Drug Product
Excipients & Specialty Ingredients
Company Overview
About
Indena is a pharmaceutical CDMO offering comprehensive services.
Key Expertise
Specialized in Gene Therapy, Cell Therapy, mRNA
Therapeutic Areas
Oncology
Hematology
Quick Facts
HQ:Italy
Founded:1995
Employees:1,469
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
BSL-2 (Biosafety Level 2)
Production Scales
R&D / Pre-clinical
Lab Scale
Pilot Scale
Markets Served
Europe
Manufacturing Facilities
1 site worldwide
Indena SpA
Viale Ortles, 12, Milano, Milano, 20139
Site Capabilities
1 capabilityAPI MANUFACTURE
International Regulatory
EU GMP Certificates
30
Regulatory Bodies
EMA/EudraGMDP
Regulatory Approvals
Drug Approval JY1IKH
Health Canada · #APR-2LU9TPCV · 2020-09-01
Drug Approval HLIR2V
FDA · #APR-DKYFJZQH · 2021-11-01
Certifications
EMA GMP Certificate
European Medicines Agency
Cert #: CERT-PFR6Q0J3
Issued: 2020-09-13
Expires: 2025-01-24
ISO 9001:2015
International Organization for Standardization
Cert #: CERT-ZPNBM4YB
Issued: 2020-09-28
Expires: 2025-04-12
ISO 13485:2016
International Organization for Standardization
Cert #: CERT-SOE388P9
Issued: 2020-05-14
Expires: 2025-09-28
WHO GMP
World Health Organization
Cert #: CERT-350DUD2Q
Issued: 2020-04-28
Expires: 2025-01-16
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Key facts about Indena
- Indena is headquartered in Italy.
- Indena was founded in 1995.
- Indena has 1,469 employees.
- Indena has one manufacturing site listed on CDMO Hub, in Milano, Italy.
- Indena's capabilities include Oral Solid Dose, Solid Dose Manufacturing and Formulation Development.
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