Medac CDMO (medac Gesellschaft für klinische Spezialpräparate mbH)
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Drug Product
Analytical & Bioanalytical Services
Regulatory, Tech Transfer & Support Services
Company Overview
About
Medac CDMO (medac Gesellschaft für klinische Spezialpräparate mbH) is a pharmaceutical CDMO offering comprehensive services.
Key Expertise
Specialized in Gene Therapy, Cell Therapy, mRNA
Therapeutic Areas
Respiratory
Allergy
Quick Facts
HQ:Czechia
Founded:2016
Employees:2,524
Capabilities & Services
Core Capabilities
- Biologics Drug Substance
- Biologics Manufacturing
- Formulation Development
Types of Organization
GMP Manufacturing
Quality Systems
Regulatory Support
Dosage Forms
Sterile Injectable
Containment Capabilities
BSL-2 (Biosafety Level 2)
Production Scales
Phase II
Clinical
Pilot Scale
Markets Served
Europe
Regulatory Approvals
Drug Approval 1R67JG
EMA · #APR-0FXSL92L · 2020-05-01
Drug Approval W78J4J
Health Canada · #APR-LQ7VC2UN · 2020-03-01
Certifications
FDA Registration
U.S. Food and Drug Administration
Cert #: CERT-15AQO54E
Issued: 2020-01-06
Expires: 2025-11-28
Health Canada GMP
Health Canada
Cert #: CERT-UG35A5KG
Issued: 2020-06-17
Expires: 2025-04-10
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Key facts about Medac CDMO (medac Gesellschaft für klinische Spezialpräparate mbH)
- Medac CDMO (medac Gesellschaft für klinische Spezialpräparate mbH) is headquartered in Czechia.
- Medac CDMO (medac Gesellschaft für klinische Spezialpräparate mbH) was founded in 2016.
- Medac CDMO (medac Gesellschaft für klinische Spezialpräparate mbH) has 2,524 employees.
- Medac CDMO (medac Gesellschaft für klinische Spezialpräparate mbH)'s capabilities include Biologics Drug Substance, Biologics Manufacturing and Formulation Development.
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