Suppliers / Thymoorgan Pharmazie

Thymoorgan Pharmazie

Germany Updated 9 July 2026

Thymoorgan Pharmazie is a finished-dose manufacturer based in Germany. It appears in 13 regulatory filings across 6 regulators, without an active US DMF or CEP on file. Its filings concentrate with JFDA (JO), ARCSA (EC) and INVIMA (CO). Its GMP standing is certified by ZLG (DE) and EMA. Its most recent recorded inspection, by US FDA, closed on 25 April 2023 as VAI.

0
active US DMFs
0
valid CEPs
7
registered plants 1 with an FDA FEI number
13
filings across 6 regulators
These figures were checked against the regulators' own files on 25 July 2026
Plants
1 of 1 confirmed
Inspections
8 of 8 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

  • 25 April 2023 VAI US FDA
  • 6 October 2022 VAI US FDA
  • 20 June 2019 VAI US FDA
  • 23 April 2018 NAI US FDA
  • 16 December 2016 NAI US FDA
  • 24 September 2015 NAI US FDA
  • 22 May 2014 VAI US FDA
  • 9 February 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
Goslar, United Arab Emirates Not on file
Fuerth, Germany Not on file
Bavaria, Germany Not on file
Germany, Germany 3002320821
VIENENBURG, Germany Not on file
Lower Saxony, Germany Not on file

1 further sites are on record.

Filings and GMP by regulator

Regulator Filings GMP certificates
JFDA (JO) 7 None
ARCSA (EC) 2 None
INVIMA (CO) 1 None
MINSA (CR) 1 None
UZPHARM (UZ) 1 None
EDE (AE) 1 None
ZLG (DE) None 12
EMA None 3

Questions about Thymoorgan Pharmazie

Does Thymoorgan Pharmazie hold a US DMF or a CEP?
No active US drug master file or valid CEP is on record for Thymoorgan Pharmazie. It does have 13 filings with 6 regulators, so it is registered, just not with the two strong registers buyers usually screen on.
Is Thymoorgan Pharmazie FDA-registered?
One site operated by Thymoorgan Pharmazie 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 Thymoorgan Pharmazie's last inspection go?
The most recent inspection on record closed on 25 April 2023 as VAI (Voluntary Action Indicated: issues were found but did not warrant regulatory action). 8 inspections are on file.
Where does Thymoorgan Pharmazie manufacture?
7 registered sites are on record, in United Arab Emirates and Germany (Goslar, Fuerth and Bavaria among others). Every site is listed on this page with the register it came from.
Which regulators recognise Thymoorgan Pharmazie'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 25 April 2023.

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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