Suppliers / Esteve Química

Esteve Química

Spain 2 duplicate records merged Updated 9 July 2026

Esteve Química is an API manufacturer based in Spain. It holds 4 active US drug master files across a filed portfolio of 8 molecules. Its GMP standing is certified by AEMPS (ES).

4
active US DMFs
0
valid CEPs
1
registered plants
5
filings across 1 regulators

Registered plants

Site FDA FEI
Gerona, Spain Not on file

What they file, and where

Molecule Regulators Docs
Omeprazole SFDA (Saudi Arabia), US FDA 3
Azelastine SFDA (Saudi Arabia), US FDA 2
Levetiracetam SFDA (Saudi Arabia), US FDA 2
Bosutinib SFDA (Saudi Arabia) 1
Crisaborole SFDA (Saudi Arabia) 1
Cyclopentolate US FDA 1
Esomeprazole SFDA (Saudi Arabia) 1
Voxilaprevir SFDA (Saudi Arabia) 1

Also appears on these molecule pages

Azelastine API Bosutinib API Crisaborole API Omeprazole API Esomeprazole API Levetiracetam API

Filings and GMP by regulator

Regulator Filings GMP certificates
MINSA (CR) 5 None
AEMPS (ES) None 1

Questions about Esteve Química

Does Esteve Química hold a US DMF or a CEP?
Esteve Química 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.
Where does Esteve Química manufacture?
1 registered site is on record, in Spain (Gerona). Every site is listed on this page with the register it came from.
What does Esteve Química make?
8 molecules are on record against Esteve Química, including Omeprazole, Azelastine, Levetiracetam and Bosutinib. Each links through to that molecule's full manufacturer list.
Which regulators recognise Esteve Química's GMP?
Current GMP certificates are on record from 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.

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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