Aquestive Therapeutics
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
- 6465 Ameriplex Drive, Portage, Indiana (IN) 46368, United States (USA)
- Operations here
- analysisdistributelabelmanufacturepackrelabelrepack
- FDA identifiers
- FEI 3004395604 · DUNS 079269181
FDA inspection history
Outcomes of closed FDA inspections at this site (drug and biologic program areas).
- VAIDrug Quality Assurance2025-01-30
- VAIDrug Quality Assurance2015-04-03
- VAIDrug Quality Assurance2012-09-13
- VAIDrug Quality Assurance2011-06-28
- VAIDrug Quality Assurance2010-03-23
- VAIDrug Quality Assurance2008-10-23
Drugs this plant is listed as making
1 distinct drugs across 4 products name this site in their FDA label.
- buprenorphine hydrochloride, naloxone hydrochlorideIndivior 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.