Drug Product
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Company Overview
About
Hongene Biotech is a pharmaceutical CDMO offering comprehensive services.
Key Expertise
Specialized in Formulation Development, Process Development, Scale-up
Therapeutic Areas
Oncology
Hematology
Quick Facts
HQ:China
Founded:2003
Employees:2,275
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
Containment Capabilities
Cytotoxic / ADC Handling
Production Scales
Commercial Scale
Large Scale (Metric Ton+)
Markets Served
North America
Regulatory Approvals
Drug Approval 0VLXJF
EMA · #APR-ETXHA5QP · 2019-08-01
Drug Approval 8SNRUM
FDA · #APR-DW0LRM6C · 2019-04-01
Certifications
FDA Registration
U.S. Food and Drug Administration
Cert #: CERT-AF2UABCJ
Issued: 2020-12-10
Expires: 2025-09-19
EMA GMP Certificate
European Medicines Agency
Cert #: CERT-GNYM51BJ
Issued: 2020-06-20
Expires: 2025-11-12
MHRA GMP
UK Medicines and Healthcare products Regulatory Agency
Cert #: CERT-F8RMF2LV
Issued: 2020-02-24
Expires: 2025-10-14
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Key facts about Hongene Biotech
- Hongene Biotech is headquartered in China.
- Hongene Biotech was founded in 2003.
- Hongene Biotech has 2,275 employees.
- Hongene Biotech's capabilities include Oral Solid Dose, Solid Dose Manufacturing and Formulation Development.
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