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Cardiol Therapeutics' Pharmaceutical Partner Noramco Presents at U.S. FDA Public Hearing on CBD
Oakville, Ontario--(Newsfile Corp. - June 3, 2019) - Cardiol Therapeutics Inc. ( TSX: CRDL) (O...
About this update from Cardiol Therapeutics Inc. Class A
[{"type":"text","content":"Cardiol Therapeutics' Pharmaceutical Partner Noramco Presents at U.S. FDA Public Hearing on CBDAddresses Need for Improved Standards and RegulationsOakville, Ontario--(Newsfile Corp. - June 3, 2019) - Cardiol Therapeutics Inc. (TSX: CRDL) (OTCQX: CRTPF) (\"Cardiol\" or the \"Company\"), a leader in the research and commercial development of pharmaceutical cannabidiol (CBD) and targeted therapies for inflammatory diseases, announces that Noramco, Inc. (Noramco) of Wilmington, Delaware, Cardiol's pharmaceutical partner and manufacturer of its pure pharmaceutical CBD, was selected to present at the Food and Drug Administration's (FDA) Scientific Data and Information about Products Containing Cannabis or Cannabis-Derived Compounds, Part 15 Public Hearing, that took place on Friday, May 31, 2019, in Silver Spring, Maryland.The goal of the hearing was to obtain additional scientific data and other information related to cannabis and cannabis-derived compounds to inform the FDA about these products. The FDA invited important stakeholders, including patients, researchers, manufacturers, retailers, and public health and government bodies, all of whom contributed data and experience. Noramco has more than 40 years' experience and expertise in the manufacture and supply of controlled drug substance active pharmaceutical ingredients (APIs), including cannabinoids. Their APIs are sold in over 30 countries and they have 24 active US Drug Master Files (DMF), including a DMF for pharmaceutical CBD. Noramco is fully cGMP-compliant (FDA inspected and regulated) and has demonstrated a total capacity of >750,000 kg annually in state-of-the-art facilities. Key messages and recommendations presented at the Hearing by Bill Grubb, Chief Innovation Officer and Executive VP of Business Development of Noramco, included the following:There is a Need for Federal Oversight of Manufacturing and Testing of CBD Products Noramco's own analysis using certified analytical reference standards and scientifically-sound analytical methods confirmed impurities of up to 4.39% in several available botanical CBD products - over 1,000 times higher than Noramco's pure pharmaceutical CBD. Numerous other examples of mislabeled and impure CBD products in the marketplace have been cited, including a Journal of the American Medical Association (JAMA) study finding 69% of...