Drug Product
Regulatory, Tech Transfer & Support Services
Company Overview
About
G.L. Pharma GmbH is a pharmaceutical CDMO offering comprehensive services.
Key Expertise
Specialized in Formulation Development, Process Development, Scale-up
Therapeutic Areas
Oncology
Hematology
Quick Facts
HQ:Austria
Founded:2015
Employees:2,854
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
R&D / Pre-clinical
Lab Scale
Pilot Scale
Markets Served
Global
International Regulatory
EU GMP Certificates
57
WHO Prequalified Products
3
Regulatory Bodies
EMA/EudraGMDP
WHO
Regulatory Approvals
Drug Approval 8RQ11T
EMA · #APR-XSOMX2TS · 2018-01-01
Certifications
FDA Registration
U.S. Food and Drug Administration
Cert #: CERT-SG6279E4
Issued: 2020-05-20
Expires: 2025-02-19
EMA GMP Certificate
European Medicines Agency
Cert #: CERT-3E70T1QP
Issued: 2020-11-02
Expires: 2025-07-04
ISO 9001:2015
International Organization for Standardization
Cert #: CERT-5JEIKE6N
Issued: 2020-12-20
Expires: 2025-02-06
WHO GMP
World Health Organization
Cert #: CERT-6QUOF13K
Issued: 2020-05-16
Expires: 2025-06-19
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Key facts about G.L. Pharma GmbH
- G.L. Pharma GmbH is headquartered in Austria.
- G.L. Pharma GmbH was founded in 2015.
- G.L. Pharma GmbH has 2,854 employees.
- G.L. Pharma GmbH's capabilities include Oral Solid Dose, Solid Dose Manufacturing and Formulation Development.
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