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LONDON - Ananda Pharma PLC (AQSE:ANA, OTCQB: ANANF) has manufactured 40 liters of its lead investigational product MRX1 and 40 liters of matched placebo in compliance with pharmaceutical Good Manufacturing Practices (GMP), the company announced Monday.
The GMP-validated production represents the largest volume of MRX1 manufactured to date by the UK-based biopharmaceutical company and meets a key requirement for use in human clinical trials.
MRX1, a CBD formulation, is planned for use in Phase 2 randomized controlled trials targeting chemotherapy-induced peripheral neuropathy and endometriosis-associated pain. A portion will also be used in a Phase 1 trial in Australia.
The manufacturing was completed at a certified GMP facility through Ananda’s Contract Development and Manufacturing Organization, with bottling finished according to regulatory standards. The materials will remain in controlled storage until release to clinical trial sites in Scotland or Australia.
"The regulatory pathway is central to our strategy. Our goal is to secure approval for MRX1 as a CBD formulation from the FDA, EMA, and MHRA," said Melissa Sturgess, Ananda’s CEO, in the press release statement.
Manufacturing MRX1 as an investigational medicinal product (IMP) requires stricter regulatory oversight than producing unlicensed specials, the category covering most cannabis-based medicines prescribed in the UK. IMPs require release by a Qualified Person ensuring compliance with GMP and clinical trial standards.
Ananda Pharma is developing regulatory approved cannabinoid medicines for complex chronic conditions, including epilepsy, endometriosis, and chemotherapy pain, working with scientists from institutions including the University of Edinburgh and University College London.
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