Galephar Pharmaceutical Research

Humacao, Puerto Rico
Hybrid — also manufactures internal programs
Oral Solid Dose Controlled Substances Inhalation & Nasal
Program data pending ClinicalTrials.gov matching
Profiled
Not yet scored
✓ FDA Inspections (2) ○ Clinical Trials ○ SEC Filings ○ Press ○ EMA GMP ○ MHRA GMP ✓ HC GMP (11)

Quick Facts: Galephar Pharmaceutical Research

Signal Score
Profiled, not yet scored. Scores are published after regulatory evidence is attached and reviewed. How scoring works
Headquarters
Humacao, Puerto Rico
Website
Modalities
Oral Solid Dose, Controlled Substances, Inhalation & Nasal
Active Programs
No ClinicalTrials.gov matches confirmed
Data Sources
FDA Data Dashboard, ClinicalTrials.gov, SEC EDGAR, press monitoring

About Galephar Pharmaceutical Research

Galephar Pharmaceutical Research makes its own pharmaceutical products and also offers contract development and manufacturing services. Capabilities: Oral Solid Dose, Controlled Substances, Inhalation & Nasal. 2 manufacturing sites registered with the U.S. FDA and Health Canada. Website: https://www.galephar.com/

Signal Score

Profiled, not yet scored. Scores are published after regulatory evidence is attached and reviewed. How scoring works

Galephar Pharmaceutical Research FDA Inspection History

2025-06
2024-10
NAI VAI OAI
Date Site Type Observations Classification
2025-06-05
Galephar Pharmaceutical Research Inc.
Humacao, Puerto Rico Company-level
Drug Quality Assurance No No Action Indicated (NAI)
2024-10-18
Galephar Pharmaceutical Research Inc.
Juncos, Puerto Rico Company-level
Drug Quality Assurance Yes Voluntary Action Indicated (VAI)
Source: FDA Data Dashboard · Retrieved Oct 31, 2026

Galephar Pharmaceutical Research FDA 483 Findings 1 observations · 2024-10-18 → 2024-10-18 ?

By subsystem

  • CAPA 1 (100.0%)

By severity

  • 3 — Moderate: 1
  • Repeat observations: 0

Most severe findings

  • Moderate (3) CAPA 2024-10-18 21 CFR 211.188(b)(12)
    Investigations made into any unexplained discrepancy

    "Batch production and control records do not include the results of any investigation made into any unexplained discrepancy, whether or not the batch of drug product had already been distributed."

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 Galephar Pharmaceutical Research

How many FDA inspections does Galephar Pharmaceutical Research have on record?
CDMO Signal tracks 2 FDA inspections for Galephar Pharmaceutical Research, sourced from the FDA inspection database. See the full inspection history above.
Has Galephar Pharmaceutical Research received an FDA warning letter?
CDMO Signal has no FDA warning letters on record for Galephar Pharmaceutical Research.
Does Galephar Pharmaceutical Research have a CDMO Signal Score?
Not yet. Galephar Pharmaceutical Research is profiled, not yet scored. Scores are published after regulatory evidence is attached and reviewed.
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