Drug Product
Advanced Modalities
Analytical & Bioanalytical Services
Company Overview
About
Genezen (USA) is a pharmaceutical CDMO offering comprehensive services.
Key Expertise
Specialized in Gene Therapy, Cell Therapy, mRNA
Therapeutic Areas
Infectious Disease
Quick Facts
HQ:United States
Founded:1998
Employees:602
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
BSL-2 (Biosafety Level 2)
Production Scales
Phase III Clinical Trials
Commercial Scale
Clinical
Markets Served
Europe
Manufacturing Facilities
1 site worldwide
Genezen MA, Inc.
113 Hartwell Ave, Lexington, Massachusetts, 02421
Site Capabilities
3 capabilitiesANALYSIS
API MANUFACTURE
MANUFACTURE
International Regulatory
EU GMP Certificates
1
Regulatory Bodies
EMA/EudraGMDP
Regulatory Approvals
Drug Approval E9UTON
FDA · #APR-Q73UBQSR · 2021-06-01
Certifications
FDA Registration
U.S. Food and Drug Administration
Cert #: CERT-8K67XI1T
Issued: 2020-06-04
Expires: 2025-06-09
EMA GMP Certificate
European Medicines Agency
Cert #: CERT-VO1A5KSL
Issued: 2020-01-10
Expires: 2025-09-18
MHRA GMP
UK Medicines and Healthcare products Regulatory Agency
Cert #: CERT-AIP4PRN0
Issued: 2020-01-17
Expires: 2025-10-09
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Key facts about Genezen (USA)
- Genezen (USA) is headquartered in the United States.
- Genezen (USA) was founded in 1998.
- Genezen (USA) has 602 employees.
- Genezen (USA) has one manufacturing site listed on CDMO Hub, in Lexington, United States.
- Genezen (USA)'s capabilities include Small Molecule API, Small Molecule Drug Product and Oral Solid Dose.
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