EN
登录

Ease Labs在巴西生产的首个大麻全谱产品获得当地卫生监管机构批准

First Cannabis full-spectrum product, manufactured in Brazil by Ease Labs, is approved by the local Health Regulatory Agency

CISION 等信源发布 2024-01-25 00:19

可切换为仅中文


It is the first full-spectrum extract manufactured locally and approved by the regulatory agency;

这是第一个在当地生产并经监管机构批准的全谱提取物;

Studies indicate that the product may bring benefits in the treatment of fibromyalgia, dementia and chronic pain.

研究表明,该产品可能对治疗纤维肌痛、痴呆和慢性疼痛有益。

SÃO PAULO, Jan. 24, 2024 /PRNewswire/ -- Ease Labs Pharma, a GMP Certified Pharmaceutical Company pioneer in the Cannabis market in Brazil, has just received the approval from the Brazilian Health Regulatory Agency  to commercialize the Cannabis sativa Extract locally, containing 750mg (25mg/mL) of CBD, up-to 0.2% THC, and other cannabinoids – a full-spectrum extract, that was developed and formulated at the pharmaceutical facility, located in Belo Horizonte (MG).

圣保罗,2024年1月24日/PRNewswire/--Ease Labs Pharma是一家通过GMP认证的巴西大麻市场先驱制药公司,刚刚获得巴西卫生管理局的批准,将大麻提取物在当地商业化,该提取物含有750mg(25mg/mL)的CBD,高达0.2%的THC和其他大麻素-一种全谱提取物,这是在位于贝洛奥里藏特(MG)的制药厂开发和配制的。

The product will be available for sale in pharmacies, with a medical prescription, from March this year..

该产品将于今年3月起在药店出售,并附有医疗处方。。

Brazil's current regulation for pharmaceutical Cannabis was approved in 2019, which classifies   cannabinoids as pharmaceutical drugs, and requires complex safety data and restricted pharmaceutical certifications to enable production, registration and sale in pharmacies. According to Kaya Mind, the market has grown substantially – 96% from 2022 to 2023, reaching $140M and is expected to double in 2024 with the distribution of products by the government and entry of big-pharma companies..

巴西现行的药用大麻法规于2019年获得批准,该法规将大麻素归类为药用药物,需要复杂的安全数据和受限制的药物认证才能在药店进行生产,注册和销售。据卡亚·明德(Kaya Mind)称,2022年至2023年,该市场大幅增长了96%,达到1.4亿美元,随着政府产品分销和大型制药公司的进入,预计2024年将翻一番。。

'It is the first product containing THC manufactured in Brazil approved by Anvisa, which will help patients with different diseases. The approval was possible because of our strict safety and quality standards, our team's outstanding technical expertise and our agility,' explains Gustavo Palhares, Ease Labs CEO and co-founder.

“这是Anvisa批准的第一个在巴西生产的含有THC的产品,它将帮助患有不同疾病的患者。Ease实验室首席执行官兼联合创始人古斯塔沃·帕哈雷斯(GustavoPalhares)解释说,之所以能够获得批准,是因为我们严格的安全和质量标准,我们团队出色的技术专长和灵活性。

According to him, until now, patients were relying exclusively on imported products that are sold at much higher prices..

据他说,到目前为止,患者完全依赖于价格高得多的进口产品。。

The full-spectrum Cannabis extract preserves various components of the plant and brings a variety of phytocannabinoids in addition to CBD and THC. The product was approved at all safety and quality tests required within GMP standards, at affordable prices – lower than currently practiced, with imported extracts – with discounts representing a reduction between 40% and 70%..

全谱大麻提取物保留了植物的各种成分,除了CBD和THC之外,还带来了多种植物大麻素。该产品在GMP标准要求的所有安全和质量测试中均获得批准,价格实惠-低于目前的进口提取物-折扣在40%至70%之间。。

'Scientific studies indicate that Cannabis extracts can bring benefits in conditions such as fibromyalgia, dementia and chronic pain,' says Flávia Guimarães, head of the Scientific Intelligence (SI) area at Ease Labs, who highlights that the doctor will always be responsible for prescribing the treatment..

“科学研究表明,大麻提取物可以在纤维肌痛、痴呆和慢性疼痛等疾病中带来益处,”安逸实验室科学情报(SI)区负责人弗拉维亚·吉马雷斯(FláviaGuimarães)说,他强调医生将始终负责开处方治疗。。

This is the third product approved in Brazil by Ease Labs. In 2023, the company started selling CBD isolate in pharmacies across the country - It currently sells the product in more than 4K, in 27 states.

这是Ease实验室在巴西批准的第三种产品。2023年,该公司开始在全国各地的药店销售CBD分离物-目前该产品在27个州的4K多个州销售。

CONTACT: Giuliana Gonçalvese-mail: [email protected]

联系人:Giuliana Gonçalvese邮件:[受电子邮件保护]