Suppliers / Takeda Pharmaceuticals (formerly Nycomed)

Takeda Pharmaceuticals (formerly Nycomed)

Germany 825 employees Updated 9 July 2026

Takeda Pharmaceuticals (formerly Nycomed) is a finished-dose manufacturer based in Germany. It appears in 1 regulatory filing across 1 regulator, without an active US DMF or CEP on file. Its GMP standing is certified by ANVISA (Brazil) and US FDA. Its most recent recorded inspection, by US FDA, closed on 12 April 2024 as NAI.

0
active US DMFs
0
valid CEPs
3
registered plants 2 with an FDA FEI number
1
filings across 1 regulators
These figures were checked against the regulators' own files on 25 July 2026
Plants
2 of 2 confirmed
Inspections
8 of 8 confirmed
Sources: FDA Establishment Registration, read 4 May 2026. FDA drug inspection classifications, read 4 May 2026.

Inspection history

  • 12 April 2024 NAI US FDA
  • 6 November 2023 VAI US FDA
  • 19 July 2021 VAI US FDA
  • 26 November 2019 OAI US FDA
  • 9 August 2019 VAI US FDA
  • 7 November 2017 NAI US FDA
  • 29 August 2017 NAI US FDA
  • 30 October 2015 VAI US FDA

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

Registered plants

Site FDA FEI
OSAKA, Japan Not on file
Japan, Japan 3004664162
Japan, Japan 3002808311

Filings and GMP by regulator

Regulator Filings GMP certificates
EDA (EG) 1 None
ANVISA (Brazil) None 3
US FDA None 2

Questions about Takeda Pharmaceuticals (formerly Nycomed)

Does Takeda Pharmaceuticals (formerly Nycomed) hold a US DMF or a CEP?
No active US drug master file or valid CEP is on record for Takeda Pharmaceuticals (formerly Nycomed). It does have 1 filing with one regulator, so it is registered, just not with the two strong registers buyers usually screen on.
Is Takeda Pharmaceuticals (formerly Nycomed) FDA-registered?
2 sites operated by Takeda Pharmaceuticals (formerly Nycomed) 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 Pharmaceuticals (formerly Nycomed)'s last inspection go?
The most recent inspection on record closed on 12 April 2024 as NAI (No Action Indicated: nothing objectionable was found). 8 inspections are on file, of which 1 closed as OAI.
Where does Takeda Pharmaceuticals (formerly Nycomed) manufacture?
3 registered sites are on record, in Japan (Osaka and Japan among others). Every site is listed on this page with the register it came from.
Which regulators recognise Takeda Pharmaceuticals (formerly Nycomed)'s GMP?
Current GMP certificates are on record from 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 12 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