Suppliers / Laboratorios Leon Farma S A

Laboratorios Leon Farma S A

Spain 125 employees Updated 9 July 2026

Laboratorios Leon Farma S A is a finished-dose manufacturer based in Spain. It appears in 164 regulatory filings across 13 regulators, without an active US DMF or CEP on file. Its filings concentrate with ARCSA (EC), NCELS (KZ) and MINSA (CR). Its GMP standing is certified by ANVISA (Brazil), EAEU_EEC and EMA, among 5 authorities.

0
active US DMFs
0
valid CEPs
4
registered plants
164
filings across 13 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
Leon, United Arab Emirates Not on file
León, Spain Not on file
LEÓN, Spain Not on file
Villaquilambre, Spain Not on file

Filings and GMP by regulator

Regulator Filings GMP certificates
ARCSA (EC) 43 None
NCELS (KZ) 42 None
MINSA (CR) 25 None
MPA (SE) 14 None
DIGEMAPS (DO) 13 None
UZPHARM (UZ) 8 None
ANVISA (Brazil) None 10
EAEU_EEC None 2
EMA None 1
NAFDAC (NG) None 1
AEMPS (ES) None 1

Questions about Laboratorios Leon Farma S A

Does Laboratorios Leon Farma S A hold a US DMF or a CEP?
No active US drug master file or valid CEP is on record for Laboratorios Leon Farma S A. It does have 164 filings with 13 regulators, so it is registered, just not with the two strong registers buyers usually screen on.
Where does Laboratorios Leon Farma S A manufacture?
4 registered sites are on record, in United Arab Emirates and Spain (Leon, León and León among others). Every site is listed on this page with the register it came from.
Which regulators recognise Laboratorios Leon Farma S A's GMP?
Current GMP certificates are on record from ANVISA (Brazil), EEC (Eurasian Economic Union), EMA, NAFDAC (NG) 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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Sources on this page

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