The application follows the Company's approval from the New Mexico Board of Pharmacy this year.
GRANTS, NM, March 07, 2024 (GLOBE NEWSWIRE) -- Bright Green Corporation, a Delaware corporation (the "Company"), announced today the submission of its DEA Registration for Bulk Production of Schedule I and Schedule II Controlled Substances. The application is an official and substantial step in Bright Green's expansion into the legal manufacturing of plant-based controlled substances including psilocybin, peyote, ibogaine and opium poppy, alongside their active pharmaceutical ingredients ("API") for medical, research, and other legal purposes. The move aligns with Bright Green's commitment to providing a domestic supply of essential medications, addressing critical concerns associated with disruptions to the global pharmaceutical supply chain, and the national security risk currently posed by the United States' dependency on imports.
Last year, Bright Green obtained its DEA Registration for the Bulk Manufacturing of Cannabis, a Schedule I Controlled Substance, and recently received approval from the New Mexico Board of Pharmacy to produce additional Schedule I and Schedule II Controlled Substances. In response to these approvals already in place, Bright Green has undergone substantial renovations and expansions at its Grants, New Mexico facility to support this new era of operations.
"Our vision is to play a vital role in production, storage and supply of plant and fungi-based controlled substances domestically to secure and continue the plan for "Drugs Made in America" said Bright Green's CEO Groovy Singh on Monday. "Through continued rigorous compliance with federal, state, and local regulations, we aim to contribute to the advancement of medical research and alleviate the impact of chronic diseases affecting a significant portion of the U.S. population."
Bright Green's application demonstrates its dedication to meeting the public interest factors outlined by 21 U.S.C. § 823(a), including effective diversion control, compliance with laws, promotion of technical advances, and a commitment to public health and safety. The Company has assembled a team of experienced professionals to lead its controlled substance production efforts, ensuring adherence to stringent security and compliance standards.
The submission of this registration marks a significant milestone for Bright Green Corporation as it pioneers the "Drugs Made in America" movement. The Company looks forward to collaborating with the DEA and the State of New Mexico to facilitate the safe and responsible production and distribution of medications to meet rapidly growing demand.
該申請是在該公司今年獲得新墨西哥州藥房委員會的批准之後提出的。
新墨西哥州格蘭茨，2024年3月7日（GLOBE NEWSWIRE）——特拉華州的一家公司Bright Green Corporation（“公司”）今天宣佈提交了其附表一和附表二受控物質批量生產的緝毒局註冊。該申請是Bright Green向合法生產植物基受管制物質（包括迷幻藥、peyote、ibogaine和罌粟）以及用於醫療、研究和其他法律目的的活性藥物成分（“API”）邁出的正式和實質性的一步。此舉符合Bright Green的承諾，即提供國內基本藥物供應，解決與全球藥品供應鏈中斷相關的關鍵問題，以及美國目前依賴進口造成的國家安全風險。
去年，Bright Green獲得了附表一管制物質大麻批量生產的美國藥物管理局註冊，最近還獲得了新墨西哥州藥房委員會的批准，可以生產更多的附表一和附表二受控物質。爲了回應已經獲得的這些批准，Bright Green對其位於新墨西哥州的格蘭茨工廠進行了大規模的翻新和擴建，以支持這一新時代的運營。
Bright Green首席執行官Groovy Singh週一表示：“我們的願景是在國內植物和真菌類管制物質的生產、儲存和供應中發揮至關重要的作用，以確保並繼續實施 “美國製造的藥物” 計劃。“通過持續嚴格遵守聯邦、州和地方法規，我們的目標是爲醫學研究的進步做出貢獻，減輕影響美國很大一部分人口的慢性病的影響。”
Bright Green的申請表明其致力於滿足《美國法典》第 21 篇第 823 (a) 節概述的公共利益因素，包括有效的分流控制、遵守法律、促進技術進步以及對公共健康和安全的承諾。該公司組建了一支由經驗豐富的專業人員組成的團隊，領導其受控物質生產工作，確保遵守嚴格的安全和合規標準。
該註冊的提交標誌着Bright Green Corporation的一個重要里程碑，因爲該公司開創了 “美國製造的藥品” 運動。該公司期待與美國藥物管理局和新墨西哥州合作，促進藥物的安全和負責任的生產和分銷，以滿足快速增長的需求。
