Hikma (Contract Manufacturing)
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
○ EMA GMP
○ MHRA GMP
✓ HC GMP (6)
Quick Facts: Hikma (Contract Manufacturing)
- Signal Score
- Profiled, not yet scored. Scores are published after regulatory evidence is attached and reviewed. How scoring works
- Headquarters
- United States
- Website
- https://www.hikma.com/what-we-do/contract-manufacturing/
- Modalities
- Oral Solid Dose, Oral Liquids, Inhalation & Nasal, Sterile Injectables, Lyophilization, Prefilled Syringes, Cytotoxics
- Active Programs
- No ClinicalTrials.gov matches confirmed
- Data Sources
- FDA Data Dashboard, ClinicalTrials.gov, SEC EDGAR, press monitoring
About Hikma (Contract Manufacturing)
Hikma (Contract Manufacturing) makes its own pharmaceutical products and also offers contract development and manufacturing services. Capabilities: Oral Solid Dose, Oral Liquids, Inhalation & Nasal, Sterile Injectables, Lyophilization, Prefilled Syringes, Cytotoxics. 4 manufacturing sites registered with the U.S. FDA and Health Canada. Website: https://www.hikma.com/what-we-do/contract-manufacturing/
Signal Score
Profiled, not yet scored.
Scores are published after regulatory evidence is attached and reviewed.
How scoring works
Hikma (Contract Manufacturing) FDA Inspection History
2025-03
2023-04
2022-10
NAI
VAI
OAI
| Date | Site | Type | Observations | Classification |
|---|---|---|---|---|
| 2025-03-26 |
Thymoorgan Pharmazie Gmbh
Goslar
Company-level
|
Drug Quality Assurance | No | Voluntary Action Indicated (VAI) |
| 2023-04-25 |
Thymoorgan Pharmazie Gmbh
Goslar
Company-level
|
Drug Quality Assurance | Yes | Voluntary Action Indicated (VAI) |
| 2022-10-06 |
Thymoorgan Pharmazie Gmbh
Goslar
Company-level
|
Drug Quality Assurance | No | Voluntary Action Indicated (VAI) |
Source: FDA Data Dashboard · Retrieved Oct 31, 2026
Hikma (Contract Manufacturing) FDA 483 Findings 3 observations · 2023-04-25 → 2023-04-25 ?
By subsystem
By severity
- 4 — Serious: 1
- 3 — Moderate: 1
- 2 — Minor: 1
- Repeat observations: 0
Most severe findings
-
Environmental Monitoring System
"Aseptic processing areas are deficient regarding the system for monitoring environmental conditions."
-
Investigations of discrepancies, failures
"There is a failure to thoroughly review any unexplained discrepancy whether or not the batch has been already distributed."
-
SOPs not followed / documented
"Written production and process control procedures are not followed in the execution of production and process control functions and documented at the time of performance."
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 Hikma (Contract Manufacturing)
How many FDA inspections does Hikma (Contract Manufacturing) have on record?
CDMO Signal tracks 3 FDA inspections for Hikma (Contract Manufacturing), sourced from the FDA inspection database. See the full inspection history above.
Has Hikma (Contract Manufacturing) received an FDA warning letter?
CDMO Signal has no FDA warning letters on record for Hikma (Contract Manufacturing).
Does Hikma (Contract Manufacturing) have a CDMO Signal Score?
Not yet. Hikma (Contract Manufacturing) is profiled, not yet scored. Scores are published after regulatory evidence is attached and reviewed.
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