ROTOP

ROTOP is a pharmaceutical company. They manufacture cGMP-compliant radiopharmaceuticals for diagnostics and therapy in the fields of nuclear medicine. They provide API/precursor synthesis, analysis kit development, project management,  full regulatory support spect, PET, quality control, and therapy services.  Their customers contact through email and phone number.

ROTOP Pharmaka GmbH is a German radiopharmaceutical company that specializes in the development, manufacturing, and registration of radiopharmaceuticals. As of February 2022, the company manufactured NephroScan, a radiodiagnostic imaging drug used as an aid for the evaluation of renal parenchymal disorders in adults and pediatric patients, including term neonates. NephroScan is a kit for the preparation of technetium Tc 99 million succimer injection, designed to image the renal cortices using gamma scintigraphy or single photon emission computed tomography. The radiodiagnostic agent binds to the cortical regions of the kidneys, enabling the identification of patients at risk for parenchymal scarring, hypertension, and chronic renal failure. It can also determine split renal function, kidney shape, size, position, and homogeneity. ROTOP Pharmaka has over 20 years of experience in producing cGMP-compliant cold kits and radiopharmaceuticals, supplying to over 30 countries worldwide.

Theragnostics gets FDA approval for NephroScan to detect renal disorders

Theragnostics Announces US FDA Approval for its Radiodiagnostic Imaging Drug NephroScan™ (Kit for the Preparation of Technetium Tc 99m Succimer Injection)

Radioactive materials open up new pathways in patient treatment and medication

Radiopharmaceuticals

ROTOP Pharmaka GmbH is a German radiopharmaceutical company that specializes in the development, manufacturing, and registration of radiopharmaceuticals. As of February 2022, the company manufactured NephroScan, a radiodiagnostic imaging drug used as an aid for the evaluation of renal parenchymal disorders in adults and pediatric patients, including term neonates. NephroScan is a kit for the preparation of technetium Tc 99 million succimer injection, designed to image the renal cortices using gamma scintigraphy or single photon emission computed tomography. The radiodiagnostic agent binds to the cortical regions of the kidneys, enabling the identification of patients at risk for parenchymal scarring, hypertension, and chronic renal failure. It can also determine split renal function, kidney shape, size, position, and homogeneity. ROTOP Pharmaka has over 20 years of experience in producing cGMP-compliant cold kits and radiopharmaceuticals, supplying to over 30 countries worldwide.

Avid Radiopharmaceuticals, a subsidiary of Eli Lilly, developed the first radioactive diagnostic agent approved by the US Food and Drug Administration (FDA) for imaging tau neurofibrillary tangles on positron emission tomography (PET) scans. The F-18 flortaucipir tracer, marketed under the name Tauvid, helps clinicians estimate the density and distribution of tau tangles in the brains of adults with cognitive impairment being evaluated for Alzheimer's disease.
Tauvid works by binding to tau proteins that form neurofibrillary tangles, which are a hallmark of Alzheimer's disease along with amyloid plaques. Previously, doctors could only diagnose Alzheimer's neuropathologically by identifying both plaques and tangles in the brain after death. With Tauvid, physicians can now visualize and assess tau pathology in living patients through PET imaging.
The FDA's approval of Tauvid in May 2020 was supported by two clinical studies evaluating the agent's safety and effectiveness. These studies demonstrated that readers interpreting Tauvid PET scans had a high probability of accurately detecting tau pathology and an average-to-high probability of correctly identifying patients without tau pathology.

Avid Radiopharmaceuticals

Trevarx is a biomedical company focused on developing radiopharmaceutical technologies to combat breast, ovarian, and prostate cancer. The company specializes in small molecule radiopharmaceuticals, offering a unique theranostic solution. Trevarx's approach combines therapeutic and diagnostic capabilities, potentially enhancing cancer treatment efficacy. The company leverages its expertise in scientific research and multi-center trials to advance its radiopharmaceutical technologies. Trevarx's business model includes providing support for multi-center trials, regulatory assistance, and GMP (Good Manufacturing Practice) manufacturing. These services aim to accelerate the commercialization process of their radiopharmaceutical technologies. The company's team comprises experts with extensive experience in the field, positioning Trevarx to efficiently develop and bring its solutions to market.

Trevarx Biomedical

Alpha Source is a company that manufactures and supplies alpha radiation sources, primarily composite alpha sources containing Pu-239, Am-241, and Cm-244 radionuclides electroplated onto platinum or platinum-clad nickel foils. These sources are designed for alpha spectroscopy systems, providing alpha particles in the energy range of approximately 5100 to 5800 keV with line widths typically less than 20 keV FWHM. This wide energy range allows for valid energy calibration of most alpha-emitting nuclides. Alpha Source offers its composite alpha sources in three configurations: A-1, A-2, and PM. The sources are uncovered and have an active area of 5.0 mm. When purchased as NIST traceable standards, the sources can also be used to determine detector efficiencies for alpha particles, with total and individual activities provided on the Certificate of Calibration.
In addition to its core alpha source product line, Alpha Source also provides nationwide service for extending the life of ultrasound imaging equipment through preventative maintenance and quality replacement parts. The company offers high-quality replacement parts for biomedical equipment, along with value-added services to streamline supply chain operations.
Alpha Source has over 30 years of expertise in manufacturing and sourcing high-quality medical replacement battery packs, offering solutions that optimize battery life and costs for healthcare facilities.

Alpha Source

Ionetix is a cyclotron technology and isotope manufacturing company based in the US. It developed the world's first commercial compact superconducting cyclotron, the ION-12SC, which is used to produce N-13 Ammonia, a highly accurate Positron Emission Tomography (PET) imaging agent for detecting Coronary Artery Disease (CAD). The company's proprietary cyclotron technology platform enables access to scarce radioisotopes used for diagnostic and therapeutic radiopharmaceuticals.
Ionetix's cyclotrons can produce high-purity alpha-emitting radionuclides like Actinium-225 (Ac-225) and Astatine-211 (At-211), which are utilized in targeted alpha therapies for cancer treatment. In April 2023, the company successfully produced Astatine-211 at its new Alpha Isotope Manufacturing facility in Lansing, Michigan, using a 30 MeV cyclotron. This facility is dedicated exclusively to producing alpha-emitting radionuclides via cyclotrons. In June 2024, Ionetix announced the successful production of Actinium-225, marking a pivotal milestone as the first commercial cyclotron-produced Ac-225.
Ionetix's business model involves establishing a network of ION-12SC cyclotrons installed on or near the campuses of PET programs across the US. The company covers the costs related to installation and operation, making N-13 Ammonia available to providers through a pay-by-the-dose model, ensuring accessibility and affordability. Ionetix also provides N-13, F-18, and Ga-68 for diagnostic imaging. Its distribution supply chain includes contract drug manufacturing and "white glove" distribution logistics, enabling global access to these imaging agents and targeted radiotherapies.

Ionetix

Therapeia GmbH & Co. KG is a German specialist company focused on developing diagnostic and therapeutic radiopharmaceuticals to address unmet patient needs. Their lead product candidate, ACD-101, is a family of products for the diagnosis and treatment of malignant glioma (brain cancer). ACD-101 combines several anti-cancer effects within a single molecule, including cytostatic properties, an intrinsic radio-sensitizer effect that enhances the efficacy of external radiation therapy (the current standard treatment), and the ability to be radiolabeled with 131I for intracellular 131I-irradiation ("endo-radiotherapy"), similar to radioiodine therapy used for thyroid cancer.
ACD-101 is actively transported across the intact blood-brain barrier and accumulates in tumor tissue, where it is retained for up to a week. This intratumor accumulation occurs independently of histological tumor type in both low and high-grade gliomas (WHO grades II-IV), allowing for universal therapeutic use regardless of glioma histology. In a rat model, experimental human gliomas were curatively treated for the first time using 131I-ACD-101. This endo-radiotherapy can be combined with conventional external radiotherapy to maximize synergies of different anti-tumor modes of action.

Therapeia GmbH & Co. KG

Companies that use radioactive isotopes to develop medication for the treatment of diseases in patients.

Companies that use radioisotopes to develop solutions for the diagnosis of patients. Solutions are typically synthesized for internal use on patients and are employed in tandem with a diagnostic imaging device to identify disease or causes of diseases.

Companies that produce and supply radioisotopes to pharmaceutical companies creating radiopharmaceuticals.

Companies providing support services to radiopharmaceutical-related companies. These include testing services, research, and training.

Some drug developers use connected medical devices for monitoring treatment administration and drug development

ROTOP

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