- MediPharm Labs holds unique US Food and Drug Administration (FDA) site registration in relation to the manufacturing and release of pharmaceutical cannabis products.
- MediPharm is the only US FDA Audited purpose-built commercial cannabis facility in Canada. One of a handful globally.
- The possible rescheduling of cannabis in the US opens new opportunities for MediPharm in categories where the Company maintains a competitive advantage.
TORONTO, Aug. 13, 2025 /PRNewswire/ – 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 share insights on its US FDA site registration in relation to the possible rescheduling of cannabis in the United States.
Communication from the US Federal Government and various media reports have indicated that the administration is reviewing the rescheduling of cannabis federally in the US. Speculation is that this will mean changing the classification of cannabis from a Schedule I drug to a Schedule III drug.
What rescheduling means for cannabis in the United States:
- The rescheduling would recognize the medical benefits of cannabis at a federal level.
- Schedule III registration would drastically expand the possibility for US based research on medical cannabis products. Current, Schedule I drug classification puts controls in place that make it difficult for this research to be funded and undertaken today.
- This would open up the possibility for the US to expand special access medical cannabis programs, like those in Canada, Australia and Germany.
How MediPharm is best positioned in the event of rescheduling cannabis in the US:
- MediPharm has gone through the complex process of a foreign drug manufacturing site registration with the US FDA. Following a week-long inspection by an FDA representative MediPharm was granted the ability to produce, label, test and release drugs.
- MediPharm has filed a drug master file (DMF) with the US FDA for CBD active pharmaceutical ingredient (API). The active ingredient file is required for drug manufacturers to source CBD for late-stage clinical trials and finished dose products.
- MediPharm has already shipped medical cannabis API and cannabis products to the US for research, including a National Institutes of Health (NIH) funded clinical trial. This delivery required the US FDA site registration and import permits issued by the US DEA.
- Upon possible rescheduling of cannabis, MediPharm Labs holds existing licences and expertise to serve the anticipated expansion of US based research and possible new medical special access programs.
- To MediPharm’s understanding no other publicly listed cannabis-focused company in North America has this stack of licensing, including an FDA inspected cannabis facility. It takes years of regulatory and quality activities to achieve this suite of licensing, and enable clinical research with pharmaceutical cannabis.
MediPharm Labs continues to maintain their top tier pharmaceutical licenses and registrations to continue its position as a leader in the global cannabis market. The Company will continue to monitor changes in the US scheduling of cannabis to serve researchers and patients with quality cannabis API and products.
About MediPharm Labs
Founded in 2015, MediPharm Labs specializes in the development and manufacture of purified, pharmaceutical-quality cannabis concentrates, active pharmaceutical ingredients (API) and advanced derivative products utilizing a Good Manufacturing Practices certified facility with ISO 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 License from Health Canada, becoming the only company in North America to hold a commercial scale domestic Good Manufacturing License 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 via Canna Farms medical ecommerce platform, and in Australia and Germany through Beacon Medical PTY 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.
Website: www.medipharmlabs.com
Cautionary Note Regarding Forward-Looking Information:
This news release contains “forward-looking information” and “forward-looking statements” (collectively, “forward-looking statements”) within the meaning of the applicable Canadian securities legislation. All statements, other than statements of historical fact, are forward-looking statements and are based on expectations, estimates and projections as at the date of this news release. Any statement that involves discussions with respect to predictions, expectations, beliefs, plans, projections, objectives, assumptions, future events or performance (often but not always using phrases such as “expects”, or “does not expect”, “is expected”, “anticipates” or “does not anticipate”, “plans”, “budget”, “scheduled”, “forecasts”, “estimates”, “believes” or “intends” or variations of such words and phrases or stating that certain actions, events or results “may” or “could”, “would”, “might” or “will” be taken to occur or be achieved) are not statements of historical fact and may be forward-looking statements. In this news release, forward-looking statements relate to, among other things, possible rescheduling of cannabis in the United States, the expansion of US based research on medical cannabis products, the expansion of special access medical cannabis programs in the US, opportunities for future clinical research opportunities, future marketable pharmaceutical products, and future Canadian and international commercial products that leverage MediPharm’s unique pharmaceutical expertise. Forward-looking statements are necessarily based upon a number of estimates and assumptions that, while considered reasonable, are subject to known and unknown risks, uncertainties, and other factors which may cause the actual results and future events to differ materially from those expressed or implied by such forward-looking statements. Such factors include, but are not limited to: general business, economic, competitive, political and social uncertainties; the inability of MediPharm Labs to obtain adequate financing; the delay or failure to receive regulatory approvals; MediPharm’s competitive licensing and FDA site inspection and registration; and other factors discussed in MediPharm Labs’ filings, available on the SEDAR+ website at www.sedarplus.ca. There can be no assurance that such statements will prove to be accurate, as actual results and future events could differ materially from those anticipated in such statements. Accordingly, readers should not place undue reliance on the forward-looking statements and information contained in this news release. Except as required by law, MediPharm Labs assumes no obligation to update the forward-looking statements of beliefs, opinions, projections, or other factors, should they change.
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SOURCE MediPharm Labs Corp.
