Suppliers / Towa Pharmaceutical Europe, S.L

Towa Pharmaceutical Europe, S.L

Spain Updated 9 July 2026

Towa Pharmaceutical Europe, S.L is a finished-dose manufacturer based in Spain. It appears in 2,146 regulatory filings across 12 regulators, without an active US DMF or CEP on file. Its filings concentrate with AIFA (IT), INFARMED (PT) and AEMPS (ES). Its GMP standing is certified by AEMPS (ES) and EMA. Its most recent recorded inspection, by US FDA, closed on 9 September 2022 as VAI.

0
active US DMFs
0
valid CEPs
5
registered plants 1 with an FDA FEI number
2,146
filings across 12 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

  • 9 September 2022 VAI US FDA
  • 18 January 2019 NAI US FDA
  • 31 March 2017 VAI US FDA
  • 13 February 2015 VAI US FDA
  • 10 May 2013 NAI US FDA
  • 19 February 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
Barcelona, Spain Not on file
Martorelles, Spain Not on file
Spain, Spain 3003121577
Montijo, Portugal Not on file
Montjo, Portugal Not on file

Filings and GMP by regulator

Regulator Filings GMP certificates
AIFA (IT) 1,033 None
INFARMED (PT) 443 None
AEMPS (ES) 351 1
EMA 290 1
MPA (SE) 9 None
ARCSA (EC) 6 None

Questions about Towa Pharmaceutical Europe, S.L

Does Towa Pharmaceutical Europe, S.L hold a US DMF or a CEP?
No active US drug master file or valid CEP is on record for Towa Pharmaceutical Europe, S.L. It does have 2,146 filings with 12 regulators, so it is registered, just not with the two strong registers buyers usually screen on.
Is Towa Pharmaceutical Europe, S.L FDA-registered?
One site operated by Towa Pharmaceutical Europe, S.L 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 Towa Pharmaceutical Europe, S.L's last inspection go?
The most recent inspection on record closed on 9 September 2022 as VAI (Voluntary Action Indicated: issues were found but did not warrant regulatory action). 6 inspections are on file.
Where does Towa Pharmaceutical Europe, S.L manufacture?
5 registered sites are on record, in Spain and Portugal (Barcelona, Martorelles and Spain among others). Every site is listed on this page with the register it came from.
Which regulators recognise Towa Pharmaceutical Europe, S.L's GMP?
Current GMP certificates are on record from AEMPS (ES) and EMA. 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 9 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