Suppliers / Aquestive Therapeutics,Inc

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.

0
active US DMFs
0
valid CEPs
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
Plants
1 of 1 confirmed
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

Questions about Aquestive Therapeutics,Inc

Does Aquestive Therapeutics,Inc hold a US DMF or a CEP?
No active US drug master file or valid CEP is on record for Aquestive Therapeutics,Inc. It does have 4 filings with 2 regulators, so it is registered, just not with the two strong registers buyers usually screen on.
Is Aquestive Therapeutics,Inc FDA-registered?
One site operated by Aquestive Therapeutics,Inc carries an FDA establishment identifier (FEI), which means it is registered with the FDA as a drug establishment. Registration is not the same as approval or inspection clearance.
How did Aquestive Therapeutics,Inc's last inspection go?
The most recent inspection on record closed on 30 January 2025 as VAI (Voluntary Action Indicated: issues were found but did not warrant regulatory action). 6 inspections are on file.
Where does Aquestive Therapeutics,Inc manufacture?
2 registered sites are on record, in United States (Indianapolis and Portage). Every site is listed on this page with the register it came from.
Which regulators recognise Aquestive Therapeutics,Inc's GMP?
Current GMP certificates are on record from ANVISA (Brazil) and US FDA. GMP recognition covers the manufacturing site, separately from any filing on the substance itself.

Answered from this company's own record. Where a register holds nothing, the question is not asked rather than answered with a zero. How we count our figures.

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Open risk flags

  • The most recent inspection outcome was VAI, on 30 January 2025.

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Sources on this page

FDA
Drug master files, establishment registration, inspection classifications
EDQM
Certificates of suitability
EudraGMDP and national regulators
GMP certificates