Rotop Pharmaka GmbH

Overview

ROTOP Pharmaka GmbH is a specialized Contract Development and Manufacturing Organization (CDMO) focused exclusively on radiopharmaceuticals for nuclear medicine and molecular imaging. Based in Dresden-Rossendorf, Germany, the company has over 25 years of experience in developing, manufacturing, and supplying cGMP-compliant radiopharmaceuticals distributed to more than 40 countries worldwide.

Core Services

ROTOP provides fully integrated, end-to-end CDMO services for radiopharmaceuticals:

• Precursor and API synthesis for radiopharmaceutical production
• Lyophilized cold kit development and manufacturing (Tc-99m cold kits for nuclear medicine diagnostics)
• Process scale-up and method validation from development to commercial scale
• Clinical and commercial GMP manufacturing in dedicated cleanroom facilities
• Integrated quality control and stability testing
• Regulatory support for EU, US, and Rest of World markets
• Global distribution network ensuring worldwide availability

Manufacturing Capabilities

Radiopharmaceutical Cold Kits: ROTOP produces sterile, GMP-compliant radiopharmaceutical cold kits in dedicated cleanrooms on the Helmholtz-Zentrum Dresden-Rossendorf campus. These kits serve as the basis for radioactive labeling in clinics and medical practices for functional disorders, oncological indications, and modern imaging procedures.

Ready-to-Use Radiopharmaceuticals: The company operates a modern radiopharmacy facility (operational since 2020) featuring three GMP-compliant hot cells for processing high activities of iodine-123. All steps—from radionuclide production via on-site cyclotron to manufacturing, automated filling, and packaging—are consolidated in one location, ensuring maximum supply security and quality. Patient doses are produced individually and shipped across Europe within 48 hours in eco-friendly Type-A containers.

Quality & Compliance

ROTOP maintains the highest pharmaceutical standards through:

• GMP-compliant manufacturing processes
• State-of-the-art equipment and fully GxP-compliant procedures
• Strict quality testing and reproducibility protocols
• International quality standards for patient-focused diagnostics

Product Portfolio

ROTOP's radiopharmaceutical products include advanced cold kits and ready-to-use radiopharmaceuticals designed for diagnostic imaging and targeted therapy, with applications in oncology and other therapeutic areas. Notable products include CardioTOP, MAG-3 Kit, NephroMAG, Mertioscan, IELMAG3, ROTOP-DMSA, NanoHSA-Rotop, Nanotop, NanoSPECT, and RoTecPSMA®.

Strategic Growth

ROTOP recently received a building permit for a new radiopharmaceutical manufacturing facility in Dresden, representing a major step in the company's growth strategy. Since 2025, the company has expanded capacity for clinical trial materials (alpha, beta, and gamma emitters), with further cleanroom facility expansion planned through 2028 to increase radiopharmaceutical production.