CPDC’s Radiopharmaceutical Manufacturing Facility Receives Clearance from FDA

January 9, 2020 CPDC

Hamilton, Ontario, Canada – January 9, 2020 – The Centre for Probe Development and Commercialization (CPDC), a global leader in the development, production and commercialization of radiopharmaceuticals, is announcing today that, following a successful U.S. Food and Drug Administration (FDA) inspection in July, CPDC’s site in Hamilton, Ontario, is cleared to ship products to the U.S. 

Justyna Kelly, interim CEO of CPDC, stated, “We are delighted with the outcome of the FDA inspection. We look forward to continuing to support the clinical development efforts of our many global partners and we’re thankful for the excellent support from all of our staff.”

FDA’s inspection of CPDC closed with no 483 observations and was classified as NAI (No Action Indicated).

About CPDC

The Centre for Probe Development and Commercialization (CPDC) is a Centre of Excellence for Commercialization and Research (CECR) located at McMaster University in Hamilton, Ontario, Canada. CPDCis a private, not-for-profit company and global leader in the discovery, development and commercialization of next-generation radiopharmaceuticals that was created with the support of multiple stakeholders, including the Networks of Centres of Excellence (NCE), McMaster University and The Ontario Institute for Cancer Research (OICR). Since its foundation in 2008, CPDC has established a pipeline of products along with a robust and reliable global supply of innovative diagnostic and therapeutic radiopharmaceuticals used daily for the detection and treatment of human diseases such as cancer. For more information about CPDC, please visit: www.imagingprobes.ca.

Contacts

Centre for Probe Development and Commercialization
Angela Lauretani, 905 525-9140, ext. 21212
cpdc@imagingprobes.ca

More news from CPDC

CPDC Announces Four New Appointments To Board of Directors

HAMILTON, ON, July 13, 2021 – The Centre for Probe Development and Commercialization (CPDC), a global leader in the development, production and commercialization of radiopharmaceuticals, announced today that it has appointed four new Members to join its Board of Directors effective June 17, 2021.  The new Members are as follows: Dr. Bettina Hamelin, is the current President and

The CARI program and overcoming commercialization challenges in the Canadian isotope sector

CARI is a collaboration between The Centre for Probe Development and Commercialization (CPDC) and adMare BioInnovations (adMare) working to bring respective resources together to advance an area of tremendous therapeutic and commercial potential in which Canada can gain considerable global competitive advantage in radiopharmaceuticals. Join us for this event where we will learn how the

CARI Blog #3: CARI: Q&A session with our experts

Over the past few months, adMare BioInnovations and the Centre for Probe Development and Commercialization (CPDC) have shared with you information about the role and the potential of radiopharmaceuticals in healthcare and in the life sciences ecosystem in Canada. Now we want to share some further thoughts from our resident experts bringing this initiative and this potential to

For more information contact us at: