Cannabis Research Company Submits FDA Responses For Gel Capsule Approval

Cannabis researcher MMJ International Holdings Corp recently reached a milestone when it officially submitted requested responses to the U.S. Food and Drug Administration (FDA) regarding its cannabis formulation. This submission comes in response to an FDA notification highlighting chemistry, manufacturing and control (CMC) concerns.

See Also: 'Justice Delayed Is Justice Denied' - FDA Sanctioned Marijuana Clinical Trials, Researcher's Suit Moves To DC Appellate Court

Dr. Elio Mariani, MMJ's chief scientist, expressed confidence in the submission, stating that it comprehensively addresses the CMC questions related to its all-natural plant-based soft gel capsule containing THC and CBD. These responses were pivotal as they paved the way for MMJ's forthcoming clinical trials for conditions such as multiple sclerosis and Huntington's Disease, per a press release.

MMJ's president, Duane Boise anticipates significant developments upon approval. He notes that MMJ International Holdings, along with its subsidiaries MMJ BioPharma Cultivation and MMJ BioPharma Labs will become one of the few federally legal companies approved by both the DEA and FDA. This approval extends to their capacity to cultivate, manufacture, transport, import and export cannabis for pharmaceutical development and clinical trials.

MMJ BioPharma Labs, with its DEA Analytical Lab Registration for Schedule 1 drugs, assumes a prominent role in cannabis research and development. However, it is worth noting that MMJ continues to face delays in the DEA approval process for MMJ BioPharma Cultivation's API Bulk Manufacturing registration, leading to litigation.

Chairman Tim Moynahan emphasized the significance of these achievements, underlining the need for safe and reproducible marijuana medicine to set the standard for reliable results in clinical trials.

As the cannabis sector continues to evolve, industry enthusiasts can look forward to the 17th edition of the Benzinga Cannabis Capital Conference in Chicago on September 27 and 28. Get your tickets today before prices increase and secure a spot at the epicenter of cannabis investment, research, culture, politics and branding. All information is available on bzcannabis.com

Read Next: Congress Gets Warning Letter: Be Aware The DEA Is Breaking The Law, Cannabis Company Says

Image by El Planteo

Market News and Data brought to you by Benzinga APIs
Comments
Loading...
Posted In: BiotechCannabisGovernmentNewsRegulationsFDAMarketsGeneralBenzinga Cannabis Capital ConferenceDEA Analytical Lab RegistrationDr. Elio MarianiDuane BoiseMMJ BioPharma LabsMMJ International Holdings CorpU.S. Food and Drug Administration
Benzinga simplifies the market for smarter investing

Trade confidently with insights and alerts from analyst ratings, free reports and breaking news that affects the stocks you care about.

Join Now: Free!

The Top Cannabis Event In New Jersey

Join the Benzinga Cannabis Market Spotlight in New Jersey on June 17th! Grow your business, raise money and capitalize on the booming NJ recreational market. Don’t miss this must-attend event in New Brunswick. Secure your tickets now. Very few spots are left. Use the code "JAVIER20" for 20% off!


Loading...