MediPharm Labs Receives Export Authorization to Ship Medical Cannabis to Brazil
MediPharm Labs has received regulatory approval from Brazil's ANVISA and Canada's Health Canada to ship medical cannabis oil for compassionate care. Initial shipments will support patient trials, contributing to future product marketing under Brazil's medical cannabis program, which serves over 20,000 patients, growing at 1,500 per month. The partnership with XLR8, a local distributor, aims to enhance clinical research and patient care. This milestone paves the way for broader product distribution in the significant LATAM cannabis market.
- Regulatory approvals obtained from ANVISA and Health Canada for medical cannabis shipments to Brazil.
- Initial shipments will support patient trials, aiding future product marketing authorizations.
- Growing patient market in Brazil, with over 20,000 patients and 1,500 new patients monthly.
- Partnership with local distributor XLR8 enhances credibility and market entry.
- None.
- Completed the regulatory process required to ship medical cannabis to Brazil with import permits issued from ANVISA and export permits issued from Health Canada. Initial deliveries will be under the compassionate care program.
- First shipments to Brazil to be used for patient trials to collect data that may be used in future product marketing authorizations under Brazil’s medical cannabis program. A program that saw over 20,000 patients in 2020 and is growing by 1,500 patients a month.
BARRIE, Ontario, Aug. 18, 2021 (GLOBE NEWSWIRE) -- MediPharm Labs Corp. (TSX: LABS) (OTCQX: MEDIF) (FSE: MLZ) (“MediPharm Labs” or the “Company”) a pharmaceutical company that specializes in cannabis, is pleased to announce that it has received approval to ship medical cannabis oil to Brazil. This approval, issued by both ANVISA and Health Canada, allows initial shipments to patients for the Company’s partner XLR8. The shipment is a crucial milestone for the Company in using its pharmaceutical Good Manufacturing Practices (“GMP”) platform for international manufacturing and distribution.
The Company and XLR8, a Curitiba based value-added distributor serving Brazil, entered into an agreement in September 2020. The two-year agreement is to commence from the time of ANVISA Sanitary Product Authorization, which is expected later this year. The registration will be for a mix of medical oil SKUs such as balanced and high CBD formulas. This initially approved delivery goes directly to patients under the compassionate care program, allowing XLR8 to begin its medical cannabis research. This first delivery opens a regulatory pathway for future opportunities for authorized product distribution. Brazil is one of the most significant medical cannabis market opportunities in LATAM.
“MediPharm Labs continues to execute our on plan to provide pharmaceutical-grade medical cannabis products to patients around the world. It is with great partners, like XLR8, with local country expertise that we can effectively achieve this goal,” said Keith Strachan, President and Interim CEO, MediPharm Labs.
”Based on our business pillars, clinical research development is a strategic path to provide substantial clinical evidence to support physicians in making appropriate decisions in patient care and cannabis is a real alternative. Our clinical research follows all national and international ethical standards, demonstrating our responsibility to provide all necessary resources to our patients” said Thiago Callado, CEO and Founder, XLR8 BRAZIL.
The Company looks forward to announcing further executed deliveries to Brazil in the coming months.
About MediPharm Labs
Founded in 2015, MediPharm is a pharmaceutical company that specializes in the development and manufacture of purified, pharmaceutical-quality cannabis concentrates, active pharmaceutical ingredients and advanced derivative products utilizing a Good Manufacturing Practices certified facility with ISO standard-built clean rooms. MediPharm has invested in an expert, research driven team, state-of-the-art technology, downstream purification methodologies and purpose-built facilities with four primary extraction lines for delivery of pure, trusted and precision-dosed cannabis products for its customers. Through its wholesale and white label platforms, MediPharm formulates, develops (including through sensory testing), processes, packages and distributes cannabis extracts and advanced cannabinoid-based products to domestic and international markets. As a global leader, MediPharm has completed commercial exports to Australia and completed commercialization of its Australian extraction facility which generated its first revenues in H1 2020. MediPharm Labs Australia was established in 2017.
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, statements regarding growth of the patient market in Brazil; opened regulatory pathways for future opportunities; providing pharmaceutical-grade medical cannabis products to patients around the world; and further executed deliveries to Brazil in the coming months. 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; and other factors discussed in MediPharm Labs’ filings, available on the SEDAR website at www.sedar.com. 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.
All information contained in this press release with respect to XLR8 was supplied by XLR8 for inclusion herein.
FAQ
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