medac GmbH (medac CDMO)
Germany
Drug Product
Analytical & Bioanalytical Services
Regulatory, Tech Transfer & Support Services
Excipients & Specialty Ingredients
Company Overview
About
medac GmbH operates a dedicated CDMO division (medac CDMO) offering end-to-end sterile injectable manufacturing services from clinical supply through large-scale commercial production. Based in Germany with facilities in Wedel and Dessau (Germany) and Brno (Czech Republic), medac specializes in small molecules, biologics (mAbs, proteins, peptides, oligonucleotides), and ADCs. They handle aseptic filling, terminal sterilization, lyophilization, and high-potent API processing down to OEL = 10 ng/m3. Manufacturing scales range from 1-50 L (small) to 50-1,500 L (large) with campaigns up to 11,000 L. They partner with Cerbios under the PROVEO brand for integrated ADC services. Over 40 years of regulatory expertise with approvals from multiple international health authorities.
Key Expertise
Sterile injectables, aseptic filling, lyophilization, high-potency API handling, ADC manufacturing, biologics (mAbs, peptides, oligonucleotides), clinical-to-commercial scale-up
Therapeutic Areas
Oncology
Quick Facts
HQ:Germany
Capabilities & Services
Core Capabilities
- Small Molecule Drug Product
- Biologics Drug Substance
- Biologics Drug Product
Production Scales
Phase I Clinical Trials
Phase II
Phase III Clinical Trials
Clinical
Commercial Scale
Markets Served
Europe
Manufacturing Facilities
1 site worldwide
medac GmbH (medac CDMO) - Germany Facility
Germany
Site Capabilities
API Manufacturing
Sterile Fill/Finish
Lyophilization
Clinical Trial Experience
Involvement in 2 clinical trials
Therapeutic Areas
Oncology
Certifications
FDA Registration
U.S. Food and Drug Administration
PMDA (Japan Pharmaceuticals and Medical Devices Agency)
Pharmaceuticals and Medical Devices Agency
Customer Reviews
No reviews available yet.
Company Documents
No documents available.