MHRA approval relates to the company’s midlands-based drug development facilities.
Celadon – a company focused on the development of cannabis-based medicines – has announced that its midlands-based UK facility has now 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).
GMP is the globally recognised quality standard required to manufacture pharmaceutical medicines for clinical trials and human use. The approval is a compulsory requirement for the commercialisation of Celadon’s medicinal cannabis product, which is supplied in oil form as an API.
Celadon’s API is manufactured using a combination of genetics, extraction technology and indoor hydroponic cultivation. Incorporating a controlled environment, cultivation allows Celadon to achieve pharmaceutical-level consistency and replicability.
The company’s GMP product and its ongoing R&D programme have seen it partner with leading universities, government bodies and fellow pharmaceutical companies undertaking cannabinoid research and drug development.
James Short, chief executive officer at Celadon, reflected: “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.”
He added: “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’s current home office licence permits it to legally grow medicinal cannabis for the purpose of producing test batches of cannabis oil to support its application to the MHRA. While there is no guarantee that the home office will update the current licence, nor any timeframe for this, the company’s directors are confident that the licence will be updated in due course.