Suppliers / Urquima

Urquima

Spain 31 employees 2 duplicate records merged Updated 9 July 2026

Urquima is an API manufacturer based in Spain. It holds 4 active US drug master files across a filed portfolio of 4 molecules. Its filings concentrate with AIFA (IT), INFARMED (PT) and EMA. Its most recent recorded inspection, by US FDA, closed on 21 October 2021 as VAI.

4
active US DMFs
0
valid CEPs
1
registered plants 1 with an FDA FEI number
22
filings across 4 regulators
These figures were checked against the regulators' own files on 25 July 2026
Plants
1 of 1 confirmed
Inspections
5 of 5 confirmed
Sources: FDA Establishment Registration, read 4 May 2026. FDA drug inspection classifications, read 4 May 2026.

Inspection history

  • 21 October 2021 VAI US FDA
  • 21 September 2017 VAI US FDA
  • 29 September 2016 VAI US FDA
  • 4 April 2014 VAI US FDA
  • 17 June 2011 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 3002808432

What they file, and where

Molecule Regulators Docs
Azelastine SFDA (Saudi Arabia), US FDA 2
Glipizide US FDA 1
Ivabradine US FDA 1
Rupatadine US FDA 1

Also appears on these molecule pages

Azelastine API Glipizide API Ivabradine API Rupatadine API

Filings and GMP by regulator

Regulator Filings GMP certificates
AIFA (IT) 11 None
INFARMED (PT) 6 None
EMA 3 None
AEMPS (ES) 2 None

Questions about Urquima

Does Urquima hold a US DMF or a CEP?
Urquima holds 4 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 Urquima FDA-registered?
One site operated by Urquima 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 Urquima's last inspection go?
The most recent inspection on record closed on 21 October 2021 as VAI (Voluntary Action Indicated: issues were found but did not warrant regulatory action). 5 inspections are on file.
Where does Urquima manufacture?
1 registered site is on record, in Spain (Spain). Every site is listed on this page with the register it came from.
What does Urquima make?
4 molecules are on record against Urquima, including Azelastine, Glipizide, Ivabradine and Rupatadine. Each links through to that molecule's full manufacturer list.
Where does Urquima file?
Filings are on record with AIFA (IT), INFARMED (PT), EMA and AEMPS (ES), 22 in total.

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 21 October 2021.

Comparable suppliers

Hetero shares 2 molecules Zydus Lifesciences shares 2 molecules MSN Laboratories shares 1 molecule Alembic Pharmaceuticals shares 1 molecule Olon shares 1 molecule

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