Suppliers / Catalent Germany Schorndorf

Catalent Germany Schorndorf

Germany Updated 9 July 2026

Catalent Germany Schorndorf is a finished-dose manufacturer based in Germany. It appears in 20 regulatory filings across 6 regulators, without an active US DMF or CEP on file. Its filings concentrate with EDE (AE), INVIMA (CO) and MINSA (CR). Its GMP standing is certified by ZLG (DE), ANVISA (Brazil) and EMA, among 5 authorities. Its most recent recorded inspection, by US FDA, closed on 17 March 2022 as VAI.

0
active US DMFs
0
valid CEPs
5
registered plants 1 with an FDA FEI number
20
filings across 6 regulators
These figures were checked against the regulators' own files on 25 July 2026
Plants
1 of 1 confirmed
Inspections
7 of 7 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

  • 17 March 2022 VAI US FDA
  • 14 February 2020 VAI US FDA
  • 21 September 2018 VAI US FDA
  • 26 October 2016 VAI US FDA
  • 7 February 2014 NAI US FDA
  • 10 February 2012 NAI US FDA
  • 3 September 2009 VAI US FDA

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

Registered plants

Site FDA FEI
73614 Schorndorf, United Arab Emirates Not on file
73614 Schorndorf, United Arab Emirates Not on file
SCHORNDORF, Germany Not on file
Germany, Germany 3003831171
Baden-Wuerttemberg, Germany Not on file

Filings and GMP by regulator

Regulator Filings GMP certificates
EDE (AE) 7 None
INVIMA (CO) 5 None
MINSA (CR) 3 None
NPRA (MY) 2 None
NAFDAC (NG) 2 None
UZPHARM (UZ) 1 None
ZLG (DE) None 8
ANVISA (Brazil) None 5
EMA None 2
NCELS (KZ) None 1
EAEU_EEC None 1

Questions about Catalent Germany Schorndorf

Does Catalent Germany Schorndorf hold a US DMF or a CEP?
No active US drug master file or valid CEP is on record for Catalent Germany Schorndorf. It does have 20 filings with 6 regulators, so it is registered, just not with the two strong registers buyers usually screen on.
Is Catalent Germany Schorndorf FDA-registered?
One site operated by Catalent Germany Schorndorf 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 Schorndorf's last inspection go?
The most recent inspection on record closed on 17 March 2022 as VAI (Voluntary Action Indicated: issues were found but did not warrant regulatory action). 7 inspections are on file.
Where does Catalent Germany Schorndorf manufacture?
5 registered sites are on record, in United Arab Emirates and Germany (73614 Schorndorf, Schorndorf and Germany among others). Every site is listed on this page with the register it came from.
Which regulators recognise Catalent Germany Schorndorf's GMP?
Current GMP certificates are on record from ZLG (DE), ANVISA (Brazil), EMA, NCELS (KZ) and EEC (Eurasian Economic Union). 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 17 March 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