Business
MediPharm Labs Makes First Delivery of Cannabis Clinical Trial Material to US Research Partner and Provides Update on US FDA Status
MediPharm Labs Makes First Delivery of Cannabis Clinical Trial Material to US Research Partner an...
About this update from Medipharm Labs Corp.
[{"type":"text","content":"\n \n \n \n MediPharm Labs Makes First Delivery of Cannabis Clinical Trial Material to US Research Partner and Provides Update on US FDA Status\n \n \n /* Style Definitions */\nspan.prnews_span\n{\nfont-size:8pt;\nfont-family:\"Arial\";\ncolor:black;\n}\na.prnews_a\n{\ncolor:blue;\n}\nli.prnews_li\n{\nfont-size:8pt;\nfont-family:\"Arial\";\ncolor:black;\n}\np.prnews_p\n{\nfont-size:0.62em;\nfont-family:\"Arial\";\ncolor:black;\nmargin:0in;\n}\n \n \n \n \n \n \n Canada NewsWire\n \n \n \n \n \n MediPharm announces first delivery of pharmaceutical cannabis product for NIH funded clinical trial, following import permit from the US Drug Enforcement Agency (DEA) and Health Canada export permit.\n \n \n MediPharm has provided a full response to the US Food and Drug Administration (FDA) in relation to the initial pre-approval site inspection of its\n \n Barrie\n \n facility regarding a new Drug Master File (DMF) being referenced in a recent Abbreviated New Drug Application (ANDA).\n \n \n This is the first US FDA Audit of a purpose-built commercial cannabis facility in\n \n Canada\n \n .\n \n \n The US delivery and FDA inspection represent major milestones in MediPharm Labs being a pharmaceutical cannabis supplier of choice to the global pharmaceutical industry.\n \n \n \n \n \n TORONTO\n \n \n ,\n \n \n Aug. 1, 2023\n \n \n /CNW/ - MediPharm Labs Corp. (TSX: LABS) (OTCQB: MEDIF) (FSE: MLZ) (\"MediPharm\", \"MediPharm Labs\" or the \"Company\") a pharmaceutical company specialized in precision-based cannabinoids, is pleased to announce it has made its first delivery to\n \n the United States\n \n , and has completed the US FDA drug API manufacturer inspection at the Company's\n \n Barrie, Ontario\n \n facility.\n \n \n \n \n \n \n \n \n \n \n First Delivery of Pharmaceutical Cannabis Product to the US\n \n \n \n On\n \n July 28, 2023\n \n , MediPharm completed a commercial shipment of cannabis clinical trial materials to the US, for use in an NIH funded clinical trial. This clinical trial material is finished good cannabis oil that contains both CBD and THC. To the Company's knowledge, this is the first Phase 2 clinical trial of its kind sourced from a Canadian Licenced Producer.\n \n \n The complex process relied on MediPharm's GMP Drug Establishment License, product stability data, US FDA Innovative New Drug Approval, and US DEA nar...