Suppliers / Unión Químico Farmacéutica

Unión Químico Farmacéutica

Spain Updated 9 July 2026

Unión Químico Farmacéutica is an API manufacturer based in Spain. It holds 22 active US drug master files across a filed portfolio of 22 molecules. Its GMP standing is certified by EMA and AEMPS (ES). Its most recent recorded inspection, by US FDA, closed on 7 July 2022 as VAI.

22
active US DMFs
0
valid CEPs
3
registered plants 1 with an FDA FEI number
2
filings across 1 regulators
These figures were checked against the regulators' own files on 25 July 2026
Plants
1 of 1 confirmed
Inspections
4 of 4 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

  • 7 July 2022 VAI US FDA
  • 1 March 2019 VAI US FDA
  • 15 May 2015 NAI US FDA
  • 18 June 2009 VAI US FDA

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

Registered plants

Site FDA FEI
Spain, Spain 3002808431
Barcelona, Spain Not on file
Sant Celoni, Spain Not on file

What they file, and where

Molecule Regulators Docs
Allopurinol US FDA 2
Esomeprazole SFDA (Saudi Arabia), US FDA 2
Mivacurium US FDA 2
Omeprazole SFDA (Saudi Arabia), US FDA 2
Quetiapine SFDA (Saudi Arabia), US FDA 2
Sitagliptin US FDA 2
Acyclovir US FDA 1
Bicalutamide US FDA 1
Cimetidine US FDA 1
Clindamycin US FDA 1
Show all 22 molecules on file
Doxylamine US FDA 1
Emtricitabine SFDA (Saudi Arabia) 1
Famotidine US FDA 1
Ketoconazole US FDA 1
Lansoprazole US FDA 1
Memantine SFDA (Saudi Arabia) 1
Nimodipine US FDA 1
Pantoprazole SFDA (Saudi Arabia) 1
Ranitidine US FDA 1
Ranolazine US FDA 1
Solifenacin Succinate US FDA 1
Tropicamide US FDA 1

Also appears on these molecule pages

Acyclovir API Allopurinol API Bicalutamide API Cimetidine API Clindamycin API Doxylamine API Emtricitabine API Esomeprazole API Famotidine API Ketoconazole API Lansoprazole API Nimodipine API
Show 8 more molecule pages
Omeprazole API Ranitidine API Ranolazine API Solifenacin API Quetiapine API Sitagliptin API Pantoprazole API Memantine API

Filings and GMP by regulator

Regulator Filings GMP certificates
INFARMED (PT) 2 None
EMA None 1
AEMPS (ES) None 1

Questions about Unión Químico Farmacéutica

Does Unión Químico Farmacéutica hold a US DMF or a CEP?
Unión Químico Farmacéutica holds 22 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 Unión Químico Farmacéutica FDA-registered?
One site operated by Unión Químico Farmacéutica 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 Unión Químico Farmacéutica's last inspection go?
The most recent inspection on record closed on 7 July 2022 as VAI (Voluntary Action Indicated: issues were found but did not warrant regulatory action). 4 inspections are on file.
Where does Unión Químico Farmacéutica manufacture?
3 registered sites are on record, in Spain (Spain, Barcelona and Sant Celoni). Every site is listed on this page with the register it came from.
What does Unión Químico Farmacéutica make?
22 molecules are on record against Unión Químico Farmacéutica, including Allopurinol, Esomeprazole, Mivacurium and Omeprazole. Each links through to that molecule's full manufacturer list.
Which regulators recognise Unión Químico Farmacéutica's GMP?
Current GMP certificates are on record from EMA 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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Open risk flags

  • 1 active litigation matter is on record.
  • The most recent inspection outcome was VAI, on 7 July 2022.

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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