Drug Product
Analytical & Bioanalytical Services
Regulatory, Tech Transfer & Support Services
Company Overview
About
Hovione is a pharmaceutical CDMO offering comprehensive services.
Key Expertise
Specialized in Gene Therapy, Cell Therapy, mRNA
Therapeutic Areas
Rare Disease
Metabolic
Quick Facts
HQ:Portugal
Founded:2008
Employees:2,893
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
OEB 5 (≤1 µg/m³)
Cytotoxic / ADC Handling
Production Scales
Pilot Scale
Phase I Clinical Trials
Clinical
Markets Served
Asia-Pacific
Manufacturing Facilities
1 site worldwide
HOVIONE FARMACIENCIA, S.A.
Quinta Sao Pedro, Loures, 2674-506
Site Capabilities
3 capabilitiesANALYSIS
API MANUFACTURE
MANUFACTURE
International Regulatory
EU GMP Certificates
4
Regulatory Bodies
EMA/EudraGMDP
Regulatory Approvals
Drug Approval 7UOFNI
Health Canada · #APR-2W39I5UH · 2022-11-01
Drug Approval A63P7J
EMA · #APR-JOHIQK2T · 2020-02-01
Certifications
ISO 9001:2015
International Organization for Standardization
Cert #: CERT-IR05AM8P
Issued: 2020-01-19
Expires: 2025-02-28
ISO 13485:2016
International Organization for Standardization
Cert #: CERT-CVAWP3EG
Issued: 2020-08-20
Expires: 2025-03-03
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Key facts about Hovione
- Hovione is headquartered in Portugal.
- Hovione was founded in 2008.
- Hovione has 2,893 employees.
- Hovione has one manufacturing site listed on CDMO Hub, in Loures, Portugal.
- Hovione's capabilities include Biologics Drug Substance, Biologics Drug Product and Biologics Manufacturing.
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