Aquestive Therapeutics
United States
Hybrid — also manufactures internal programs
Program data pending ClinicalTrials.gov matching
Profiled
Not yet scored
✓ FDA Inspections (3)
○ Clinical Trials
○ SEC Filings
✓ Press (2)
○ EMA GMP
○ MHRA GMP
✓ HC GMP (6)
Quick Facts: Aquestive Therapeutics
- Signal Score
- Profiled, not yet scored. Scores are published after regulatory evidence is attached and reviewed. How scoring works
- Headquarters
- United States
- Website
- https://aquestive.com/
- Modalities
- Semi-solids & Liquids
- Active Programs
- No ClinicalTrials.gov matches confirmed
- Data Sources
- FDA Data Dashboard, ClinicalTrials.gov, SEC EDGAR, press monitoring
About Aquestive Therapeutics
Aquestive Therapeutics makes its own pharmaceutical products and also offers contract development and manufacturing services. Capabilities: Semi-solids & Liquids. 1 manufacturing site registered with the U.S. FDA and Health Canada. Website: https://aquestive.com/
Signal Score
Profiled, not yet scored.
Scores are published after regulatory evidence is attached and reviewed.
How scoring works
Aquestive Therapeutics FDA Inspection History
2025-01
2024-12
2021-10
NAI
VAI
OAI
| Date | Site | Type | Observations | Classification |
|---|---|---|---|---|
| 2025-01-30 |
Aquestive Therapeutics
Portage, Indiana
Company-level
|
Drug Quality Assurance | No | Voluntary Action Indicated (VAI) |
| 2024-12-06 |
Aquestive Therapeutics Inc.
Warren, New Jersey
Company-level
|
Bioresearch Monitoring | No | No Action Indicated (NAI) |
| 2021-10-07 |
Aquestive Therapeutics Inc.
Warren, New Jersey
Company-level
|
Bioresearch Monitoring | Yes | Voluntary Action Indicated (VAI) |
Source: FDA Data Dashboard · Retrieved Oct 31, 2026
Aquestive Therapeutics FDA 483 Findings 4 observations · 2021-10-07 → 2021-10-07 ?
By subsystem
By severity
- 2 — Minor: 4
- Repeat observations: 0
Most severe findings
-
Late submission of quarterly safety reports
"Not all quarterly periodic adverse drug experience reports have been submitted within 30 days of the close of the quarter."
-
Timely submission
"An annual report was not submitted within 60 days of the anniversary date of U.S. approval of the application to the FDA division responsible for reviewing the application."
-
Failure to develop written procedures
"Written procedures have not been developed for the surveillance, receipt, evaluation and reporting to FDA of post marketing adverse drug experiences."
Hiring Activity Beta
Built from public job postings when a company's own roles can be read. Job postings are signals, not statements by the company; each one below links to the original. How we collect this
No hiring data yet. We haven't found a public jobs feed for this company.
Source:
public careers pages
· Checked Oct 30, 2026
Company Signals 2 articles
Company announcements, not verified evidence. They do not change any score.
Aquestive Therapeutics to Report Third Quarter 2026 Financial Results and Recent Business Highlights on November 3 and Host Conference Call on November 4 at 8:00 a.m. ET - Yahoo Finance Australia
Aquestive Therapeutics to Report Third Quarter 2026 Financial Results and Recent Business Highlights on November 3 and Host Conference Call on November 4 at 8:00 a.m. ET Yahoo Finance Australia
Aquestive Therapeutics moves R&D to HELIX in New Brunswick - NJBIZ
Aquestive Therapeutics moves R&D to HELIX in New Brunswick NJBIZ
Frequently Asked Questions About Aquestive Therapeutics
How many FDA inspections does Aquestive Therapeutics have on record?
CDMO Signal tracks 3 FDA inspections for Aquestive Therapeutics, sourced from the FDA inspection database. See the full inspection history above.
Has Aquestive Therapeutics received an FDA warning letter?
CDMO Signal has no FDA warning letters on record for Aquestive Therapeutics.
Does Aquestive Therapeutics have a CDMO Signal Score?
Not yet. Aquestive Therapeutics is profiled, not yet scored. Scores are published after regulatory evidence is attached and reviewed.
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