ROTOP CDMO Services

early stage development to commercial supply from a single source

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Years of Know-How
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Product approvals worldwide
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Export countries

ROTOP is a worldwide leading company in the field of development, cGMP manufacturing, registration and commercialization of cold kits and radiopharmaceuticals for diagnostic imaging agents. Headquartered in Dresden, Germany, with more than 180 employees.

NEWS

First marketing authorization for RoTecPSMA®

We are thrilled to announce that RoTecPSMA® has been approved in the United Kingdom!

RoTecPSMA® is a technetium-99m cold kit for SPECT imaging of prostate cancer patients and the first PSMA-SPECT tracer approved in a European country. It marks a significant step forward in closing a gap in patient care, making advanced diagnostics more accessible for those affected by prostate cancer.

 

Scope of Supply and Services

  • Early Stage Development

  • cGMP Manufacturing

  • European Product Release

  • Clinical Trial Services

  • Cold Kits // Radiopharmaceuticals

  • Regulatory Consultancy

NEWS

Upcoming events

August 23, 2025 | Open Labs Day (Campus Helmholtz-Zentrum Dresden-Rossendorf)

On Saturday, August 23, 2025, the HZDR invites you to explore science at the research campus in Dresden-Rossendorf and meet their scientists. Many guided tours of large-scale facilities and laboratories will allow you to take a look behind the scenes of current research.

More information about Open Labs Day: https://www.hzdr.de/db/Cms?pNid=1036

October 05-08, 2025 | EANM (Barcelona, Spain)

Annual Meeting European Association of Nuclear Medicine

Please contact our team to make an appointment: cdmo@rotop-pharmaka.com

NEWS

RoTecPSMA® Approved in Switzerland – Expanding Access to Advanced Prostate Cancer Diagnostics

Quality and reliability

Our products

Together with our customers and partners, we are developing cold kits and radiopharmaceuticals for the treatment of patients.

CAREER
job offers

We are offering numerous jobs in many different fields, from product manufacturing to administration and sales.