'Tremendous milestone': Celadon Pharma gets UK approval for medical cannabis facility

The British company announced yesterday (January 16) that its Midlands facility has now been registered by the UK Medicines and Healthcare products Regulatory Agency (MRHA) for the Good Manufacturing Practiced (GMP) of its cannabis active pharmaceutical ingredient (API).

This first registration sees a pharmaceutical facility for high Δ9-tetrahydrocannabinol (THC) cannabis API since the legalisation of medical cannabis in 2018.

Celadon has now become one of a small number of global companies with the capability to produce the EU-GMP grade high-THC cannabinoid API. In order to sell this high-grade medicinal cannabis in the UK, a GMP registration and a Home Office licence is needed. 

Celadon GMP registration 

The registration follows seven harvests and extractions during 2022 and the MRHA inspection in the last quarter of last year (2022).

James Short, chief executive officer at Celadon 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​.”

At the moment, patients in the UK who are currently prescribed medicinal cannabis are reliant on imported products that currently involve long delays and high costs, the company hopes its product in oil form, will ease these burdens.

Home Office confirmation 

The company says its API is manufactured using a proprietary combination of genetics, extraction technology and indoor hydroponic cultivation. Making the most advanced controlled environment cultivation Celadon says this allows it to achieve pharmaceutical-level consistency, quality, and replicability, having done seven successful harvests to-date, resulting in this EU-GMP-grade product suitable for human use.

James added that Celadon’s GMP product and its ongoing research and development programme, make it a partner of choice for leading universities, government bodies and global pharmaceutical companies undertaking cannabinoid research and development and drug development.

Celadon will now 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. 

While there is no guarantee that the Home Office will update the current licence, nor any timeframe for this, Celadon's directors are confident that the licence will be updated in due course. The company has reportedly worked closely with the Home Office for four years, including securing updates to its licence, and has had a conversation about updating the licence for GMP at the Home Office’s last site inspection.