ROTOP CDMO Services

early stage development to commercial supply from a single source

0
Years of Know-How
0
Product approvals worldwide
0
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 170 employees.

NEWS

ROTOP is expanding! To address the rapidly growing radiopharmaceutical market, we took a significant step in our expansion and future investment by acquiring over 15,000 square meters (161,000 sq ft) at the Dresden-Rossendorf site. The main focus will be on services for contract development/manufacturing (CDMO) for clinical studies, as well as on commercial cGMP manufacturing of radiopharmaceutical drugs in the field of cancer diagnostics and therapy. The new premises are substantially enhancing ROTOP’s research and manufacturing capabilities, thereby sustaining its dynamic expansion. Follow us to keep up with our journey.

Scope of Supply and Services

  • Early Stage Development

  • cGMP Manufacturing

  • European Product Release

  • Clinical Trial Services

  • Cold Kits // Radiopharmaceuticals

  • Regulatory Consultancy

NEWS

Upcoming events

October 19-23, 2024 | EANM (Hamburg, Germany)

Annual Meeting European Association of Nuclear Medicine

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

Investigator Initiated Trials (IIT)

The prostate-specific membrane antigen (PSMA) has emerged as an attractive diagnostic and therapeutic target for small molecule ligands in prostate cancer. SPECT and 99mTc infrastructure is widely available in many countries and therefore allows patients to receive care close to home. That is why ROTOP is pursuing the development of a 99mTc-PSMA SPECT/CT tracer candidate. We currently support several Investigator Initiated Trials (IITs) with 99mTc-PSMA world-wide. Please contact us if you are interested to use the tracer in your clinical studies: PSMA1404@rotop-pharmaka.com

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.