Bright Green Corporation (BGXX) submits for historic DEA Registration for Production of Schedule I and Schedule II controlled substances.
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Insights
The submission of the DEA Registration for Bulk Production of Schedule I and Schedule II Controlled Substances by Bright Green Corporation marks a strategic pivot towards securing a domestic supply chain for critical medications. This move is particularly significant in light of recent global supply chain disruptions and the U.S. government's focus on reducing reliance on imported pharmaceuticals. By expanding into the production of controlled substances such as psilocybin and coca leaves, Bright Green is positioning itself at the forefront of an emerging sector within the pharmaceutical industry that has the potential to offer novel treatments for chronic diseases.
From an industry perspective, this development could signal a shift towards more U.S.-based production facilities for controlled substances, which may affect the competitive landscape. Companies that can successfully navigate the complex regulatory environment and establish domestic production capabilities may enjoy a strategic advantage. For stakeholders, the implications are twofold: there is the potential for enhanced stock valuation due to growth prospects in new markets, but also the risk associated with the stringent regulatory compliance required for controlled substances.
Bright Green's commitment to producing active pharmaceutical ingredients (APIs) for plant-based controlled substances aligns with a growing interest in alternative therapies for chronic diseases. The production of compounds like psilocybin, which is currently being researched for its potential in treating mental health conditions, could accelerate clinical trials and the development of new medications. This could benefit the medical research community by providing a reliable domestic source of high-quality APIs.
From a public health standpoint, the ability to produce these substances domestically may lead to faster access to innovative treatments. However, the challenge lies in ensuring that these substances are used responsibly and in accordance with FDA guidelines. The potential for misuse and diversion is a concern that requires robust diversion control mechanisms, as outlined by 21 U.S.C. § 823(a). Bright Green's focus on effective diversion control and compliance is essential in maintaining public trust and safeguarding patient health.
The legal implications of Bright Green Corporation's DEA registration submission are significant, as it reflects compliance with the Controlled Substances Act (CSA) and adherence to federal, state and local regulations. The company's dedication to meeting the public interest factors required by 21 U.S.C. § 823(a) demonstrates a proactive approach to the legal challenges associated with controlled substance production.
For investors and stakeholders, it's important to recognize that the legal landscape for controlled substances is evolving and companies like Bright Green that can establish themselves as compliant leaders in the space may be well-positioned to capitalize on future regulatory changes. However, the rigorous legal scrutiny and potential for regulatory shifts pose a risk that must be carefully managed. The company's ability to maintain strict compliance will be critical in its efforts to secure long-term success and avoid legal pitfalls.
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, coca leaves, 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.
About Bright Green
Bright Green became the first publicly-traded company in almost a century to receive federal approval for the production of Schedule I and Schedule II controlled substances in 2024 when it received unique licensing from the New Mexico State Board of Pharmacy. As one of the very few companies selected by the US government to grow, manufacture, and sell, legally under federal and state laws, cannabis and cannabis-related products for research, pharmaceutical applications and affiliated export, Bright Green is a pioneer for the “Drugs Made in America” movement. Our approval based on already agreed terms from the U.S. Drug Enforcement Administration gives us the opportunity to advance our vision of improving quality of life through the opportunities presented by plant, fungus, and cannabis-derived therapies. To learn more, visit www.brightgreen.us.
Media Contacts: Interdependence Public Relations Owen Phillips / Grace Connor BrightGreen@Interdependence.com
Cautionary Note Regarding Forward-Looking Statements
This press release contains “forward-looking statements” within the meaning of the “safe harbor” provisions of the Private Securities Litigation Reform Act of 1995. These forward-looking statements are made as of the date they were first issued and were based on current expectations, estimates, forecasts and projections as well as the beliefs and assumptions of management as of such date. Words such as “expect,” “anticipate,” “should,” “believe,” “hope,” “target,” “project,” “goals,” “estimate,” “potential,” “predict,” “may,” “will,” “might,” “could,” “intend,” “shall” and variations of these terms or the negative of these terms and similar expressions are intended to identify these forward-looking statements. Forward-looking statements are subject to a number of risks and uncertainties, many of which involve factors or circumstances that are beyond the Company’s control, including but not limited to, the inability of the Company to raise funds under the Company’s EB-5 program, and the impact that new officers, directors and employees may have on the Company and the Company’s business and results of operations. The Company’s actual results could differ materially from those stated or implied in forward-looking statements due to a number of factors, including but not limited to, risks detailed in the Company’s Annual Report on Form 10-K and Quarterly Report on Form 10-Q, as amended and supplemented, as well as other documents that may be filed by the Company from time to time with the SEC. The forward-looking statements included in this press release represent the Company’s views as of the date of this press release. The Company anticipates that subsequent events and developments will cause its views to change. The Company undertakes no intention or obligation to update or revise any forward-looking statements, whether as a result of new information, future events or otherwise. These forward-looking statements should not be relied upon as representing the Company’s views as of any date subsequent to the date of this press release. Additional information regarding these and other factors that could affect the Company’s results is included in the Company’s SEC filings, which may be obtained by visiting the SEC's website at www.sec.gov.
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