AMW (AMW GmbH)
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Drug Product
Regulatory, Tech Transfer & Support Services
Company Overview
About
AMW (AMW GmbH) is a pharmaceutical CDMO offering comprehensive services.
Key Expertise
Specialized in Quality Control, Stability Testing, Method Development
Therapeutic Areas
Oncology
Hematology
Quick Facts
HQ:Germany
Founded:1991
Employees:853
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 4 (1-10 µg/m³)
Production Scales
Pilot Scale
Phase I Clinical Trials
Clinical
Markets Served
Global
International Regulatory
EU GMP Certificates
2
Regulatory Bodies
EMA/EudraGMDP
Regulatory Approvals
Drug Approval XN5VLU
FDA · #APR-EWJ9Z009 · 2019-04-01
Case Studies
0 published case studies showcasing past projects, challenges and outcomes.
Certifications
EMA GMP Certificate
European Medicines Agency
Cert #: CERT-K2K2FT5F
Issued: 2020-10-14
Expires: 2025-04-16
ISO 9001:2015
International Organization for Standardization
Cert #: CERT-L78A9MFY
Issued: 2020-10-21
Expires: 2025-09-24
Health Canada GMP
Health Canada
Cert #: CERT-RZKSLNWY
Issued: 2020-04-06
Expires: 2025-11-11
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Key facts about AMW (AMW GmbH)
- AMW (AMW GmbH) is headquartered in Germany.
- AMW (AMW GmbH) was founded in 1991.
- AMW (AMW GmbH) has 853 employees.
- AMW (AMW GmbH)'s capabilities include Oral Solid Dose, Solid Dose Manufacturing and Formulation Development.
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