AJNA Biosciences Files for DEA Authorization to Grow Cannabis Under FDA Drug Framework

LITTLETON – AJNA Biosciences, a botanical drug development company, applied to the DEA for registration as a bulk manufacturer of Schedule I controlled substances. The filing, made available for public inspection on 30 October and scheduled for publication in the Federal Register today, covers marijuana, marijuana extracts, and tetrahydrocannabinols – three controlled substance categories the company intends to produce under a new FDA-regulated drug program.

According to the DEA notice, AJNA plans to use the material for internal research, clinical trials, and analytical purposes, while also supplying customers. The filing does not specify which medical conditions the company plans to target, which trials it intends to run, or what production volumes to expect. No FDA approval of any resulting drug product has been granted.

This filing extends a federal regulatory track record AJNA has been building. In June 2025, the company applied to manufacture psilocybin and psilocyn for research and clinical trials; the DEA granted that registration in December 2025. A second psilocybin-related application followed in April 2026.

AJNA was founded by Joel Stanley, who previously co-founded Charlotte’s Web, one of the best-known CBD companies in the United States. In a March 2026 interview, Stanley was direct about where his company stands relative to the consumer Cannabis market: “We have DEA licensing and we’re FDA registered. We’re not operating in the dietary supplement space or retail marijuana state-to-state programs.”

AJNA’s lead candidate, AJA001 [a full-spectrum hemp-derived formulation developed through a joint venture with Charlotte’s Web and British American Tobacco], cleared for a Phase 2 clinical trial targeting autism spectrum disorder (ASD). The company also has candidates in development for PTSD and anxiety disorders. Its scientific team includes Dr. Orrin Devinsky, the neurologist who led the principal investigation for Epidiolex – the Cannabis-derived drug approved by the FDA.

What this new Cannabis manufacturing application highlights is a company committed to operating inside federal pharmaceutical structures rather than alongside them. Regardless of how the DEA rules on this registration, the filing reinforces a broader reality taking shape across the sector: companies that are building durable, long-term positions in Cannabis medicine are doing so through regulatory science. Those investing in this infrastructure now hold the most advantage when the market finally catches up to the clinical work.