Fraunhofer-Gesellschaft
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Analytical & Bioanalytical Services
Regulatory, Tech Transfer & Support Services
Company Overview
About
Fraunhofer-Gesellschaft is a pharmaceutical CDMO offering comprehensive services.
Key Expertise
Specialized in Gene Therapy, Cell Therapy, mRNA
Therapeutic Areas
Cardiovascular
Endocrinology
Quick Facts
HQ:Germany
Founded:2006
Employees:715
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 5 (≤1 µg/m³)
Cytotoxic / ADC Handling
Production Scales
Commercial Scale
Large Scale (Metric Ton+)
Markets Served
Asia-Pacific
Regulatory Approvals
Drug Approval 204W00
Health Canada · #APR-Y9V6MAVO · 2021-05-01
Case Studies
0 published case studies showcasing past projects, challenges and outcomes.
Certifications
FDA Registration
U.S. Food and Drug Administration
Cert #: CERT-NB5R5E6V
Issued: 2020-08-20
Expires: 2025-06-20
ISO 13485:2016
International Organization for Standardization
Cert #: CERT-66U3KUNI
Issued: 2020-02-22
Expires: 2025-01-11
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Key facts about Fraunhofer-Gesellschaft
- Fraunhofer-Gesellschaft is headquartered in Germany.
- Fraunhofer-Gesellschaft was founded in 2006.
- Fraunhofer-Gesellschaft has 715 employees.
- Fraunhofer-Gesellschaft's capabilities include Sterile Injectable, Sterile Fill/Finish and Fill/Finish (Vials).
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