Clinical Trial Supply & Logistics
Regulatory, Tech Transfer & Support Services
Company Overview
About
TSafe GmbH is a pharmaceutical CDMO offering comprehensive services.
Key Expertise
Specialized in Biologics Manufacturing, Monoclonal Antibodies, Vaccines
Therapeutic Areas
Cardiovascular
Endocrinology
Quick Facts
HQ:Germany
Founded:1990
Employees:1,697
Capabilities & Services
Core Capabilities
- Sterile Injectable
- Sterile Fill/Finish
- Fill/Finish (Vials)
Types of Organization
GMP Manufacturing
Quality Systems
Regulatory Support
Dosage Forms
Cartridge / Pen
Containment Capabilities
OEB 4 (1-10 µg/m³)
Production Scales
Commercial Scale
Large Scale (Metric Ton+)
Markets Served
Global
Regulatory Approvals
Drug Approval 22I42R
FDA · #APR-C6BADXO2 · 2020-07-01
Drug Approval 7EBLPH
EMA · #APR-GQ5BLPE5 · 2021-11-01
Case Studies
0 published case studies showcasing past projects, challenges and outcomes.
Certifications
FDA Registration
U.S. Food and Drug Administration
Cert #: CERT-98HL1ZM9
Issued: 2020-03-20
Expires: 2025-02-14
EMA GMP Certificate
European Medicines Agency
Cert #: CERT-NV4WMO5R
Issued: 2020-11-28
Expires: 2025-10-13
WHO GMP
World Health Organization
Cert #: CERT-ZMW8APXI
Issued: 2020-03-12
Expires: 2025-01-12
MHRA GMP
UK Medicines and Healthcare products Regulatory Agency
Cert #: CERT-Q00RFDR8
Issued: 2020-08-07
Expires: 2025-01-04
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Key facts about TSafe GmbH
- TSafe GmbH is headquartered in Germany.
- TSafe GmbH was founded in 1990.
- TSafe GmbH has 1,697 employees.
- TSafe GmbH's capabilities include Sterile Injectable, Sterile Fill/Finish and Fill/Finish (Vials).
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