BioFusion JSC
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Excipients & Specialty Ingredients
Company Overview
About
BioFusion JSC is a pharmaceutical CDMO offering comprehensive services.
Key Expertise
Specialized in API Manufacturing, Sterile Fill/Finish, Lyophilization
Therapeutic Areas
Rare Disease
Metabolic
Quick Facts
HQ:Poland
Founded:2013
Employees:1,747
Capabilities & Services
Core Capabilities
- Biologics Drug Substance
- Biologics Drug Product
- Biologics Manufacturing
Types of Organization
GMP Manufacturing
Quality Systems
Regulatory Support
Dosage Forms
Prefilled Syringe
Sterile Injectable
Containment Capabilities
OEB 4 (1-10 µg/m³)
Production Scales
Commercial Scale
Large Scale (Metric Ton+)
Markets Served
Global
Regulatory Approvals
Drug Approval PDRJDQ
PMDA · #APR-30V86AIX · 2018-07-01
Certifications
ISO 13485:2016
International Organization for Standardization
Cert #: CERT-I06WT5R2
Issued: 2020-05-03
Expires: 2025-07-26
FDA Registration
U.S. Food and Drug Administration
Cert #: CERT-SSHMGAXX
Issued: 2020-08-09
Expires: 2025-05-26
EMA GMP Certificate
European Medicines Agency
Cert #: CERT-KUOC7Y5S
Issued: 2020-09-10
Expires: 2025-09-16
WHO GMP
World Health Organization
Cert #: CERT-7NDWTU9Z
Issued: 2020-01-17
Expires: 2025-09-12
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Key facts about BioFusion JSC
- BioFusion JSC is headquartered in Poland.
- BioFusion JSC was founded in 2013.
- BioFusion JSC has 1,747 employees.
- BioFusion JSC's capabilities include Biologics Drug Substance, Biologics Drug Product and Biologics Manufacturing.
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