Excipients & Specialty Ingredients
Regulatory, Tech Transfer & Support Services
Company Overview
About
Genepep SAS is a pharmaceutical CDMO offering comprehensive services.
Key Expertise
Specialized in Formulation Development, Process Development, Scale-up
Therapeutic Areas
Rare Disease
Metabolic
Quick Facts
HQ:France
Founded:2015
Employees:2,688
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
Cytotoxic / ADC Handling
Production Scales
Phase III Clinical Trials
Commercial Scale
Clinical
Markets Served
North America
Regulatory Approvals
Drug Approval DXBDXT
FDA · #APR-U53N2JVM · 2022-05-01
Drug Approval FTHLF5
Health Canada · #APR-7ML1HIB4 · 2019-01-01
Certifications
EMA GMP Certificate
European Medicines Agency
Cert #: CERT-L5R4LC09
Issued: 2020-12-15
Expires: 2025-07-21
ISO 9001:2015
International Organization for Standardization
Cert #: CERT-7PAD7X43
Issued: 2020-09-10
Expires: 2025-09-01
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Key facts about Genepep SAS
- Genepep SAS is headquartered in France.
- Genepep SAS was founded in 2015.
- Genepep SAS has 2,688 employees.
- Genepep SAS's capabilities include Biologics Drug Substance, Biologics Drug Product and Biologics Manufacturing.
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