CPDC's Radiopharmaceutical Manufacturing Facility Receives Clearance from FDA
HAMILTON, ON, Jan. 9, 2020 /PRNewswire/ - 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).
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. CPDC is 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.
SOURCE Centre for Probe Development and Commercialization