An anonymous director reports

MEDIPHARM LABS MAKES FIRST DELIVERY OF CANNABIS CLINICAL TRIAL MATERIAL TO US RESEARCH PARTNER AND PROVIDES UPDATE ON US FDA STATUS

Medipharm Labs Corp. has made its first delivery to the United States and has completed the U.S. Food and Drug Administration (FDA) drug API (active pharmaceutical ingredient) manufacturer inspection at the company's Barrie, Ont., facility.

Highlights:

• Medipharm announces first delivery of pharmaceutical cannabis product for NIH (National Institutes of Health) funded clinical trial, following import permit from the U.S. Drug Enforcement Agency (DEA) and Health Canada export permit.
• Medipharm has provided a full response to the U.S. FDA in relation to the initial preapproval site inspection of its Barrie facility regarding a new drug master file (DMF) being referenced in a recent abbreviated new drug application (ANDA).
• This is the first U.S. FDA audit of a purpose-built commercial cannabis facility in Canada.
• The U.S. delivery and FDA inspection represent major milestones in Medipharm Labs being a pharmaceutical cannabis supplier of choice to the global pharmaceutical industry.

First delivery of pharmaceutical cannabis product to the United States

On July 28, 2023, Medipharm completed a commercial shipment of cannabis clinical trial materials to the United States, for use in an NIH funded clinical trial. This clinical trial material is finished good cannabis oil that contains both CBD (cannabidiol) and THC (tetrahydrocannabinol). To the company's knowledge, this is the first phase 2 clinical trial of its kind sourced from a Canadian licensed producer.

The complex process relied on Medipharm's GMP (good manufacturing practice) drug establishment licence, product stability data, U.S. FDA innovative new drug approval and U.S. DEA narcotic import approval. Steps to meet these requirements were initiated five years ago and involved large capital investments, demonstrating a unique pharmaceutical capability and approach that distinguishes Medipharm from other cannabis companies.

This development is significant as the majority of cannabis operators in the United States are operating under state-specific regulations that prohibit them from manufacturing for FDA sanctioned research activities and DEA approved shipments under federal narcotic laws.

U.S. FDA status update

Medipharm completed a U.S. FDA five-day, in-person inspection from Nov. 21 to Nov. 25, 2022. This was initiated in relation to Medipharm's cannabidiol active pharmaceutical ingredient (API) drug master file (DMF) being referenced in an abbreviated new drug application (ANDA) submitted to the U.S. FDA in September, 2023, by a global pharmaceutical company. Following the inspection, Medipharm was presented with inspection observations. Medipharm has responded in writing to all observations through a corrective action plan. These actions have now been implemented and any additional FDA feedback is expected by way of comments on the company's DMF and partner's ANDA filings. As this process is completed, Medipharm continues to be a registered foreign drug manufacturing site with the U.S. FDA. The company believes it is the only Canadian pharmaceutical company or licensed producer with this registration.

This U.S. FDA inspection was the first of its kind for a purpose-built cannabis facility in Canada and rare for a global GMP facility that also manufactures botanical THC. This further solidifies Medipharm's position as a global leader in the pharmaceutical development and production of pharmaceutical cannabinoids. This distinction will enable the company to be a leader in future emerging markets, including drugs containing cannabinoids, international medical cannabis programs and over-the-counter CBD as a non-prescription natural health product.

The full acceptance of Medipharm's API DMF, of which the FDA inspection is a major step, allows for a number of commercial opportunities for the company. This will allow Medipharm to further market cannabidiol API to pharmaceutical companies for new novel drugs, generic drugs, modified generic drugs (FDA 505(b)(2)) and clinical trial materials.

About Medipharm Labs Corp.

Founded in 2015, Medipharm Labs specializes in the development and manufacture of purified, pharmaceutical-quality cannabis concentrates, active pharmaceutical ingredients and advanced derivative products utilizing a GMP certified facility with ISO (International Organization for Standardization) standard built clean rooms. Medipharm Labs has invested in an expert, research-driven team, state-of-the-art technology, downstream purification methodologies and purpose-built facilities for delivery of pure, trusted and precision-dosed cannabis products for its customers. Medipharm Labs develops, formulates, processes, packages and distributes cannabis and advanced cannabinoid-based products to domestic and international medical markets.

In 2021, Medipharm Labs received a pharmaceutical drug establishment licence from Health Canada, becoming the only company in North America to hold a commercial-scale domestic good manufacturing licence for the extraction of multiple natural cannabinoids. The company carries out its operations in compliance with all applicable laws in the countries in which it operates.

In 2023, Medipharm acquired Vivo Cannabis Inc., which expanded Medipharm's reach to medical patients in Canada through the Canna Farms medical e-commerce platform and in Australia and Germany through Beacon Medical Pty. Ltd. and Beacon Medical GmbH. This acquisition also included Harvest Medical Clinics in Canada, which provides medical cannabis patients with physician consultations for medical cannabis education and prescriptions.

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