Axio BioPharma
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Drug Product
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Company Overview
About
Axio BioPharma is a pharmaceutical CDMO offering comprehensive services.
Key Expertise
Specialized in Gene Therapy, Cell Therapy, mRNA
Therapeutic Areas
Infectious Disease
Quick Facts
HQ:United States
Founded:2009
Employees:1,105
Capabilities & Services
Core Capabilities
- Small Molecule API
- Small Molecule Drug Product
- Oral Solid Dose
Types of Organization
GMP Manufacturing
Quality Systems
Regulatory Support
Dosage Forms
Oral Solid Dose
Containment Capabilities
OEB 4 (1-10 µg/m³)
Production Scales
Phase II
Clinical
Pilot Scale
Markets Served
Global
Regulatory Approvals
Drug Approval DOWOAA
Health Canada · #APR-3NP8UO7S · 2022-04-01
Drug Approval 8N40WE
PMDA · #APR-SK5NXT03 · 2021-09-01
Case Studies
0 published case studies showcasing past projects, challenges and outcomes.
Certifications
FDA Registration
U.S. Food and Drug Administration
Cert #: CERT-SIT34S8H
Issued: 2020-03-08
Expires: 2025-05-27
EMA GMP Certificate
European Medicines Agency
Cert #: CERT-EZS9OPWR
Issued: 2020-08-18
Expires: 2025-09-21
MHRA GMP
UK Medicines and Healthcare products Regulatory Agency
Cert #: CERT-WI71OMSF
Issued: 2020-04-27
Expires: 2025-10-27
ISO 9001:2015
International Organization for Standardization
Cert #: CERT-STTQN9HO
Issued: 2020-09-16
Expires: 2025-04-17
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Key facts about Axio BioPharma
- Axio BioPharma is headquartered in the United States.
- Axio BioPharma was founded in 2009.
- Axio BioPharma has 1,105 employees.
- Axio BioPharma's capabilities include Small Molecule API, Small Molecule Drug Product and Oral Solid Dose.
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