Pharmaniaga Manufacturing Berhad
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Drug Product
Qualification/Validation Services
Regulatory, Tech Transfer & Support Services
Company Overview
About
Pharmaniaga Manufacturing Berhad is a pharmaceutical CDMO offering comprehensive services.
Key Expertise
Specialized in Formulation Development, Process Development, Scale-up
Therapeutic Areas
Rare Disease
Metabolic
Quick Facts
HQ:Malaysia
Founded:2007
Employees:2,292
Capabilities & Services
Core Capabilities
- Biologics Drug Substance
- Biologics Drug Product
- Biologics Manufacturing
Types of Organization
GMP Manufacturing
Quality Systems
Regulatory Support
Dosage Forms
Prefilled Syringe
Sterile Injectable
Containment Capabilities
OEB 5 (≤1 µg/m³)
Cytotoxic / ADC Handling
Production Scales
Commercial Scale
Large Scale (Metric Ton+)
Markets Served
Asia-Pacific
Regulatory Approvals
Drug Approval 677768
FDA · #APR-K5Z96WGE · 2018-04-01
Drug Approval JS8DCV
PMDA · #APR-D824YV06 · 2018-09-01
Certifications
EMA GMP Certificate
European Medicines Agency
Cert #: CERT-3OUHD6AI
Issued: 2020-07-17
Expires: 2025-09-03
ISO 13485:2016
International Organization for Standardization
Cert #: CERT-8W7IRH0A
Issued: 2020-03-27
Expires: 2025-07-07
WHO GMP
World Health Organization
Cert #: CERT-3XZ56BMJ
Issued: 2020-02-24
Expires: 2025-06-01
MHRA GMP
UK Medicines and Healthcare products Regulatory Agency
Cert #: CERT-GGT614FM
Issued: 2020-06-19
Expires: 2025-12-24
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Key facts about Pharmaniaga Manufacturing Berhad
- Pharmaniaga Manufacturing Berhad is headquartered in Malaysia.
- Pharmaniaga Manufacturing Berhad was founded in 2007.
- Pharmaniaga Manufacturing Berhad has 2,292 employees.
- Pharmaniaga Manufacturing Berhad's capabilities include Biologics Drug Substance, Biologics Drug Product and Biologics Manufacturing.
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