GE Healthcare is an API and finished-dose manufacturer based in Norway. It holds 13 active US drug master files and 4 valid CEPs across a filed portfolio of 8 molecules. Its filings concentrate with US FDA, AIFA (IT) and FAMHP (BE). Its GMP standing is certified by ZLG (DE), EMA and EDQM, among 8 authorities. Its most recent recorded inspection, by US FDA, closed on 19 September 2025 as NAI.
NAI means no action indicated, VAI means voluntary action indicated, and OAI means official action indicated.
| Site | FDA FEI |
|---|---|
| CORK, United Arab Emirates | Not on file |
| Oslo, United Arab Emirates | Not on file |
| Pasching, Austria | Not on file |
| SAO PAULO, Brazil | Not on file |
| São Paulo, Brazil | Not on file |
| Opfikon, Switzerland | Not on file |
18 further sites are on record.
| Molecule | Regulators | Docs |
|---|---|---|
| Quinidine | EDQM, US FDA | 3 |
| Indium | US FDA | 2 |
| Mannose | US FDA | 2 |
| Gadoteric Acid | SFDA (Saudi Arabia) | 1 |
| Iodixanol | EDQM | 1 |
| Iohexol | EDQM | 1 |
| Quinine | US FDA | 1 |
| Tetra-O-Acetyl-Mannose Triflate For Radiopharmaceutical Preparations | EDQM | 1 |
Also appears on these molecule pages
| Regulator | Filings | GMP certificates |
|---|---|---|
| US FDA | 166 | 2 |
| AIFA (IT) | 141 | None |
| FAMHP (BE) | 120 | None |
| EMA | 120 | 6 |
| SWISSMEDIC (CH) | 102 | None |
| MPA (SE) | 74 | None |
| ZLG (DE) | None | 14 |
| EDQM | None | 4 |
| MFDS (Korea) | None | 4 |
| NAFDAC (NG) | None | 3 |
| ANVISA (Brazil) | None | 2 |
| EAEU_EEC | None | 1 |
| Year | Revenue | Exports | Destinations |
|---|---|---|---|
| 2024 | $1.3B | Not reported | Not reported |
Export figures are customs aggregates. We do not publish the identity of any buyer. Revenue shown in US dollars, converted from the reported currency.
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