Suppliers / Idt Biologika

Idt Biologika

Germany 499 employees Updated 9 July 2026

Idt Biologika is a finished-dose manufacturer based in Germany. It appears in 52 regulatory filings across 8 regulators, without an active US DMF or CEP on file. Its filings concentrate with MPA (SE), NCELS (KZ) and MINSA (CR). Its GMP standing is certified by ZLG (DE), ANVISA (Brazil) and MFDS (Korea), among 7 authorities. Its most recent recorded inspection, by US FDA, closed on 8 September 2023 as VAI.

0
active US DMFs
0
valid CEPs
4
registered plants 1 with an FDA FEI number
52
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

  • 8 September 2023 VAI US FDA
  • 25 August 2023 VAI US FDA
  • 10 September 2020 VAI US FDA
  • 22 November 2016 VAI US FDA
  • 9 December 2014 VAI US FDA
  • 18 October 2012 NAI US FDA

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

Registered plants

Site FDA FEI
DESSAU-ROSSLAU, Germany Not on file
Germany, Germany 3005001757
Dessau Rosslau, Germany Not on file
Dessau-Rosslau, Nigeria Not on file

Filings and GMP by regulator

Regulator Filings GMP certificates
MPA (SE) 11 None
NCELS (KZ) 10 1
MINSA (CR) 8 None
ARCSA (EC) 7 None
DIGEMAPS (DO) 7 None
NAFDAC (NG) 6 1
ZLG (DE) None 6
ANVISA (Brazil) None 4
MFDS (Korea) None 2
EMA None 1
US FDA None 1

Questions about Idt Biologika

Does Idt Biologika hold a US DMF or a CEP?
No active US drug master file or valid CEP is on record for Idt Biologika. It does have 52 filings with 8 regulators, so it is registered, just not with the two strong registers buyers usually screen on.
Is Idt Biologika FDA-registered?
One site operated by Idt Biologika 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 Idt Biologika's last inspection go?
The most recent inspection on record closed on 8 September 2023 as VAI (Voluntary Action Indicated: issues were found but did not warrant regulatory action). 6 inspections are on file.
Where does Idt Biologika manufacture?
4 registered sites are on record, in Germany and Nigeria (Dessau-rosslau, Germany and Dessau Rosslau among others). Every site is listed on this page with the register it came from.
Which regulators recognise Idt Biologika's GMP?
Current GMP certificates are on record from ZLG (DE), ANVISA (Brazil), MFDS (Korea), NAFDAC (NG), EMA and 2 more. 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 8 September 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