Who is allowed to make psilocybin

A company in Canada that wants to ship psilocybin to a researcher abroad needs four separate authorisations. Three of them come from Health Canada: a Dealer’s Licence, a Drug Establishment Licence that is a second authorisation with its own process, and an export permit granted per shipment. The fourth is an import permit from whichever regulator sits at the other end.

That list comes from the registration statement Optimi Health Corp. filed on 13 March 2026, a Form F-1/A, which sets the stack out because it has to describe its own permissions to investors. Psyence Biomedical’s filed licensing agreement recites two of those four, which corroborates the holder on the licences and leaves the per-shipment permits resting on one company’s account.

Every question about who may make this drug turns into a question about which of the four you mean.

Two American states publish their licence registers, and when a register is published the work is clerical. Twenty-one organizations hold 28 production-side licences at Approved or listed across the two: in Colorado, 8 product manufacturer and 14 standard cultivation licences on the 5 September 2026 read; in Oregon, 6 manufacturer licences on the 1 September 2026 read. These are licences issued under each state’s supervised-services programme, never for retail sale.

Counting every status, live or otherwise, gives 31 organizations. Two separate things make up that gap, and a reader who assumes it is all refusals will be wrong. The all-status count includes withdrawn, pending and denied licences, and it also includes a fourth class of licence, micro cultivation, that the twenty-one does not.

One count describes who may operate today and the other describes everyone who has ever been in the queue, and neither is the honest figure on its own. A state cultivation licence and a federal dealer’s licence are also different instruments, so adding the two registers to anything national would produce a number with no category attached to it.

A prospectus supplement filed on 8 December 2023, describing Filament Health Corp., tells the investing public that Health Canada’s list of licensed psilocybin producers “is available upon request to parties interested in access to psilocybin through the SAP or for scientific research”.

So the list exists, and it has a defined audience. That is ordinary controlled-drug practice and not obstruction, and one email from somebody in that class converts this floor into a count. What it is not is published: there is no page you can open, and the only public description of the register is a sentence a company wrote for its investors.

That is a filing describing a register on the day it was filed, and it is the closest thing to an answer that the public record contains. Everything else in this piece is a count of somebody who happened to be in a register that someone chose to publish.

Australia is the country where a doctor may lawfully prescribe psilocybin, through a restricted authorised-prescriber pathway, which makes it the obvious place to look for a producer. Its Office of Drug Control addressed the question directly on its own page, whose stated last update is 25 July 2023:

The same page points elsewhere for the rest of the answer: to the states and territories, and to the Therapeutic Goods Administration, which it says does have power to licence the manufacture of psilocybine as a therapeutic good under a Good Manufacturing Practice licence.

That is what one agency said about its own authority on that date. It is not a statement about who holds an authorisation in Australia today, and an agency page is not a register.

The Dutch Opium Act puts a minister at the centre of the country’s medicinal cannabis supply, at articles 8h and 8i. The minister must see that enough is grown for medical research and for making medicines, and may licence only a party the ministry has contracted with.

In the same Act there is no such article for psilocybine, as the statute spells it, and none for the psilocybin-containing mushrooms that sit on the very schedule cannabis is on.

In nothing read for this work does a government manufacture psilocybin itself, and an absence like that is usually unprovable. This project’s rule is that an absence claim needs its positive control sitting on the same document or it does not get written. The Opium Act supplies one.

One statute, two substances, and a legislature that built a state supply route for one and not the other.

Governments report their manufacture to the International Narcotics Control Board, and the published series has four points: approximately 1 kilogram in 2020, 13 in 2022, 36.10 in 2023 and 19.22 in 2024. No figure is published for 2021; the Board says only that manufacture changed slightly that year. Why 2023 ran to nearly twice 2024 is not something the return explains.

Of the 2024 total, the United Kingdom reported 9.78 kilograms and the United States 9.16, with Canada, Switzerland and Germany reporting a few grams each.

That total counts pure substance reported under the 1971 Convention, which means it excludes every mushroom grown under an American state programme, because natural material sits outside the treaty that produces the figure.

A separate American number is often confused with this one. The DEA sets an aggregate production quota, and for 2026 it set 50,000 grams of psilocybin and 80,000 of psilocyn, which is the related molecule the body produces from it. A quota is a ceiling for one country in one year. An INCB return is an actual, across the world, in a different year. The two measure different things and dividing one by the other produces nothing.

In March 2025 the National Institutes of Health bought GMP psilocybin synthesis for US$789,896.88, on a task order to Benuvia Operations, LLC. That company sits on none of the rows of our own organization register. The United States government found a manufacturer we had not caught, by the straightforward method of buying from one.