LTS Lohmann Therapie-Systeme

Andernach, Germany
Semi-solids & Liquids
Program data pending ClinicalTrials.gov matching
Profiled
Not yet scored
✓ FDA Inspections (5) ○ Clinical Trials ○ SEC Filings ✓ Press (4) ✓ EMA GMP (2) ○ MHRA GMP ✓ HC GMP (9)

Quick Facts: LTS Lohmann Therapie-Systeme

Signal Score
Profiled, not yet scored. Scores are published after regulatory evidence is attached and reviewed. How scoring works
Headquarters
Andernach, Germany
Website
Modalities
Semi-solids & Liquids
Active Programs
No ClinicalTrials.gov matches confirmed
Data Sources
FDA Data Dashboard, ClinicalTrials.gov, SEC EDGAR, press monitoring

About LTS Lohmann Therapie-Systeme

LTS Lohmann Therapie-Systeme is a contract development and manufacturing organization (CDMO). Capabilities: Semi-solids & Liquids. 4 manufacturing sites registered with the U.S. FDA and Health Canada. Website: https://www.ltslohmann.com/en/

Signal Score

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

LTS Lohmann Therapie-Systeme FDA Inspection History

2026-07
2025-09
2024-02
2023-06
2022-05
NAI VAI OAI
Date Site Type Observations Classification
2026-07-29
LTS Lakewood, LLC
Lakewood, New Jersey Company-level
Drug Quality Assurance Yes Voluntary Action Indicated (VAI)
2025-09-30
LTS Therapy Systems, LLC
Saint Paul, Minnesota Company-level
Drug Quality Assurance No Voluntary Action Indicated (VAI)
2024-02-01
LTS Lohmann Therapy Systems Corp
West Caldwell, New Jersey Company-level
Drug Quality Assurance No No Action Indicated (NAI)
2023-06-06
LTS Lakewood, LLC
Lakewood, New Jersey Company-level
Drug Quality Assurance No Voluntary Action Indicated (VAI)
2022-05-18
LTS Lohmann Therapie-Systeme AG
Andernach Company-level
Drug Quality Assurance No No Action Indicated (NAI)
Source: FDA Data Dashboard · Retrieved Oct 31, 2026

LTS Lohmann Therapie-Systeme FDA 483 Findings 1 observations · 2026-07-29 → 2026-07-29 ?

By subsystem

  • Documentation & Records 1 (100.0%)

By severity

  • 2 — Minor: 1
  • Repeat observations: 0

Most severe findings

  • Minor (2) Documentation & Records 2026-07-29 21 CFR 211.100(a)
    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."

LTS Lohmann Therapie-Systeme EMA GMP Compliance 2 certificates

2025-03
2025-03
Compliant Non-Compliant
Certificate Site Country Inspection Date Status
DE_RP_01_GMP_2025_0036 LTS LOHMANN Therapie-Systeme AG Germany 2025-03-26 COMPLIANT
DE_RP_01_GMP_2025_0019 LTS Lohmann Therapie-Systeme AG Germany 2025-03-20 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

Company Signals 4 articles

Company announcements, not verified evidence. They do not change any score.
news Tue, 14 Oc
LTS to Acquire Renaissance Lakewood - Contract Pharma
news Tue, 03 Se
Simtra BioPharma Solutions Appoints Chief Commercial Officer - Contract Pharma
news Mon, 12 No
LTS – Your Partner for Innovative Solutions - Pharmaceutical Business review -
news Fri, 09 Au
LTS, GRAM Enter Strategic Fill Finish Pact for Wearable Injectors - Contract Pharma

Frequently Asked Questions About LTS Lohmann Therapie-Systeme

How many FDA inspections does LTS Lohmann Therapie-Systeme have on record?
CDMO Signal tracks 5 FDA inspections for LTS Lohmann Therapie-Systeme, sourced from the FDA inspection database. See the full inspection history above.
Has LTS Lohmann Therapie-Systeme received an FDA warning letter?
CDMO Signal has no FDA warning letters on record for LTS Lohmann Therapie-Systeme.
Does LTS Lohmann Therapie-Systeme hold EMA or MHRA GMP certificates?
CDMO Signal tracks 2 EMA GMP certificates for LTS Lohmann Therapie-Systeme.
Does LTS Lohmann Therapie-Systeme have a CDMO Signal Score?
Not yet. LTS Lohmann Therapie-Systeme is profiled, not yet scored. Scores are published after regulatory evidence is attached and reviewed.
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