- MediPharm Labs expands its Brazilian presence where the medical
cannabis market is estimated to be worth $198 million in 2024, serving over 670,000
patients.1
- Products include full-spectrum, GMP sublingual oral solutions
with extensive pharmaceutical validation and characterization.
- Teuto is one of Brazil's
largest pharmaceutical manufacturers of both generic and branded
medicines, with an extensive portfolio of oncologic specialty
drugs, making it an ideal partner for MediPharm.
BARRIE,
ON, Jan. 8, 2025 /CNW/ - MediPharm Labs
Corp. (TSX: LABS) (OTCQX: MEDIF) ("MediPharm" or the "Company"), a
leader in pharmaceutical-grade cannabis manufacturing, is proud to
announce a commercial agreement with Laboratório Teuto ("Teuto"), a
leading pharmaceutical manufacturer and marketer in Brazil. This partnership signifies a
significant milestone as MediPharm expands its reach into one of
the most tightly regulated medical cannabis markets globally.
ANVISA Product Approval Marks Commercial Milestone
Achievement
ANVISA (Agência Nacional de Vigilância Sanitária) granted Teuto
Sanitary Authorizations for two products manufactured by Medipharm.
The approvals, published on December 30,
2024, mark the culmination of a rigorous process that
underscores MediPharm's commitment to compliance, quality, and
innovation in the global medical cannabis space. MediPharm and
Teuto have been working closely together on the ANVISA approvals,
which included pharmaceutical-level product filings, extensive
quality control documentation, and responding to multiple requests
for information over many months. Initial Shipments are expected to
begin in the new year after applicable import and export permits
from ANVISA and Health Canada are received.
Brazil's medical cannabis
market is known for its stringent regulatory requirements,
including:
- ANVISA onsite GMP Inspections: Ensuring adherence to the
highest pharmaceutical standards.
- Comprehensive Product Dossier Submissions: Requiring a minimum
of 12 months of stability testing and rigorous quality
assurance.
- Extended Product Approval Timelines: Reflecting Brazil's
commitment to patient safety and product efficacy.
There are currently only 36 valid cannabis product
authorizations issued by ANVISA under RDC 327/2019.2
MediPharm Labs is one of just a few North American companies
with products to receive multiple sanitary authorizations for
cannabis products while holding an ANVISA GMP licence. The
Brazilian medical cannabis market is growing over 20% annually and
is projected to exceed $260 million
by 2026.3 Teuto can use its existing deep roots in
Brazil and sales and marketing
expertise to position itself as a leader in pharmaceutical
cannabis.
Teuto: A Trusted Partner in Brazil
Teuto, a household name for trusted medicines in Brazil, boasts over 77 years of industry
leadership. As one of the largest pharmaceutical companies in the
country, Teuto operates a state-of-the-art manufacturing facility
spanning over 140,000 square meters and produces more than 500
pharmaceutical products annually.4 Teuto's extensive
distribution network, national sales force and commitment to
quality make it an ideal partner for MediPharm as the Company
brings pharmaceutical-grade cannabis solutions to Brazilian
patients. This agreement reflects MediPharm's strategic focus on
leveraging its pharmaceutical GMP-certified platform to expand
globally into large, complex and highly regulated markets.
MediPharm's expertise aligns seamlessly with Teuto's vision to
provide innovative healthcare solutions to the Brazilian market,
including over 215 million people.
Management Commentary
"Globally, we believe that the higher the regulatory bar, the
more complex and stringent the quality standards are in a country,
the better for MediPharm. Brazil
is a perfect example of a large complex market, and we are very
fortunate to have a long-term partnership with Teuto, one of the
leading Brazilian pharmaceutical companies." said David Pidduck, CEO at MediPharm Labs.
"Medical cannabis is an important product for our line of
Specialty Care, increasing our relationship with physicians,
completing our CNS portfolio and Oncology on palliative care. Our
partnership with MediPharm will allow TEUTO to grow faster in this
market, bringing more full-spectrum products with the highest
quality to Brazilian patients in need." said Marcelo Henriques, CEO of Teuto.
About Laboratório Teuto
Established in 1947, Teuto is a pioneering pharmaceutical
company in Brazil, dedicated to
delivering high-quality medicines and healthcare solutions. Known
for its innovation and trust, Teuto has become a cornerstone of
Brazil's healthcare ecosystem.
Teuto works incessantly to maintain its products in perfect
condition. The company, which is synonymous with quality and
confidence at affordable prices, constantly seeks to provide more
quality of life to its clients, employees, and partners,
reaffirming that "If its Teuto, its trustworthy".
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.
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, MediPharm's access to and unique position
in the international medical markets, Remidose project capital
expenses, future revenue growth in Germany and internationally, customer product
authorizations, German 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.
1 Kaya,
Medicinal Cannabis Yearbook 2024, Kaya Mind Dados e
Pesquisas LTDA.
https://kayamind.com/anuario-da-cannabis-medicinal-2024/
|
2 Brazilian
Health Regulatory Agency (2025, January 7).
Consultations https://consultas.anvisa.gov.br/#/cannabis/q/?situacaoRegistro=V
|
3 Kaya,
Medicinal Cannabis Yearbook 2024, Kaya Mind Dados e
Pesquisas LTDA.
|
4
Laboratório Teuto (2025, January 7). Corporate website,
https://www.teuto.com.br/
|
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SOURCE MediPharm Labs Corp.