Biopharma Group CDMO
Drug Product
Analytical & Bioanalytical Services
Regulatory, Tech Transfer & Support Services
Company Overview
About
Biopharma Group CDMO is a pharmaceutical CDMO offering comprehensive services.
Key Expertise
Specialized in Formulation Development, Process Development, Scale-up
Therapeutic Areas
Neurology
Quick Facts
HQ:China
Founded:2015
Employees:348
Capabilities & Services
Core Capabilities
- Cytotoxic / ADC Handling
- High-Potency API
- Sterile Fill/Finish
Technology Platforms
GMP Manufacturing
Quality Systems
Regulatory Support
Dosage Forms
Topical / Transdermal
Containment Capabilities
BSL-2 (Biosafety Level 2)
Production Scales
Phase III Clinical Trials
Commercial Scale
Clinical
Markets Served
Europe
Manufacturing Facilities
4 sites worldwide
Biopharma Group CDMO - China Facility
China
Site Capabilities
Formulation Development
Process Development
Scale-up
Biopharma Group CDMO - France Facility
France
Site Capabilities
Formulation Development
Process Development
Scale-up
Biopharma Group CDMO - Italy Facility
Italy
Site Capabilities
Formulation Development
Process Development
Scale-up
Biopharma Group CDMO - United States Facility
United States
Site Capabilities
Formulation Development
Process Development
Scale-up
Regulatory Approvals
Drug Approval AZR8XM
EMA · #APR-HT4JNEI3 · 2021-10-01
Certifications
EMA GMP Certificate
European Medicines Agency
Cert #: CERT-VRCSES4F
Issued: 2020-01-02
Expires: 2025-10-25
ISO 9001:2015
International Organization for Standardization
Cert #: CERT-83Q9X4GV
Issued: 2020-11-10
Expires: 2025-05-01
ISO 13485:2016
International Organization for Standardization
Cert #: CERT-F7ZKIQLI
Issued: 2020-05-25
Expires: 2025-03-22
MHRA GMP
UK Medicines and Healthcare products Regulatory Agency
Cert #: CERT-AFG98QXZ
Issued: 2020-03-27
Expires: 2025-03-23
Customer Reviews
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Company Documents
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