Esteve CDMO US, Inc. dba Regis Chemical Company
A single plant registered with the FDA to make drugs for the US market. Below is where it is and the drugs whose FDA labels list this site as performing a manufacturing step — so if this plant has a problem, these are the products that could be affected.
- Country
- United States
- Registered address
- 8210 Austin Avenue, Morton Grove, Illinois (IL) 60053, United States (USA)
- Operations here
- analysisapi manufacturemanufacture
- FDA identifiers
- FEI 1416120 · DUNS 005065594
FDA inspection history
Outcomes of closed FDA inspections at this site, every FDA program area; the official-action banner above considers Drug Quality Assurance inspections only.
- VAIDrug Quality Assurance2022-11-16
- NAIDrug Quality Assurance2019-04-23
- NAIDrug Quality Assurance2016-08-15
- NAIDrug Quality Assurance2013-12-17
- NAIDrug Quality Assurance2012-03-30
- VAIDrug Quality Assurance2011-03-08
- VAIDrug Quality Assurance2009-05-08
Drugs this plant is listed as making
1 distinct drugs across 1 products name this site for a manufacturing step (any MANUFACTURE-type role, API included). Counts are per distinct generic name (case-insensitive).
- LevoketoconazoleXeris Pharmaceuticals, Inc.
Sources:the establishment's name, address, and country from FDA's Drug Establishments Current Registration Site (DECRS); the drug-to-facility links from DailyMed SPL drug labels, matched by the facility's DUNS number; inspection outcomes from the FDA Data Dashboard, matched by FEI; shortage status from FDA's drug shortage database. More on how this is built. Educational only.