NorthStar Medical Radioisotopes, LLC
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Drug Product
Company Overview
About
NorthStar Medical Radioisotopes, LLC is a pharmaceutical CDMO offering comprehensive services.
Key Expertise
Specialized in Gene Therapy, Cell Therapy, mRNA
Therapeutic Areas
Respiratory
Allergy
Quick Facts
HQ:United States
Founded:2015
Employees:366
Capabilities & Services
Core Capabilities
- Biologics Drug Substance
- Biologics Manufacturing
- Formulation Development
Types of Organization
GMP Manufacturing
Quality Systems
Regulatory Support
Dosage Forms
Sterile Injectable
Production Scales
Phase II
Clinical
Pilot Scale
Markets Served
North America
Europe
Manufacturing Facilities
3 sites worldwide
NorthStar Medical Radioisotopes, LLC
1800 Gateway Blvd., Beloit, Wisconsin, 53511
Site Capabilities
4 capabilitiesANALYSIS
API MANUFACTURE
LABEL
PACK
NorthStar Medical Radioisotopes, LLC
5249 Femrite Dr, Madison, Wisconsin, 53718
NorthStar Medical Radioisotopes, LLC
1513 Research Park Dr Ste 299, Columbia, Missouri, 65211
Regulatory Approvals
Drug Approval LBL7Q2
PMDA · #APR-6L4V9IAR · 2022-10-01
Certifications
FDA Registration
U.S. Food and Drug Administration
Cert #: CERT-IRW4ORM8
Issued: 2020-11-24
Expires: 2025-08-24
EMA GMP Certificate
European Medicines Agency
Cert #: CERT-M4B3MY3Q
Issued: 2020-02-08
Expires: 2025-03-27
ISO 13485:2016
International Organization for Standardization
Cert #: CERT-IJ2PTHDF
Issued: 2020-03-25
Expires: 2025-07-25
WHO GMP
World Health Organization
Cert #: CERT-4QA1ROXO
Issued: 2020-10-25
Expires: 2025-08-21
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Key facts about NorthStar Medical Radioisotopes, LLC
- NorthStar Medical Radioisotopes, LLC is headquartered in the United States.
- NorthStar Medical Radioisotopes, LLC was founded in 2015.
- NorthStar Medical Radioisotopes, LLC has 366 employees.
- NorthStar Medical Radioisotopes, LLC has 3 manufacturing sites listed on CDMO Hub, in Beloit, United States, Madison, United States and Columbia, United States.
- NorthStar Medical Radioisotopes, LLC's capabilities include Biologics Drug Substance, Biologics Manufacturing and Formulation Development.
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