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NRF iThemba LABS and isoSolutions announce the successful submission of a Drug Master File for the iThemba LABS 68Ge/68Ga Generator to Health Canada.

Lizeth ⎜Feb 13, 2025 ⎜ Calendar Company Industry Products

VANCOUVER, BRITISH COLUMBIA, CANADA,

February 10, 2024

Cape Town, South Africa and Vancouver, Canada – iThemba LABS, in collaboration with isoSolutions, is proud to announce the successful submission of a Drug Master File (DMF) for the iThembaLABS  68Ge/68Ga Generator to Health Canada. This significant milestone marks a major advancement in the field of medical imaging, particularly in positron emission tomography (PET) imaging, and showcases the commitment of both companies to improving diagnostic capabilities across Canada.
A product of NRF – iThemba LABS, the 68Ge/68Ga Generator is engineered to provide a reliable and efficient source of Gallium-68, a radiotracer widely used in oncological, cardiological, and neurological imaging applications. By facilitating the on-site production of Ga-68, the generator aims to enhance the accessibility of critical imaging technologies while streamlining workflows in clinical environments.
As the producer, iThemba LABS has dedicated extensive resources to the research and development of the Ga-68 generator, ensuring it meets the highest standards of quality and regulatory compliance. isoSolutions, as the distributor, is committed to bringing innovative medical imaging solutions to healthcare providers across Canada, enhancing patient care through improved access to cutting-edge technologies.
“This collaboration with isoSolutions represents an important moment for nuclear medicine innovation,” said Dr. Deidre Prince, Head of Nuclear Medicine at iThemba LABS. “Developed in South Africa through cutting-edge research and technology, the iThemba 68Ge/68Ga Generator is set to significantly improve PET imaging worldwide. We are eager to collaborate with Health Canada to bring this important tool to healthcare providers, enhancing diagnostics and improving patient outcomes on a global scale”.
Arun Singh, CEO of isoSolutions, added, “This DMF submission underscores our shared commitment to delivering high-quality imaging solutions that can transform patient care. We look forward to working closely with iThemba LABS and Health Canada to ensure the successful commercialization of the iThemba LABS 68Ge/68Ga Generator.”
Key Benefits of the iThemba LABS 68Ge/68Ga Generator:
Reliable Supply: The generator ensures a consistent and on-demand supply of Ga-68, addressing the growing needs of healthcare facilities for timely PET imaging.
Operational Efficiency: Designed for quick and effective production, the Ga-68 generator minimizes patient wait times and optimizes operational flow in diagnostic imaging centers.
Cost-Effective Solution: By enabling in-house radiotracer production, the Ga-68 generator offers a cost-efficient alternative, making advanced diagnostic imaging more accessible to patients.
The review process by Health Canada will pave the way for the commercialization of the iThemba LABS 68Ge/68Ga Generator, with the potential for widespread adoption in diagnostic imaging facilities across Canada.
For more information about the iThemba LABS 68Ge/68Ga Generator and the collaboration between iThemba LABS and isoSolutions, please visit our websites or contact our media relations teams.

About iThemba LABS:
iThemba LABS is a leading innovator in medical imaging, focused on developing advanced solutions that enhance patient care. Committed to quality and efficacy, iThemba aims to empower healthcare providers with state-of-the-art diagnostic tools.

About The NRF:
The National Research Foundation (NRF) is an independent statutory body established in accordance with the National Research Foundation Act. Its mandate is to support and promote research through funding, human resource development and the provision of the necessary research facilities in order to facilitate the creation of knowledge, innovation and development in all fields of science and technology, including indigenous knowledge; developing, supporting and maintaining national research facilities; supporting and promoting public awareness of, and engagement with, science; and promoting the development and maintenance of the national science system and support of Government priorities, thereby contributing to the improvement of the quality of life of all South Africans.

About isoSolutions:
isoSolutions is a global distributor of medical imaging and therapy products, dedicated to providing innovative solutions that improve diagnostic accuracy and patient outcomes. With a focus on collaboration and excellence, isoSolutions aims to support healthcare providers across Canada and all over the World.

For additional details, interviews, or media inquiries, please contact:

NRF:
Bongani Nkosi
Media Relations Officer
NRF Corporate Communications
Phone: +27 61 477 3064
Email: b.nkosi@nrf.ac.za

iThemba LABS:
Debbie Christians
Phone: +(27) 21-843-1338
Email: debbie@tlabs.ac.za
Website: tlabs.ac.za

isoSolutions:
Marvin Calderon
Phone: +1 (604) 669-7277
Email: mcalderon@isosolutions.com
Website: www.isosolutions.com

Reference on the NRF-site:

https://www.nrf.ac.za/nrf-ithemba-labs-and-isosolutions-bring-major-boost-to-canadas-innovative-diagnostic-capabilities/

As well as via X:

https://x.com/NRF_News/status/1887847514902016212?t=uxIEEKbw6In8dM0n78d-tg&s=08

Molybdenum ( Mo-100)

Lizeth ⎜Apr 10, 2024 ⎜ Company Industry Products

isoSolutions is pleased to announce the availability of Molybdenum Mo-100 (Radiochemical) with high enrichment and high purity from a cGMP facility.


Mo-100 is a stable isotope and it is widely used for research and studies of double beta-ray decay, in the nuclear medicine industry for imaging procedures after processing into Technetium Tc-99m in specialized cyclotrons.


For orders, please contact our Sales team or write to us at:
info@isosolutions.com and one of our team members will be happy to assist you.

isoSolutions is excited to announce our recent partnership with Agilent.

Lizeth ⎜Feb 9, 2024 ⎜ Company Industry Products

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Q BioMed Signs Distribution Agreement with isoSolutions for the Sales of Strontium89 in Canada

Lizeth ⎜Aug 10, 2021 ⎜ Company Industry Products

Treatment with Strontium89 is available immediately in Canada via Named Patient Program

NEW YORK, Aug. 10, 2021 /PRNewswire/ — Q BioMed Inc. (OTCQB: QBIO), a commercial stage biotech company, announced today that it has recently entered into an exclusive distribution agreement with isoSolutions Marketing & Management Inc., a well-known distributor in Canada providing services and solutions to the nuclear medicine, radioisotope research, pharmaceutical, and medical device industries.  Under the terms of the agreement, isoSolutions has received exclusive rights to distribute Strontium89 in Canada.

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isoSolutions supplier IRE is proud to announce a partnership with ASML

David T. Drummond ⎜Feb 1, 2018 ⎜ Products

IRE is proud to announce a partnership with ASML to further develop a new, non-fission production method for medical isotopes such as Mo-99/Tc-99m. This partnership has resulted in the start of the LightHouse Isotopes BV, an ambitious initiative for the development of a promising alternative production method for a sustainable long term supply of Mo-99.

Click here to see full post.

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Automation of the Radiosynthesis of Six Different 18 F-labeled radiotracers on the AllinOne

David T. Drummond ⎜Nov 15, 2016 ⎜ Products

Background
Fast implementation of positron emission tomography (PET) into clinical and preclinical studies highly demands automated synthesis for the preparation of PET radiopharmaceuticals in a safe and reproducible manner. The aim of this study was to develop automated synthesis methods for these six 18F-labeled radiopharmaceuticals produced on a routine basis at the University of Pennsylvania using (more…)

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UPENN 2016 Automation of the Radiosynthesis of Six radiotracers

David T. Drummond ⎜Sep 24, 2016 ⎜ Products

[18F]ISO-1,
[18F]FTT,
[18F]FTP,
[18F]Fallypride,
[18F]Flubatine and
[18F]F-G
ln produced on a routine basis at UPENN with the Trasis AllinOne synthesizer.

By Ramona Delcea, Trasis Download pdf

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