Applied StemCell
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Advanced Modalities
Analytical & Bioanalytical Services
Chemistry, Manufacturing and Controls
Company Overview
About
Applied StemCell is a pharmaceutical CDMO offering comprehensive services.
Key Expertise
Specialized in API Manufacturing, Sterile Fill/Finish, Lyophilization
Therapeutic Areas
Oncology
Hematology
Quick Facts
HQ:United States
Founded:2019
Employees:641
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
BSL-2 (Biosafety Level 2)
Production Scales
Pilot Scale
Clinical
Commercial Scale
Markets Served
Europe
Regulatory Approvals
Drug Approval ZAQJH4
FDA · #APR-6O9SZK73 · 2020-12-01
Drug Approval ILCF9Q
Health Canada · #APR-GP6DSD10 · 2018-12-01
Certifications
FDA Registration
U.S. Food and Drug Administration
Cert #: CERT-1WFZ8PH8
Issued: 2020-01-12
Expires: 2025-12-19
EMA GMP Certificate
European Medicines Agency
Cert #: CERT-A8WFBKBW
Issued: 2020-09-25
Expires: 2025-09-27
ISO 9001:2015
International Organization for Standardization
Cert #: CERT-9ZL9XIXS
Issued: 2020-01-01
Expires: 2025-05-15
Health Canada GMP
Health Canada
Cert #: CERT-TC3GNP17
Issued: 2020-03-15
Expires: 2025-04-18
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Key facts about Applied StemCell
- Applied StemCell is headquartered in the United States.
- Applied StemCell was founded in 2019.
- Applied StemCell has 641 employees.
- Applied StemCell's capabilities include Oral Solid Dose, Solid Dose Manufacturing and Formulation Development.
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