Fresenius Kabi Ab is an API and finished-dose manufacturer based in Italy. It holds 28 active US drug master files and 6 valid CEPs. Its filings concentrate with AIFA (IT), US FDA and EMA. Its GMP standing is certified by EMA, ZLG (DE) and ANVISA (Brazil), among 13 authorities. Its most recent recorded inspection, by US FDA, closed on 28 August 2025 as NAI.
NAI means no action indicated, VAI means voluntary action indicated, and OAI means official action indicated.
| Site | FDA FEI |
|---|---|
| Uppsala, United Arab Emirates | Not on file |
| Graz, United Arab Emirates | Not on file |
| Friedberg, United Arab Emirates | Not on file |
| Bad Homburg, United Arab Emirates | Not on file |
| H.P, United Arab Emirates | Not on file |
| Schweinfurt, United Arab Emirates | Not on file |
6 further sites are on record.
| Molecule | Regulators | Docs |
|---|---|---|
| Lactulose | EDQM, SFDA (Saudi Arabia), US FDA | 11 |
| Ampicillin | US FDA | 3 |
| Ceftriaxone | SFDA (Saudi Arabia), US FDA | 3 |
| Cloxacillin | SFDA (Saudi Arabia), US FDA | 3 |
| Ambroxol | SFDA (Saudi Arabia) | 2 |
| Cefepime | US FDA | 2 |
| Starches | EDQM | 2 |
| Amoxicillin | US FDA | 1 |
| Avibactam | US FDA | 1 |
| Azacitidine | SFDA (Saudi Arabia) | 1 |
| Aztreonam | US FDA | 1 |
| Belinostat | US FDA | 1 |
| Ceftazidime | US FDA | 1 |
| Cimetidine | DAV (Vietnam) | 1 |
| Degarelix | US FDA | 1 |
| Dexamethasone | DAV (Vietnam) | 1 |
| Gemcitabine | SFDA (Saudi Arabia) | 1 |
| Gentamicin | DAV (Vietnam) | 1 |
| Glucagon | US FDA | 1 |
| Hetacillin | US FDA | 1 |
| Icatibant | US FDA | 1 |
| Irinotecan | SFDA (Saudi Arabia) | 1 |
| Kali Clorid | DAV (Vietnam) | 1 |
| Lincomycin | DAV (Vietnam) | 1 |
| Liraglutide | US FDA | 1 |
| Norepinephrine | DAV (Vietnam) | 1 |
| Octreotide | US FDA | 1 |
| Ondansetron | DAV (Vietnam) | 1 |
| Oxaliplatin | SFDA (Saudi Arabia) | 1 |
| Paclitaxel | SFDA (Saudi Arabia) | 1 |
Also appears on these molecule pages
| Regulator | Filings | GMP certificates |
|---|---|---|
| AIFA (IT) | 1,018 | None |
| US FDA | 626 | 6 |
| EMA | 502 | 28 |
| FAMHP (BE) | 378 | None |
| MPA (SE) | 251 | None |
| DAV (Vietnam) | 208 | None |
| ZLG (DE) | None | 18 |
| ANVISA (Brazil) | None | 11 |
| MFDS (Korea) | None | 6 |
| CDSCO (India) | None | 4 |
| BPOM (ID) | None | 4 |
| MHRA (UK) | None | 4 |
| HSA (SG) | None | 4 |
| SAHPRA (ZA) | None | 3 |
| NAFDAC (NG) | None | 2 |
| FDA (GH) | None | 1 |
| NCELS (KZ) | None | 1 |
| Year | Revenue | Exports | Destinations |
|---|---|---|---|
| 2023 | $330.0B | Not reported | Not reported |
| 2022 | $280.0B | Not reported | Not reported |
| 2021 | $260.0B | Not reported | Not reported |
Export figures are customs aggregates. We do not publish the identity of any buyer.
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