Red Light Holland's Partner FDA-Compliant and DEA-Registered Irvine Labs Receives 2025 Psilocybin DEA Quotas, Including Import Quota
Red Light Holland (TRUFF) announces a significant milestone as its partner Irvine Labs, an FDA-compliant and DEA-registered facility in California, has received its 2025 psilocybin DEA quotas including an import quota.
The companies will now proceed with the import permit application process to enable shipping of natural psilocybin products from Red Light Holland's Netherlands farm to Irvine's facilities. Once materials arrive, Irvine Labs will test proprietary dehydration and packaging solutions aimed at extending the shelf life of naturally derived psilocybin microdosing capsules.
Irvine Labs, licensed for prescription and OTC drug manufacturing by the California Department of Public Health, holds DEA Schedule 1 authorization for various substances including psilocybin. The partnership aims to develop commercialized products for export to emerging markets and use in government-funded pilot programs and clinical trials within the United States.
Red Light Holland (TRUFF) annuncia un traguardo importante: il suo partner Irvine Labs, una struttura conforme alla FDA e registrata presso la DEA in California, ha ricevuto le quote DEA per la psilocibina del 2025, inclusa una quota di importazione.
Le aziende procederanno ora con la richiesta del permesso di importazione per consentire la spedizione di prodotti naturali a base di psilocibina dalla fattoria di Red Light Holland nei Paesi Bassi alle strutture di Irvine. Una volta arrivati i materiali, Irvine Labs testerà soluzioni proprietarie di disidratazione e confezionamento volte a prolungare la durata di conservazione delle capsule di microdosaggio di psilocibina di origine naturale.
Irvine Labs, autorizzata alla produzione di farmaci su prescrizione e da banco dal Dipartimento della Salute Pubblica della California, detiene l'autorizzazione DEA Schedule 1 per varie sostanze, inclusa la psilocibina. La partnership punta a sviluppare prodotti commercializzati per l'esportazione verso mercati emergenti e per l'uso in programmi pilota finanziati dal governo e in studi clinici negli Stati Uniti.
Red Light Holland (TRUFF) anuncia un hito importante, ya que su socio Irvine Labs, una instalación en California que cumple con la FDA y está registrada en la DEA, ha recibido sus cuotas DEA de psilocibina para 2025, incluida una cuota de importación.
Las empresas procederán ahora con la solicitud del permiso de importación para permitir el envío de productos naturales de psilocibina desde la granja de Red Light Holland en los Países Bajos a las instalaciones de Irvine. Una vez que lleguen los materiales, Irvine Labs probará soluciones patentadas de deshidratación y envasado destinadas a extender la vida útil de las cápsulas de microdosificación de psilocibina de origen natural.
Irvine Labs, autorizado para la fabricación de medicamentos con receta y de venta libre por el Departamento de Salud Pública de California, cuenta con la autorización DEA Schedule 1 para diversas sustancias, incluida la psilocibina. La asociación tiene como objetivo desarrollar productos comercializados para exportación a mercados emergentes y para su uso en programas piloto financiados por el gobierno y ensayos clínicos dentro de los Estados Unidos.
Red Light Holland (TRUFF)은 중요한 이정표를 발표했습니다. FDA 기준을 준수하고 DEA에 등록된 캘리포니아의 파트너 Irvine Labs가 2025년 psilocybin DEA 할당량과 수입 할당량을 받았습니다.
이제 두 회사는 네덜란드의 Red Light Holland 농장에서 Irvine 시설로 천연 psilocybin 제품을 배송할 수 있도록 수입 허가 신청 절차를 진행할 예정입니다. 자재가 도착하면 Irvine Labs는 천연 유래 psilocybin 마이크로도징 캡슐의 유통기한을 연장하기 위한 독자적인 탈수 및 포장 솔루션을 테스트할 것입니다.
캘리포니아 공중보건부에서 처방약 및 일반의약품 제조 허가를 받은 Irvine Labs는 psilocybin을 포함한 다양한 물질에 대해 DEA Schedule 1 승인을 보유하고 있습니다. 이 파트너십은 미국 내 신흥 시장으로 수출할 상업용 제품 개발과 정부 지원 파일럿 프로그램 및 임상 시험에 사용되는 제품 개발을 목표로 합니다.
Red Light Holland (TRUFF) annonce une étape importante : son partenaire Irvine Labs, une installation conforme à la FDA et enregistrée auprès de la DEA en Californie, a reçu ses quotas DEA pour la psilocybine en 2025, incluant un quota d'importation.
Les entreprises vont désormais entamer la procédure de demande de permis d'importation afin de permettre l'expédition de produits naturels à base de psilocybine de la ferme de Red Light Holland aux Pays-Bas vers les installations d'Irvine. Une fois les matériaux arrivés, Irvine Labs testera des solutions propriétaires de déshydratation et d'emballage visant à prolonger la durée de conservation des capsules de microdosage de psilocybine d'origine naturelle.
Irvine Labs, agréé pour la fabrication de médicaments sur ordonnance et en vente libre par le Département de la Santé Publique de Californie, détient une autorisation DEA Schedule 1 pour diverses substances, dont la psilocybine. Ce partenariat vise à développer des produits commercialisés pour l'exportation vers les marchés émergents et pour une utilisation dans des programmes pilotes financés par le gouvernement ainsi que dans des essais cliniques aux États-Unis.
Red Light Holland (TRUFF) verkündet einen bedeutenden Meilenstein, da sein Partner Irvine Labs, eine FDA-konforme und bei der DEA registrierte Einrichtung in Kalifornien, seine DEA-Quoten für Psilocybin 2025 einschließlich einer Importquote erhalten hat.
Die Unternehmen werden nun mit dem Antragsverfahren für die Einfuhrgenehmigung fortfahren, um den Versand natürlicher Psilocybin-Produkte von der Farm von Red Light Holland in den Niederlanden zu den Einrichtungen von Irvine zu ermöglichen. Nach Ankunft der Materialien wird Irvine Labs firmeneigene Dehydrations- und Verpackungslösungen testen, die darauf abzielen, die Haltbarkeit von natürlich gewonnenen Psilocybin-Microdosing-Kapseln zu verlängern.
Irvine Labs, lizenziert für die Herstellung von verschreibungspflichtigen und rezeptfreien Arzneimitteln durch das kalifornische Gesundheitsministerium, besitzt eine DEA Schedule 1 Genehmigung für verschiedene Substanzen, einschließlich Psilocybin. Die Partnerschaft zielt darauf ab, kommerzielle Produkte für den Export in aufstrebende Märkte sowie für den Einsatz in staatlich geförderten Pilotprogrammen und klinischen Studien in den Vereinigten Staaten zu entwickeln.
- Secured DEA import quota for 2025, enabling US market entry
- Partnership with FDA-compliant and DEA-registered facility
- Development of proprietary preservation technology for extended product shelf life
- Potential access to US government-funded programs and clinical trials
- Product development and shelf-life challenges with natural psilocybin compounds
- Multiple regulatory approvals still required before commercialization
- No immediate revenue impact as import permit pending
- The companies are now moving forward with the import permit application process.
- Following expected approval of the import permit, Red Light Holland will ship materials from its Netherlands farm to Irvine Labs.
Toronto, Ontario--(Newsfile Corp. - April 15, 2025) - Red Light Holland Corp. (CSE: TRIP) (FSE: 4YX) (OTCQB: TRUFF) ("Red Light Holland" or the "Company"), an Ontario-based corporation engaged in the production, growth, and sale of functional mushrooms and mushroom home grow kits in North America and Europe, as well as a premium brand of psilocybin truffles in the legal, recreational market within the Netherlands, in compliance with all applicable laws is excited to announce that its research and development partner, Irvine Labs Inc. ("Irvine Labs"), an FDA-compliant and DEA-registered facility in California, United States has successfully received its 2025 psilocybin DEA quotas including an import quota.
With the DEA quota now secured, Irvine Labs will submit the import permit necessary to receive Red Light Holland's natural psilocybin products, grown in the company's farm in the Netherlands.
Red Light Holland's partner, Irvine Labs is licensed for prescription and over-the-counter (OTC) drug manufacturing by the California Department of Public Health (CDPH) and is a DEA Schedule 1 Bulk drug cultivator, manufacturer, importer and exporter; including psilocybin, psilocin, marijuana, THC, extracts, DET, DMT, LSD, peyote and mescaline.
First Milestone Achieved:
"We are thrilled to announce this significant milestone in our partnership with Irvine Labs, as they have now received their 2025 psilocybin DEA import quota," said Todd Shapiro, CEO and Director of Red Light Holland. "This advancement allows us to immediately begin the import permit application process, bringing us one step closer to shipping our naturally derived psilocybin from our Netherlands farm to Irvine's state-of-the-art facilities in California. Once the materials arrive, the plans is for Irvine Labs to begin testing their proprietary dehydration and packaging solutions designed to extend the shelf life of our naturally derived psilocybin microdosing capsules. This progress underscores our commitment to expanding into global emerging legal markets with the highest quality products that meet rigorous standards for distribution and commercialization."
Shaun Land, President of Irvine Labs, added, "Receiving our 2025 psilocybin import quota from the DEA represents a critical milestone in our collaboration with Red Light Holland. We are now focused on securing the import permit and preparing our facilities to receive the raw materials from the Netherlands. We have extensive experience working with naturally derived pharmaceutical ingredients and are excited to support Red Light Holland's microdosing program with our expertise in manufacturing and compliance, aiming to extend these innovative products stability and shelf life."
The preservation of psilocybin from naturally derived compounds presents unique challenges in product development and manufacturing. Through Red Light Holland's partnership with Irvine Labs and the implementation of proprietary preservation technology, Red Light Holland aims to overcome these challenges by developing precise dehydration, manufacturing and storage protocols that maintain the integrity of natural compounds while significantly extending product shelf life. Combined with research into advanced packaging solutions, these innovations represent a comprehensive approach to ensuring product stability and quality throughout the supply chain.
Red Light and Irvine Labs combined goal is to develop a commercialized product that can be legally exported to emerging markets and used in government-funded pilot programs and clinical trials within the United States.
About Irvine Labs
Irvine Labs was established in 1997. Since 2013, Irvine Labs has had a significant investment in medical research and development through its Pharmaceutical Biotechnology Division with a focus on natural medicines, including cannabis, cannabinoids, psilocybin, herbs and other sources of natural medicines. Irvine Labs is licensed for Prescription and Over-the-Counter (OTC) drug manufacturing by the California Department of Public Health (CDPH). Irvine Labs is a DEA Schedule 1 Bulk drug manufacturer, importer and exporter (including marijuana, THC, extracts, psilocybin, psilocin, DET, DMT, LSD, Peyote and Mescaline, and Schedule 1-5 testing lab).
About Red Light Holland
Red Light Holland is an Ontario-based corporation engaged in the production, growth and sale of functional mushrooms and mushroom home grow kits in North America and Europe, and a premium brand of psilocybin truffles to the legal, recreational market within the Netherlands, in compliance with all applicable laws.
For additional information on the Company:
Todd Shapiro Chief Executive Officer & Director Tel: 647-643-TRIP (8747) Email: todd@redlight.co Website: www.RedLight.co.
Forward-Looking Statements and Cautionary Note
CAUTIONARY NOTE REGARDING FORWARD-LOOKING STATEMENTS
This press release contains "forward-looking information" within the meaning of applicable Canadian securities legislation. These statements relate to future events or future performance. The use of any of the words "could", "intend", "expect", "believe", "will", "projected", "estimated" and similar expressions and statements relating to matters that are not historical facts are intended to identify forward-looking information and are based on the Company's current belief or assumptions as to the outcome and timing of such future events.
The forward-looking information and forward-looking statements contained herein include, but are not limited to, statements regarding: the Company's performance, business objectives and milestones and the anticipated timing thereof, and costs in connection with, the execution or achievement of such objectives and milestones, including its plans to continue seeking legal opportunities to increase responsible access to natural psilocybin around the world and Irvine lab's development of the Company's psilocybin; the Company and the Company's partners to maintain its stated licenses and obtain all necessary additional licenses and regulatory approval required for the Company to carry out its plans as described; the expectations with respect to the Company's planned psilocybin import following Irvine Labs' successful receipt of its 2025 psilocybin DEA quota and pending import permit approval; the Company's continued commitment towards ensuring legal, responsible access to Red Light's standardized natural psilocybin products; the Company's commitment to making further announcements with respect to its overall R&D project, including its partnership with Irvine Labs Inc. and the research project to develop a process for the commercial manufacture of microdosing capsules derived from the Company's psilocybin truffles; the Company proving out potential therapeutic benefits of Psilocybin; the Company receiving important insights from naturally occurring psilocybin truffles; the Company's ability to extract and expand access to psilocybin products; and the Company's ability to scalable production of high-quality, and approved microdoing capsules with extended shelf life via Irvine Labs ability to export their manufactured products from the United States to emerging markets, or sell to government funded pilot programs or clinical trials in the United States or around the world.
Forward-Looking information in this press release are based on certain assumptions and expected future events, namely: the Company's ability to maintain or exceed its current performance, and carry out its business objectives and milestones and under the anticipated timing and costs in connection with, the execution or achievement of such objectives and milestones; the Company and the Company's partners' abilities, including Irvine Labs to maintain its stated licenses and obtain all necessary additional licenses and regulatory approval required for the Company to carry out its plans as described; the Company's ability to realize its plans for its planned psilocybin imports following Irvine Labs' successful receipt of its 2025 psilocybin DEA quota and pending import permit approval; the Company's ability for its continued commitment towards ensuring legal, responsible access to Red Light's standardized natural psilocybin products; the Company's ability to maintain its commitment to making further announcements with respect to its overall R&D project, including its partnership with Irvine Labs and their research project to develop a process for the commercial manufacture of natural-source microdoing capsules derived from the Company's psilocybin truffles; the Company proving out potential therapeutic benefits of Psilocybin; the Company receiving important insights from naturally occurring psilocybin truffles; the ability to extract and expand access to psilocybin products; and the Company's ability to have scalable production of high-quality, microdosing capsules with extended shelf life for Global Distribution and The Company's ability to import their products into the United States and eventually the Companys ability to export their manufactured products from the United States to emerging markets, or sell to government funded pilot programs or clinical trials in the us or around the world.
These statements involve known and unknown risks, uncertainties and other factors, which may cause actual results, performance or achievements to differ materially from those expressed or implied by such statements, including but not limited to: the Company's inability to maintain or exceed its current performance, and carry out its business objectives and milestones and under the anticipated timing and costs in connection with, the execution or achievement of such objectives and milestones; the Company and the Company's partners' inabilities, including Irvine Labs, to maintain its stated licenses and obtain all necessary additional licenses and regulatory approval required for the Company to carry out its plans as described; the Company's inability to realize upon its plans for its planned psilocybin import despite Irvine Labs' successful receipt of its 2025 psilocybin DEA quota; delays or issues with the import permit process; the Company's inability to maintain its commitment towards ensuring legal, responsible access to Red Light's standardized natural psilocybin products; the Company's inability to maintain its commitment to making further announcements with respect to its overall R&D project, including its partnership with Irvine Labs; and The Company's ability to expand and extract access to psilocybin products.
The Company cannot make medical claims and is purely in a R&D phase with its partners Irvine Labs Inc.
Readers are further cautioned not to place undue reliance on forward-looking statements, as there can be no assurance that the plans, intentions or expectations upon which they are placed will occur. Such information, although considered reasonable by management at the time of preparation, may prove to be incorrect and actual results may differ materially from those anticipated.
Forward-Looking statements contained in this press release are expressly qualified by this cautionary statement and reflect the Company's expectations as of the date hereof and are subject to change thereafter. The Company undertakes no obligation to update or revise any forward-looking statements, whether as a result of new information, estimates or opinions, future events or results or otherwise or to explain any material difference between subsequent actual events and such forward-looking information, except as required by applicable law.
To view the source version of this press release, please visit https://www.newsfilecorp.com/release/248548
FAQ
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