Symbolic Groundbreaking for ROTOP’s New CMO Center in Dresden-Rossendorf

Symbolic Groundbreaking for ROTOP’s New CMO Center in Dresden-Rossendorf

Symbolic Groundbreaking for ROTOP’s New CMO Center in Dresden-Rossendorf

  • ROTOP marked an important milestone for its new CMO Center with a symbolic groundbreaking ceremony on September 21, 2026.
  • The facility will expand commercial manufacturing capacity for diagnostic and, in particular, therapeutic radiopharmaceuticals, including patient doses for radioligand therapy, an innovative, targeted form of cancer treatment.
  • In its initial expansion phase, the CMO Center is designed to produce approximately 70,000 sterile patient doses annually. At full build-out, annual production capacity is expected to exceed 200,000 patient doses. The site is expected to create around 60 manufacturing jobs.

DRESDEN, Germany, September 21, 2026. ROTOP today joined employees, project partners, representatives of the planning and construction companies involved, and guests from government and industry for a symbolic groundbreaking ceremony marking the upcoming start of construction on its new CMO Center in Dresden-Rossendorf. Guests included Dirk Hilbert, Mayor of Dresden, and Regina Kraushaar, Saxony’s State Minister for Infrastructure and Regional Development.

With the new CMO Center, ROTOP is expanding its capacity for the commercial contract manufacturing of diagnostic and therapeutic radiopharmaceuticals, further strengthening its position as a contract development and manufacturing organization (CDMO) partner. In its initial expansion phase, the CMO Center is designed to produce approximately 70,000 sterile patient doses annually. At full build-out, annual production capacity is expected to exceed 200,000 patient doses. Actual production volumes will depend on the specific product, batch size and utilization. ROTOP is planning additional construction and expansion projects on other parcels at the site. A particular focus is on patient doses for radioligand therapy, an innovative, targeted form of cancer treatment.

Capacity for Diagnostics and Therapy

Radiopharmaceuticals require specialized manufacturing, quality assurance, radiation protection and time-critical logistics. The new CMO Center brings these functions together in a dedicated production infrastructure. Plans include radiopharmaceutical manufacturing and cleanroom areas, quality control laboratories, separate materials handling zones, and administrative and technical areas.
The center complements ROTOP’s existing development and manufacturing capabilities in Dresden-Rossendorf. Together with the existing CDMO Center, it will support partners in advancing radiopharmaceutical programs from clinical development through commercial manufacturing.

“With the CMO Center, we are creating additional specialized capacity for sterile radiopharmaceuticals, particularly patient doses for radioligand therapy. This will strengthen the production base for innovative cancer therapies and help our partners transition radiopharmaceutical programs from development to commercial supply. To support this work, we are strategically expanding our infrastructure in Dresden-Rossendorf,” said Jens Junker, CEO of ROTOP Pharmaka GmbH.

The CMO Center is designed for GMP-compliant radiopharmaceutical manufacturing while meeting the specific requirements for radiation protection. Its flexible facility design will allow ROTOP to expand production capacity in line with future demand.

Strengthening the Dresden-Rossendorf Site

The approximately 86,000-square-foot (8,000-square-meter) site is located in the Eschdorf/Rossendorf business park, close to Helmholtz-Zentrum Dresden-Rossendorf and ROTOP’s existing manufacturing and administrative facilities. At full build-out, the site is expected to support around 60 pharmaceutical manufacturing jobs.
For the City of Dresden, the project combines the expansion of an established company with new opportunities for Dresden-Rossendorf as a center for science and manufacturing.

“ROTOP has grown in Dresden-Rossendorf and is investing in the site once again. The new CMO Center strengthens the link between scientific expertise and pharmaceutical manufacturing and creates opportunities for highly skilled jobs. This benefits Dresden as an internationally recognized center for nuclear medicine,” said Dirk Hilbert, Mayor of Dresden.

Beyond its regional significance, the project expands industrial capacity in a highly specialized medical technology field. The Free State of Saxony views the project as an important contribution to the state’s economic development.

“Radiopharmaceuticals from Dresden-Rossendorf represent a highly innovative advancement in nuclear medicine. For patients, they offer greater certainty in diagnosis and hope for treatment. Medical innovation realizes its full value when it moves beyond the laboratory and reaches the people who need it. Today’s groundbreaking ceremony lays the foundation for expanded capacity at a site where scientific and industrial expertise come together with an exceptional commitment to patient care. At the same time, the new facility is a clear vote of confidence in the innovative capabilities of its employees and in Saxony as a business location,” said Regina Kraushaar, Saxon Minister for Infrastructure and Regional Development.” said Regina Kraushaar, Saxony’s State Minister for Infrastructure and Regional Development.

About ROTOP Pharmaka GmbH

ROTOP Pharmaka GmbH is a radiopharmaceutical manufacturer based in Dresden-Rossendorf. For more than 25 years, the company has developed, manufactured and marketed radiopharmaceuticals for diagnostic and therapeutic applications in nuclear medicine and molecular imaging.
ROTOP supports partners with CDMO services throughout key phases of radiopharmaceutical development and manufacturing. The company distributes its products in more than 50 countries. Integrity, expertise and commitment guide everything ROTOP does.

Media Contact

Julia Neubert (Head of Marketing)
ROTOP Pharmaka GmbH
Bautzner Landstraße 400 · 01328 Dresden
Phone: +49 (0) 351 26310 100 · Email: marketing@rotop-pharmaka.de
www.rotop-pharmaka.com

Images: https://www.picdrop.com/ronaldbonssphotographie/bkSNuMm6jt

Press Release for download: ROTOP Press Release CMO Center (EN)

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