Borealis (Healthcare Materials)
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Excipients & Specialty Ingredients
Company Overview
About
Borealis (Healthcare Materials) is a pharmaceutical CDMO offering comprehensive services.
Key Expertise
Specialized in API Manufacturing, Sterile Fill/Finish, Lyophilization
Therapeutic Areas
Cardiovascular
Endocrinology
Quick Facts
HQ:Austria
Founded:1991
Employees:795
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
Cytotoxic / ADC Handling
Production Scales
Pilot Scale
Phase I Clinical Trials
Clinical
Markets Served
North America
Regulatory Approvals
Drug Approval 8SLE96
EMA · #APR-TJQPENJQ · 2020-08-01
Drug Approval K3U2AA
PMDA · #APR-V13MOBLQ · 2021-12-01
Case Studies
0 published case studies showcasing past projects, challenges and outcomes.
Certifications
FDA Registration
U.S. Food and Drug Administration
Cert #: CERT-78JUL8A0
Issued: 2020-01-21
Expires: 2025-05-23
EMA GMP Certificate
European Medicines Agency
Cert #: CERT-R3QUPO3A
Issued: 2020-04-06
Expires: 2025-12-17
WHO GMP
World Health Organization
Cert #: CERT-R0YXP6O1
Issued: 2020-05-18
Expires: 2025-06-19
Health Canada GMP
Health Canada
Cert #: CERT-N1QPH7OD
Issued: 2020-01-05
Expires: 2025-02-22
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Key facts about Borealis (Healthcare Materials)
- Borealis (Healthcare Materials) is headquartered in Austria.
- Borealis (Healthcare Materials) was founded in 1991.
- Borealis (Healthcare Materials) has 795 employees.
- Borealis (Healthcare Materials)'s capabilities include Sterile Injectable, Sterile Fill/Finish and Fill/Finish (Vials).
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