American Regent, Inc.
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
- 6610 New Albany Road East, New Albany, Ohio (OH) 43054, United States (USA)
- Operations here
- labelmanufacturepack
- FDA identifiers
- FEI 3010209784 · DUNS 027223179
FDA inspection history
Outcomes of closed FDA inspections at this site (drug and biologic program areas).
- VAIDrug Quality Assurance2026-01-29
- VAIDrug Quality Assurance2022-09-30
- NAIDrug Quality Assurance2016-10-28
- VAIDrug Quality Assurance2016-05-05
- VAIDrug Quality Assurance2015-03-19
Drugs this plant is listed as making
12 distinct drugs across 18 products name this site in their FDA label.
- Calcium ChlorideCivica, Inc.
- Chlorothiazide SodiumAmerican Regent, Inc.
- Estradiol ValerateAmerican Regent, Inc.
- LevocarnitineAmerican Regent, Inc.
- nicardipine hydrochlorideCivica, Inc.
- OlanzapineAmerican Regent, Inc.
- Potassium PhosphateAmerican Regent, Inc.
- Potassium Phosphate, Monobasic Potassium Phosphate, DibasicAmerican Regent, Inc.
- potassium phosphatesAmerican Regent, Inc.
- sodium phosphate, monobasic, monohydrate and sodium phosphate, dibasic anhydrousAmerican Regent, Inc.
- tranexamic acidAmerican Regent, Inc.
- VasopressinCivica, 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.