Suppliers / Takeda Manufacturing Austria

Takeda Manufacturing Austria

Austria Updated 9 July 2026

Takeda Manufacturing Austria is a finished-dose manufacturer based in Austria. It appears in 264 regulatory filings across 20 regulators, without an active US DMF or CEP on file. Its filings concentrate with AIFA (IT), EDE (AE) and FAMHP (BE). Its GMP standing is certified by EMA, EAEU_EEC and ANVISA (Brazil), among 4 authorities. Its most recent recorded inspection, by US FDA, closed on 24 April 2024 as NAI.

0
active US DMFs
0
valid CEPs
12
registered plants 6 with an FDA FEI number
264
filings across 20 regulators
These figures were checked against the regulators' own files on 25 July 2026
Plants
6 of 6 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

  • 24 April 2024 NAI US FDA
  • 24 June 2022 VAI US FDA
  • 1 March 2016 VAI US FDA
  • 5 February 2016 VAI US FDA
  • 31 January 2012 VAI US FDA
  • 19 January 2012 VAI US FDA
  • 28 January 2010 VAI US FDA
  • 21 January 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
Lessines, United Arab Emirates Not on file
IndustriestraBe 67 - Vienna, United Arab Emirates Not on file
Lange Allee 24 - Vienna, United Arab Emirates Not on file
VIENNA, Austria Not on file
Austria, Austria 3004073331
Austria, Austria 3003608834

6 further sites are on record.

Filings and GMP by regulator

Regulator Filings GMP certificates
AIFA (IT) 36 None
EDE (AE) 34 None
FAMHP (BE) 33 None
EMA 28 10
SFDA (Saudi Arabia) 22 None
MPA (SE) 19 None
EAEU_EEC None 4
ANVISA (Brazil) None 4
US FDA None 1

Questions about Takeda Manufacturing Austria

Does Takeda Manufacturing Austria hold a US DMF or a CEP?
No active US drug master file or valid CEP is on record for Takeda Manufacturing Austria. It does have 264 filings with 20 regulators, so it is registered, just not with the two strong registers buyers usually screen on.
Is Takeda Manufacturing Austria FDA-registered?
6 sites operated by Takeda Manufacturing Austria carry an FDA establishment identifier (FEI), which means they are registered with the FDA as a drug establishment. Registration is not the same as approval or inspection clearance.
How did Takeda Manufacturing Austria's last inspection go?
The most recent inspection on record closed on 24 April 2024 as NAI (No Action Indicated: nothing objectionable was found). 8 inspections are on file.
Where does Takeda Manufacturing Austria manufacture?
12 registered sites are on record, in United Arab Emirates and Austria (Lessines, Industriestrabe 67 - Vienna and Lange Allee 24 - Vienna among others). Every site is listed on this page with the register it came from.
Which regulators recognise Takeda Manufacturing Austria's GMP?
Current GMP certificates are on record from EMA, EEC (Eurasian Economic Union), ANVISA (Brazil) 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 NAI, on 24 April 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