Drug Product
Advanced Modalities
Analytical & Bioanalytical Services
Company Overview
About
HALIX is a pharmaceutical CDMO offering comprehensive services.
Key Expertise
Specialized in API Manufacturing, Sterile Fill/Finish, Lyophilization
Therapeutic Areas
Rare Disease
Metabolic
Quick Facts
HQ:Netherlands
Founded:1995
Employees:225
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
Phase III Clinical Trials
Commercial Scale
Clinical
Markets Served
Asia-Pacific
International Regulatory
EU GMP Certificates
2
Regulatory Bodies
EMA/EudraGMDP
Regulatory Approvals
Drug Approval NAK9GZ
FDA · #APR-7QZTR5ON · 2018-12-01
Case Studies
0 published case studies showcasing past projects, challenges and outcomes.
Certifications
ISO 9001:2015
International Organization for Standardization
Cert #: CERT-6E4NENR1
Issued: 2020-01-02
Expires: 2025-02-07
ISO 13485:2016
International Organization for Standardization
Cert #: CERT-4BRQY6PX
Issued: 2020-02-12
Expires: 2025-01-04
MHRA GMP
UK Medicines and Healthcare products Regulatory Agency
Cert #: CERT-JRSMT1HP
Issued: 2020-11-27
Expires: 2025-12-21
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Key facts about HALIX
- HALIX is headquartered in the Netherlands.
- HALIX was founded in 1995.
- HALIX has 225 employees.
- HALIX's capabilities include Biologics Drug Substance, Biologics Drug Product and Biologics Manufacturing.
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