Drug Product
Company Overview
About
Abiogen Pharma S.p.A. is a pharmaceutical CDMO offering comprehensive services.
Key Expertise
Specialized in Formulation Development, Process Development, Scale-up
Therapeutic Areas
Cardiovascular
Endocrinology
Quick Facts
HQ:Italy
Founded:2009
Employees:1,637
Capabilities & Services
Core Capabilities
- Sterile Injectable
- Sterile Fill/Finish
- Fill/Finish (Vials)
Types of Organization
GMP Manufacturing
Quality Systems
Regulatory Support
Dosage Forms
Cartridge / Pen
Containment Capabilities
Cytotoxic / ADC Handling
Production Scales
Phase III Clinical Trials
Commercial Scale
Clinical
Markets Served
North America
International Regulatory
EU GMP Certificates
2
Regulatory Bodies
EMA/EudraGMDP
Regulatory Approvals
Drug Approval 8A28XE
PMDA · #APR-VHWVJH03 · 2018-10-01
Drug Approval GEQF8U
Health Canada · #APR-AO5Z4N44 · 2019-05-01
Certifications
EMA GMP Certificate
European Medicines Agency
Cert #: CERT-6AH4NQ53
Issued: 2020-07-09
Expires: 2025-02-17
ISO 9001:2015
International Organization for Standardization
Cert #: CERT-VIBX0AKG
Issued: 2020-06-20
Expires: 2025-09-17
ISO 13485:2016
International Organization for Standardization
Cert #: CERT-32RYHBMQ
Issued: 2020-03-06
Expires: 2025-10-21
WHO GMP
World Health Organization
Cert #: CERT-MPX8AHW1
Issued: 2020-11-19
Expires: 2025-09-21
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Key facts about Abiogen Pharma S.p.A.
- Abiogen Pharma S.p.A. is headquartered in Italy.
- Abiogen Pharma S.p.A. was founded in 2009.
- Abiogen Pharma S.p.A. has 1,637 employees.
- Abiogen Pharma S.p.A.'s capabilities include Sterile Injectable, Sterile Fill/Finish and Fill/Finish (Vials).
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