Drug Product
Company Overview
About
Erregierre SpA is a pharmaceutical CDMO offering comprehensive services.
Key Expertise
Specialized in API Manufacturing, Sterile Fill/Finish, Lyophilization
Therapeutic Areas
Oncology
Hematology
Quick Facts
HQ:Italy
Founded:2005
Employees:120
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
Phase II
Clinical
Pilot Scale
Markets Served
Asia-Pacific
Manufacturing Facilities
2 sites worldwide
Erregierre SpA
Via Valle delle Fontane, 2, Sovere, Bergamo, 24060
Site Capabilities
2 capabilitiesANALYSIS
API MANUFACTURE
Erregierre SpA
Via Francesco Baracca, 19, San Paolo, Bergamo, 24060
Site Capabilities
2 capabilitiesANALYSIS
API MANUFACTURE
International Regulatory
EU GMP Certificates
12
Regulatory Bodies
EMA/EudraGMDP
Regulatory Approvals
Drug Approval HW8IEE
PMDA · #APR-8BMVRLXQ · 2021-11-01
Certifications
ISO 9001:2015
International Organization for Standardization
Cert #: CERT-DG5Z54DB
Issued: 2020-10-09
Expires: 2025-03-25
WHO GMP
World Health Organization
Cert #: CERT-PFLDIY0T
Issued: 2020-03-05
Expires: 2025-10-26
MHRA GMP
UK Medicines and Healthcare products Regulatory Agency
Cert #: CERT-IJF9ARS9
Issued: 2020-08-17
Expires: 2025-10-17
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Key facts about Erregierre SpA
- Erregierre SpA is headquartered in Italy.
- Erregierre SpA was founded in 2005.
- Erregierre SpA has 120 employees.
- Erregierre SpA has 2 manufacturing sites listed on CDMO Hub, in Sovere, Italy and San Paolo, Italy.
- Erregierre SpA's capabilities include Oral Solid Dose, Solid Dose Manufacturing and Formulation Development.
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