Suppliers / Takeda

Takeda

Germany 4 duplicate records merged Updated 9 July 2026

Takeda is an API and finished-dose manufacturer based in Germany. It holds 2 valid CEPs across a filed portfolio of 2 molecules. Its filings concentrate with EMA, DMP (NO) and NMRC (NA). 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 28 November 2025 as VAI.

0
active US DMFs
2
valid CEPs
10
registered plants 2 with an FDA FEI number
157
filings across 12 regulators
These figures were checked against the regulators' own files on 25 July 2026
Plants
2 of 2 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

  • 28 November 2025 VAI US FDA
  • 12 November 2025 VAI US FDA
  • 6 May 2021 VAI US FDA
  • 30 October 2020 VAI US FDA
  • 27 March 2018 NAI US FDA
  • 16 March 2018 VAI US FDA
  • 22 April 2016 NAI US FDA
  • 11 March 2016 VAI US FDA

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

Registered plants

Site FDA FEI
Singen, United Arab Emirates Not on file
Oranienburg, United Arab Emirates Not on file
Konstanz, Germany Not on file
ORANIENBURG, Germany Not on file
Oranienburg, Germany Not on file
Velten, Germany Not on file

4 further sites are on record.

What they file, and where

Molecule Regulators Docs
Pantoprazole EDQM 1
Succinylcholine EDQM 1

Also appears on these molecule pages

Alogliptin finished dose Anagrelide finished dose Ciclesonide finished dose Dexlansoprazole finished dose Emtricitabine finished dose Leuprolide finished dose Milk Thistle finished dose Pantoprazole API Pioglitazone finished dose Succinylcholine API Warfarin finished dose

Filings and GMP by regulator

Regulator Filings GMP certificates
EMA 39 3
DMP (NO) 31 None
NMRC (NA) 20 None
EDA (EG) 13 None
INFARMED (PT) 12 None
FAMHP (BE) 12 None
ZLG (DE) None 16
ANVISA (Brazil) None 7
US FDA None 2
FDA (GH) None 1

Questions about Takeda

Does Takeda hold a US DMF or a CEP?
Takeda holds 2 valid CEPs. 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 FDA-registered?
2 sites operated by Takeda 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's last inspection go?
The most recent inspection on record closed on 28 November 2025 as VAI (Voluntary Action Indicated: issues were found but did not warrant regulatory action). 8 inspections are on file.
Where does Takeda manufacture?
10 registered sites are on record, in United Arab Emirates and Germany (Singen, Oranienburg and Konstanz among others). Every site is listed on this page with the register it came from.
What does Takeda make?
2 molecules are on record against Takeda, including Pantoprazole and Succinylcholine. Each links through to that molecule's full manufacturer list.
Which regulators recognise Takeda's GMP?
Current GMP certificates are on record from ZLG (DE), ANVISA (Brazil), EMA, US FDA and FDA (GH). 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 28 November 2025.

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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