Drug Product
Company Overview
About
Alcaliber is a pharmaceutical CDMO offering comprehensive services.
Key Expertise
Specialized in Gene Therapy, Cell Therapy, mRNA
Therapeutic Areas
Cardiovascular
Endocrinology
Quick Facts
HQ:Spain
Founded:1991
Employees:979
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
OEB 5 (≤1 µg/m³)
Cytotoxic / ADC Handling
Production Scales
Commercial Scale
Large Scale (Metric Ton+)
Markets Served
Asia-Pacific
International Regulatory
EU GMP Certificates
5
Regulatory Bodies
EMA/EudraGMDP
Regulatory Approvals
Drug Approval FQX63D
FDA · #APR-1NO73EGH · 2019-01-01
Certifications
FDA Registration
U.S. Food and Drug Administration
Cert #: CERT-OZX3TVVE
Issued: 2020-10-12
Expires: 2025-07-04
EMA GMP Certificate
European Medicines Agency
Cert #: CERT-KU37CY5Z
Issued: 2020-11-12
Expires: 2025-12-20
ISO 9001:2015
International Organization for Standardization
Cert #: CERT-B1OJQ3BP
Issued: 2020-05-01
Expires: 2025-02-14
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Key facts about Alcaliber
- Alcaliber is headquartered in Spain.
- Alcaliber was founded in 1991.
- Alcaliber has 979 employees.
- Alcaliber's capabilities include Sterile Injectable, Sterile Fill/Finish and Fill/Finish (Vials).
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