Suppliers / Fresenius Kabi Deutschland

Fresenius Kabi Deutschland

Germany 339 employees Updated 9 July 2026

The public registers hold a second record for Fresenius Kabi Deutschland. The fuller profile, with 32 active US DMFs and 6 valid CEPs, is at Fresenius Kabi. Figures on this page cover only this record.

Fresenius Kabi Deutschland is a finished-dose manufacturer based in Germany. It appears in 157 regulatory filings across 3 regulators, without an active US DMF or CEP on file. Its filings concentrate with EMA, DAV (Vietnam) and BFARM (DE). Its GMP standing is certified by ZLG (DE) and EMA. Its most recent recorded inspection, by US FDA, closed on 19 October 2022 as VAI.

0
active US DMFs
0
valid CEPs
4
registered plants 1 with an FDA FEI number
157
filings across 3 regulators
These figures were checked against the regulators' own files on 25 July 2026
Plants
1 of 1 confirmed
Inspections
3 of 3 confirmed
EU GMP
1 of 1 confirmed
Sources: FDA Establishment Registration, read 4 May 2026. FDA drug inspection classifications, read 4 May 2026. EudraGMDP (MIA + third-country GMP certs), read 4 May 2026.

Inspection history

  • 19 October 2022 VAI US FDA
  • 11 April 2018 VAI US FDA
  • 26 September 2014 VAI US FDA

NAI means no action indicated, VAI means voluntary action indicated, and OAI means official action indicated.

Registered plants

Site FDA FEI
FRIEDBERG, Germany Not on file
Germany, Germany 3002851530
Friedberg (Hessen), Germany Not on file
Hesse, Germany Not on file

Filings and GMP by regulator

Regulator Filings GMP certificates
EMA 133 3
DAV (Vietnam) 20 None
BFARM (DE) 4 None
ZLG (DE) None 12

Questions about Fresenius Kabi Deutschland

Does Fresenius Kabi Deutschland hold a US DMF or a CEP?
No active US drug master file or valid CEP is on record for Fresenius Kabi Deutschland. It does have 157 filings with 3 regulators, so it is registered, just not with the two strong registers buyers usually screen on.
Is Fresenius Kabi Deutschland FDA-registered?
One site operated by Fresenius Kabi Deutschland carries an FDA establishment identifier (FEI), which means it is registered with the FDA as a drug establishment. Registration is not the same as approval or inspection clearance.
How did Fresenius Kabi Deutschland's last inspection go?
The most recent inspection on record closed on 19 October 2022 as VAI (Voluntary Action Indicated: issues were found but did not warrant regulatory action). 3 inspections are on file.
Where does Fresenius Kabi Deutschland manufacture?
4 registered sites are on record, in Germany (Friedberg, Germany and Friedberg (hessen) among others). Every site is listed on this page with the register it came from.
Which regulators recognise Fresenius Kabi Deutschland's GMP?
Current GMP certificates are on record from ZLG (DE) and EMA. GMP recognition covers the manufacturing site, separately from any filing on the substance itself.

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.

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Open risk flags

  • The most recent inspection outcome was VAI, on 19 October 2022.

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Sources on this page

FDA
Drug master files, establishment registration, inspection classifications
EDQM
Certificates of suitability
EudraGMDP and national regulators
GMP certificates