MediPharm Labs Receives First GMP Certification, Now Permitted to Serve Global Medical Cannabis Market
BARRIE, Ontario, Dec. 13, 2019 (GLOBE NEWSWIRE) -- MediPharm Labs Corp. (TSX: LABS) (OTCQX: MEDIF) (FSE: MLZ) (“MediPharm Labs” or the “Company”) a global leader in specialized research-driven
cannabis extraction, distillation and purification, today announced that the Australian Therapeutic Goods Administration (the “TGA”) has notified the Company that its Canadian manufacturing
facility meets the requirements for Good Manufacturing Practice for Medicinal Products (“GMP”), a key business breakthrough that increases MediPharm Labs’ global manufacturing capabilities.
The TGA is the branch of the of the Australian Government’s Department of Health responsible for regulating therapeutic goods including prescription medicines, vaccines and medical devices, and is one of 52 regulatory authority members of the Pharmaceutical Inspection Co-operation Scheme (PIC/S), an international co-operative that harmonizes GMP standards and quality systems of inspectorates in the field of medicinal products.
During an intensive audit under the TGA’s clearance program for the overseas manufacture of medicine and Active Pharmaceutical Ingredients (“APIs”) for supply to Australia, MediPharm Labs demonstrated that its state-of-the-art Canadian facility met the PIC/S GMP requirements as a Medicines Manufacturer of both Cannabis as a Medicine (oral liquids) in accordance with Part I of the PIC/S GMP guide and Cannabis as an API in accordance with Part II of the PIC/S GMP. The site was also successfully audited for chemical testing and analysis of cannabis as a medicine.
GMP Status: A Catalyst for Global Growth
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MediPharm Labs received its certification less than 60 days from its TGA inspection, which was completed between October 14-16, 2019. While the certificate was issued by Australia’s TGA to permit MediPharm Labs’ Canadian facility to deliver APIs and final medicinal products to the Australian medical cannabis market, upon MediPharm Labs’ Australian production facility receiving its GMP certificate, the Company will be positioned to leverage a global supply chain to sell cannabis APIs and finished products to countries across the EU, including Germany, due to a Mutual Recognition Agreement between Australia and the EU.