Drug Product
Excipients & Specialty Ingredients
Company Overview
About
BIOFAC A/S (BIOFAC Group) is a pharmaceutical CDMO offering comprehensive services.
Key Expertise
Specialized in Gene Therapy, Cell Therapy, mRNA
Therapeutic Areas
Immunology
Rheumatology
Quick Facts
HQ:Denmark
Founded:2016
Employees:1,411
Capabilities & Services
Core Capabilities
- Peptide Synthesis
- Small Molecule API
- Formulation Development
Types of Organization
GMP Manufacturing
Quality Systems
Regulatory Support
Dosage Forms
Inhalation
Containment Capabilities
OEB 5 (≤1 µg/m³)
Cytotoxic / ADC Handling
Production Scales
R&D / Pre-clinical
Lab Scale
Pilot Scale
Markets Served
Asia-Pacific
Manufacturing Facilities
2 sites worldwide
Biofac A/S
Ejbyvej 44, Lille Skensved, Sjaelland, 4623
Site Capabilities
1 capabilityAPI MANUFACTURE
A/S Orthana Kemisk Fabrik
Englandsvej 350-356, Kastrup, Hovedstaden, 2770
Site Capabilities
1 capabilityMANUFACTURE
International Regulatory
EU GMP Certificates
14
Regulatory Bodies
EMA/EudraGMDP
Regulatory Approvals
Drug Approval EQG9FV
EMA · #APR-N7K8PGLH · 2021-11-01
Case Studies
0 published case studies showcasing past projects, challenges and outcomes.
Certifications
FDA Registration
U.S. Food and Drug Administration
Cert #: CERT-UXLGK2JP
Issued: 2020-10-26
Expires: 2025-01-02
EMA GMP Certificate
European Medicines Agency
Cert #: CERT-YZ5MBZY1
Issued: 2020-04-20
Expires: 2025-11-11
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Key facts about BIOFAC A/S (BIOFAC Group)
- BIOFAC A/S (BIOFAC Group) is headquartered in Denmark.
- BIOFAC A/S (BIOFAC Group) was founded in 2016.
- BIOFAC A/S (BIOFAC Group) has 1,411 employees.
- BIOFAC A/S (BIOFAC Group) has 2 manufacturing sites listed on CDMO Hub, in Lille Skensved, Denmark and Kastrup, Denmark.
- BIOFAC A/S (BIOFAC Group)'s capabilities include Peptide Synthesis, Small Molecule API and Formulation Development.
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