In a groundbreaking development, Vitura Health’s joint venture, Cortexa Pty. Ltd., has initiated batch manufacturing of GMP MDMA 40mg capsules. This move supports both clinical trials and clinical use under the TGA’s Authorized Prescriber pathway. The achievement marks a significant milestone for Cortexa, as it establishes domestic Australian manufacturing, reinforcing its position as a leader in the Australian psychedelic landscape.
A Reliable Local Supply
Cortexa’s domestic manufacturing capability represents a crucial step forward. By producing MDMA capsules locally, the venture aims to free local clinicians and researchers from the costly and time-consuming burden of importation. This seamless access to medication ensures a reliable supply for patients.
Optima Ovest: The Exclusive Contract Manufacturer
After rigorous due diligence, Cortexa has entered an exclusive arrangement with Perth-based contract manufacturer Optima Ovest. With extensive experience in producing GMP, clinical-grade pharmaceutical products, Optima is well-equipped to scale operations in line with demand. The collaboration not only enables onshore manufacturing but also guarantees a secure, domestic source of medication, independent of the international supply chain.
Cortexa’s Impact on the Australian Market
Since its inception in May 2023, Cortexa has rapidly become a leader in the emerging field of psychedelic-assisted therapy in Australia. The venture has navigated regulatory frameworks, completed importation, and supplied products for clinical trials and the authorized prescriber scheme. Now, with local manufacturing underway, Cortexa continues to grow the Australian market for LaNeoTM MDMA.