Register entry
GE Healthcare Inc.
- Registered sites
- 5
- Drug products
- 14
- Live patents
- 7
- Countries
- 4
- Base
- Norway
Authorisation
Registered operations
What the FDA has registered these sites to do. This is the regulatory record, not a marketing claim.
Analytical testingActive ingredient (API) manufactureLabellingFinished drug manufacturePackaging
Sites
Facilities
5| Site | Location | Operations | FEI |
|---|---|---|---|
| GE Healthcare (Shanghai) Co Ltd. | China (Shanghai) Pilot Free Trade ZoneChina | Analytical testing, Labelling, Finished drug manufacture, Packaging | 3005292384 |
| GE Healthcare Ireland Limited | CarrigtohillIreland | Labelling, Finished drug manufacture, Packaging | 3003579953 |
| GE Healthcare AS avd Lindesnes | LindesnesNorway | Analytical testing, Active ingredient (API) manufacture, Packaging | 3002807778 |
| GE Healthcare AS | OsloNorway | Analytical testing, Active ingredient (API) manufacture, Labelling, Finished drug manufacture, Packaging | 3002807779 |
| GE Healthcare Inc. (Medi-Physics, Inc. dba GE Healthcare) | Arlington Heights, ILUnited States | Analytical testing, Active ingredient (API) manufacture, Labelling, Finished drug manufacture, Packaging | 1417338 |
Exclusivity
Patents
7Unexpired Orange Book patents where this company is the application holder.
| Product | Active ingredient | Expiry |
|---|---|---|
| FLYRCADO | FLURPIRIDAZ F-18 | Jun 2028 |
| FLYRCADO | FLURPIRIDAZ F-18 | May 2031 |
| FLYRCADO | FLURPIRIDAZ F-18 | Jun 2031 |
| FLYRCADO | FLURPIRIDAZ F-18 | Nov 2032 |
| FLYRCADO | FLURPIRIDAZ F-18 | May 2042 |
| VIZAMYL | FLUTEMETAMOL F-18 | Sept 2028 |
Catalogue
Marketed products
14Showing 14 of 14.
| Brand | Generic name | Form | Category |
|---|---|---|---|
| CERIANNA | FLUOROESTRADIOL F 18 | INJECTION | NDA |
| CLARISCAN | gadoterate meglumine | INJECTION, SOLUTION | ANDA |
| Flyrcado | FLURPIRIDAZ F-18 | INJECTION | NDA |
| OMNIPAQUE | Iohexol | INJECTION, SOLUTION | NDA |
| OMNIPAQUE | Iohexol | INJECTION, SOLUTION | NDA |
| OMNIPAQUE | Iohexol | INJECTION, SOLUTION | NDA |
| OMNIPAQUE | Iohexol | INJECTION, SOLUTION | NDA |
| OMNIPAQUE | Iohexol | SOLUTION | NDA |
| OMNIPAQUE | Iohexol | SOLUTION | NDA |
| OMNISCAN | gadodiamide | INJECTION | NDA |
| Omnipaque | Iohexol | INJECTION, SOLUTION | NDA |
| Optison Perflutren Protein-Type A Microspheres | Human Albumin Microspheres and Perflutren | INJECTION, SOLUTION | NDA |
| Visipaque | Iodixanol | INJECTION, SOLUTION | NDA |
| Visipaque | Iodixanol | INJECTION, SOLUTION | NDA |
Provenance
Facility and operations data from the FDA Drug Establishments Current Registration Site. Product data from the openFDA National Drug Code Directory. Patent and exclusivity data from the FDA Orange Book. Shortage data from the FDA drug shortage database. Contact details the FDA publishes for registered establishments are deliberately not reproduced here. This entry is compiled from public records and has not been claimed by the company.