UK medical cannabis manufacturer granted GMP registration

The first good manufacturing practice (GMP) registration of a UK pharmaceutical facility for high Δ9-tetrahydrocannabinol (THC) cannabis active pharmaceutical ingredient (API) has been granted since the legalisation of medical cannabis in 2018.

Celadon Pharmaceuticals’ Midlands site is now registered by the UK Medicines and Healthcare products Regulatory Agency (MHRA) for GMP manufacturing. The firm’s medicinal cannabis product will be supplied in oil form as an API.

Navigating the cannabis API market

A new GMP registration is positive news for the sector. Currently, UK patients prescribed medicinal cannabis are reliant on imported product, often facing lengthy delays and high costs.

According to Celadon, the company plans to begin using its high-THC API products for use in the chronic pain market. It has plans to expand to other indications such as autism and multiple sclerosis.

James Short, Chief Executive Officer of Celadon stated: “With the receipt of GMP registration, Celadon has joined a very select group of cannabis-focused pharmaceutical companies globally. This is a tremendous milestone… given the significant capital and regulatory requirements in this sector.”

Authorising medical cannabis in the UK

An MHRA issued manufacturing licence (API registration) is required to manufacture unlicensed medical cannabis-based products (CBPMs).

The organisation specifies that a GMP inspection of these manufacturing sites are required to confirm suitability. Manufacturers must be able to verify appropriate Pharmaceutical Quality System (PQS) and that required activities such as process and analytical validation have been undertaken.

GMP registration and a Home Office (Controlled Drugs licence) is required in order to sell high-THC medicinal cannabis in the UK.