Adare Pharmaceuticals
Vandalia, Ohio, United States
Program data pending ClinicalTrials.gov matching
Profiled
Not yet scored
✓ FDA Inspections (6)
○ Clinical Trials
○ SEC Filings
○ Press
✓ EMA GMP (5)
○ MHRA GMP
✓ HC GMP (13)
Quick Facts: Adare Pharmaceuticals
- Signal Score
- Profiled, not yet scored. Scores are published after regulatory evidence is attached and reviewed. How scoring works
- Headquarters
- Vandalia, Ohio, United States
- Website
- https://adarepharmasolutions.com/
- Modalities
- Oral Solid Dose
- Active Programs
- No ClinicalTrials.gov matches confirmed
- Data Sources
- FDA Data Dashboard, ClinicalTrials.gov, SEC EDGAR, press monitoring
About Adare Pharmaceuticals
Adare Pharmaceuticals is a contract development and manufacturing organization (CDMO). Capabilities: Oral Solid Dose. 5 manufacturing sites registered with the U.S. FDA and Health Canada, including the former Frontida BioPharm plants in Philadelphia and Aurora. Website: https://adarepharmasolutions.com/
Signal Score
Profiled, not yet scored.
Scores are published after regulatory evidence is attached and reviewed.
How scoring works
Adare Pharmaceuticals FDA Inspection History
2026-04
2025-10
2025-06
2025-02
2023-12
2022-10
NAI
VAI
OAI
| Date | Site | Type | Observations | Classification |
|---|---|---|---|---|
| 2026-04-02 |
Frontida BioPharm Inc
Philadelphia, Pennsylvania
Company-level
|
Drug Quality Assurance | No | No Action Indicated (NAI) |
| 2025-10-24 |
Frontida Biopharm, LLC
Aurora, Illinois
Company-level
|
Drug Quality Assurance | Yes | Voluntary Action Indicated (VAI) |
| 2025-06-06 |
Adare Pharmaceuticals Srl
Pessano Con Bornago
Company-level
|
Drug Quality Assurance | No | Voluntary Action Indicated (VAI) |
| 2025-02-25 |
Adare Pharmaceuticals, Inc.
Vandalia, Ohio
Company-level
|
Drug Quality Assurance | Yes | Voluntary Action Indicated (VAI) |
| 2023-12-07 |
Frontida BioPharm Inc
Philadelphia, Pennsylvania
Company-level
|
Drug Quality Assurance | No | Voluntary Action Indicated (VAI) |
| 2022-10-28 |
Adare Pharmaceuticals Srl
Pessano Con Bornago
Company-level
|
Drug Quality Assurance | No | Voluntary Action Indicated (VAI) |
Source: FDA Data Dashboard · Retrieved Oct 31, 2026
Adare Pharmaceuticals FDA 483 Findings 5 observations · 2025-02-25 → 2025-10-24 ?
By subsystem
By severity
- 3 — Moderate: 1
- 2 — Minor: 4
- Repeat observations: 0
Most severe findings
-
Investigations of discrepancies, failures
"There is a failure to thoroughly review any unexplained discrepancy and the failure of a batch or any of its components to meet any of its specifications whether or not the batch has been already distributed."
-
Control procedures to monitor and validate performance
"Control procedures are not established which validate the performance of those manufacturing processes that may be responsible for causing variability in the characteristics of in-process material and the drug product."
-
Procedures not in writing, fully followed
"The responsibilities and procedures applicable to the quality control unit are not in writing and fully followed."
Adare Pharmaceuticals EMA GMP Compliance 5 certificates
2025-06
2024-10
2024-07
2020-09
2016-10
Compliant
Non-Compliant
| Certificate | Site | Country | Inspection Date | Status |
|---|---|---|---|---|
| IT/206/H/2025 | Adare Pharmaceuticals S.r.l. | Italy | 2025-06-06 | COMPLIANT |
| NBF/1/2025/V | Adare Pharmaceuticals S.r.l. | Italy | 2024-10-30 | COMPLIANT |
| IT/255/H/2024 | Adare Pharmaceuticals S.r.l. | Italy | 2024-07-12 | COMPLIANT |
| 20MPP039HFR01 | ADARE PHARMACEUTICALS SAS | France | 2020-09-11 | COMPLIANT |
| 16MPP083HFR02 | ADARE PHARMACEUTICALS SAS | France | 2016-10-06 | COMPLIANT |
Source: EMA EudraGMDP · Retrieved Oct 31, 2026
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
Frequently Asked Questions About Adare Pharmaceuticals
How many FDA inspections does Adare Pharmaceuticals have on record?
CDMO Signal tracks 6 FDA inspections for Adare Pharmaceuticals, sourced from the FDA inspection database. See the full inspection history above.
Has Adare Pharmaceuticals received an FDA warning letter?
CDMO Signal has no FDA warning letters on record for Adare Pharmaceuticals.
Does Adare Pharmaceuticals hold EMA or MHRA GMP certificates?
CDMO Signal tracks 5 EMA GMP certificates for Adare Pharmaceuticals.
Does Adare Pharmaceuticals have a CDMO Signal Score?
Not yet. Adare Pharmaceuticals is profiled, not yet scored. Scores are published after regulatory evidence is attached and reviewed.
Evaluating Adare Pharmaceuticals for a manufacturing program?
Use the free AI matchmaker to compare Adare Pharmaceuticals against other CDMOs by FDA, EMA, and clinical-trial data — no login required.
Find & compare CDMOs →
Represent this organization? Contact us to verify or update this profile.
Similar CDMOs
Codis
St. Louis, Missouri, United States
Spray Drying, Particle Engineering, Oral Solid Dose
Mikart
Atlanta, Georgia, United States
Oral Solid Dose, Oral Liquids, Controlled Substances, Packaging & Labeling
Vetio Animal Health
United States
Oral Solid Dose, Semi-solids & Liquids, Sterile Fill-Finish
Alcami Carolinas
United States
Oral Solid Dose, Sterile Fill-Finish, Small Molecule API
Almac
United Kingdom
Small Molecule API, Oral Solid Dose, Packaging & Labeling
Compare Adare Pharmaceuticals with another CDMO
Side-by-side scoring, FDA inspection history, EMA/MHRA GMP coverage, and clinical-program footprint.