IRA Istituto Ricerche Applicate S.p.A.
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Drug Product
Regulatory, Tech Transfer & Support Services
Company Overview
About
I.R.A. Istituto Ricerche Applicate srl is a pharmaceutical CDMO offering comprehensive services.
Key Expertise
Specialized in API Manufacturing, Sterile Fill/Finish, Lyophilization
Therapeutic Areas
Neurology
Quick Facts
HQ:Italy
Founded:2000
Employees:2,325
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
Cytotoxic / ADC Handling
Production Scales
Phase III Clinical Trials
Commercial Scale
Clinical
Markets Served
North America
Regulatory Approvals
Drug Approval TLINZE
EMA · #APR-7PZNO3J5 · 2021-08-01
Case Studies
0 published case studies showcasing past projects, challenges and outcomes.
Certifications
EMA GMP Certificate
European Medicines Agency
Cert #: CERT-DO2I3IPT
Issued: 2020-03-05
Expires: 2025-05-24
ISO 13485:2016
International Organization for Standardization
Cert #: CERT-KTQEN1NA
Issued: 2020-07-15
Expires: 2025-07-07
Health Canada GMP
Health Canada
Cert #: CERT-Y6LM3SX8
Issued: 2020-08-01
Expires: 2025-06-24
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Key facts about IRA Istituto Ricerche Applicate S.p.A.
- IRA Istituto Ricerche Applicate S.p.A. is headquartered in Italy.
- IRA Istituto Ricerche Applicate S.p.A. was founded in 2000.
- IRA Istituto Ricerche Applicate S.p.A. has 2,325 employees.
- IRA Istituto Ricerche Applicate S.p.A.'s capabilities include Cytotoxic / ADC Handling, High-Potency API and Sterile Fill/Finish.
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