Suppliers / Synthon Hispania, S.L

Synthon Hispania, S.L

Spain Updated 9 July 2026

Synthon Hispania, S.L is a finished-dose manufacturer based in Spain. It appears in 69 regulatory filings across 9 regulators, without an active US DMF or CEP on file. Its filings concentrate with UZPHARM (UZ), DIGEMAPS (DO) and MINSA (CR). Its GMP standing is certified by EMA, AEMPS (ES) and ANVISA (Brazil). Its most recent recorded inspection, by US FDA, closed on 20 April 2023 as VAI.

0
active US DMFs
0
valid CEPs
4
registered plants 1 with an FDA FEI number
69
filings across 9 regulators
These figures were checked against the regulators' own files on 25 July 2026
Plants
1 of 1 confirmed
Inspections
4 of 4 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

  • 20 April 2023 VAI US FDA
  • 28 March 2019 VAI US FDA
  • 23 May 2014 NAI US FDA
  • 1 October 2010 VAI US FDA

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

Registered plants

Site FDA FEI
Barcelona, United Arab Emirates Not on file
BARCELONA, Spain Not on file
Sant Boi De Llobregat, Spain Not on file
Spain, Spain 3004837462

Filings and GMP by regulator

Regulator Filings GMP certificates
UZPHARM (UZ) 21 None
DIGEMAPS (DO) 13 None
MINSA (CR) 10 None
JFDA (JO) 7 None
EDE (AE) 7 None
EDA (EG) 6 None
EMA None 1
AEMPS (ES) None 1
ANVISA (Brazil) None 1

Questions about Synthon Hispania, S.L

Does Synthon Hispania, S.L hold a US DMF or a CEP?
No active US drug master file or valid CEP is on record for Synthon Hispania, S.L. It does have 69 filings with 9 regulators, so it is registered, just not with the two strong registers buyers usually screen on.
Is Synthon Hispania, S.L FDA-registered?
One site operated by Synthon Hispania, 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 Synthon Hispania, S.L's last inspection go?
The most recent inspection on record closed on 20 April 2023 as VAI (Voluntary Action Indicated: issues were found but did not warrant regulatory action). 4 inspections are on file.
Where does Synthon Hispania, S.L manufacture?
4 registered sites are on record, in United Arab Emirates and Spain (Barcelona, Barcelona and Sant Boi De Llobregat among others). Every site is listed on this page with the register it came from.
Which regulators recognise Synthon Hispania, S.L's GMP?
Current GMP certificates are on record from EMA, AEMPS (ES) and ANVISA (Brazil). 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 20 April 2023.

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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