Salinen Austria AG
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Excipients & Specialty Ingredients
Company Overview
About
Salinen Austria AG is a pharmaceutical CDMO offering comprehensive services.
Key Expertise
Specialized in Biologics Manufacturing, Monoclonal Antibodies, Vaccines
Therapeutic Areas
Cardiovascular
Endocrinology
Quick Facts
HQ:Austria
Founded:2017
Employees:2,933
Capabilities & Services
Core Capabilities
- Sterile Injectable
- Sterile Fill/Finish
- Fill/Finish (Vials)
Types of Organization
GMP Manufacturing
Quality Systems
Regulatory Support
Dosage Forms
Cartridge / Pen
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
6
Regulatory Bodies
EMA/EudraGMDP
Regulatory Approvals
Drug Approval 6TKGRM
FDA · #APR-OOLGMH8M · 2022-03-01
Drug Approval 6BJD61
EMA · #APR-I5H7EET8 · 2020-10-01
Case Studies
0 published case studies showcasing past projects, challenges and outcomes.
Certifications
FDA Registration
U.S. Food and Drug Administration
Cert #: CERT-S9MI3WXY
Issued: 2020-06-03
Expires: 2025-10-15
EMA GMP Certificate
European Medicines Agency
Cert #: CERT-GAQUNZUQ
Issued: 2020-08-12
Expires: 2025-07-05
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Key facts about Salinen Austria AG
- Salinen Austria AG is headquartered in Austria.
- Salinen Austria AG was founded in 2017.
- Salinen Austria AG has 2,933 employees.
- Salinen Austria AG's capabilities include Sterile Injectable, Sterile Fill/Finish and Fill/Finish (Vials).
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