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.

MediPharm Labs是北美第一家专门建造的大麻制药公司，获得了巴西卫生管理局（ANVISA）的GMP证书，用于生产大麻成品。

This strengthens MediPharm Labs' position in Brazil to manufacture both API and end products for Brazilian medical cannabis patients.

这加强了MediPharm实验室在巴西的地位，为巴西医用大麻患者生产原料药和最终产品。

Brazil, with a population of 215M, has seen tremendous growth in medical cannabis patients with a 480% increase in prescriptions in 2022.

巴西拥有2.15亿人口，医用大麻患者数量大幅增长，2022年处方量增加了480%。

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.

多伦多，2024年2月7日/PRNewswire/-MediPharm Labs Corp.（TSX:Labs）（OTCQB:MEDIF）（FSE:MLZ）（“MediPharm”，“MediPharm Labs”或“公司”）是一家专门生产精准大麻素的制药公司，很高兴地宣布其安大略省巴里工厂已获得巴西制药行业管理机构ANVISA的GMP认证。

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..

MediPharm实验室现已获得美国FDA、欧盟、澳大利亚TGA的GMP认证，并持有加拿大卫生部的药品经营许可证。。

Commercial Opportunity

商业机会

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.

这次ANVISA GMP认证检查是北美专门建造的大麻设施的首次此类检查，对于生产植物CBD和THC的全球GMP设施来说是罕见的。ANVISA GMP认证进一步巩固了MediPharm在药物大麻素开发和生产领域的全球领先地位。

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..

ANVISA GMP意味着巴西患者现在可以购买符合ANVISA认证设施中完成的最严格制造流程的产品。这种区别将进一步进入巴西医用大麻市场，并有助于进入其他全球市场，这些市场认可MediPharm不断增长的药物认证清单。。

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

根据行业观察机构Kaya Mind 2023年的报告，2025年巴西医用大麻市场预计将达到3.8亿加元。

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.

MediPharm实验室目前生产两种医用大麻产品，并根据巴西第327/19号决议获得ANVISA产品的完全授权，该决议管理巴西的高价值处方大麻产品。ANVISA目前正在审查其他产品授权。

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.

除现有巴西客户外，该公司于2023年7月与巴西一家顶级仿制药公司签订了供应协议。自签署协议以来，该客户已向ANVISA申请了一些MediPharm生产的大麻产品营销授权。

The receipt of GMP certification is a key milestone and critical required element of the rigorous ANVISA Pharma product approval process..

GMP认证的接收是严格的ANVISA制药产品批准流程的关键里程碑和关键要求要素。。

GMP Certification Details

GMP认证详情

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..

这项为期五天的亲自检查于2023年12月完成，是针对MediPharm目前通过其巴西客户群获得的医用大麻产品授权而启动的。只有根据该公司的加拿大卫生部药品建立许可证、特定产品GMP验证和各种长期稳定性研究，才能获得产品授权。。

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.

此次检查的重点是MediPharm的质量管理体系和与ANVISA GMP法规相关的成品制造能力，这些法规在国际制药行业享有严格合规的声誉。检查后，向MediPharm提供了观察结果。

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..

MediPharm通过自愿纠正行动计划书面回应了所有观察结果。我们的巴西客户和ANVISA接受了这些行动，从而达到了GMP合规状态。。

Management Commentary

管理层评论

'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.

“这项来自巴西的GMP认证加强了MediPharm作为世界上最专注于制药的医用大麻公司之一的地位。该认证加入了我们的全球监管成就清单，包括美国FDA、澳大利亚TGA、欧盟药品GMP和加拿大药品GMP授权。

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..

无论是用于大麻药物研究、国际大麻医疗计划还是未来可销售的大麻药物，MediPharm都投资并实施了全球制药和医疗渠道的开发。MediPharm实验室首席执行官大卫·皮德达克（DavidPidduck）评论道：“我们相信，这为我们未来的发展奠定了良好的基础，我们拥有一套全球无与伦比的功能、认证和批准。”。。

About MediPharm Labs

关于MediPharm实验室

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实验室成立于2015年，专业开发和制造纯化的药用质量大麻浓缩物、活性药物成分（API）和先进的衍生产品，利用经良好生产规范认证的设施和ISO标准建造的洁净室。

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..

MediPharm实验室投资了一个专家、研究驱动的团队、最先进的技术、下游净化方法和专门建造的设施，为客户提供纯净、可靠和精确剂量的大麻产品。MediPharm实验室为国内和国际医疗市场开发、配制、加工、包装和分销大麻和先进的大麻素产品。。

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..

2021年，MediPharm实验室获得了加拿大卫生部颁发的制药企业许可证，成为北美唯一拥有商业规模国内良好生产规范许可证的公司，用于提取多种天然大麻素。该GMP许可证是该公司目前在美国FDA进行国外药品生产现场注册的第一步。。

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..

2023年，MediPharm收购了维梧大麻公司，该公司通过Canna Farms医疗电子商务平台将MediPharm的业务扩展到加拿大的医疗患者，并通过Beacon medical PTY和Beacon medical GMBH在澳大利亚和德国。此次收购还包括加拿大的Harvest医疗诊所，该诊所为医用大麻患者提供医生咨询，以进行医用大麻教育和处方。。

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

公司按照其经营所在国的所有适用法律开展业务。

Cautionary Note Regarding Forward-Looking Information:

关于前瞻性信息的注意事项：

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.

本新闻稿包含适用加拿大证券法规含义内的“前瞻性信息”和“前瞻性声明”（统称“前瞻性声明”）。除历史事实声明外，所有声明均为前瞻性声明，并基于截至本新闻发布之日的预期、估计和预测。

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.

涉及预测、期望、信念、计划、预测、目标、假设、，未来活动或表现（经常但不总是使用诸如“期望”、“不期望”、“被期望”、“期望”或“不期望”、“计划”、“预算”、“预定”、“预测”、“估计”、“相信”或“打算”之类的短语，或使用此类词和短语的变体，或说明某些行动、事件或结果“可能”、“可能”、“会”、“可能”或“将”发生或实现）不是历史事实的陈述，可能是前瞻性的陈述。

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.

在本新闻稿中，前瞻性陈述涉及MediPharm在国际医疗市场的进入和独特地位、巴西和国际未来收入增长、客户产品授权、巴西大麻市场增长、与国际产品相关的利润率以及MediPharm独特的制药专业知识。

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.

前瞻性陈述必须基于一些估计和假设，这些估计和假设虽然被认为是合理的，但受到已知和未知风险、不确定性以及其他因素的影响，这些因素可能导致实际结果和未来事件与此类前瞻性陈述所明示或暗示的结果和未来事件存在重大差异。

Such factors include, but are not limited to: general business, economic, competit.

这些因素包括但不限于：一般商业、经济、竞争。

SOURCE MediPharm Labs Inc.

SOURCE MediPharm实验室公司。