BioInvent International AB
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Drug Product
Analytical & Bioanalytical Services
Regulatory, Tech Transfer & Support Services
Company Overview
About
BioInvent International AB is a pharmaceutical CDMO offering comprehensive services.
Key Expertise
Specialized in API Manufacturing, Sterile Fill/Finish, Lyophilization
Therapeutic Areas
Infectious Disease
Quick Facts
HQ:Sweden
Founded:2011
Employees:1,572
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
Containment Capabilities
OEB 5 (≤1 µg/m³)
Cytotoxic / ADC Handling
Production Scales
Commercial Scale
Large Scale (Metric Ton+)
Markets Served
Asia-Pacific
International Regulatory
EU GMP Certificates
1
Regulatory Bodies
EMA/EudraGMDP
Regulatory Approvals
Drug Approval PRJE2B
EMA · #APR-2NEN17E9 · 2019-06-01
Drug Approval FFQXX0
FDA · #APR-P6MGSPDO · 2022-02-01
Case Studies
0 published case studies showcasing past projects, challenges and outcomes.
Certifications
FDA Registration
U.S. Food and Drug Administration
Cert #: CERT-P11JWVIN
Issued: 2020-07-25
Expires: 2025-09-14
EMA GMP Certificate
European Medicines Agency
Cert #: CERT-GHGOPNIS
Issued: 2020-06-03
Expires: 2025-11-09
MHRA GMP
UK Medicines and Healthcare products Regulatory Agency
Cert #: CERT-31RH3PQ2
Issued: 2020-09-08
Expires: 2025-12-21
Health Canada GMP
Health Canada
Cert #: CERT-L5F0OX4J
Issued: 2020-01-12
Expires: 2025-12-15
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Key facts about BioInvent International AB
- BioInvent International AB is headquartered in Sweden.
- BioInvent International AB was founded in 2011.
- BioInvent International AB has 1,572 employees.
- BioInvent International AB's capabilities include Small Molecule API, Small Molecule Drug Product and Oral Solid Dose.
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