Drug Product
Regulatory, Tech Transfer & Support Services
Company Overview
About
Biose Industrie is a pharmaceutical CDMO offering comprehensive services.
Key Expertise
Specialized in Solid Dose Manufacturing, Oral Liquids, Topicals
Therapeutic Areas
Rare Disease
Metabolic
Quick Facts
HQ:France
Founded:2003
Employees:2,783
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
BSL-2 (Biosafety Level 2)
Production Scales
Phase II
Clinical
Pilot Scale
Markets Served
Europe
International Regulatory
EU GMP Certificates
8
Regulatory Bodies
EMA/EudraGMDP
Regulatory Approvals
Drug Approval 6ZWLQP
Health Canada · #APR-S6RI4RO9 · 2020-02-01
Drug Approval JQOD3I
PMDA · #APR-NBZ45XS9 · 2018-07-01
Certifications
FDA Registration
U.S. Food and Drug Administration
Cert #: CERT-EG16KN9Z
Issued: 2020-09-06
Expires: 2025-03-02
EMA GMP Certificate
European Medicines Agency
Cert #: CERT-DZU81EZI
Issued: 2020-04-10
Expires: 2025-03-07
MHRA GMP
UK Medicines and Healthcare products Regulatory Agency
Cert #: CERT-M5V094J3
Issued: 2020-04-23
Expires: 2025-09-17
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Key facts about Biose Industrie
- Biose Industrie is headquartered in France.
- Biose Industrie was founded in 2003.
- Biose Industrie has 2,783 employees.
- Biose Industrie's capabilities include Biologics Drug Substance, Biologics Drug Product and Biologics Manufacturing.
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