Drug Product
Company Overview
About
Genetic S.P.A. is a pharmaceutical CDMO offering comprehensive services.
Key Expertise
Specialized in Formulation Development, Process Development, Scale-up
Therapeutic Areas
Immunology
Rheumatology
Quick Facts
HQ:Italy
Founded:2001
Employees:2,496
Capabilities & Services
Core Capabilities
- Peptide Synthesis
- Small Molecule API
- Formulation Development
Types of Organization
GMP Manufacturing
Quality Systems
Regulatory Support
Dosage Forms
Inhalation
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
2
Regulatory Bodies
EMA/EudraGMDP
Regulatory Approvals
Drug Approval OKMOLQ
EMA · #APR-HSVEI784 · 2018-10-01
Drug Approval KRTJFQ
EMA · #APR-LAHX3CS7 · 2020-05-01
Certifications
FDA Registration
U.S. Food and Drug Administration
Cert #: CERT-5YC96O7Q
Issued: 2020-12-13
Expires: 2025-03-23
MHRA GMP
UK Medicines and Healthcare products Regulatory Agency
Cert #: CERT-O0G78QAJ
Issued: 2020-11-14
Expires: 2025-01-06
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Key facts about Genetic S.P.A.
- Genetic S.P.A. is headquartered in Italy.
- Genetic S.P.A. was founded in 2001.
- Genetic S.P.A. has 2,496 employees.
- Genetic S.P.A.'s capabilities include Peptide Synthesis, Small Molecule API and Formulation Development.
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