Berlin‑Chemie (Menarini Group)
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Drug Product
Company Overview
About
Berlin‑Chemie (Menarini Group) is a pharmaceutical CDMO offering comprehensive services.
Key Expertise
Specialized in Quality Control, Stability Testing, Method Development
Therapeutic Areas
Rare Disease
Metabolic
Quick Facts
HQ:Germany
Founded:2009
Employees:2,901
Capabilities & Services
Core Capabilities
- Biologics Drug Substance
- Biologics Drug Product
- Biologics Manufacturing
Types of Organization
GMP Manufacturing
Quality Systems
Regulatory Support
Dosage Forms
Prefilled Syringe
Sterile Injectable
Containment Capabilities
OEB 5 (≤1 µg/m³)
Cytotoxic / ADC Handling
Production Scales
Phase II
Clinical
Pilot Scale
Markets Served
Asia-Pacific
International Regulatory
EU GMP Certificates
5
Regulatory Bodies
EMA/EudraGMDP
EMA
Regulatory Approvals
Drug Approval 32A9GD
Health Canada · #APR-VYHYQB0L · 2021-07-01
Drug Approval QJ92EM
FDA · #APR-L9IN76L6 · 2021-02-01
Case Studies
0 published case studies showcasing past projects, challenges and outcomes.
Certifications
FDA Registration
U.S. Food and Drug Administration
Cert #: CERT-LUJZDJ9A
Issued: 2020-03-07
Expires: 2025-05-01
ISO 13485:2016
International Organization for Standardization
Cert #: CERT-Z5PKFYV1
Issued: 2020-03-11
Expires: 2025-06-07
WHO GMP
World Health Organization
Cert #: CERT-KO3PU2HF
Issued: 2020-12-06
Expires: 2025-03-06
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Key facts about Berlin‑Chemie (Menarini Group)
- Berlin‑Chemie (Menarini Group) is headquartered in Germany.
- Berlin‑Chemie (Menarini Group) was founded in 2009.
- Berlin‑Chemie (Menarini Group) has 2,901 employees.
- Berlin‑Chemie (Menarini Group)'s capabilities include Biologics Drug Substance, Biologics Drug Product and Biologics Manufacturing.
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