Celadon Pharmaceuticals has confirmed that its Midlands UK facility has been registered by the UK Medicines and Healthcare products Regulatory Agency (MHRA) for the Good Manufacturing Practice (GMP) manufacturing of its cannabis Active Pharmaceutical Ingredient (API).
The registration is an essential requirement for the commercialisation of Celadon’s medicinal cannabis product, which will be supplied in oil form as an API.
Celadon’s API is manufactured using a proprietary combination of genetics, extraction technology and indoor hydroponic cultivation.
The company states it ustilises advanced controlled environment cultivation to achieve pharmaceutical-level consistency, quality and replicability, having done seven successful harvests to date, resulting in an EU-GMP-grade product suitable for human use.
Read more: Apollon Formularies and Global Hemp Group sign Letter of Intent
CEO of Celadon, James Short, said: “With the receipt of GMP registration, Celadon has joined a very select group of cannabis-focused pharmaceutical companies globally. 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.”
Celadon will require receipt of confirmation from the Home Office that they have updated its current Home Office licence before they will be able to supply its GMP API to third parties.
The company has stated that the current Home Office licence permits it to legally grow high-THC medicinal cannabis for the purpose of producing test batches of cannabis oil to support its application to the MHRA. During 2022, the company completed seven successful harvests and highlights that whilst there is no guarantee that the Home Office will update the current licence, the Directors are confident that the licence will be updated.
