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 NCELS (KZ). 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
NCELS (KZ) 2 None
DIGEMAPS (DO) 2 None
JFDA (JO) 2 None
SAHPRA (ZA) 1 None
ANVISA (Brazil) None 3
EMA None 2
MINPROMTORG (RU) None 1
AEMPS (ES) None 1

Questions about Berlimed

Does Berlimed hold a US DMF or a CEP?
No active US drug master file or valid CEP is on record for Berlimed. It does have 31 filings with 11 regulators, so it is registered, just not with the two strong registers buyers usually screen on.
Is Berlimed FDA-registered?
One site operated by Berlimed 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 Berlimed's last inspection go?
The most recent inspection on record closed on 9 March 2023 as VAI (Voluntary Action Indicated: issues were found but did not warrant regulatory action). 5 inspections are on file.
Where does Berlimed manufacture?
6 registered sites are on record, in United Arab Emirates and Spain (Madrid, Alcala De Henares and Madrid among others). Every site is listed on this page with the register it came from.
Which regulators recognise Berlimed's GMP?
Current GMP certificates are on record from ANVISA (Brazil), EMA, MINPROMTORG (RU) 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 9 March 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