Alkermes, 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
- 265 Olinger Circle, Wilmington, Ohio (OH) 45177-2484, United States (USA)
- Operations here
- analysismanufacture
- FDA identifiers
- FEI 1000142940 · DUNS 858582083
FDA inspection history
Outcomes of closed FDA inspections at this site (drug and biologic program areas).
- VAIDrug Quality Assurance2023-10-19
- NAIDrug Quality Assurance2017-08-14
- NAIDrug Quality Assurance2015-04-17
- NAIDrug Quality Assurance2014-08-15
- NAIDrug Quality Assurance2014-04-23
- NAIDrug Quality Assurance2013-09-23
- VAIDrug Quality Assurance2013-06-28
- NAIDrug Quality Assurance2012-06-29
- VAIDrug Quality Assurance2011-11-04
- NAIDrug Quality Assurance2009-11-23
Drugs this plant is listed as making
3 distinct drugs across 10 products name this site in their FDA label.
- aripiprazole lauroxilAlkermes, Inc.
- NaltrexoneAmneal Pharmaceuticals NY LLC
- risperidoneJanssen 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.