- 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.