Suppliers / Meiji Seika Pharma

Meiji Seika Pharma

Japan 252 employees Updated 9 July 2026

Meiji Seika Pharma is an API and finished-dose manufacturer based in Japan. It holds 2 active US drug master files and 2 valid CEPs across a filed portfolio of 2 molecules. Its filings concentrate with AEMPS (ES), INFARMED (PT) and EMA. Its GMP standing is certified by EMA and AEMPS (ES). Its most recent recorded inspection, by US FDA, closed on 2 September 2022 as VAI.

2
active US DMFs
2
valid CEPs
6
registered plants 2 with an FDA FEI number
96
filings across 11 regulators
These figures were checked against the regulators' own files on 25 July 2026
Plants
2 of 2 confirmed
Inspections
6 of 6 confirmed
EU GMP
0 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

  • 2 September 2022 VAI US FDA
  • 20 July 2018 VAI US FDA
  • 3 June 2016 VAI US FDA
  • 4 March 2016 VAI US FDA
  • 14 December 2012 VAI US FDA
  • 7 December 2012 VAI US FDA

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

Registered plants

Site FDA FEI
Madrid, Spain Not on file
Alcala De Henares, Spain Not on file
Tokyo, Japan Not on file
Japan, Japan 3002902776
Japan, Japan 3008927877
ALCALA DE HENARES, Portugal Not on file

What they file, and where

Molecule Regulators Docs
Daunorubicin EDQM, US FDA 2
Doxorubicin EDQM, US FDA 2

Also appears on these molecule pages

Cefditoren finished dose Daunorubicin API Doxorubicin API Lornoxicam finished dose Safinamide finished dose Sulbactam finished dose

Filings and GMP by regulator

Regulator Filings GMP certificates
AEMPS (ES) 40 1
INFARMED (PT) 17 None
EMA 12 1
DIGEMAPS (DO) 8 None
ARCSA (EC) 6 None
DAV (Vietnam) 5 None

Questions about Meiji Seika Pharma

Does Meiji Seika Pharma hold a US DMF or a CEP?
Meiji Seika Pharma holds 2 active US drug master files and 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 Meiji Seika Pharma FDA-registered?
2 sites operated by Meiji Seika Pharma 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 Meiji Seika Pharma's last inspection go?
The most recent inspection on record closed on 2 September 2022 as VAI (Voluntary Action Indicated: issues were found but did not warrant regulatory action). 6 inspections are on file.
Where does Meiji Seika Pharma manufacture?
6 registered sites are on record, in Spain, Japan and Portugal (Madrid, Alcala De Henares and Tokyo among others). Every site is listed on this page with the register it came from.
What does Meiji Seika Pharma make?
2 molecules are on record against Meiji Seika Pharma, including Daunorubicin and Doxorubicin. Each links through to that molecule's full manufacturer list.
Which regulators recognise Meiji Seika Pharma's GMP?
Current GMP certificates are on record from EMA and AEMPS (ES). 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 2 September 2022.

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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