Suppliers / Takeda Austria

Takeda Austria

Austria Updated 9 July 2026

Takeda Austria is a finished-dose manufacturer based in Austria. It holds one valid CEP. Its filings concentrate with EMA, RAMA (GE) and ARCSA (EC). Its GMP standing is certified by ANVISA (Brazil), MFDS (Korea) and EMA, among 5 authorities. Its most recent recorded inspection, by US FDA, closed on 11 September 2025 as NAI.

0
active US DMFs
1
valid CEPs
5
registered plants 1 with an FDA FEI number
16
filings across 5 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

  • 11 September 2025 NAI US FDA
  • 14 February 2025 VAI US FDA
  • 9 November 2018 VAI US FDA
  • 23 January 2017 VAI US FDA
  • 28 May 2015 VAI US FDA
  • 11 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
Linz, United Arab Emirates Not on file
LINZ, Austria Not on file
Austria, Austria 3001157285
Oberösterreich, Austria Not on file
Oberoesterreich, Austria Not on file

What they file, and where

Molecule Regulators Docs
Deproteinised Hemoderivative Of Calf Blood EDQM 1

Also appears on these molecule pages

Atropine finished dose Diazepam finished dose Lornoxicam finished dose Pantoprazole finished dose Prednisolone finished dose Succinylcholine finished dose

Filings and GMP by regulator

Regulator Filings GMP certificates
EMA 10 2
RAMA (GE) 3 None
ARCSA (EC) 1 None
INVIMA (CO) 1 None
MINSA (CR) 1 None
ANVISA (Brazil) None 3
MFDS (Korea) None 2
EAEU_EEC None 1
US FDA None 1

Questions about Takeda Austria

Does Takeda Austria hold a US DMF or a CEP?
Takeda Austria holds 1 valid CEP. A drug master file is a submission to the FDA describing how an ingredient is made; a CEP is the EDQM's certificate that the substance meets its European Pharmacopoeia monograph. Both are filings rather than approvals.
Is Takeda Austria FDA-registered?
One site operated by Takeda Austria 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 Takeda Austria's last inspection go?
The most recent inspection on record closed on 11 September 2025 as NAI (No Action Indicated: nothing objectionable was found). 6 inspections are on file.
Where does Takeda Austria manufacture?
5 registered sites are on record, in United Arab Emirates and Austria (Linz, Linz and Austria among others). Every site is listed on this page with the register it came from.
What does Takeda Austria make?
1 molecule is on record against Takeda Austria, including Deproteinised Hemoderivative Of Calf Blood. Each links through to that molecule's full manufacturer list.
Which regulators recognise Takeda Austria's GMP?
Current GMP certificates are on record from ANVISA (Brazil), MFDS (Korea), 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 NAI, on 11 September 2025.

Comparable suppliers

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Ranked by shared active ingredients where we have them, otherwise by country and comparable credentials.

Sources on this page

FDA
Drug master files, establishment registration, inspection classifications
EDQM
Certificates of suitability
EudraGMDP and national regulators
GMP certificates