Borregaard
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Drug Product
Company Overview
About
Borregaard is a pharmaceutical CDMO offering comprehensive services.
Key Expertise
Specialized in Biologics Manufacturing, Monoclonal Antibodies, Vaccines
Therapeutic Areas
Neurology
Quick Facts
HQ:Norway
Founded:2004
Employees:751
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
BSL-2 (Biosafety Level 2)
Production Scales
Phase II
Clinical
Pilot Scale
Markets Served
Europe
Manufacturing Facilities
1 site worldwide
Borregaard AS
Hjalmar Wessels vei 6, Sarpsborg, 1721
Site Capabilities
1 capabilityAPI MANUFACTURE
International Regulatory
EU GMP Certificates
1
Regulatory Bodies
EMA/EudraGMDP
Regulatory Approvals
Drug Approval PIHMN8
Health Canada · #APR-O6V4JV82 · 2022-06-01
Case Studies
0 published case studies showcasing past projects, challenges and outcomes.
Certifications
FDA Registration
U.S. Food and Drug Administration
Cert #: CERT-FAQICXJW
Issued: 2020-01-25
Expires: 2025-07-23
EMA GMP Certificate
European Medicines Agency
Cert #: CERT-MQ3EQD2R
Issued: 2020-09-23
Expires: 2025-04-13
ISO 9001:2015
International Organization for Standardization
Cert #: CERT-NDOOR24E
Issued: 2020-05-15
Expires: 2025-01-04
MHRA GMP
UK Medicines and Healthcare products Regulatory Agency
Cert #: CERT-8D0QK1ZD
Issued: 2020-06-15
Expires: 2025-07-07
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Key facts about Borregaard
- Borregaard is headquartered in Norway.
- Borregaard was founded in 2004.
- Borregaard has 751 employees.
- Borregaard has one manufacturing site listed on CDMO Hub, in Sarpsborg, Norway.
- Borregaard's capabilities include Cytotoxic / ADC Handling, High-Potency API and Sterile Fill/Finish.
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