in the same town
12- PETNET Solutions, Inc.DALLAS, TX; HOUSTON, TX · 2 sites
- Cardinal Health 418, Inc.Dallas, TX; Houston, TX · 2 sites
- Eisinger Smith LLCDallas, TX · 2 sites
- The University of Texas MD Anderson Cancer CenterHouston, TX · 2 sites
- Catalent Pharma Solutions Inc.Kansas City, MO
- Viatris Inc.Morgantown, WV
- Lonza Biologics IncHouston, TX
- ILMO Products CompanyDecatur, IL
- L'Oreal USA Products IncSOMERSET, NJ
- S. J. Smith Co., Inc.DECATUR, IL
- Univar Solutions USA LLCDallas, TX
- Advanced Pharmaceutical Services, Inc. Dba Affordable Quality PharmaceuticalsTotowa, NJ
Compare
Comparable companies in United States
- Siegfried USA, LLC12 sites · 54 NDC
- The Procter & Gamble Manufacturing Company11 sites · 849 NDC
- AbbVie Inc.13 sites · 131 NDC
- Zoetis Inc11 sites · 29 NDC
- Pfizer Inc11 sites · 27 NDC
- Sigma-Aldrich Corporation13 sites · 25 NDC
- Eli Lilly and Company10 sites · 189 NDC
- Wyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc.10 sites · 30 NDC
- Medical-technical Gases, Inc.10 sites · 7 NDC
- Alcami Carolinas Corporation10 sites · 1 NDC
Enquiry
Common questions
- Is SOFIE Co. dba SOFIE FDA approved?
- SOFIE Co. dba SOFIE holds 12 FDA-registered establishments in the United States. 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 SOFIE Co. dba SOFIE's drugs manufactured?
- The FDA register lists Dallas, TX; Decatur, IL; Gilroy, CA; Houston, TX; Kansas City, MO; Miami Lakes, FL, and 6 more. Registered operations: finished drug manufacture, positron emission tomography drug production.
- What drugs does SOFIE Co. dba SOFIE make?
- 5 products are listed under SOFIE Co. dba SOFIE in the openFDA NDC Directory, most often as injection. 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.