Over 25 years of experience
Our corporate history & milestones
2025
25 Years of ROTOP Pharmaka and Strategic Growth
In 2025, we celebrated the 25th anniversary of ROTOP Pharmaka GmbH – marking a quarter century of continuous development in radiopharmacy and nuclear medicine. During the same year, our company was strengthened by new investors GENUI, SHS Capital, and WMS – Wachstumsfonds Mittelstand Sachsen, further supporting our long-term growth and innovation.
We also received regulatory approval for RoTecPSMA® in Switzerland and the United Kingdom, making our innovative Tc-99m-PSMA SPECT tracer available internationally.
At the same time, we expanded our CDMO capacities with the installation of a new hot cell line in our CDMO Center, enabling more efficient and scalable contract development and manufacturing.
2023
Submission of the RoTecPSMA® Marketing Authorization and Opening of the CDMO Center
In 2023, we reached a major milestone in radiopharmacy and nuclear medicine: the marketing authorization application for RoTecPSMA®, the world’s first Tc-99m-PSMA SPECT tracer, was submitted. This innovative radiopharmaceutical supports precise imaging of prostate cancer and further strengthens our position as a pioneer in diagnostic radiopharmaceuticals.
In the same year, we opened our CDMO Center, elevating our contract development and manufacturing (CDMO services) to a new level. With state-of-the-art infrastructure for cold kits, APIs, and clinical trial materials, we provide our partners with comprehensive support along the entire radiopharmaceutical value chain.
2022
Market launch of GalliAd® and expansion of CDMO capacities
In 2022, we successfully introduced the Ge-68/Ga-68 generator GalliAd® to the market. This generator enables the reliable supply of Gallium-68, an important radionuclide used for precise imaging in nuclear medicine.
At the same time, we significantly expanded our CDMO manufacturing capacities. This included both the production of cold kits and the manufacturing of active pharmaceutical ingredients (APIs) for radiopharmaceutical applications.
2021
Expansion of the portfolio with CDMO services
In 2021, we strategically expanded our service portfolio by officially introducing ROTOP CDMO Services. With this step, we support partners from the pharmaceutical industry, biotechnology, and research in the development, manufacturing, and quality control of radiopharmaceuticals.
Our CDMO services (Contract Development and Manufacturing Organization) include process development, cGMP-compliant production, as well as analytical and regulatory support for radiopharmaceutical projects. This allows us to accompany our partners along the entire value chain – from early development to clinical application.
2020
Start of radioactive cGMP production and 20 years of ROTOP Pharmaka
In 2020, we took another important step in our company’s development: with the opening of our radioactive cGMP production facility (ROTOP Radiopharmacy), we significantly expanded our capabilities for manufacturing radioactive radiopharmaceuticals under cGMP conditions.
The new infrastructure enables us to produce radiopharmaceutical active ingredients and preparations for nuclear medicine under the highest quality and safety standards.
In the same year, we also celebrated 20 years of ROTOP Pharmaka GmbH – two decades of continuous development in radiopharmacy, diagnostics, and nuclear medicine manufacturing.
2017
Introduction of Tektrotyd as the first non-generic radiopharmaceutical
In 2017, we reached an important milestone in our corporate development: with Tektrotyd, we launched our first non-generic radiopharmaceutical.
Tektrotyd is used in nuclear medicine diagnostics, particularly for imaging neuroendocrine tumors. With this product, we expanded our portfolio beyond traditional kit products and strengthened our position as a manufacturer of innovative radiopharmaceuticals for nuclear medicine.
2015 – 2016
Expansion of cGMP production and development of innovative radiopharmaceuticals
In 2015, we further expanded our cGMP-compliant radiopharmaceutical production capacities. With the construction of a second cleanroom facility, we enhanced our infrastructure for quality-controlled production and were able to meet the growing demand for radiopharmaceuticals.
In 2016, another important milestone followed: we developed and manufactured Ga-68-PSMA as a clinical trial material. This project was carried out as part of our CDMO services, supporting the development of new radiopharmaceutical approaches for the precise diagnosis of prostate cancer.
2011 – 2014
New EU approvals and further development of the ROTOP brand
Between 2011 and 2014, we further expanded our radiopharmaceutical portfolio for nuclear medicine. During this period, both the Pertector technetium generator and the NanoHSA technetium kit received EU and German marketing authorization.
The Pertector generator enables the reliable supply of Technetium-99m, one of the most important radionuclides used in nuclear medicine diagnostics. With NanoHSA, we added another diagnostic kit to our portfolio.
At the same time, we modernized and further developed the ROTOP brand, reflecting our growth and our increasing international orientation as a manufacturer of radiopharmaceuticals and a partner for nuclear medicine applications.
2010
New building at the Helmholtz-Zentrum Dresden-Rossendorf
In 2010, we reached another important milestone: on the occasion of the 10th anniversary of ROTOP Pharmaka, we opened our new facility on the campus of Helmholtz-Zentrum Dresden-Rossendorf (HZDR).
The new location significantly expanded and modernized our production and development environment for radiopharmaceuticals. The proximity to HZDR continues to strengthen the close link between research, development, and industrial manufacturing in radiopharmacy.
.
2005 – 2009
Expansion of the radiopharmaceutical portfolio and EU approvals
Between 2005 and 2009, we continuously expanded our radiopharmaceutical product portfolio. During this period, our offering grew to ten kit products used in nuclear medicine diagnostics.
A major milestone was the EU approval of the MAG-3 kit, used for nuclear medicine kidney diagnostics. In addition, CardioTOP received European approval, further expanding our portfolio for cardiological nuclear medicine imaging.
.
2000
Founding of ROTOP Pharmaka GmbH
In 2000, ROTOP Pharmaka GmbH was founded at the Rossendorf Technology Center (ROTECH). With an initial team of ten employees, Monika Johannsen laid the foundation for an independent company in radiopharmacy and nuclear medicine diagnostics.
As part of the founding process, ROTOP acquired the patent and trademark rights for MAG-3, an important radiopharmaceutical used in nuclear medicine kidney diagnostics. The distribution of this product became a key building block for establishing ROTOP as a provider of radiopharmaceuticals for clinical applications.
1992
Continuation of radiopharmaceutical research in Rossendorf
In 1992, the Rossendorf Research Center was newly established, allowing scientific work and development in radiopharmacy and nuclear medicine at the Rossendorf site to continue and expand.
During this time, radiopharmaceutical products developed in Rossendorf were internationally marketed through the distribution partner Mallinckrodt. This collaboration lasted until 2000 and played a significant role in making Rossendorf-developed radiopharmaceuticals available worldwide.
1959
Our roots in radiopharmacy in Rossendorf
Our roots lie in Rossendorf near Dresden, where the production of radiopharmaceuticals began in 1959 based on the 10-MW research reactor. The radioactive isotopes produced there formed the foundation for early nuclear medicine applications in medical diagnostics and research.
Under the name ROTOP – Rossendorf Isotope, these products were already marketed nationally and internationally. This marked the beginning of one of the early structures for the development, manufacturing, and distribution of radiopharmaceuticals from Rossendorf.
