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
Spain, Spain 3004837462
Sant Boi De Llobregat, Spain Not on file

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

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Open risk flags

  • The most recent inspection outcome was VAI, on 20 April 2023.

Sources on this page

FDA
Drug master files, establishment registration, inspection classifications
EDQM
Certificates of suitability
EudraGMDP and national regulators
GMP certificates