Advanced Modalities
Analytical & Bioanalytical Services
Company Overview
About
Histocell is a pharmaceutical CDMO offering comprehensive services.
Key Expertise
Specialized in Biologics Manufacturing, Monoclonal Antibodies, Vaccines
Therapeutic Areas
Oncology
Hematology
Quick Facts
HQ:Spain
Founded:2019
Employees:2,923
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 4 (1-10 µg/m³)
Production Scales
Phase III Clinical Trials
Commercial Scale
Clinical
Markets Served
Global
International Regulatory
EU GMP Certificates
5
Regulatory Bodies
EMA/EudraGMDP
Regulatory Approvals
Drug Approval H5OVY7
Health Canada · #APR-24I3CZLN · 2018-12-01
Certifications
FDA Registration
U.S. Food and Drug Administration
Cert #: CERT-EUZBCFKW
Issued: 2020-03-27
Expires: 2025-01-23
Health Canada GMP
Health Canada
Cert #: CERT-3WMYMNQ1
Issued: 2020-09-05
Expires: 2025-03-02
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Key facts about Histocell
- Histocell is headquartered in Spain.
- Histocell was founded in 2019.
- Histocell has 2,923 employees.
- Histocell's capabilities include Oral Solid Dose, Solid Dose Manufacturing and Formulation Development.
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