Radiopharmaceutical Research and Production Unit - UPPR
About UPPR
Opened in April 2008, the CDTN Radiopharmaceutical Research and Production Unit (UPPR) is a high-tech facility designed to produce radiopharmaceuticals for use in various areas of medicine using nuclear medicine procedures. These features not only qualify it to serve the Minas Gerais market, but also other states in the country. All these years of operation have made it a model facility in the country.
The Radiopharmaceutical Research and Production Unit (UPPR) produces and sells radiopharmaceuticals for positron emission tomography (PET) scans in nuclear medicine services. The main radiopharmaceuticals supplied commercially are Fludesoxyglucose (18 F) and Sodium fluoride (18 F). It was the first production unit in the country to obtain registration with ANVISA for the sale of the radiopharmaceutical Fludesoxyglucose (18 F) – Radioglic®. In 2018, it obtained registration for Sodium Fluoride (18 F) – Radionaf®.
UPPR meets the requirements established by the National Nuclear Energy Commission (CNEN) and the National Health Surveillance Agency (ANVISA), holding all the necessary valid operating licenses.
In addition to production, UPPR professionals also work in the research and development of radiopharmaceuticals, in collaboration with local and international universities and research centers. UPPR has the necessary infrastructure for the synthesis and quality control of new radiopharmaceuticals, in addition to facilities suitable for conducting preclinical trials of these and other new compounds.
Technology
Nuclear medicine is a medical specialty that uses non-invasive methods to make use of radiopharmaceuticals for diagnostic and therapeutic purposes. It is mainly used in the area of oncology, but it already has an important role in cardiology and neurology. New applications are emerging all the time, expanding this spectrum of action to investigate various functions of the body.
UPPR works in two completely complementary areas:
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Production and sale of radiopharmaceuticals for positron emission tomography (PET) examinations.
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Research and development of new radiopharmaceuticals for diagnosis and therapy, in collaboration with universities and research centers.
The former routinely meets all the demand requested of it, in addition to generating new challenges for the latter. In this case, the partnership with medical research centers, whether in universities or hospitals, presents new challenges at every moment that UPPR seeks to meet. A translational vision permeates the entire process focused on the greater objective, which is the medical patient.
Products
Fludeoxyglucose (18 F) – Radioglic®
Fludeoxyglucose or 18FDG, a glucose analogue, is a radiopharmaceutical used for diagnosis, staging and therapeutic evaluation based on PET images. Unlike traditional imaging techniques, which are based on anatomical changes, PET images obtained with 18FDG allow the evaluation of metabolic changes prior to morphological or anatomical changes by assessing glucose consumption in tissues. Radioglic® Package Insert
Sodium fluoride (18 F) – Radionaf®
Sodium fluoride or Na18F is a radiopharmaceutical used in PET to obtain high-resolution bone images. The retention of Na18F in bone tissue is based on the exchange of hydroxyl ions present in the bone matrix for fluoride ions (18F). Na18F can be used in the diagnosis and staging of bone lesions and in monitoring the efficacy of medication or surgery. Radionaf® Package Insert
Quality
In fulfilling its mission, the CDTN seeks to apply the best professional practices in its daily activities with the following objectives:
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Meet customer requirements, seeking to increase their satisfaction.
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Continuously improve the effectiveness of the Quality Management System.
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Create a work environment that promotes people's satisfaction and fulfillment.
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Continuously train people and value teamwork.
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Meet the requirements established by the ABNT NBR ISO 9001 standard.
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Offer testing and calibration products and services with a high level of quality.
As a quality policy, applicable to all CDTN laboratories, it is declared that: In order to achieve the quality of its products and services, CDTN laboratories seek to continually improve their quality management system and thus satisfy the requirements of their customers and the applicable regulatory requirements.
Certificates and Licenses
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Operating Authorization issued by the National Nuclear Energy Commission (CNEN)
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Operating Authorization for Pharmaceutical Companies issued by Anvisa Good Manufacturing Practices Certification by ANVISA
Pharmacovigilance
The CDTN Radiopharmaceutical Research and Production Unit has set aside this space to report possible adverse events (adverse effects or other problems related to radiopharmaceuticals) that may occur or be observed in a patient during the use of our products. Simply fill out the Reporting Form for Suspected Adverse Reaction to Radiopharmaceuticals and send it by email to radiofarmacoscdtn@cdtn.br. We will contact you as soon as this document reaches the CDTN.
Contact us
Tel.: +55 31 3439-9740, 8 am to 5 pm, Monday to Friday.
Customer Service: 0800 729 1968