Edelmann GmbH
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Manufacturing & Lab Equipment
Company Overview
About
Edelmann GmbH is a pharmaceutical CDMO offering comprehensive services.
Key Expertise
Specialized in Biologics Manufacturing, Monoclonal Antibodies, Vaccines
Therapeutic Areas
Cardiovascular
Endocrinology
Quick Facts
HQ:Brazil
Founded:1992
Employees:2,003
Capabilities & Services
Core Capabilities
- Sterile Injectable
- Sterile Fill/Finish
- Fill/Finish (Vials)
Types of Organization
GMP Manufacturing
Quality Systems
Regulatory Support
Dosage Forms
Cartridge / Pen
Containment Capabilities
OEB 4 (1-10 µg/m³)
Production Scales
Commercial Scale
Large Scale (Metric Ton+)
Markets Served
Global
Regulatory Approvals
Drug Approval BAS3RK
FDA · #APR-NI6TW6F2 · 2019-04-01
Drug Approval A7687J
FDA · #APR-Z6XSTJYK · 2022-03-01
Case Studies
0 published case studies showcasing past projects, challenges and outcomes.
Certifications
FDA Registration
U.S. Food and Drug Administration
Cert #: CERT-MUIRJZI7
Issued: 2020-07-05
Expires: 2025-03-03
EMA GMP Certificate
European Medicines Agency
Cert #: CERT-59G9K9S1
Issued: 2020-08-19
Expires: 2025-10-27
ISO 9001:2015
International Organization for Standardization
Cert #: CERT-PFQHTGB5
Issued: 2020-02-20
Expires: 2025-05-21
Health Canada GMP
Health Canada
Cert #: CERT-6EGFJSFL
Issued: 2020-07-17
Expires: 2025-10-25
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Key facts about Edelmann GmbH
- Edelmann GmbH is headquartered in Brazil.
- Edelmann GmbH was founded in 1992.
- Edelmann GmbH has 2,003 employees.
- Edelmann GmbH's capabilities include Sterile Injectable, Sterile Fill/Finish and Fill/Finish (Vials).
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