Amneal Pharmaceuticals
Bridgewater, NJ
Program data pending ClinicalTrials.gov matching
78.7
Signal Score
✓ FDA Inspections (1)
○ Clinical Trials
○ SEC Filings
✓ Press (10)
○ EMA GMP
○ MHRA GMP
Quick Facts: Amneal Pharmaceuticals
- Signal Score
- 78.7/100
- Quality Compliance
- 100.0/100
- Headquarters
- Bridgewater, NJ
- Modalities
- Small Molecule (Oral Solid Dose), Sterile Injectables, Biosimilars, Generic Drug Products, Blow-Fill-Seal (BFS), Ophthalmics, Inhalation (MDI/DPI)
- Active Programs
- No ClinicalTrials.gov matches confirmed
- Data Sources
- FDA Data Dashboard, ClinicalTrials.gov, SEC EDGAR, press monitoring
- Scored By
- CDMO Signal — independent CDMO intelligence platform
About Amneal Pharmaceuticals
Auto-created by AI matchmaker. Data verification pending.
Signal Score & Pillar Breakdown
Quality Compliance
100.0
FDA Inspections1 on record
Warning Letters0
Last InspectionNo Action Indicated (NAI) (2025-03-28)
Operations
—
No ClinicalTrials.gov facility matches confirmed for this manufacturer.
Programs
— no verified data
Sponsors— no verified data
ModalitiesSmall Molecule (Oral Solid Dose), Sterile Injectables, Biosimilars, Generic Drug Products, Blow-Fill-Seal (BFS), Ophthalmics, Inhalation (MDI/DPI)
No clinical trial matches found for this manufacturer
Operational score requires ClinicalTrials.gov data
Data sourced from ClinicalTrials.gov, FDA, SEC EDGAR, and verified press only. No unverified estimates shown.
Financial Stability
60.0
Private company
Financial assessment: 60.0/100
Source: SEC EDGAR, press monitoring
Profile-based financial assessment
SEC FilingsPrivate company
Private company
Financial assessment: 60.0/100
Capacity
60.0
Broad modality coverage (7 modalities)
Source: SEC EDGAR, press monitoring, company profiles
Profile-based capacity assessment
Recent Press10 articles
Broad modality coverage (7 modalities)
Amneal Pharmaceuticals FDA Inspection History
2025-03
NAI
VAI
OAI
| Date | Site | Type | Observations | Classification |
|---|---|---|---|---|
| 2025-03-28 | Piscataway, New Jersey | Bioresearch Monitoring | No | No Action Indicated (NAI) |
Source: FDA Data Dashboard · Retrieved Aug 22, 2026
Recent News 10 articles
Amneal signs agreement with Zambon for Parkinson’s disease therapy - Pharmaceutical Technology
Shyamakant Giri Appointed Group CEO of Apothecon Pharmaceuticals to Lead Global Expansion Strategy - cxodigitalpulse.com
Amneal and VantAI unveil fresh branding to kick off 2026 plans - Fierce Pharma
FDA picks seven companies for pilot to accelerate US drug manufacturing - The Pharma Letter
FDA launches PreCheck Pilot program to accelerate domestic drug manufacturing facility approvals - AllSci
FDA approves Amneal Pharmaceuticals' cyclosporine ophthalmic emulsion 0.05% - Ophthalmology Times Europe
Amneal to buy a biosimilar company; Samsung Bio workers protest - Endpoints News
Shyamakant Giri Appointed as Group Chief Executive Officer at Apothecon Pharmaceuticals Pvt. Ltd. - hrtoday.in
7 Facilities Pilot PreCheck for Faster Approval - Pharmaceutical Online
EyeWorld Weekly, September 26, 2025 - EyeWorld
Frequently Asked Questions About Amneal Pharmaceuticals
How many FDA inspections does Amneal Pharmaceuticals have on record?
CDMO Signal tracks 1 FDA inspection for Amneal Pharmaceuticals, sourced from the FDA inspection database. See the full inspection history above.
Has Amneal Pharmaceuticals received an FDA warning letter?
CDMO Signal has no FDA warning letters on record for Amneal Pharmaceuticals.
What is Amneal Pharmaceuticals's CDMO Signal Score?
Amneal Pharmaceuticals has a Signal Score of 79/100, based on quality, operations, financial stability, and capacity data.
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