Suppliers / Berlimed

Berlimed

Spain 42 employees Updated 9 July 2026

Berlimed is a finished-dose manufacturer based in Spain. It appears in 31 regulatory filings across 11 regulators, without an active US DMF or CEP on file. Its filings concentrate with ARCSA (EC), MINSA (CR) and JFDA (JO). Its GMP standing is certified by ANVISA (Brazil), EMA and MINPROMTORG (RU), among 4 authorities. Its most recent recorded inspection, by US FDA, closed on 9 March 2023 as VAI.

0
active US DMFs
0
valid CEPs
6
registered plants 1 with an FDA FEI number
31
filings across 11 regulators
These figures were checked against the regulators' own files on 25 July 2026
Plants
1 of 1 confirmed
Inspections
5 of 5 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 March 2023 VAI US FDA
  • 29 March 2019 VAI US FDA
  • 25 September 2018 VAI US FDA
  • 29 January 2016 VAI US FDA
  • 23 June 2009 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, United Arab Emirates Not on file
Alcala de Henares, United Arab Emirates Not on file
MADRID, Spain Not on file
Madrid, Spain Not on file
Alcala De Henares, Spain Not on file
Spain, Spain 3004492234

Filings and GMP by regulator

Regulator Filings GMP certificates
ARCSA (EC) 12 None
MINSA (CR) 7 None
JFDA (JO) 2 None
NCELS (KZ) 2 None
DIGEMAPS (DO) 2 None
ISP (CL) 1 None
ANVISA (Brazil) None 3
EMA None 2
MINPROMTORG (RU) None 1
AEMPS (ES) None 1

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Open risk flags

  • The most recent inspection outcome was VAI, on 9 March 2023.

Sources on this page

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