Drug Product
Regulatory, Tech Transfer & Support Services
Company Overview
About
Pharmalinea Ltd is a pharmaceutical CDMO offering comprehensive services.
Key Expertise
Specialized in API Manufacturing, Sterile Fill/Finish, Lyophilization
Therapeutic Areas
Neurology
Quick Facts
HQ:Slovenia
Founded:2016
Employees:2,559
Capabilities & Services
Core Capabilities
- Cytotoxic / ADC Handling
- High-Potency API
- Sterile Fill/Finish
Types of Organization
GMP Manufacturing
Quality Systems
Regulatory Support
Dosage Forms
Topical / Transdermal
Containment Capabilities
OEB 5 (≤1 µg/m³)
Cytotoxic / ADC Handling
Production Scales
Pilot Scale
Clinical
Commercial Scale
Markets Served
Asia-Pacific
Regulatory Approvals
Drug Approval TUUU5Z
Health Canada · #APR-S8XSGPOD · 2020-09-01
Certifications
FDA Registration
U.S. Food and Drug Administration
Cert #: CERT-RZ0F65JC
Issued: 2020-04-23
Expires: 2025-07-22
EMA GMP Certificate
European Medicines Agency
Cert #: CERT-66KE4IC3
Issued: 2020-02-17
Expires: 2025-01-22
ISO 9001:2015
International Organization for Standardization
Cert #: CERT-EHD3ARUH
Issued: 2020-11-18
Expires: 2025-03-16
Health Canada GMP
Health Canada
Cert #: CERT-M8IOY3IG
Issued: 2020-07-14
Expires: 2025-12-15
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Key facts about Pharmalinea Ltd
- Pharmalinea Ltd is headquartered in Slovenia.
- Pharmalinea Ltd was founded in 2016.
- Pharmalinea Ltd has 2,559 employees.
- Pharmalinea Ltd 's capabilities include Cytotoxic / ADC Handling, High-Potency API and Sterile Fill/Finish.
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