GEA Group
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Manufacturing & Lab Equipment
Regulatory, Tech Transfer & Support Services
Company Overview
About
GEA Group is a pharmaceutical CDMO offering comprehensive services.
Key Expertise
Specialized in Formulation Development, Process Development, Scale-up
Therapeutic Areas
Neurology
Quick Facts
HQ:Germany
Founded:2012
Employees:355
Capabilities & Services
Core Capabilities
- Cytotoxic / ADC Handling
- High-Potency API
- Sterile Fill/Finish
Types of Organization
GMP Manufacturing
Quality Systems
Regulatory Support
Dosage Forms
Topical / Transdermal
Containment Capabilities
Cytotoxic / ADC Handling
Production Scales
Commercial Scale
Large Scale (Metric Ton+)
Markets Served
North America
Regulatory Approvals
Drug Approval 8MS4CK
PMDA · #APR-G871ABV0 · 2022-10-01
Drug Approval O9CXVK
EMA · #APR-3DIXMCPU · 2019-09-01
Certifications
FDA Registration
U.S. Food and Drug Administration
Cert #: CERT-JJ50G832
Issued: 2020-10-07
Expires: 2025-02-11
ISO 13485:2016
International Organization for Standardization
Cert #: CERT-C0WZQ62G
Issued: 2020-08-16
Expires: 2025-08-09
MHRA GMP
UK Medicines and Healthcare products Regulatory Agency
Cert #: CERT-RQWAP28D
Issued: 2020-11-06
Expires: 2025-04-18
Health Canada GMP
Health Canada
Cert #: CERT-P1NQSNSQ
Issued: 2020-12-06
Expires: 2025-01-18
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Key facts about GEA Group
- GEA Group is headquartered in Germany.
- GEA Group was founded in 2012.
- GEA Group has 355 employees.
- GEA Group's capabilities include Cytotoxic / ADC Handling, High-Potency API and Sterile Fill/Finish.
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