Drug Product
Advanced Modalities
Analytical & Bioanalytical Services
Company Overview
About
GenScript ProBio is a pharmaceutical CDMO offering comprehensive services.
Key Expertise
Specialized in Gene Therapy, Cell Therapy, mRNA
Therapeutic Areas
Oncology
Hematology
Quick Facts
HQ:China
Founded:1990
Employees:2,716
Capabilities & Services
Core Capabilities
- Oral Solid Dose
- Solid Dose Manufacturing
- Formulation Development
Types of Organization
GMP Manufacturing
Quality Systems
Regulatory Support
Dosage Forms
Lyophilized (Freeze-Dried)
Sterile Injectable
Production Scales
Phase III Clinical Trials
Commercial Scale
Clinical
Markets Served
North America
Europe
Regulatory Approvals
Drug Approval 64011J
FDA · #APR-I39OAXP5 · 2018-12-01
Drug Approval 4995RB
FDA · #APR-JIL9J7Q7 · 2020-09-01
Case Studies
0 published case studies showcasing past projects, challenges and outcomes.
Certifications
FDA Registration
U.S. Food and Drug Administration
Cert #: CERT-EMPVEYX5
Issued: 2020-10-23
Expires: 2025-05-13
ISO 13485:2016
International Organization for Standardization
Cert #: CERT-N6BQB4CY
Issued: 2020-06-16
Expires: 2025-02-28
Health Canada GMP
Health Canada
Cert #: CERT-P0267WZY
Issued: 2020-09-25
Expires: 2025-06-15
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Key facts about GenScript ProBio
- GenScript ProBio is headquartered in China.
- GenScript ProBio was founded in 1990.
- GenScript ProBio has 2,716 employees.
- GenScript ProBio's capabilities include Oral Solid Dose, Solid Dose Manufacturing and Formulation Development.
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