Drug Product
Analytical & Bioanalytical Services
Regulatory, Tech Transfer & Support Services
Company Overview
About
Bioneer A/S is a pharmaceutical CDMO offering comprehensive services.
Key Expertise
Specialized in Formulation Development, Process Development, Scale-up
Therapeutic Areas
Immunology
Rheumatology
Quick Facts
HQ:Denmark
Founded:2017
Employees:1,915
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
Cytotoxic / ADC Handling
Production Scales
Phase III Clinical Trials
Commercial Scale
Clinical
Markets Served
North America
Regulatory Approvals
Drug Approval KMTB2I
Health Canada · #APR-8MUTOO2X · 2019-06-01
Drug Approval FYSCM7
Health Canada · #APR-D66X3Y7K · 2020-04-01
Certifications
FDA Registration
U.S. Food and Drug Administration
Cert #: CERT-LO2881G1
Issued: 2020-08-24
Expires: 2025-03-12
EMA GMP Certificate
European Medicines Agency
Cert #: CERT-3G24XM5V
Issued: 2020-12-04
Expires: 2025-02-26
ISO 9001:2015
International Organization for Standardization
Cert #: CERT-LXIBPB1X
Issued: 2020-07-15
Expires: 2025-06-11
ISO 13485:2016
International Organization for Standardization
Cert #: CERT-IBY72S25
Issued: 2020-04-14
Expires: 2025-11-03
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Key facts about Bioneer A/S
- Bioneer A/S is headquartered in Denmark.
- Bioneer A/S was founded in 2017.
- Bioneer A/S has 1,915 employees.
- Bioneer A/S's capabilities include Peptide Synthesis, Small Molecule API and Formulation Development.
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