Drug Product
Excipients & Specialty Ingredients
Company Overview
About
Linnea SA is a pharmaceutical CDMO offering comprehensive services.
Key Expertise
Specialized in Biologics Manufacturing, Monoclonal Antibodies, Vaccines
Therapeutic Areas
Rare Disease
Metabolic
Quick Facts
HQ:Switzerland
Founded:2016
Employees:845
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
BSL-2 (Biosafety Level 2)
Production Scales
Phase II
Clinical
Pilot Scale
Markets Served
Europe
International Regulatory
EU GMP Certificates
1
Regulatory Bodies
EMA/EudraGMDP
Regulatory Approvals
Drug Approval TRQRJ6
EMA · #APR-C1TNQD4O · 2018-09-01
Certifications
FDA Registration
U.S. Food and Drug Administration
Cert #: CERT-X7FC0UZL
Issued: 2020-07-17
Expires: 2025-05-02
EMA GMP Certificate
European Medicines Agency
Cert #: CERT-C89ULXTJ
Issued: 2020-10-07
Expires: 2025-03-23
ISO 13485:2016
International Organization for Standardization
Cert #: CERT-LZV76IEV
Issued: 2020-05-08
Expires: 2025-05-12
WHO GMP
World Health Organization
Cert #: CERT-JK5IYFUD
Issued: 2020-11-27
Expires: 2025-06-12
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Key facts about Linnea SA
- Linnea SA is headquartered in Switzerland.
- Linnea SA was founded in 2016.
- Linnea SA has 845 employees.
- Linnea SA's capabilities include Biologics Drug Substance, Biologics Drug Product and Biologics Manufacturing.
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