Our radiopharmaceutical CDMO services support your drug from early development to commercial production—ensuring speed, efficiency, and regulatory compliance.
Starting capacity
10k
product vials/year Rochester, MN Ability to scale manufacturing capacity over time
Up to
50k
product vials/year at full capacity Rochester, MN Capable of providing continuous production schedule
450k
product vials/year with 47K sq. ft. of manufacturing space at Springhouse Innovation Park, PA
Whether you have a new drug molecule and are seeking research and development support for drug approval, an FDA-approved drug seeking additional manufacturing space—or anywhere in between—we can scale our services to support you.
Our team of seasoned industry leaders brings 150+ collective years of experience in manufacturing and 250+ collective years of experience in radiopharmaceutical supply chain to the table.
We’ve expedited drug production by building development and manufacturing facilities near prominent destination medical centers and key distribution hubs—making sure that patients receive your life-extending treatments exactly when they need them.
We’ve woven a tight web across the entire supply chain with our customers in mind—from hospitals and universities to radioisotope suppliers and regulatory agencies. This interconnected network gives us unparalleled insights and resources to navigate the complex world of radiotherapies.
To avoid potential conflicts of interest, risks to your intellectual property, and issues with resource allocation, our sole focus is your drug—we don’t develop our own.
With 2,000 sq. feet of dedicated R&D space in our state-of-the-art facility in Rochester, MN, Nucleus RadioPharma has the capacity and ability to prioritize your radiotherapy or theranostic product development, regardless of the isotope.
With an isotope-flexible approach and specialty logistics, Nucleus RadioPharma is redefining supply chain excellence to overcome some of the biggest hurdles in the high-stakes world of radiopharmaceuticals.
With one fully operational space in Rochester, MN, and one expansion site under construction, Nucleus RadioPharma has the capacity and specialized infrastructure to meet any radiopharmaceutical manufacturing need—from clinical trials through commercial production.
With all of Nucleus Radiopharma’s manufacturing facilities built to exceed compliance with 21 CRF 211, our proactive design will help you meet radiopharmaceutical regulatory, safety, and operational requirements today and into the future.
Camfil® brand radiocarbon exhaust filtration system engineered to handle any quantity of volatile radionuclides like Terbium-161, I-131, I-123 and I-125. Compliant to USNRC Regulatory Guide 1.52 for residence time and volumetric airflow.
Non-exhaustive list of radioisotopes our team has experience with:
Nuclear and Environmental Licenses and Permits: R&D RAM License, Manufacturing RAM License, US DOT Class 7 Type A/7A package certification, ATF Ethyl Alcohol Permit, HAZMAT Compressed Gas and Flammable materials permit.
Compliant to IATA 7A/Type A requirements for domestic and international shipping with single-use and disposable GPS tracking technology, allowing customers to see their shipment location in real-time by using our proprietary mobile app
All our facilities are built to exceed compliance and our proactive design will help you meet radiopharmaceutical regulatory, safety, and operational requirements today and into the future.
Facilities built for operating under 21 CFR 211 with PA expansion site also aligned to EU Annex 1. ISO 13408-6 Aseptic processing of health care products.
Manufacturing and R&D facilities independently licensed for radioactive materials and transportation approvals for shipping hazardous materials. State of the Art Carbon Filtration System Compliant to USNRC Regulatory Guide 1.52 for residence time and volumetric airflow.
Corporate Quality Management System established and aligned to 21 CFR 211 and ICH Q10.
Curious about how our CDMO services can help your organization? Contact our Business Development Team to discuss our capabilities.
Contact UsExplore our open radiopharmaceutical jobs in Rochester, MN and Pennsylvania facilities.
