Advanced Modalities
Analytical & Bioanalytical Services
Regulatory, Tech Transfer & Support Services
Company Overview
About
ReiThera Srl is a pharmaceutical CDMO offering comprehensive services.
Key Expertise
Specialized in Formulation Development, Process Development, Scale-up
Therapeutic Areas
Oncology
Hematology
Quick Facts
HQ:Italy
Founded:2008
Employees:780
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 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
4
Regulatory Bodies
EMA/EudraGMDP
Regulatory Approvals
Drug Approval FRP1A9
PMDA · #APR-M4DJQZ3G · 2018-09-01
Drug Approval CRSZ2B
PMDA · #APR-9Q8UGS3J · 2019-02-01
Case Studies
0 published case studies showcasing past projects, challenges and outcomes.
Certifications
FDA Registration
U.S. Food and Drug Administration
Cert #: CERT-QM2C3Z7T
Issued: 2020-08-16
Expires: 2025-11-10
EMA GMP Certificate
European Medicines Agency
Cert #: CERT-X6W2SKM6
Issued: 2020-09-07
Expires: 2025-05-07
ISO 13485:2016
International Organization for Standardization
Cert #: CERT-02FZ9VFX
Issued: 2020-08-21
Expires: 2025-11-09
Health Canada GMP
Health Canada
Cert #: CERT-1RPA2G9E
Issued: 2020-07-16
Expires: 2025-01-11
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Key facts about ReiThera Srl
- ReiThera Srl is headquartered in Italy.
- ReiThera Srl was founded in 2008.
- ReiThera Srl has 780 employees.
- ReiThera Srl's capabilities include Oral Solid Dose, Solid Dose Manufacturing and Formulation Development.
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