Drug Product
Company Overview
About
ERBOZETA S.p.A. 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:2002
Employees:674
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
BSL-2 (Biosafety Level 2)
Production Scales
Pilot Scale
Clinical
Commercial Scale
Markets Served
Europe
Regulatory Approvals
Drug Approval G6S0LO
Health Canada · #APR-CWSMLKQ7 · 2018-12-01
Drug Approval XWV0T5
Health Canada · #APR-CPJG9MIS · 2021-01-01
Certifications
EMA GMP Certificate
European Medicines Agency
Cert #: CERT-M52EDV7J
Issued: 2020-02-27
Expires: 2025-07-24
ISO 9001:2015
International Organization for Standardization
Cert #: CERT-AUYNOW8U
Issued: 2020-04-04
Expires: 2025-12-20
ISO 13485:2016
International Organization for Standardization
Cert #: CERT-M7FL3O43
Issued: 2020-05-28
Expires: 2025-06-23
MHRA GMP
UK Medicines and Healthcare products Regulatory Agency
Cert #: CERT-N0GAWVBY
Issued: 2020-04-28
Expires: 2025-05-11
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Key facts about ERBOZETA S.p.A.
- ERBOZETA S.p.A. is headquartered in Italy.
- ERBOZETA S.p.A. was founded in 2002.
- ERBOZETA S.p.A. has 674 employees.
- ERBOZETA S.p.A.'s capabilities include Cytotoxic / ADC Handling, High-Potency API and Sterile Fill/Finish.
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