medac GmbH (medac CDMO)
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Drug Product
Analytical & Bioanalytical Services
Regulatory, Tech Transfer & Support Services
Company Overview
About
medac GmbH (medac CDMO) is a pharmaceutical CDMO offering comprehensive services.
Key Expertise
Specialized in API Manufacturing, Sterile Fill/Finish, Lyophilization
Therapeutic Areas
Oncology
Hematology
Quick Facts
HQ:Germany
Founded:2002
Employees:2,577
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
Production Scales
Phase III Clinical Trials
Commercial Scale
Clinical
Markets Served
North America
Europe
Regulatory Approvals
Drug Approval XMCUYV
PMDA · #APR-7PFQF0OK · 2020-01-01
Drug Approval 9VG2GJ
EMA · #APR-YP8IEGCJ · 2019-04-01
Case Studies
0 published case studies showcasing past projects, challenges and outcomes.
Certifications
FDA Registration
U.S. Food and Drug Administration
Cert #: CERT-0HGUS1P1
Issued: 2020-03-09
Expires: 2025-07-18
EMA GMP Certificate
European Medicines Agency
Cert #: CERT-XT4GUPNR
Issued: 2020-02-22
Expires: 2025-12-02
ISO 9001:2015
International Organization for Standardization
Cert #: CERT-0ABCV3Y7
Issued: 2020-03-19
Expires: 2025-02-26
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Key facts about medac GmbH (medac CDMO)
- medac GmbH (medac CDMO) is headquartered in Germany.
- medac GmbH (medac CDMO) was founded in 2002.
- medac GmbH (medac CDMO) has 2,577 employees.
- medac GmbH (medac CDMO)'s capabilities include Oral Solid Dose, Solid Dose Manufacturing and Formulation Development.
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