Drug Product
Advanced Modalities
Analytical & Bioanalytical Services
Regulatory, Tech Transfer & Support Services
Company Overview
About
MabPlex International is a pharmaceutical CDMO offering comprehensive services.
Key Expertise
Specialized in Quality Control, Stability Testing, Method Development
Therapeutic Areas
Cardiovascular
Endocrinology
Quick Facts
HQ:China
Founded:2017
Employees:2,283
Capabilities & Services
Core Capabilities
- Sterile Injectable
- Sterile Fill/Finish
- Fill/Finish (Vials)
Types of Organization
GMP Manufacturing
Quality Systems
Regulatory Support
Dosage Forms
Cartridge / Pen
Containment Capabilities
Cytotoxic / ADC Handling
Production Scales
Pilot Scale
Phase I Clinical Trials
Clinical
Markets Served
North America
Regulatory Approvals
Drug Approval FSESYK
PMDA · #APR-AFR46SI3 · 2022-07-01
Drug Approval 4GADYY
PMDA · #APR-D840B846 · 2022-04-01
Certifications
EMA GMP Certificate
European Medicines Agency
Cert #: CERT-NR615FBO
Issued: 2020-11-07
Expires: 2025-06-08
ISO 9001:2015
International Organization for Standardization
Cert #: CERT-PREVZ4OP
Issued: 2020-03-03
Expires: 2025-02-09
ISO 13485:2016
International Organization for Standardization
Cert #: CERT-C26KCMHA
Issued: 2020-06-09
Expires: 2025-06-21
WHO GMP
World Health Organization
Cert #: CERT-AB5RGQ5U
Issued: 2020-01-17
Expires: 2025-03-12
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Key facts about MabPlex International
- MabPlex International is headquartered in China.
- MabPlex International was founded in 2017.
- MabPlex International has 2,283 employees.
- MabPlex International's capabilities include Sterile Injectable, Sterile Fill/Finish and Fill/Finish (Vials).
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