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
- 5 Ramsey Road, Shirley, New York (NY) 11967, United States (USA)
- Operations here
- analysislabelmanufacturepack
- FDA identifiers
- FEI 2410375 · DUNS 002033710
FDA inspection history
Outcomes of closed FDA inspections at this site (drug and biologic program areas).
- VAIDrug Quality Assurance2024-04-24
- NAIDrug Quality Assurance2019-11-15
- VAIDrug Quality Assurance2018-04-11
- VAIDrug Quality Assurance2016-02-28
- VAIDrug Quality Assurance2016-02-26
- VAIDrug Quality Assurance2014-10-29
- VAIDrug Quality Assurance2012-03-29
- OAIDrug Quality Assurance2011-03-15
- VAIDrug Quality Assurance2010-10-29
- VAIDrug Quality Assurance2009-11-05
- VAIDrug Quality Assurance2008-12-16
- VAIPostmarket Surv. and Epidemiology2008-12-16
Drugs this plant is listed as making
18 distinct drugs across 41 products name this site in their FDA label.
- acetylcysteineAmerican Regent, Inc.
- Aminocaproic AcidCivica, Inc.
- Atropine Sulfatein shortageAmerican Regent, Inc.
- Caffeine and Sodium BenzoateAmerican Regent, Inc.
- CyanocobalaminBluePoint Laboratories
- DroperidolAmerican Regent, Inc.
- GlycopyrrolateAmerican Regent, Inc.
- Hydralazine HydrochlorideCivica, Inc.
- Hydroxyzine HydrochlorideAmerican Regent, Inc.
- iron sucroseAmerican Regent, Inc.
- nitroglycerinAmerican Regent, Inc.
- Selenious AcidAmerican Regent, Inc.
- Trace Elements 4American Regent, Inc.
- Trace Elements 5American Regent, Inc.
- Trace Elements Injection 4American Regent, Inc.
- Waterin shortageAmerican Regent, Inc.
- Zinc SulfateAmerican Regent, 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.