Amapharm Group
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Drug Product
Company Overview
About
Amapharm Group is a pharmaceutical CDMO offering comprehensive services.
Key Expertise
Specialized in Formulation Development, Process Development, Scale-up
Therapeutic Areas
Oncology
Hematology
Quick Facts
HQ:Germany
Founded:1996
Employees:2,272
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 5 (≤1 µg/m³)
Cytotoxic / ADC Handling
Production Scales
Pilot Scale
Clinical
Commercial Scale
Markets Served
Asia-Pacific
Regulatory Approvals
Drug Approval V0OQVL
EMA · #APR-6TDS85JX · 2020-08-01
Drug Approval 8H4WU0
Health Canada · #APR-LUFY0MF3 · 2020-09-01
Case Studies
0 published case studies showcasing past projects, challenges and outcomes.
Certifications
FDA Registration
U.S. Food and Drug Administration
Cert #: CERT-3MUNMNOA
Issued: 2020-01-04
Expires: 2025-02-21
EMA GMP Certificate
European Medicines Agency
Cert #: CERT-PVQS8V9E
Issued: 2020-06-15
Expires: 2025-04-05
ISO 9001:2015
International Organization for Standardization
Cert #: CERT-G5UXSC0Z
Issued: 2020-03-11
Expires: 2025-05-23
ISO 13485:2016
International Organization for Standardization
Cert #: CERT-8K21OQVX
Issued: 2020-03-06
Expires: 2025-08-07
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Key facts about Amapharm Group
- Amapharm Group is headquartered in Germany.
- Amapharm Group was founded in 1996.
- Amapharm Group has 2,272 employees.
- Amapharm Group's capabilities include Oral Solid Dose, Solid Dose Manufacturing and Formulation Development.
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