MediPharm Labs Achieves Pharmaceutical GMP Certification with Brazilian Health Authority

Rhea-AI Summary

MediPharm Labs has received a GMP certificate from the Brazilian Health Regulatory Agency, ANVISA, making it the first pharmaceutical cannabis company in North America to do so. This certification allows the company to manufacture both active pharmaceutical ingredients (API) and end products for medical cannabis patients in Brazil. With a population of 215 million, Brazil has seen a 480% increase in medical cannabis prescriptions in 2022, indicating a significant market opportunity. The certification strengthens MediPharm's global position as a leader in the development and production of pharmaceutical cannabinoids, providing access to the Brazilian medical cannabis market and facilitating entry into additional global markets. The Brazilian medical cannabis market is expected to reach $380 million CAD in 2025, and MediPharm Labs currently manufactures two medical cannabis products with full ANVISA product authorization under Brazil's Resolution 327/19. The company has also entered into a supply agreement with a top-tier generic pharmaceutical company in Brazil, further expanding its market reach. The GMP certification was obtained after a rigorous inspection of MediPharm's manufacturing capabilities and quality management system, resulting in a compliant GMP status.

Positive

• MediPharm Labs is the first pharmaceutical cannabis company in North America to receive a GMP certificate from ANVISA, strengthening its position in the Brazilian medical cannabis market.
• The Brazilian medical cannabis market is expected to reach $380 million CAD in 2025, providing a significant commercial opportunity for MediPharm Labs.
• The company's GMP certification allows it to manufacture both API and end products for medical cannabis patients in Brazil, as well as facilitates entry into additional global markets.
• MediPharm Labs has a strong track record of global regulatory achievements, including US FDA, Australian TGA, European Union pharmaceutical GMP, and Canadian pharmaceutical GMP authorizations.

Negative

• None.

• MediPharm Labs is the first purpose-built pharmaceutical cannabis company in North America to receive a GMP certificate from the Brazilian Health Regulatory Agency (ANVISA), for production of cannabis finished goods.
• This strengthens MediPharm Labs' position in Brazil to manufacture both API and end products for Brazilian medical cannabis patients.
• Brazil, with a population of 215M, has seen tremendous growth in medical cannabis patients with a 480% increase in prescriptions in 2022.

TORONTO, Feb. 7, 2024 /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 announce receipt of GMP certification for their Barrie, Ontario facility from ANVISA, the governing body of Brazil's pharmaceutical industry. MediPharm Labs now has GMP certification from the United States FDA, European Union, Australia's TGA and holds a drug establishment license from Health Canada.

Commercial Opportunity

This ANVISA GMP certification inspection is the first of its kind for a purpose-built cannabis facility in North America and rare for a global GMP facility that manufactures botanical CBD and THC. The ANVISA GMP certification further solidifies MediPharm's position as a global leader in the development and production of pharmaceutical cannabinoids. The ANVISA GMP means Brazilian patients can now purchase products which adhere to the strictest manufacturing  processes completed in an ANVISA-accredited facility. This distinction will provide further access to the Brazilian medical cannabis market as well as facilitate access to additional global markets that recognize MediPharm's growing list of pharmaceutical certifications.

The Brazilian medical cannabis market is expected to reach $380 million CAD in 2025, according to a 2023 report by industry observer Kaya Mind.  

MediPharm Labs currently manufactures two medical cannabis products with full ANVISA product authorization under Brazil's Resolution 327/19, which governs high-value prescription cannabis products in Brazil. Additional product authorizations are currently under review with ANVISA.

In addition to existing Brazilian customers, the Company entered into a supply agreement with a top-tier generic pharmaceutical company in Brazil in July 2023. Since signing the agreement, the customer has applied to ANVISA for a number of MediPharm produced cannabis product marketing authorizations. The receipt of GMP certification is a key milestone and critical required element of the rigorous ANVISA Pharma product approval process.

GMP Certification Details

The five-day in-person inspection, completed in December 2023, was initiated in relation to MediPharm's current medical cannabis product authorizations through its Brazilian customer base. A product authorization was only possible based on the Company's Health Canada pharmaceutical Drug Establishment License, product-specific GMP validation and various long-term stability studies.

The inspection focused on MediPharm's quality management system and manufacturing capabilities for finished goods in relation to ANVISA GMP regulations, which have an international pharmaceutical industry reputation of strict compliance. Following the inspection, MediPharm was presented with observations. MediPharm responded in writing to all observations via a voluntary corrective action plan. Our Brazilian clients and ANVISA accepted these actions, resulting in a compliant GMP status.

Management Commentary

"This GMP certification from Brazil strengthens MediPharm's position as one of the most pharmaceutically focused medical cannabis companies in the world. The certification joins our long list of global regulatory achievements, including US FDA, Australian TGA, European Union pharmaceutical GMP and Canadian pharmaceutical GMP authorizations. Whether it is the production for cannabis-based drug research, international cannabis medical programs or future marketable cannabis drugs, MediPharm has invested in and executed on the development of global pharmaceutical and medical channels. We believe this positions us well for future growth with a suite of capabilities, certifications and approvals unmatched globally," commented David Pidduck, MediPharm Labs CEO.

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 Practices License for the extraction of multiple natural cannabinoids. This GMP license was the first step in the Company's current foreign drug manufacturing site registration with the US FDA.

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.

The Company carries out its operations in compliance with all applicable laws in the countries in which it operates.

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, MediPharm's access to and unique position in the international medical markets, future revenue growth in Brazil and internationally, customer product authorizations, Brazilian cannabis market growth, margin related to international product and MediPharm's unique pharma 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; 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.

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SOURCE MediPharm Labs Inc.

FAQ

What is the significance of MediPharm Labs receiving a GMP certificate from ANVISA?

The GMP certificate allows the company to manufacture both active pharmaceutical ingredients (API) and end products for medical cannabis patients in Brazil, strengthening its position in the Brazilian medical cannabis market and facilitating entry into additional global markets.

What is the expected size of the Brazilian medical cannabis market in 2025?

The Brazilian medical cannabis market is expected to reach $380 million CAD in 2025, providing a significant commercial opportunity for MediPharm Labs.

What are some of the global regulatory achievements of MediPharm Labs?

MediPharm Labs has obtained US FDA, Australian TGA, European Union pharmaceutical GMP, and Canadian pharmaceutical GMP authorizations, demonstrating its strong track record in global regulatory compliance.

What products does MediPharm Labs currently manufacture with full ANVISA product authorization?

The company currently manufactures two medical cannabis products with full ANVISA product authorization under Brazil's Resolution 327/19, which governs high-value prescription cannabis products in Brazil.