UNITED KINGDOM— Celadon Pharmaceuticals has become the first company in the UK to be licensed to produce high-tetrahydrocannabinol (high-THC) medicinal cannabis.
The UK Medicines and Healthcare products Regulatory Agency (MRHA) has granted Celadon Pharmaceuticals a Good Manufacturing Practice (GMP) registration, allowing its Midlands facility to produce medical cannabis.
GMP is a globally recognized quality standard that must be met when producing pharmaceutical medicines for clinical trials and human use.
Celadon’s API is created through the use of genetics, extraction technology, and indoor hydroponic cultivation.
The company’s GMP product and ongoing R&D program have led to collaborations with leading universities, government agencies, and pharmaceutical companies engaged in cannabinoid research and drug development.
Medicinal cannabis, which was legalized in 2018, is currently “reliant on imported product, often facing lengthy delays and high costs,” the company said in its latest statement.
According to Prohibition Partners and Global Market Insights, the UK cannabis market is expected to be worth £1 billion (US$1.2 billion) by 2026, while the US industry is currently worth US$9 billion.
“The directors believe Celadon has now become one of a limited number of companies globally with the approvals in place to cultivate and manufacture EU-GMP grade high-THC medicinal cannabis,” the British pharmaceutical company added.
Typically, medical cannabis in the UK contains low levels of THC but Celadon added it “is understood to be the first for high-THC API in the UK since medicinal cannabis was legalized in 2018.”
Before it can begin producing active pharmaceutical ingredients, the company needs approval from the Home Office.
The government department’s license currently allows the organization to produce test batches of cannabis oil, with seven successful harvests occurring in 2022.
James Short, chief executive of 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.”
Meanwhile, Bedrocan, a Dutch medicinal cannabis producer, is increasing its production capacity by establishing a new GMP-approved facility in Denmark for medicinal cannabis cultivation and packaging.
The new facility will be built in Køge, Denmark, about 30 kilometers south of Copenhagen.
Bedrocan’s main reason for expanding into Denmark is to better meet the growing international demand for its high-quality medicinal cannabis products.
Bedrocan’s products are currently only available in the Netherlands through the Dutch Office of Medicinal Cannabis (OMC), which is part of the Ministry of Health.
Bedrocan anticipates significantly increasing the availability of its products to vulnerable patients worldwide. Bedrocan can do business with other commercial entities directly in Denmark.
In Australia, pharmaceutical cannabis products approved by the Therapeutic Goods Administration (TGA) include nabiximols (Sativex) and synthetic cannabinoids like Dronabinol.
Sativex, which is available as a nasal or oral spray, is approved in over 24 countries for the treatment of spasticity caused by multiple sclerosis.
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