Analytical & Bioanalytical Services
Company Overview
About
Biofortuna is a pharmaceutical CDMO offering comprehensive services.
Key Expertise
Specialized in Biologics Manufacturing, Monoclonal Antibodies, Vaccines
Therapeutic Areas
Infectious Disease
Quick Facts
HQ:United Kingdom
Founded:2016
Employees:849
Capabilities & Services
Core Capabilities
- Small Molecule API
- Small Molecule Drug Product
- Oral Solid Dose
Types of Organization
GMP Manufacturing
Quality Systems
Regulatory Support
Dosage Forms
Oral Solid Dose
Production Scales
Phase III Clinical Trials
Commercial Scale
Clinical
Markets Served
North America
Europe
Manufacturing Facilities
1 site worldwide
Biofortuna Limited
Unit 2, Tenth Avenue, Deeside
Regulatory Approvals
Drug Approval JX5MYY
FDA · #APR-X7QQ4IZK · 2019-02-01
Case Studies
0 published case studies showcasing past projects, challenges and outcomes.
Certifications
FDA Registration
U.S. Food and Drug Administration
Cert #: CERT-F30HVL9Z
Issued: 2020-12-04
Expires: 2025-04-18
ISO 13485:2016
International Organization for Standardization
Cert #: CERT-L05S7MQJ
Issued: 2020-09-16
Expires: 2025-10-10
MHRA GMP
UK Medicines and Healthcare products Regulatory Agency
Cert #: CERT-YTHDNRDE
Issued: 2020-05-07
Expires: 2025-04-11
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Key facts about Biofortuna
- Biofortuna is headquartered in the United Kingdom.
- Biofortuna was founded in 2016.
- Biofortuna has 849 employees.
- Biofortuna has one manufacturing site listed on CDMO Hub, in Deeside, United Kingdom.
- Biofortuna's capabilities include Small Molecule API, Small Molecule Drug Product and Oral Solid Dose.
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