OBiO Tech (OBiO Technology)
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Advanced Modalities
Analytical & Bioanalytical Services
Company Overview
About
OBiO Tech (OBiO Technology) is a pharmaceutical CDMO offering comprehensive services.
Key Expertise
Specialized in Formulation Development, Process Development, Scale-up
Therapeutic Areas
Immunology
Rheumatology
Quick Facts
HQ:China
Founded:1999
Employees:1,371
Capabilities & Services
Core Capabilities
- Peptide Synthesis
- Small Molecule API
- Formulation Development
Types of Organization
GMP Manufacturing
Quality Systems
Regulatory Support
Dosage Forms
Inhalation
Containment Capabilities
OEB 5 (≤1 µg/m³)
Cytotoxic / ADC Handling
Production Scales
Pilot Scale
Clinical
Commercial Scale
Markets Served
Asia-Pacific
Regulatory Approvals
Drug Approval V8JVCB
PMDA · #APR-N4D3VBG1 · 2018-05-01
Drug Approval EMG1O8
EMA · #APR-1ZAYVBGL · 2020-06-01
Certifications
FDA Registration
U.S. Food and Drug Administration
Cert #: CERT-E5DPYVLC
Issued: 2020-08-28
Expires: 2025-09-27
EMA GMP Certificate
European Medicines Agency
Cert #: CERT-74TTYQUE
Issued: 2020-04-11
Expires: 2025-11-13
ISO 13485:2016
International Organization for Standardization
Cert #: CERT-08UKVKEE
Issued: 2020-11-03
Expires: 2025-05-20
WHO GMP
World Health Organization
Cert #: CERT-UM2BNVFC
Issued: 2020-05-21
Expires: 2025-01-22
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Key facts about OBiO Tech (OBiO Technology)
- OBiO Tech (OBiO Technology) is headquartered in China.
- OBiO Tech (OBiO Technology) was founded in 1999.
- OBiO Tech (OBiO Technology) has 1,371 employees.
- OBiO Tech (OBiO Technology)'s capabilities include Peptide Synthesis, Small Molecule API and Formulation Development.
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