Suppliers / Ercros

Ercros

Spain Updated 9 July 2026

Ercros is an API manufacturer based in Spain. It holds 9 active US drug master files and 8 valid CEPs across a filed portfolio of 8 molecules. Its filings concentrate with MINSA (CR) and INVIMA (CO). Its GMP standing is certified by EMA, AEMPS (ES) and ANVISA (Brazil). Its most recent recorded inspection, by US FDA, closed on 22 June 2018 as VAI.

9
active US DMFs
8
valid CEPs
4
registered plants 1 with an FDA FEI number
5
filings across 2 regulators
These figures were checked against the regulators' own files on 25 July 2026
Plants
1 of 1 confirmed
Inspections
3 of 3 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

  • 22 June 2018 VAI US FDA
  • 12 December 2014 VAI US FDA
  • 15 July 2011 OAI US FDA

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

Registered plants

Site FDA FEI
Aranjuez, Spain Not on file
MADRID, Spain Not on file
Madrid, Spain Not on file
Spain, Spain 3003562118

What they file, and where

Molecule Regulators Docs
Fosfomycin EDQM, SFDA (Saudi Arabia), US FDA 6
Erythromycin EDQM, SFDA (Saudi Arabia), US FDA 5
Fusidic Acid EDQM, SFDA (Saudi Arabia), US FDA 5
Clarithromycin EDQM, SFDA (Saudi Arabia) 2
Sodium Fusidate EDQM, SFDA (Saudi Arabia) 2
Azithromycin EDQM 1
Erythromycin Ethylsuccinate EDQM 1
Famotidine US FDA 1

Also appears on these molecule pages

Amlodipine contract manufacturing Azithromycin contract manufacturing Calci contract manufacturing Clarithromycin contract manufacturing Erythromycin contract manufacturing Famotidine contract manufacturing Fosfomycin contract manufacturing Fusidic Acid API

Filings and GMP by regulator

Regulator Filings GMP certificates
MINSA (CR) 4 None
INVIMA (CO) 1 None
EMA None 1
AEMPS (ES) None 1
ANVISA (Brazil) None 1

Questions about Ercros

Does Ercros hold a US DMF or a CEP?
Ercros holds 9 active US drug master files and 8 valid CEPs. 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.
Is Ercros FDA-registered?
One site operated by Ercros 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 Ercros's last inspection go?
The most recent inspection on record closed on 22 June 2018 as VAI (Voluntary Action Indicated: issues were found but did not warrant regulatory action). 3 inspections are on file, of which 1 closed as OAI.
Where does Ercros manufacture?
4 registered sites are on record, in Spain (Aranjuez, Madrid and Madrid among others). Every site is listed on this page with the register it came from.
What does Ercros make?
8 molecules are on record against Ercros, including Fosfomycin, Erythromycin, Fusidic Acid and Clarithromycin. Each links through to that molecule's full manufacturer list.
Which regulators recognise Ercros's GMP?
Current GMP certificates are on record from EMA, AEMPS (ES) and ANVISA (Brazil). 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 22 June 2018.

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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