Drug Product
Analytical & Bioanalytical Services
Company Overview
About
Nucleus RadioPharma is a pharmaceutical CDMO offering comprehensive services.
Key Expertise
Specialized in Gene Therapy, Cell Therapy, mRNA
Therapeutic Areas
Rare Disease
Metabolic
Quick Facts
HQ:United States
Founded:1997
Employees:1,117
Capabilities & Services
Core Capabilities
- Biologics Drug Substance
- Biologics Drug Product
- Biologics Manufacturing
Types of Organization
GMP Manufacturing
Quality Systems
Regulatory Support
Dosage Forms
Prefilled Syringe
Sterile Injectable
Containment Capabilities
OEB 5 (≤1 µg/m³)
Cytotoxic / ADC Handling
Production Scales
Pilot Scale
Phase I Clinical Trials
Clinical
Markets Served
Asia-Pacific
Regulatory Approvals
Drug Approval XWF5JQ
Health Canada · #APR-EI3WUEO3 · 2022-06-01
Case Studies
0 published case studies showcasing past projects, challenges and outcomes.
Certifications
FDA Registration
U.S. Food and Drug Administration
Cert #: CERT-VALDRXIO
Issued: 2020-02-27
Expires: 2025-05-17
EMA GMP Certificate
European Medicines Agency
Cert #: CERT-9IYB8EAE
Issued: 2020-05-14
Expires: 2025-02-07
ISO 9001:2015
International Organization for Standardization
Cert #: CERT-GOGVL4RE
Issued: 2020-08-19
Expires: 2025-07-07
WHO GMP
World Health Organization
Cert #: CERT-N5JFEWHV
Issued: 2020-08-27
Expires: 2025-01-03
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Key facts about Nucleus RadioPharma
- Nucleus RadioPharma is headquartered in the United States.
- Nucleus RadioPharma was founded in 1997.
- Nucleus RadioPharma has 1,117 employees.
- Nucleus RadioPharma's capabilities include Biologics Drug Substance, Biologics Drug Product and Biologics Manufacturing.
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