Eczacıbaşı-Monrol
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Drug Product
Analytical & Bioanalytical Services
Company Overview
About
Eczacıbaşı-Monrol is a pharmaceutical CDMO offering comprehensive services.
Key Expertise
Specialized in Biologics Manufacturing, Monoclonal Antibodies, Vaccines
Therapeutic Areas
Rare Disease
Metabolic
Quick Facts
HQ:Germany
Founded:2015
Employees:1,118
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
Production Scales
Phase III Clinical Trials
Commercial Scale
Clinical
Markets Served
North America
Europe
Manufacturing Facilities
1 site worldwide
CIS Bio International
RTE NATIONALE 306, SACLAY, ILE DE FRANCE, 91400
Site Capabilities
5 capabilitiesANALYSIS
API MANUFACTURE
MANUFACTURE
PACK
STERILIZE
Regulatory Approvals
Drug Approval O7ZN5B
PMDA · #APR-0TNXDCJ0 · 2020-06-01
Certifications
EMA GMP Certificate
European Medicines Agency
Cert #: CERT-HHZWMT8K
Issued: 2020-05-19
Expires: 2025-07-18
ISO 9001:2015
International Organization for Standardization
Cert #: CERT-DZ0X59P1
Issued: 2020-01-05
Expires: 2025-03-27
ISO 13485:2016
International Organization for Standardization
Cert #: CERT-IS532518
Issued: 2020-02-15
Expires: 2025-12-18
MHRA GMP
UK Medicines and Healthcare products Regulatory Agency
Cert #: CERT-31OQK3YO
Issued: 2020-01-03
Expires: 2025-04-14
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Key facts about Eczacıbaşı-Monrol
- Eczacıbaşı-Monrol is headquartered in Germany.
- Eczacıbaşı-Monrol was founded in 2015.
- Eczacıbaşı-Monrol has 1,118 employees.
- Eczacıbaşı-Monrol has one manufacturing site listed on CDMO Hub, in SACLAY, France.
- Eczacıbaşı-Monrol's capabilities include Biologics Drug Substance, Biologics Drug Product and Biologics Manufacturing.
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