(Alliance News) - Celadon Pharmaceuticals PLC on Monday said its UK Midlands facility has now been registered by the UK Medicines & Healthcare products Regulatory agency for the good manufacturing practice production of its cannabis active pharmaceutical ingredient.
The London-based pharmaceutical company focusing on the research, cultivation, manufacturing and sale of breakthrough cannabis-based medicines said the GMP is an essential requirement for the commercialisation of its medicinal cannabis product.
This is because the GMP is the globally recognised quality standard that is required to manufacture pharmaceutical medicines for human use and clinical trials, it said.
Celadon claimed it becomes one of a few global companies with the capability to produce an EU GMP-grade high tetrahydrocannabinol cannabinoid API, alongside being the first registration for a UK pharmaceutical facility for a THC cannabis API since the legalisation of medical cannabis in 2018.
It has notified the Home Office to request an update to its existing licence to reflect its GMP status, as required in order to sell high THC medicinal cannabis in the UK.
The GMP registration follows seven harvests and extractions during 2022 and the MHRA inspection during the fourth quarter of the year.
"Whilst there is no guarantee that the Home Office will update the current licence, nor any timeframe for this, the directors are confident that the licence will be updated in due course," Celadon said in a statement.
Chief Executive Officer James Short added: "This is a tremendous milestone for the company given the significant capital and regulatory requirements in this sector."
"Today's announcement is the culmination of four years of hard work. I would like to thank the team and our loyal shareholders for their support and belief in our vision as we continue our journey of putting the patient first in ensuring they can access the cannabis-based medicines they so desperately need."
Shares in Celadon were up 6.8% to 55.00 pence each in London on Monday afternoon.
By Greg Rosenvinge, Alliance News reporter
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Celadon Pharma. (CEL)