Aquestive Therapeutics,Inc
United States 147 employees Updated 9 July 2026
Aquestive Therapeutics,Inc is a finished-dose manufacturer based in United States. It appears in 4 regulatory filings across 2 regulators, without an active US DMF or CEP on file. Its filings concentrate with US FDA and NPRA (MY). Its GMP standing is certified by ANVISA (Brazil) and US FDA. Its most recent recorded inspection, by US FDA, closed on 30 January 2025 as VAI.
2
registered plants
1 with an FDA FEI number
4
filings
across 2 regulators
These figures were checked against the regulators' own files on 25 July 2026
Inspections
6 of 6 confirmed
Sources: FDA Establishment Registration, read 4 May 2026. FDA drug inspection classifications, read 4 May 2026.
Inspection history
- 30 January 2025 VAI US FDA
- 3 April 2015 VAI US FDA
- 13 September 2012 VAI US FDA
- 28 June 2011 VAI US FDA
- 23 March 2010 VAI US FDA
- 23 October 2008 VAI US FDA
NAI means no action indicated, VAI means voluntary action indicated, and OAI means
official action indicated.
Registered plants
| Site | FDA FEI |
| INDIANAPOLIS, United States | Not on file |
| Portage, United States | 3004395604 |
Filings and GMP by regulator
| Regulator | Filings | GMP certificates |
| US FDA | 3 | 1 |
| NPRA (MY) | 1 | None |
| ANVISA (Brazil) | None | 2 |
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Open risk flags
- The most recent inspection outcome was VAI, on 30 January 2025.
Sources on this page
- FDA
- Drug master files, establishment registration, inspection classifications
- EDQM
- Certificates of suitability
- EudraGMDP and national regulators
- GMP certificates