Drug Product
Advanced Modalities
Analytical & Bioanalytical Services
Company Overview
About
DIATHEVA is a pharmaceutical CDMO offering comprehensive services.
Key Expertise
Specialized in Quality Control, Stability Testing, Method Development
Therapeutic Areas
Neurology
Quick Facts
HQ:Italy
Founded:1996
Employees:3,094
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
OEB 5 (≤1 µg/m³)
Cytotoxic / ADC Handling
Production Scales
R&D / Pre-clinical
Lab Scale
Pilot Scale
Markets Served
Asia-Pacific
International Regulatory
EU GMP Certificates
2
Regulatory Bodies
EMA/EudraGMDP
Regulatory Approvals
Drug Approval BH1KJY
FDA · #APR-M0EJ8I5P · 2022-08-01
Drug Approval QBHNPM
Health Canada · #APR-C9NVTIKA · 2020-11-01
Certifications
EMA GMP Certificate
European Medicines Agency
Cert #: CERT-NC37OBGI
Issued: 2020-08-15
Expires: 2025-11-08
Health Canada GMP
Health Canada
Cert #: CERT-I0G99VZ4
Issued: 2020-08-03
Expires: 2025-03-26
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Key facts about DIATHEVA
- DIATHEVA is headquartered in Italy.
- DIATHEVA was founded in 1996.
- DIATHEVA has 3,094 employees.
- DIATHEVA's capabilities include Cytotoxic / ADC Handling, High-Potency API and Sterile Fill/Finish.
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