Sovereign Pharmaceuticals
Fort Worth, Texas, United States
Program data pending ClinicalTrials.gov matching
Profiled
Not yet scored
✓ FDA Inspections (3)
○ Clinical Trials
○ SEC Filings
○ Press
○ EMA GMP
✓ MHRA GMP (1)
Quick Facts: Sovereign Pharmaceuticals
- Signal Score
- Profiled, not yet scored. Scores are published after regulatory evidence is attached and reviewed. How scoring works
- Headquarters
- Fort Worth, Texas, United States
- Website
- https://sovpharm.com/
- Modalities
- Oral Solid Dose, Oral Liquids, Topicals, Controlled Substances, Packaging & Labeling
- Active Programs
- No ClinicalTrials.gov matches confirmed
- Data Sources
- FDA Data Dashboard, ClinicalTrials.gov, SEC EDGAR, press monitoring
About Sovereign Pharmaceuticals
Sovereign Pharmaceuticals is a contract development and manufacturing organization (CDMO). Capabilities: Oral Solid Dose, Oral Liquids, Topicals, Controlled Substances, Packaging & Labeling. 1 manufacturing site registered with the U.S. FDA and the UK MHRA. Website: https://sovpharm.com/
Signal Score
Profiled, not yet scored.
Scores are published after regulatory evidence is attached and reviewed.
How scoring works
Sovereign Pharmaceuticals FDA Inspection History
2025-05
2023-08
2022-04
NAI
VAI
OAI
| Date | Site | Type | Observations | Classification |
|---|---|---|---|---|
| 2025-05-12 |
Sovereign Pharmaceuticals, LLC
Fort Worth, Texas
Company-level
|
Drug Quality Assurance | Yes | Voluntary Action Indicated (VAI) |
| 2023-08-02 |
Sovereign Pharmaceuticals, LLC
Fort Worth, Texas
Company-level
|
Drug Quality Assurance | No | Official Action Indicated (OAI) |
| 2022-04-22 |
Sovereign Pharmaceuticals, LLC
Fort Worth, Texas
Company-level
|
Drug Quality Assurance | Yes | Official Action Indicated (OAI) |
Source: FDA Data Dashboard · Retrieved Oct 31, 2026
Sovereign Pharmaceuticals FDA 483 Findings 8 observations · 2022-04-22 → 2025-05-12 ?
By subsystem
By severity
- 3 — Moderate: 4
- 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."
-
Component written specification
"Component testing is deficient in that each component is not tested for conformity with all appropriate written specifications for purity, strength, and quality."
-
Scientifically sound laboratory controls
"Laboratory controls do not include the establishment of scientifically sound and appropriate test procedures designed to assure that in-process materials and drug products conform to appropriate standards of identity, strength, quality and purity."
Sovereign Pharmaceuticals MHRA GMP Compliance 1 certificates
2014-05
Compliant
Non-Compliant
| Certificate | Site | City / Postcode | Inspection Date | Status |
|---|---|---|---|---|
| UK GMP 40047 Insp GMP 40047/3913251-0002[H] | SOVEREIGN PHARMACEUTICALS | 76118 | 2014-05-12 | COMPLIANT |
Source: MHRA GMDP Database · 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. This company's careers site asks automated readers not to collect it (robots.txt), and we respect that.
Source:
public careers pages
· Checked Oct 30, 2026
Frequently Asked Questions About Sovereign Pharmaceuticals
How many FDA inspections does Sovereign Pharmaceuticals have on record?
CDMO Signal tracks 3 FDA inspections for Sovereign Pharmaceuticals, sourced from the FDA inspection database. See the full inspection history above.
Has Sovereign Pharmaceuticals received an FDA warning letter?
CDMO Signal has no FDA warning letters on record for Sovereign Pharmaceuticals.
Does Sovereign Pharmaceuticals hold EMA or MHRA GMP certificates?
CDMO Signal tracks 1 MHRA GMP certificate for Sovereign Pharmaceuticals.
Does Sovereign Pharmaceuticals have a CDMO Signal Score?
Not yet. Sovereign Pharmaceuticals is profiled, not yet scored. Scores are published after regulatory evidence is attached and reviewed.
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