Suppliers / Medichem

Medichem

Spain 379 employees 3 duplicate records merged Updated 9 July 2026

Medichem is an API and finished-dose manufacturer based in Spain. It holds 27 active US drug master files. Its filings concentrate with DAV (Vietnam), FDA (GH) and AEMPS (ES). Its GMP standing is certified by AEMPS (ES), EMA and US FDA. Its most recent recorded inspection, by US FDA, closed on 22 June 2023 as VAI.

27
active US DMFs
0
valid CEPs
4
registered plants 1 with an FDA FEI number
80
filings across 7 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

  • 22 June 2023 VAI US FDA
  • 15 June 2018 VAI US FDA
  • 30 April 2015 NAI US FDA
  • 21 September 2012 NAI US FDA
  • 9 April 2009 NAI US FDA

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

Registered plants

Site FDA FEI
Gerona, Spain Not on file
Barcelona, Spain Not on file
Girona, Spain Not on file
Spain, Spain 3002807552

What they file, and where

Molecule Regulators Docs
Chlorhexidine US FDA 4
Brimonidine SFDA (Saudi Arabia), US FDA 3
Quetiapine SFDA (Saudi Arabia), US FDA 3
Cyclobenzaprine SFDA (Saudi Arabia), US FDA 2
Loxapine US FDA 2
Adapalene US FDA 1
Amoxapine US FDA 1
Auranofin PMDA (Japan) 1
Captopril US FDA 1
Cinacalcet SFDA (Saudi Arabia) 1
Show all 30 molecules on file
Clozapine US FDA 1
Felodipine US FDA 1
Fluvoxamine US FDA 1
Guanfacine US FDA 1
Ivacaftor US FDA 1
Lamotrigine US FDA 1
Mexiletine US FDA 1
Mirtazapine US FDA 1
Nepafenac US FDA 1
Paroxetine US FDA 1
Pazopanib US FDA 1
Pimecrolimus US FDA 1
Probucol PMDA (Japan) 1
Sunitinib Malate SFDA (Saudi Arabia) 1
Tamsulosin US FDA 1
Varenicline US FDA 1
Varenicline Tartarate SFDA (Saudi Arabia) 1
Vildagliptin SFDA (Saudi Arabia) 1
Voclosporin US FDA 1
マレイン酸エナラプリル PMDA (Japan) 1

Also appears on these molecule pages

Adapalene API Brimonidine API Calcitriol finished dose Captopril API Cefadroxil finished dose Chlorhexidine API Cinacalcet API Clozapine API Cyclobenzaprine API Felodipine API Fluvoxamine API Guanfacine API
Show 21 more molecule pages
Ivacaftor API Lamotrigine API Levocetirizine finished dose Mecobalamin finished dose Mexiletine API Mirtazapine API Nepafenac API Nimodipine finished dose Paroxetine API Pazopanib API Pimecrolimus API Quetiapine API Ribavirin finished dose Risedronic Acid finished dose Ruxolitinib finished dose Silver Sulfadiazine finished dose Tamsulosin API Travoprost finished dose Varenicline API Vildagliptin API Voclosporin API

Filings and GMP by regulator

Regulator Filings GMP certificates
DAV (Vietnam) 50 None
FDA (GH) 11 None
AEMPS (ES) 6 2
EMA 5 2
INFARMED (PT) 4 None
NCELS (KZ) 2 None
US FDA None 1

Questions about Medichem

Does Medichem hold a US DMF or a CEP?
Medichem holds 27 active US drug master files. 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 Medichem FDA-registered?
One site operated by Medichem 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 Medichem's last inspection go?
The most recent inspection on record closed on 22 June 2023 as VAI (Voluntary Action Indicated: issues were found but did not warrant regulatory action). 5 inspections are on file.
Where does Medichem manufacture?
4 registered sites are on record, in Spain (Gerona, Barcelona and Girona among others). Every site is listed on this page with the register it came from.
What does Medichem make?
30 molecules are on record against Medichem, including Chlorhexidine, Brimonidine, Quetiapine and Cyclobenzaprine. Each links through to that molecule's full manufacturer list.
Which regulators recognise Medichem's GMP?
Current GMP certificates are on record from AEMPS (ES), EMA and US FDA. 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

  • 42 active litigation matters are on record.
  • The most recent inspection outcome was VAI, on 22 June 2023.

Comparable suppliers

Hetero shares 8 molecules Apitoria Pharma shares 7 molecules Alembic Pharmaceuticals shares 7 molecules Jubilant Biosys shares 7 molecules Cipla shares 6 molecules

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