Suppliers / Daiichi Sankyo Europe

Daiichi Sankyo Europe

Germany Updated 9 July 2026

Daiichi Sankyo Europe is an API and finished-dose manufacturer based in Germany. It appears in 767 regulatory filings across 22 regulators, without an active US DMF or CEP on file. Its filings concentrate with AIFA (IT), MHRA (UK) and FAMHP (BE). Its GMP standing is certified by ANSM (FR), ZLG (DE) and MFDS (Korea), among 8 authorities. Its most recent recorded inspection, by US FDA, closed on 18 July 2025 as VAI.

0
active US DMFs
0
valid CEPs
11
registered plants 2 with an FDA FEI number
767
filings across 22 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

  • 18 July 2025 VAI US FDA
  • 19 October 2018 NAI US FDA
  • 14 June 2018 NAI US FDA
  • 22 April 2016 NAI US FDA
  • 15 May 2014 NAI US FDA
  • 20 September 2012 NAI US FDA
  • 14 June 2012 NAI US FDA
  • 29 January 2010 NAI US FDA

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

Registered plants

Site FDA FEI
Pfaffenhofen, United Arab Emirates Not on file
Zürich, Switzerland Not on file
PFAFFENHOFEN, Germany Not on file
Munich, Germany Not on file
Pfaffenhofen A.D.Ilm, Germany Not on file
Germany, Germany 3003282622

5 further sites are on record.

What they file, and where

Molecule Regulators Docs
Loxoprofen SFDA (Saudi Arabia) 1
Tranexamic Acid SFDA (Saudi Arabia) 1

Also appears on these molecule pages

Amlodipine finished dose Bempedoic Acid finished dose Cefoperazone finished dose Clotrimazole finished dose Edoxaban finished dose Erythromycin finished dose Ezetimibe finished dose Gliclazide finished dose Indocyanine Green finished dose Indomethacin finished dose Isradipine finished dose Lactulose finished dose
Show 16 more molecule pages
Lamivudine finished dose Letrozole finished dose Loxoprofen API Metoprolol finished dose Nebivolol finished dose Olmesartan finished dose Olmesartan Medoxomil finished dose Prasugrel finished dose Pravastatin finished dose Quinapril finished dose Sucralfate finished dose Tizanidine finished dose Tranexamic Acid API Valaciclovir finished dose Valacyclovir finished dose Zidovudine finished dose

Filings and GMP by regulator

Regulator Filings GMP certificates
AIFA (IT) 246 None
MHRA (UK) 123 None
FAMHP (BE) 81 None
INHRR (VE) 50 None
SWISSMEDIC (CH) 45 None
AEMPS (ES) 40 None
ANSM (FR) None 32
ZLG (DE) None 8
MFDS (Korea) None 2
NCELS (KZ) None 2
ANVISA (Brazil) None 2
HSA (SG) None 2
EMA None 1
US FDA None 1

Scale

Year Revenue Exports Destinations
2023 $18.2M Not reported Not reported

Export figures are customs aggregates. We do not publish the identity of any buyer. Revenue shown in US dollars, converted from the reported currency.

Questions about Daiichi Sankyo Europe

Does Daiichi Sankyo Europe hold a US DMF or a CEP?
No active US drug master file or valid CEP is on record for Daiichi Sankyo Europe. It does have 767 filings with 22 regulators, so it is registered, just not with the two strong registers buyers usually screen on.
Is Daiichi Sankyo Europe FDA-registered?
2 sites operated by Daiichi Sankyo Europe 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 Daiichi Sankyo Europe's last inspection go?
The most recent inspection on record closed on 18 July 2025 as VAI (Voluntary Action Indicated: issues were found but did not warrant regulatory action). 8 inspections are on file.
Where does Daiichi Sankyo Europe manufacture?
11 registered sites are on record, in United Arab Emirates, Switzerland, Germany and France (Pfaffenhofen, Zürich and Pfaffenhofen among others). Every site is listed on this page with the register it came from.
What does Daiichi Sankyo Europe make?
2 molecules are on record against Daiichi Sankyo Europe, including Loxoprofen and Tranexamic Acid. Each links through to that molecule's full manufacturer list.
Which regulators recognise Daiichi Sankyo Europe's GMP?
Current GMP certificates are on record from ANSM (FR), ZLG (DE), MFDS (Korea), NCELS (KZ), ANVISA (Brazil) and 3 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

  • 3 active litigation matters are on record.
  • The most recent inspection outcome was VAI, on 18 July 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
Company filings
Revenue as reported