Drug Product
Company Overview
About
MEDIPPEX | Sippex is a pharmaceutical CDMO offering comprehensive services.
Key Expertise
Specialized in Biologics Manufacturing, Monoclonal Antibodies, Vaccines
Therapeutic Areas
Oncology
Hematology
Quick Facts
HQ:France
Founded:2009
Employees:3,013
Capabilities & Services
Core Capabilities
- Oral Solid Dose
- Solid Dose Manufacturing
- Formulation Development
Types of Organization
GMP Manufacturing
Quality Systems
Regulatory Support
Dosage Forms
Lyophilized (Freeze-Dried)
Sterile Injectable
Containment Capabilities
OEB 5 (≤1 µg/m³)
Cytotoxic / ADC Handling
Production Scales
Commercial Scale
Large Scale (Metric Ton+)
Markets Served
Asia-Pacific
Regulatory Approvals
Drug Approval HTO3CY
FDA · #APR-AU37TVCO · 2021-07-01
Certifications
ISO 13485:2016
International Organization for Standardization
Cert #: CERT-7313IOXX
Issued: 2020-12-26
Expires: 2025-06-20
Health Canada GMP
Health Canada
Cert #: CERT-158KCE6L
Issued: 2020-02-03
Expires: 2025-02-15
ISO 9001:2015
International Organization for Standardization
Cert #: CERT-C98LBUY1
Issued: 2020-08-18
Expires: 2025-04-20
FDA Registration
U.S. Food and Drug Administration
Cert #: CERT-XO5XWIC0
Issued: 2020-03-09
Expires: 2025-04-14
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Key facts about MEDIPPEX | Sippex
- MEDIPPEX | Sippex is headquartered in France.
- MEDIPPEX | Sippex was founded in 2009.
- MEDIPPEX | Sippex has 3,013 employees.
- MEDIPPEX | Sippex's capabilities include Oral Solid Dose, Solid Dose Manufacturing and Formulation Development.
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