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

Filings and GMP by regulator

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

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Open risk flags

  • 1 active litigation matter is on record.

Sources on this page

FDA
Drug master files, establishment registration, inspection classifications
EDQM
Certificates of suitability
EudraGMDP and national regulators
GMP certificates