Headquartered in Athens, Georgia, USA, Purisys LLC is a leading provider of API contract manufacturing and development services including custom synthesis and analytical development services for clinical stage compounds. Purisys' expertise includes extensive scientific and regulatory know-how, state-of-the-art manufacturing technologies and a track record of delivering projects on time.
Woke signed an agreement with Purisys in November 2021 for the active psilocybin pharmaceutical ingredient and has placed multiple orders. Purisys meets all the requirements set by Woke as a contract manufacturer of the API, including cost, QC and QA, plus relevant licences for export.
“The high-quality API from Purisys meets our needs for developing novel formulations, clinical trials, and commercialisation.”
IDT Australia Limited (ASX: IDT) is an Australian pharmaceutical manufacturing company based in Boronia, Victoria, Australia. The Company has extensive experience in the development and production of high potency and high containment pharmaceutical products for local and international clients. IDT’s facilities are cGMP compliant and are regularly audited by the US FDA and Australian TGA. With an experienced team of specialists within world-class facilities, IDT provides a full-scale service for new drug development and scale-up, commercial active drug manufacture as well as a variety of oral and injectable finished drug dose forms.
Woke and IDT Australia signed a Letter of Intent for psilocybin-based pharmaceuticals in December 2021, and a final agreement in April 2022. IDT, which has relevant licenses from the Office of Drug Control and Victoria’s Department of Health and Human Services for Schedule 9 products, including psilocybin, is importing synthetic psilocybin on behalf of Woke from the US. The first shipment of psilocybin arrived in January 2022 and multiple orders have been placed since.
The manufacturing agreement between IDT Australia and Woke relates to the manufacture of clinical material for Woke’s two novel dosage forms of psilocybin for treatment of moderate depression and treatment-resistant depression, respectively. IDT is also warehousing and providing the API to Woke’s formulation partner, Monash University’s MMIC.
“IDT Australia has the requisite licences to import psychedelics and the skills to manufacture finished product.”