Fresenius Kabi is an API and finished-dose manufacturer based in Sweden. It holds 32 active US drug master files and 6 valid CEPs. Its filings concentrate with EMA, AIFA (IT) and US FDA. Its GMP standing is certified by EMA, ZLG (DE) and ANVISA (Brazil), among 18 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 |
| Bad Homburg, United Arab Emirates | Not on file |
| Friedberg, United Arab Emirates | Not on file |
| H.P, United Arab Emirates | Not on file |
| Schweinfurt, United Arab Emirates | Not on file |
34 further sites are on record.
| Molecule | Regulators | Docs |
|---|---|---|
| Lactulose | EDQM, SFDA (Saudi Arabia), US FDA | 12 |
| Starches | EDQM | 4 |
| 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 |
| Cimetidine | DAV (Vietnam) | 2 |
| Natri Clorid | DAV (Vietnam) | 2 |
| Acetaminophen | DAV (Vietnam) | 1 |
| Amoxicillin | US FDA | 1 |
| Avibactam | US FDA | 1 |
| Azacitidine | SFDA (Saudi Arabia) | 1 |
| Aztreonam | US FDA | 1 |
| Belinostat | US FDA | 1 |
| Calci Clorid | DAV (Vietnam) | 1 |
| Ceftazidime | US FDA | 1 |
| Degarelix | US FDA | 1 |
| Dexamethasone | DAV (Vietnam) | 1 |
| Dextrose | DAV (Vietnam) | 1 |
| Diclofenac | 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 |
| Piperacillin | US FDA | 1 |
| Piracetam | DAV (Vietnam) | 1 |
| Pivmecillinam | US FDA | 1 |
| Ropivacaine | SFDA (Saudi Arabia) | 1 |
| Salmon Calcitonin | US FDA | 1 |
Also appears on these molecule pages
| Regulator | Filings | GMP certificates |
|---|---|---|
| EMA | 1,156 | 42 |
| AIFA (IT) | 1,018 | None |
| US FDA | 626 | 7 |
| INFARMED (PT) | 419 | None |
| ANVISA (Brazil) | 394 | 22 |
| FAMHP (BE) | 378 | None |
| ZLG (DE) | None | 40 |
| EDQM | None | 12 |
| ANSM (FR) | None | 10 |
| MFDS (Korea) | None | 6 |
| NSW_HEALTH | None | 6 |
| SAHPRA (ZA) | None | 6 |
| CDSCO (India) | None | 5 |
| MHRA (UK) | None | 4 |
| BPOM (ID) | None | 4 |
| HSA (SG) | None | 4 |
| NAFDAC (NG) | None | 3 |
| COFEPRIS (MX) | None | 2 |
| NCELS (KZ) | None | 1 |
| FDA (GH) | None | 1 |
| AEMPS (ES) | None | 1 |
Answered from this company's own record. Where a register holds nothing, the question is not asked rather than answered with a zero. How we count our figures.
Choose your molecules and target markets. Fresenius Kabi comes back tiered against every other supplier able to file there.
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