Shionogi Pharma
Settsu, Osaka, Japan
Hybrid — also manufactures internal programs
Program data pending ClinicalTrials.gov matching
Profiled
Not yet scored
✓ FDA Inspections (4)
○ Clinical Trials
○ SEC Filings
○ Press
○ EMA GMP
○ MHRA GMP
✓ HC GMP (12)
Quick Facts: Shionogi Pharma
- Signal Score
- Profiled, not yet scored. Scores are published after regulatory evidence is attached and reviewed. How scoring works
- Headquarters
- Settsu, Osaka, Japan
- Website
- https://www.shionogi-ph.co.jp/en/
- Modalities
- Small Molecule API, High-Potency APIs, Oral Solid Dose, Packaging & Labeling, Clinical Trial Manufacturing
- Active Programs
- No ClinicalTrials.gov matches confirmed
- Data Sources
- FDA Data Dashboard, ClinicalTrials.gov, SEC EDGAR, press monitoring
About Shionogi Pharma
Shionogi Pharma makes its own pharmaceutical products and also offers contract development and manufacturing services. Capabilities: Small Molecule API, High-Potency APIs, Oral Solid Dose, Packaging & Labeling, Clinical Trial Manufacturing. 3 manufacturing sites registered with the U.S. FDA and Health Canada. Website: https://www.shionogi-ph.co.jp/en/
Signal Score
Profiled, not yet scored.
Scores are published after regulatory evidence is attached and reviewed.
How scoring works
Shionogi Pharma FDA Inspection History
2025-07
2025-05
2024-04
2023-10
NAI
VAI
OAI
| Date | Site | Type | Observations | Classification |
|---|---|---|---|---|
| 2025-07-01 |
Shionogi Pharma Co., Ltd.
Isawa-Gun
Company-level
|
Drug Quality Assurance | Yes | Official Action Indicated (OAI) |
| 2025-05-30 |
Shionogi Pharma Co., Ltd.
Settsu
Company-level
|
Drug Quality Assurance | No | Voluntary Action Indicated (VAI) |
| 2024-04-05 |
Shionogi Pharma Co., Ltd.
Amagasaki
Company-level
|
Drug Quality Assurance | No | No Action Indicated (NAI) |
| 2023-10-20 |
Shionogi Pharma Co. Ltd.
Tokushima
Company-level
|
Drug Quality Assurance | No | Voluntary Action Indicated (VAI) |
Source: FDA Data Dashboard · Retrieved Oct 31, 2026
Shionogi Pharma FDA 483 Findings 4 observations · 2025-07-01 → 2025-07-01 ?
By subsystem
By severity
- 4 — Serious: 2
- 2 — Minor: 2
- Repeat observations: 0
Most severe findings
-
Cleaning System
"Aseptic processing areas are deficient regarding the system for cleaning and disinfecting the room and equipment to produce aseptic conditions."
-
Validation lacking for sterile drug products
"Procedures designed to prevent microbiological contamination of drug products purporting to be sterile did not include adequate validation of the aseptic and sterilization process."
-
Mfg / Processing Operations Area
"Separate or defined areas to prevent contamination or mix-ups are deficient regarding the manufacturing and processing operations."
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 Shionogi Pharma
How many FDA inspections does Shionogi Pharma have on record?
CDMO Signal tracks 4 FDA inspections for Shionogi Pharma, sourced from the FDA inspection database. See the full inspection history above.
Has Shionogi Pharma received an FDA warning letter?
CDMO Signal has no FDA warning letters on record for Shionogi Pharma.
Does Shionogi Pharma have a CDMO Signal Score?
Not yet. Shionogi Pharma is profiled, not yet scored. Scores are published after regulatory evidence is attached and reviewed.
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