HP Halden Pharma
Norway
Program data pending ClinicalTrials.gov matching
Profiled
Not yet scored
✓ FDA Inspections (1)
○ Clinical Trials
○ SEC Filings
○ Press
✓ EMA GMP (1)
○ MHRA GMP
✓ HC GMP (1)
Quick Facts: HP Halden Pharma
- Signal Score
- Profiled, not yet scored. Scores are published after regulatory evidence is attached and reviewed. How scoring works
- Headquarters
- Norway
- Website
- https://halden-pharma.com/
- Modalities
- Sterile Fill-Finish
- Active Programs
- No ClinicalTrials.gov matches confirmed
- Data Sources
- FDA Data Dashboard, ClinicalTrials.gov, SEC EDGAR, press monitoring
About HP Halden Pharma
HP Halden Pharma is a contract development and manufacturing organization (CDMO). Capabilities: Sterile Fill-Finish. 1 manufacturing site registered with the U.S. FDA and Health Canada. Website: https://halden-pharma.com/
Signal Score
Profiled, not yet scored.
Scores are published after regulatory evidence is attached and reviewed.
How scoring works
HP Halden Pharma FDA Inspection History
2023-05
NAI
VAI
OAI
| Date | Site | Type | Observations | Classification |
|---|---|---|---|---|
| 2023-05-10 |
HP Halden Pharma AS
Halden
Company-level
|
Drug Quality Assurance | Yes | Voluntary Action Indicated (VAI) |
Source: FDA Data Dashboard · Retrieved Oct 31, 2026
HP Halden Pharma FDA 483 Findings 4 observations · 2023-05-10 → 2023-05-10 ?
By subsystem
By severity
- 3 — Moderate: 1
- 2 — Minor: 3
- Repeat observations: 0
Most severe findings
-
Investigations of discrepancies, failures
"There is a failure to thoroughly review any unexplained discrepancy whether or not the batch has been already distributed."
-
Storage under appropriate conditions
"Drug products are not stored under appropriate conditions of temperature so that their identity, strength, quality, and purity are not affected."
-
Absence of Written Procedures
"Your firm failed to establish adequate written procedures for production and process controls designed to assure that the drug products have the identity, strength, purity, and quality that they are purported or represented to possess."
HP Halden Pharma EMA GMP Compliance 1 certificates
2025-03
Compliant
Non-Compliant
| Certificate | Site | Country | Inspection Date | Status |
|---|---|---|---|---|
| 25/03829-65 | HP Halden Pharma AS | Norway | 2025-03-07 | 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 HP Halden Pharma
How many FDA inspections does HP Halden Pharma have on record?
CDMO Signal tracks 1 FDA inspection for HP Halden Pharma, sourced from the FDA inspection database. See the full inspection history above.
Has HP Halden Pharma received an FDA warning letter?
CDMO Signal has no FDA warning letters on record for HP Halden Pharma.
Does HP Halden Pharma hold EMA or MHRA GMP certificates?
CDMO Signal tracks 1 EMA GMP certificate for HP Halden Pharma.
Does HP Halden Pharma have a CDMO Signal Score?
Not yet. HP Halden Pharma is profiled, not yet scored. Scores are published after regulatory evidence is attached and reviewed.
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