Drug factory · FDA FEI 3002806937

Esteve Quimica, S.A.

C/Ter, 94 Poligon Industrial, Celra, Spain

Spain: 1

Problems found, fixed voluntarily at FDA's last inspection, Sep 18, 2025.

Voluntary Action Indicated: inspectors found problems, but not serious enough for FDA to take action. The company is expected to fix them.

6 drug inspections on record since 2010: 2 with no problems, 4 with problems fixed voluntarily, 0 with FDA action.

What it does, for whom

DrugRoleForNDC
BrensocatibMakes the active ingredient and tests it Insmed Incorporated 71558-001, 71558-002
BrepocitinibMakes the active ingredient and tests it Priovant Therapeutics, Inc. 87211-030
Darunavir, Cobicistat, Emtricitabine, and Tenofovir AlafenamideMakes the active ingredient Janssen Products LP 59676-800
ElinzanetantMakes the active ingredient Bayer HealthCare Pharmaceuticals Inc. 50419-475
NeratinibMakes the active ingredient and tests it Puma Biotechnology, Inc. 70437-240
VadadustatMakes the active ingredient and tests it Akebia Therapeutics, Inc. 59922-641, 59922-642, 59922-643

FDA inspection history

EndedResultProgramProblems noted
Sep 18, 2025Problems found, fixed voluntarilyDrug Quality Assurance—
Sep 23, 2021Problems found, fixed voluntarilyDrug Quality Assurance—
Jun 19, 2018Problems found, fixed voluntarilyDrug Quality Assurance—
Jun 16, 2017No problems foundDrug Quality Assurance—
Nov 7, 2013No problems foundDrug Quality Assurance—
Jul 8, 2010Problems found, fixed voluntarilyDrug Quality Assurance—

Registered with FDA for: analysis; api manufacture; manufacture.