Advanced Modalities
Analytical & Bioanalytical Services
Company Overview
About
NorthX Biologics is a pharmaceutical CDMO offering comprehensive services.
Key Expertise
Specialized in Formulation Development, Process Development, Scale-up
Therapeutic Areas
Infectious Disease
Quick Facts
HQ:Sweden
Founded:2001
Employees:1,809
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
Commercial Scale
Large Scale (Metric Ton+)
Markets Served
Asia-Pacific
International Regulatory
EU GMP Certificates
4
Regulatory Bodies
EMA/EudraGMDP
Regulatory Approvals
Drug Approval C8KB2W
FDA · #APR-BK45G43D · 2020-12-01
Drug Approval BH70VG
Health Canada · #APR-AN4ZMG0P · 2022-10-01
Case Studies
0 published case studies showcasing past projects, challenges and outcomes.
Certifications
FDA Registration
U.S. Food and Drug Administration
Cert #: CERT-TWNB5PSL
Issued: 2020-08-14
Expires: 2025-03-23
EMA GMP Certificate
European Medicines Agency
Cert #: CERT-ID4UAC7L
Issued: 2020-11-18
Expires: 2025-03-07
Health Canada GMP
Health Canada
Cert #: CERT-A2BIHRI3
Issued: 2020-09-24
Expires: 2025-12-26
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Key facts about NorthX Biologics
- NorthX Biologics is headquartered in Sweden.
- NorthX Biologics was founded in 2001.
- NorthX Biologics has 1,809 employees.
- NorthX Biologics's capabilities include Small Molecule API, Small Molecule Drug Product and Oral Solid Dose.
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