Guangzhou Packgene Biotechnology Co Ltd (PackGene)
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Advanced Modalities
Analytical & Bioanalytical Services
Contract Research Organization
Company Overview
About
Guangzhou Packgene Biotechnology Co Ltd (PackGene) is a pharmaceutical CDMO offering comprehensive services.
Key Expertise
Specialized in Biologics Manufacturing, Monoclonal Antibodies, Vaccines
Therapeutic Areas
Oncology
Hematology
Quick Facts
HQ:China
Founded:2010
Employees:2,419
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
OEB 4 (1-10 µg/m³)
Production Scales
Pilot Scale
Clinical
Commercial Scale
Markets Served
Global
Manufacturing Facilities
1 site worldwide
Guangzhou Tata Biotechnology Co., Ltd.
2F of Building No. 1, Building No. 2, 03, No. 13, Fengxiang Zhong Road, Jianggao Town, Baiyun District, Guangzhou, Guangzhou, 510450
Site Capabilities
2 capabilitiesLABEL
MANUFACTURE
Regulatory Approvals
Drug Approval 9C2PM1
Health Canada · #APR-B2SPT2GB · 2022-01-01
Drug Approval ARQJ19
PMDA · #APR-02GH5YUZ · 2022-02-01
Case Studies
0 published case studies showcasing past projects, challenges and outcomes.
Certifications
FDA Registration
U.S. Food and Drug Administration
Cert #: CERT-20P2QIR1
Issued: 2020-05-16
Expires: 2025-11-23
EMA GMP Certificate
European Medicines Agency
Cert #: CERT-ZQJB0OIM
Issued: 2020-06-08
Expires: 2025-07-03
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Key facts about Guangzhou Packgene Biotechnology Co Ltd (PackGene)
- Guangzhou Packgene Biotechnology Co Ltd (PackGene) is headquartered in China.
- Guangzhou Packgene Biotechnology Co Ltd (PackGene) was founded in 2010.
- Guangzhou Packgene Biotechnology Co Ltd (PackGene) has 2,419 employees.
- Guangzhou Packgene Biotechnology Co Ltd (PackGene) has one manufacturing site listed on CDMO Hub, in Guangzhou, China.
- Guangzhou Packgene Biotechnology Co Ltd (PackGene)'s capabilities include Oral Solid Dose, Solid Dose Manufacturing and Formulation Development.
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