Drug Product
Company Overview
About
Aurena Laboratories AB is a pharmaceutical CDMO offering comprehensive services.
Key Expertise
Specialized in Solid Dose Manufacturing, Oral Liquids, Topicals
Therapeutic Areas
Respiratory
Allergy
Quick Facts
HQ:Sweden
Founded:1997
Employees:927
Capabilities & Services
Core Capabilities
- Biologics Drug Substance
- Biologics Manufacturing
- Formulation Development
Types of Organization
GMP Manufacturing
Quality Systems
Regulatory Support
Dosage Forms
Sterile Injectable
Production Scales
Commercial Scale
Large Scale (Metric Ton+)
Markets Served
North America
Europe
Manufacturing Facilities
1 site worldwide
Aurena Laboratories AB
Fjarrviksvagen 22, Karlstad
Regulatory Approvals
Drug Approval 1W4057
EMA · #APR-V7ZGP08A · 2019-06-01
Drug Approval 43YZ8N
EMA · #APR-MJ7ZK62F · 2020-06-01
Case Studies
0 published case studies showcasing past projects, challenges and outcomes.
Certifications
EMA GMP Certificate
European Medicines Agency
Cert #: CERT-02AWAZ5X
Issued: 2020-07-21
Expires: 2025-01-26
ISO 13485:2016
International Organization for Standardization
Cert #: CERT-XFS2C8LS
Issued: 2020-03-08
Expires: 2025-07-09
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Key facts about Aurena Laboratories AB
- Aurena Laboratories AB is headquartered in Sweden.
- Aurena Laboratories AB was founded in 1997.
- Aurena Laboratories AB has 927 employees.
- Aurena Laboratories AB has one manufacturing site listed on CDMO Hub, in Karlstad, Sweden.
- Aurena Laboratories AB's capabilities include Biologics Drug Substance, Biologics Manufacturing and Formulation Development.
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