Advanced Modalities
Analytical & Bioanalytical Services
Company Overview
About
GENEFAB is a pharmaceutical CDMO offering comprehensive services.
Key Expertise
Specialized in API Manufacturing, Sterile Fill/Finish, Lyophilization
Therapeutic Areas
Infectious Disease
Quick Facts
HQ:United States
Founded:2014
Employees:2,024
Capabilities & Services
Core Capabilities
- Small Molecule API
- Small Molecule Drug Product
- Oral Solid Dose
Types of Organization
GMP Manufacturing
Quality Systems
Regulatory Support
Dosage Forms
Oral Solid Dose
Containment Capabilities
OEB 5 (≤1 µg/m³)
Cytotoxic / ADC Handling
Production Scales
Phase II
Clinical
Pilot Scale
Markets Served
Asia-Pacific
Regulatory Approvals
Drug Approval NFJM3T
EMA · #APR-AB091B6Y · 2021-10-01
Drug Approval S8N1HK
EMA · #APR-2KQKVOTO · 2021-03-01
Case Studies
0 published case studies showcasing past projects, challenges and outcomes.
Certifications
ISO 13485:2016
International Organization for Standardization
Cert #: CERT-3VHVBBSO
Issued: 2020-08-06
Expires: 2025-01-15
WHO GMP
World Health Organization
Cert #: CERT-QFRCL4WF
Issued: 2020-09-26
Expires: 2025-09-22
MHRA GMP
UK Medicines and Healthcare products Regulatory Agency
Cert #: CERT-FREUHJA1
Issued: 2020-12-11
Expires: 2025-11-23
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Key facts about GENEFAB
- GENEFAB is headquartered in the United States.
- GENEFAB was founded in 2014.
- GENEFAB has 2,024 employees.
- GENEFAB's capabilities include Small Molecule API, Small Molecule Drug Product and Oral Solid Dose.
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