Regulatory, Tech Transfer & Support Services
Company Overview
About
Alira Health is a pharmaceutical CDMO offering comprehensive services.
Key Expertise
Specialized in Quality Control, Stability Testing, Method Development
Therapeutic Areas
Infectious Disease
Quick Facts
HQ:United States
Founded:1991
Employees:1,944
Capabilities & Services
Core Capabilities
- Small Molecule API
- Small Molecule Drug Product
- Oral Solid Dose
Technology Platforms
GMP Manufacturing
Quality Systems
Regulatory Support
Dosage Forms
Oral Solid Dose
Containment Capabilities
OEB 5 (≤1 µg/m³)
Cytotoxic / ADC Handling
Production Scales
Phase III Clinical Trials
Commercial Scale
Clinical
Markets Served
Asia-Pacific
Manufacturing Facilities
1 site worldwide
Alira Health - United States Facility
United States
Site Capabilities
Quality Control
Stability Testing
Method Development
Regulatory Approvals
Drug Approval 8U10AR
Health Canada · #APR-E36IPHYA · 2019-09-01
Certifications
FDA Registration
U.S. Food and Drug Administration
Cert #: CERT-N29P7SY5
Issued: 2020-06-10
Expires: 2025-01-19
EMA GMP Certificate
European Medicines Agency
Cert #: CERT-ZM66DTPI
Issued: 2020-11-28
Expires: 2025-09-22
ISO 9001:2015
International Organization for Standardization
Cert #: CERT-JYTHDA2B
Issued: 2020-01-25
Expires: 2025-10-03
ISO 13485:2016
International Organization for Standardization
Cert #: CERT-5M7CAFXD
Issued: 2020-04-19
Expires: 2025-04-10
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Company Documents
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