Advanced Modalities
Analytical & Bioanalytical Services
Regulatory, Tech Transfer & Support Services
Company Overview
About
ProBioGen AG is a pharmaceutical CDMO offering comprehensive services.
Key Expertise
Specialized in Quality Control, Stability Testing, Method Development
Therapeutic Areas
Infectious Disease
Quick Facts
HQ:Germany
Founded:2003
Employees:845
Capabilities & Services
Core Capabilities
- Small Molecule API
- Small Molecule Drug Product
- Oral Solid Dose
Types of Organization
GMP Manufacturing
Quality Systems
Regulatory Support
Dosage Forms
Oral Solid Dose
Containment Capabilities
OEB 4 (1-10 µg/m³)
Production Scales
Pilot Scale
Phase I Clinical Trials
Clinical
Markets Served
Global
International Regulatory
EU GMP Certificates
2
Regulatory Bodies
EMA/EudraGMDP
Regulatory Approvals
Drug Approval LUZ2HK
Health Canada · #APR-SY4ZUYAG · 2020-07-01
Drug Approval 16QMW3
EMA · #APR-VSASZHKZ · 2020-06-01
Case Studies
0 published case studies showcasing past projects, challenges and outcomes.
Certifications
FDA Registration
U.S. Food and Drug Administration
Cert #: CERT-GHCFIVDR
Issued: 2020-09-25
Expires: 2025-02-27
EMA GMP Certificate
European Medicines Agency
Cert #: CERT-F58Z63N4
Issued: 2020-05-20
Expires: 2025-10-04
MHRA GMP
UK Medicines and Healthcare products Regulatory Agency
Cert #: CERT-7W1NU695
Issued: 2020-01-07
Expires: 2025-11-25
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Key facts about ProBioGen AG
- ProBioGen AG is headquartered in Germany.
- ProBioGen AG was founded in 2003.
- ProBioGen AG has 845 employees.
- ProBioGen AG's capabilities include Small Molecule API, Small Molecule Drug Product and Oral Solid Dose.
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