Drug Product
Analytical & Bioanalytical Services
Company Overview
About
AustinPx is a pharmaceutical CDMO offering comprehensive services.
Key Expertise
Specialized in Formulation Development, Process Development, Scale-up
Therapeutic Areas
Neurology
Quick Facts
HQ:United States
Founded:2005
Employees:306
Capabilities & Services
Core Capabilities
- Cytotoxic / ADC Handling
- High-Potency API
- Sterile Fill/Finish
Types of Organization
GMP Manufacturing
Quality Systems
Regulatory Support
Dosage Forms
Topical / Transdermal
Production Scales
Phase III Clinical Trials
Commercial Scale
Clinical
Markets Served
North America
Europe
Regulatory Approvals
Drug Approval O6QLWO
EMA · #APR-CU9AM4W3 · 2019-10-01
Case Studies
0 published case studies showcasing past projects, challenges and outcomes.
Certifications
FDA Registration
U.S. Food and Drug Administration
Cert #: CERT-L30DLM6Z
Issued: 2020-10-27
Expires: 2025-06-16
EMA GMP Certificate
European Medicines Agency
Cert #: CERT-6A2FLXVC
Issued: 2020-03-24
Expires: 2025-03-12
ISO 9001:2015
International Organization for Standardization
Cert #: CERT-CLG3IZ28
Issued: 2020-09-05
Expires: 2025-07-17
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Key facts about AustinPx
- AustinPx is headquartered in the United States.
- AustinPx was founded in 2005.
- AustinPx has 306 employees.
- AustinPx's capabilities include Cytotoxic / ADC Handling, High-Potency API and Sterile Fill/Finish.
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