WeedPress: The Paper Trail

AJNA BioSciences of Littleton, Colorado, has applied to DEA to grow marijuana for research and an FDA-regulated drug program. Registered bulk manufacturers and other applicants can object or request a hearing by Jan. 4, 2027. The research-grower track is separate from South Dakota’s state-licensed program.

By Jason Karimi, Publisher

Part of WeedPress’s South Dakota DEA Supply Chain series. Start here →

A Colorado botanical drug developer has asked the Drug Enforcement Administration to register it as a bulk manufacturer of marijuana, a federal registration it would need before growing the plant for the research and drug-development work described in the notice.¹,²,³ DEA published notice of the application in the Federal Register on Monday, Nov. 2.³

The notice says AJNA BioSciences, of Littleton, Colorado, applied on Sept. 30 to bulk manufacture three substances: marihuana extract, marihuana and tetrahydrocannabinols, or THC. DEA’s notice lists all three as Schedule I.³ (“Marihuana” is the spelling used in federal law and in DEA’s notice, which spells the company’s name “AJNA Biosciences.”)

According to the notice, the company “plans to bulk manufacture the listed controlled substances and initiate a new Food and Drug Administration (FDA) regulated drug program cultivating whole plant marihuana (7350, 7360 and 7370) to support internal research, clinical trials, and analytical purposes as well as to distribute for sale to its customers.” The notice adds: “No other activities for these drug codes are authorized for this registration.”³

The notice is an application, not an approval. It does not say whether or when DEA will act on the application.³

The deadlines

Under the notice, registered bulk manufacturers of the same basic classes of substances, and other applicants to bulk manufacture them, may submit electronic comments on or objections to the proposed registration on or before Jan. 4, 2027. Those manufacturers and applicants may file a written request for a hearing on the application by the same date. DEA says comments must be filed through regulations.gov.³

DEA’s rules require the agency to publish a notice naming each applicant to bulk manufacture a Schedule I or II controlled substance.⁴ They give registered bulk manufacturers of that class, and other applicants to bulk manufacture it, 60 days from publication to comment or object. Applications to grow marijuana must also meet the separate rules for marijuana growers in Part 1318 of DEA’s regulations.⁴

Who the company is

On its website, AJNA describes itself as a botanical drug developer. It says it is “developing full-spectrum cannabinoid and psilocybin-based medicines” for autism spectrum disorder, generalized anxiety disorder and post-traumatic stress disorder.¹ Its pipeline page lists two cannabinoid programs: AJA001, for irritability in autism spectrum disorder, developed through a joint venture called DeFloria, and AJA003, for PTSD.⁵ DEA’s notice does not say which product or study the marijuana would supply.³

Federal Register notices show this is not AJNA’s first DEA bulk-manufacturer application. The company applied in 2023, 2025 and 2026 to bulk manufacture mushrooms containing psilocybin and psilocyn “to support internal research, clinical trials, and analytical purposes.”⁶,⁷,⁸ DEA’s online notice-of-registration page for manufacturers includes two AJNA BioSciences entries, dated April 30, 2024, and Feb. 4, 2026. The 2026 entry cites the June 2025 psilocybin application notice.⁹,⁷

When WeedPress viewed DEA’s list of “DEA approved Bulk Manufacturer marijuana Growers” on Nov. 2, AJNA was not among the seven companies listed on that page.²

How DEA’s research-grower program works

DEA says growing marijuana for research or other lawful purposes requires a DEA registration. The agency finalized rules in December 2020 to “facilitate the cultivation of marihuana for research purposes and other licit purposes.”²,¹⁰ Under those rules, in Part 1318 of DEA’s regulations, registered research growers must deliver their total crops to DEA. The agency must buy and take physical possession of the crops “not later than four months after the end of the harvest,” and holds the exclusive right to import, export and wholesale that cannabis.¹¹

In choosing growers, DEA must weigh public-interest factors that include diversion controls, compliance with state and local law and past experience.¹² It gives particular emphasis to an applicant’s prior compliance with federal law, its “ability to consistently produce and supply cannabis of a high quality and defined chemical composition” and supply agreements with registered researchers or manufacturers.¹² An applicant that wants to grow for its own research or product development must also hold a Schedule I researcher registration for marijuana.¹²

Congress added a deadline in 2022 for certain marijuana research-grower applications.¹³ Under the Medical Marijuana and Cannabidiol Research Expansion Act, when the attorney general has placed a notice in the Federal Register to increase the number of registered growers supplying researchers, the attorney general must approve an application or request more information within 60 days of receiving a completed application. DEA’s notice does not say whether AJNA’s application falls under that provision.³ The law also requires an annual assessment of whether the research supply of marijuana is “adequate and uninterrupted.”¹³

DEA’s grower page lists a 2026 administrative fee of $113 per kilogram, added to the price of cannabis sold through the agency. DEA says it reached that figure by dividing the program’s estimated fiscal 2025 cost of $751,614 by the 2025 aggregate production quota of 6,675 kilograms.²

Why it matters, and how it differs from South Dakota’s program

AJNA’s application is on a different federal track from South Dakota’s medical cannabis businesses.

Under the April 2026 federal rule, only certain marijuana moved to Schedule III: marijuana in FDA-approved products or marijuana “subject to a state medical marijuana license,” and the rule created a separate DEA registration for state-licensed medical marijuana businesses.¹⁴ Under that rule, Part 1318, the research-grower rules described above, “shall not apply” to entities holding those state-license registrations.¹⁵ DEA’s timely-applicant list covers applications filed under that state-license rule, and WeedPress counted 10 South Dakota manufacturer entries on the list.¹⁶,¹⁷ WeedPress has reported on what DEA’s timely-applicant list does and does not show about South Dakota.¹⁸

AJNA’s pending application is for the Schedule I bulk-manufacturer pathway for research and drug development, which predates the April rule.³,¹⁰

WeedPress analysis: As WeedPress reads the rules cited here, federal law now has two separate paths for growing marijuana with DEA registration: the Part 1318 path for research and drug development, and the April rule’s path for state-licensed medical businesses. The two handle the crop differently. Research growers deliver their crops to DEA, which controls wholesale distribution, while state-license manufacturers set a nominal price at which DEA buys the crop and sells it back to them or a related entity.¹¹,¹⁵ How DEA handles AJNA’s application may offer a limited view of how the research path is working in 2026.

Right of reply

WeedPress emailed questions to AJNA BioSciences on Monday, Nov. 2, and asked for a reply by 5 p.m. CT Thursday, Nov. 5. WeedPress will update this story with any response.

Have information about DEA registrations? Contact weedpressnewstips@gmail.com.