Drug Product
Regulatory, Tech Transfer & Support Services
Company Overview
About
Eurosirel S.p.A. is a pharmaceutical CDMO offering comprehensive services.
Key Expertise
Specialized in Biologics Manufacturing, Monoclonal Antibodies, Vaccines
Therapeutic Areas
Rare Disease
Metabolic
Quick Facts
HQ:Italy
Founded:2018
Employees:2,634
Capabilities & Services
Core Capabilities
- Biologics Drug Substance
- Biologics Drug Product
- Biologics Manufacturing
Types of Organization
GMP Manufacturing
Quality Systems
Regulatory Support
Dosage Forms
Prefilled Syringe
Sterile Injectable
Containment Capabilities
Cytotoxic / ADC Handling
Production Scales
R&D / Pre-clinical
Lab Scale
Pilot Scale
Markets Served
North America
Regulatory Approvals
Drug Approval EXUIYE
FDA · #APR-CFLXIM0X · 2021-05-01
Drug Approval E4F6NI
FDA · #APR-A172SV6P · 2022-04-01
Certifications
FDA Registration
U.S. Food and Drug Administration
Cert #: CERT-L5V8ZTLK
Issued: 2020-01-11
Expires: 2025-03-17
EMA GMP Certificate
European Medicines Agency
Cert #: CERT-EKHZM537
Issued: 2020-04-05
Expires: 2025-07-24
ISO 13485:2016
International Organization for Standardization
Cert #: CERT-3WTBEOFI
Issued: 2020-12-22
Expires: 2025-10-08
Health Canada GMP
Health Canada
Cert #: CERT-7D68T4PZ
Issued: 2020-04-01
Expires: 2025-02-25
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Key facts about Eurosirel S.p.A.
- Eurosirel S.p.A. is headquartered in Italy.
- Eurosirel S.p.A. was founded in 2018.
- Eurosirel S.p.A. has 2,634 employees.
- Eurosirel S.p.A.'s capabilities include Biologics Drug Substance, Biologics Drug Product and Biologics Manufacturing.
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