Register entry
- Registered sites
- 5
- Active NDC listings
- 14
- Labeller names
- 2
- Live patents
- 7
- Exclusivities
- 1
- Countries
- 4
- Base
- Norway
Authorisation
Registered operations
Analytical testing4Active ingredient (API) manufacture3Labelling4Finished drug manufacture4Packaging5
Sites
Registered establishments
5| Establishment | Address | Registered for | FEI / DUNS |
|---|---|---|---|
| GE Healthcare (Shanghai) Co Ltd.Registrant: GE Healthcare Inc. | No. 1 Niudun Road, China (Shanghai) Pilot Free Trade Zone, Shanghai 201203, China (CHN) | Analytical testing, Labelling, Finished drug manufacture, Packaging | 3005292384545292716 |
| GE Healthcare Ireland LimitedRegistrant: GE Healthcare Inc. | IDA Business Park, Carrigtohill, T45 AV60, Ireland (IRL) | Labelling, Finished drug manufacture, Packaging | 3003579953988006565 |
| GE Healthcare AS avd LindesnesRegistrant: GE Healthcare Inc. | Lindesnesveien 208, Lindesnes, NO-4521, Norway (NOR) | Analytical testing, Active ingredient (API) manufacture, Packaging | 3002807778518890970 |
| GE Healthcare ASRegistrant: GE Healthcare Inc. | Nycoveien 1, Oslo, NO-0485, Norway (NOR) | Analytical testing, Active ingredient (API) manufacture, Labelling, Finished drug manufacture, Packaging | 3002807779515048908 |
| GE Healthcare Inc. (Medi-Physics, Inc. dba GE Healthcare)Registrant: GE Healthcare Inc. | 3350 North Ridge Avenue, Arlington Heights, Illinois (IL) 60004, United States (USA) | Analytical testing, Active ingredient (API) manufacture, Labelling, Finished drug manufacture, Packaging | 1417338095263729 |
Catalogue
Drug listings by form and route
1414 active NDC listings: 14 human prescription drug. By marketing category: NDA 13, ANDA 1.
| Dosage form | NDCs |
|---|---|
| injection, solution | 9 |
| injection | 3 |
| solution | 2 |
| Route | NDCs |
|---|---|
| intravenous | 9 |
| intravascular | 6 |
| oral | 6 |
| intra-articular | 3 |
| intrathecal | 3 |
| rectal | 3 |
| Labeller name on the listing | NDCs |
|---|---|
| ge healthcare inc. | 13 |
| ge healthcare | 1 |
Exclusivity
Patents and exclusivities
7| Patent | Product | Covers | Expiry |
|---|---|---|---|
| 8226929 | FLYRCADOflurpiridaz f-18 | use | Jun 2028 |
| 8916131 | VIZAMYLflutemetamol f-18 | product | Sept 2028 |
| 9603951 | FLYRCADOflurpiridaz f-18 | use | May 2031 |
| 8936777 | FLYRCADOflurpiridaz f-18 | use | Jun 2031 |
| 9687571 | FLYRCADOflurpiridaz f-18 | product | Nov 2032 |
| 12527884 | FLYRCADOflurpiridaz f-18 | product | May 2042 |
| Product | Exclusivity | Until |
|---|---|---|
| FLYRCADOFLURPIRIDAZ F-18 | NCE New chemical entity | Sept 2029 |
Catalogue
Marketed products
14| Brand | Generic name | Form / route | NDC |
|---|---|---|---|
| CERIANNA | FLUOROESTRADIOL F 18 | injection, intravenous | 72874-001NDA |
| CLARISCAN | gadoterate meglumine | injection, solution, intravenous | 0407-2943ANDA |
| Flyrcado | FLURPIRIDAZ F-18 | injection, intravenous | 0407-8787NDA |
| OMNIPAQUE | Iohexol | injection, solution, intravascular, intravenous | 0407-1401NDA |
| OMNIPAQUE | Iohexol | injection, solution, intrathecal, oral, rectal | 0407-1411NDA |
| OMNIPAQUE | Iohexol | injection, solution, intra-articular, intrathecal, intravascular, intravenous, oral, rectal | 0407-1412NDA |
| OMNIPAQUE | Iohexol | injection, solution, intra-articular, intrathecal, intravascular, intravenous, oral, rectal | 0407-1413NDA |
| OMNIPAQUE | Iohexol | injection, solution, intra-articular, intravascular, intravenous, oral | 0407-1414NDA |
| OMNIPAQUE | Iohexol | solution, oral | 0407-1415NDA |
| OMNIPAQUE | Iohexol | solution, oral | 0407-1416NDA |
| OMNISCAN | gadodiamide | injection, intravenous | 0407-0690NDA |
| Optison Perflutren Protein-Type A Microspheres | Human Albumin Microspheres and Perflutren | injection, solution, intravenous | 0407-2707NDA |
| Visipaque | Iodixanol | injection, solution, intravascular | 0407-2222NDA |
| Visipaque | Iodixanol | injection, solution, intravascular | 0407-2223NDA |
Neighbours
Registered in the same town
1- Gilead Sciences, Inc.Carrigtohill, IRL
Compare
Comparable companies in Norway
- HP Halden Pharma AS1 site · 9 NDC
- BASF AS avd Sandefjord1 site · 5 NDC
- Vistin Pharma AS1 site · 3 NDC
Enquiry
Common questions
- Is GE Healthcare Inc. FDA approved?
- GE Healthcare Inc. holds 5 FDA-registered establishments across 4 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 GE Healthcare Inc.'s drugs manufactured?
- At registered sites in China, Ireland, Norway, the United States. The FDA register lists China (Shanghai) Pilot Free Trade Zone; Carrigtohill; Lindesnes; Oslo; Arlington Heights, IL. Registered operations: analytical testing, active ingredient (API) manufacture, labelling, finished drug manufacture, packaging.
- What drugs does GE Healthcare Inc. make?
- 14 products are listed under GE Healthcare Inc. in the openFDA NDC Directory, most often as injection, solution; injection; 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.