Suppliers / Laboratorios Farmalan S A

Laboratorios Farmalan S A

Spain Updated 9 July 2026

Laboratorios Farmalan S A is a finished-dose manufacturer based in Spain. It appears in 11 regulatory filings across 6 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), AEMPS (ES) and EMA, among 4 authorities. Its most recent recorded inspection, by US FDA, closed on 17 November 2021 as VAI.

0
active US DMFs
0
valid CEPs
4
registered plants 1 with an FDA FEI number
11
filings across 6 regulators
These figures were checked against the regulators' own files on 25 July 2026
Plants
1 of 1 confirmed
Inspections
1 of 1 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

  • 17 November 2021 VAI US FDA

NAI means no action indicated, VAI means voluntary action indicated, and OAI means official action indicated.

Registered plants

Site FDA FEI
León, Spain Not on file
LEÓN, Spain Not on file
Villaquilambre, Spain Not on file
Spain, Spain 3014424887

Filings and GMP by regulator

Regulator Filings GMP certificates
ARCSA (EC) 3 None
MINSA (CR) 2 None
NCELS (KZ) 2 None
INVIMA (CO) 2 None
MPA (SE) 1 None
DIGEMAPS (DO) 1 None
ANVISA (Brazil) None 4
AEMPS (ES) None 1
EMA None 1
MINPROMTORG (RU) None 1

Questions about Laboratorios Farmalan S A

Does Laboratorios Farmalan S A hold a US DMF or a CEP?
No active US drug master file or valid CEP is on record for Laboratorios Farmalan S A. It does have 11 filings with 6 regulators, so it is registered, just not with the two strong registers buyers usually screen on.
Is Laboratorios Farmalan S A FDA-registered?
One site operated by Laboratorios Farmalan S A 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 Laboratorios Farmalan S A's last inspection go?
The most recent inspection on record closed on 17 November 2021 as VAI (Voluntary Action Indicated: issues were found but did not warrant regulatory action). 1 inspection is on file.
Where does Laboratorios Farmalan S A manufacture?
4 registered sites are on record, in Spain (León, León and Villaquilambre among others). Every site is listed on this page with the register it came from.
Which regulators recognise Laboratorios Farmalan S A's GMP?
Current GMP certificates are on record from ANVISA (Brazil), AEMPS (ES), EMA and MINPROMTORG (RU). 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 17 November 2021.

Comparable suppliers

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Ranked by shared active ingredients where we have them, otherwise by country and comparable credentials.

Sources on this page

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