Suppliers / Catalent Germany Eberbach

Catalent Germany Eberbach

Germany 56 employees Updated 9 July 2026

Catalent Germany Eberbach is a finished-dose manufacturer based in Germany. It appears in 54 regulatory filings across 8 regulators, without an active US DMF or CEP on file. Its filings concentrate with DIGEMAPS (DO), ARCSA (EC) and NPRA (MY). Its GMP standing is certified by ANVISA (Brazil), ZLG (DE) and EMA, among 5 authorities. Its most recent recorded inspection, by US FDA, closed on 2 February 2024 as VAI.

0
active US DMFs
0
valid CEPs
4
registered plants 1 with an FDA FEI number
54
filings across 8 regulators
These figures were checked against the regulators' own files on 25 July 2026
Plants
1 of 1 confirmed
Inspections
6 of 6 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

  • 2 February 2024 VAI US FDA
  • 6 September 2019 NAI US FDA
  • 2 March 2018 NAI US FDA
  • 18 March 2016 NAI US FDA
  • 12 September 2013 NAI US FDA
  • 5 March 2010 VAI US FDA

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

Registered plants

Site FDA FEI
Eberbach, United Arab Emirates Not on file
EBERBACH, Germany Not on file
Baden-Wuerttemberg, Germany Not on file
Germany, Germany 3002808098

Filings and GMP by regulator

Regulator Filings GMP certificates
DIGEMAPS (DO) 11 None
ARCSA (EC) 10 None
NPRA (MY) 8 None
EDE (AE) 8 None
MINSA (CR) 7 None
INVIMA (CO) 5 None
ANVISA (Brazil) None 7
ZLG (DE) None 6
EMA None 1
EAEU_EEC None 1
US FDA None 1

Questions about Catalent Germany Eberbach

Does Catalent Germany Eberbach hold a US DMF or a CEP?
No active US drug master file or valid CEP is on record for Catalent Germany Eberbach. It does have 54 filings with 8 regulators, so it is registered, just not with the two strong registers buyers usually screen on.
Is Catalent Germany Eberbach FDA-registered?
One site operated by Catalent Germany Eberbach 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 Catalent Germany Eberbach's last inspection go?
The most recent inspection on record closed on 2 February 2024 as VAI (Voluntary Action Indicated: issues were found but did not warrant regulatory action). 6 inspections are on file.
Where does Catalent Germany Eberbach manufacture?
4 registered sites are on record, in United Arab Emirates and Germany (Eberbach, Eberbach and Baden-wuerttemberg among others). Every site is listed on this page with the register it came from.
Which regulators recognise Catalent Germany Eberbach's GMP?
Current GMP certificates are on record from ANVISA (Brazil), ZLG (DE), EMA, EEC (Eurasian Economic Union) and US FDA. 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 2 February 2024.

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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