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UK: MHRA registration offers step forward for medicinal cannabis pharmaceuticals

Laboratory Talk

Saturday 28 Jan 2023

AIM listed UK-based Celadon Pharmaceuticals Plc, has won UK Medicines and Healthcare products Regulatory Agency (MHRA) Good Manufacturing Practice registration for the manufacturing of its cannabis Active Pharmaceutical Ingredient.

The firm stated it was the first GMP registration of a UK pharmaceutical facility for high ?9tetrahydrocannabinol cannabis API since the legalisation of medical cannabis in 2018. GMP registration and a Home Office licence is required in order to sell high-THC medicinal cannabis in the UK. Celadon has notified the Home Office to request an update to its existing licence to reflect its GMP status

GMP, the globally recognised quality standard required to manufacture pharmaceutical medicines for human use and clinical trials is essential for commercialisation of Celadon’s medicinal cannabis production.

In the UK currently, patients prescribed medicinal cannabis are reliant on imported product, often facing lengthy delays and high costs.

CEO 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."

https://laboratorytalk.com/article/2092762/mhra-registration-offers-step-forward-for-medicinal-cannabis-pharmaceuticals

 

 

 

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