Suppliers / Faes Farma

Faes Farma

Spain Updated 9 July 2026

Faes Farma is an API and finished-dose manufacturer based in Spain. It holds one valid CEP. Its filings concentrate with AEMPS (ES), EMA and INVIMA (CO). Its GMP standing is certified by AEMPS (ES), NAFDAC (NG) and EMA, among 4 authorities.

0
active US DMFs
1
valid CEPs
7
registered plants
348
filings across 23 regulators
These figures were checked against the regulators' own files on 25 July 2026
EU GMP
1 of 1 confirmed
Sources: EudraGMDP (MIA + third-country GMP certs), read 4 May 2026.

Registered plants

Site FDA FEI
Lejona, United Arab Emirates Not on file
Derio, United Arab Emirates Not on file
S.A. Leioa, Spain Not on file
LEJONA, Spain Not on file
Vizcaya/Bizkaia, Spain Not on file
Derio, Spain Not on file

1 further sites are on record.

Filings and GMP by regulator

Regulator Filings GMP certificates
AEMPS (ES) 110 2
EMA 58 1
INVIMA (CO) 40 None
ISP (CL) 19 None
ARCSA (EC) 16 None
MINSA (CR) 16 None
NAFDAC (NG) None 2
TMDA (TZ) None 1

Questions about Faes Farma

Does Faes Farma hold a US DMF or a CEP?
Faes Farma holds 1 valid CEP. A drug master file is a submission to the FDA describing how an ingredient is made; a CEP is the EDQM's certificate that the substance meets its European Pharmacopoeia monograph. Both are filings rather than approvals.
Where does Faes Farma manufacture?
7 registered sites are on record, in United Arab Emirates, Spain and Nigeria (Lejona, Derio and S.a. Leioa among others). Every site is listed on this page with the register it came from.
What does Faes Farma make?
1 molecule is on record against Faes Farma, including Diosmin. Each links through to that molecule's full manufacturer list.
Which regulators recognise Faes Farma's GMP?
Current GMP certificates are on record from AEMPS (ES), NAFDAC (NG), EMA and TMDA (TZ). 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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Sources on this page

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