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GMP MDMA shipment reaches Australia 

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PharmAla Biotech Holdings has announced that it has issued a shipment of its GMP LaNeo MDMA to Mind Medicine Australia.

PharmAla is biotechnology company focused on the research, development, and manufacturing of novel MDXX class molecules including MDMA. Currently, it is the only publicly traded company in the world to have successfully manufactured GMP MDMA drug product and to have shipped that product to Australia.

Its contract with Mind Medicine Australia – a charity which seeks to alleviate the suffering caused by mental illness in Australia through expanding treatment using psychedelic molecules – was announced in May of 2022, and is now considered complete. 

Chief Executive Officer of PharmAla, Nick Kadysh, stated: “When MMA approached us a year ago, they did so because they recognized that we were the only entity in the world which had the manufacturing capability – and the operational execution – to deliver MDMA to them along their desired timelines. 

“While the road to this execution wasn’t easy, I’m glad to say that we have delivered.

“In the future, we anticipate that Cortexa – our joint venture with Vitura Health – will be more than capable of fulfilling all demand in the Australian market, and without the additional regulatory burden of import/export.”

Additionally, the company has announced that it and its manufacturing partners have completed shipment of its GMP LaNeo MDMA capsules to the Orygen Institute, affiliated with the University of Melbourne. 

This shipment represents the first of two shipments which will support a Clinical Trial registered by the Orygen Institute, with the second shipment scheduled for 2024. The contract was previously announced in a press release dated August 22, 2022.

Shane Morris, COO, PharmAla Biotech, commented: “PharmAla continues to prove that we deliver on our commitments, and do so at the highest levels of regulatory compliance.

“Our best-in-class value chain continues to execute deliveries to customers – even on the other side of the world – and we look forward to expanding our capabilities further in the coming months as Cortexa fully comes online.”

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