The UK-based pharmaceutical company, Celadon Pharmaceuticals Plc recently announced that its facility in the Midlands has now received official registration from the MHRA (Medicines and Healthcare products Regulatory Agency) for the Good Manufacturing Practice (GMP) production of its breakthrough cannabis Active Pharmaceutical Ingredient (API).
According to a spokesperson of the company, this is the first registration of a UK pharmaceutical facility for high Δ9-tetrahydrocannabinol (THC) cannabis API since the legalisation of medical cannabis in the year 2018 in the UK.
Celadon Pharmaceuticals Plc made history in 2022 as the first licenced medicinal cannabinoid company to be allowed to list on the London Stock Exchange AIM Market since GW Pharmaceuticals in 2001.
This latest news makes Celadon one of the few global players that have the official green light to manufacture an EU-GMP grade high-THC cannabinoid API for use in pharmaceutical drug development. Celadon is quickly becoming the key global player in the industry and is no doubt on the radar of it’s main competitor GW Pharmaceuticals, a company which has recently been acquired by Jazz Pharmaceuticals for USD $7.2 billion. Is it possible that another USD $Multi-Billion acquisition is in perspective?
Celadon’s Active Pharmaceutical Ingredient (API) is created using a unique proprietary combination of genetics, extraction techniques, and indoor hydroponic cultivation methods. The company claims to have achieved pharmaceutical-grade consistency, quality, and reproducibility, having demonstrated this through seven successful harvests, the company has produced an EU-GMP compliant product that is completely suitable for human consumption and evidently, a new market-authorised drug is on the horizon.
About Celadon Pharmaceutical Plc
Celadon Pharmaceuticals Plc is a UK-based pharmaceutical firm that is specialized in the research, cultivation, manufacturing and supply of breakthrough cannabis-based medicines.
Celadon was incorporated in 2018 by founders James Short (now CEO), Paul Allen and Cormac short following the announcement of the legalisation of cannabis-based medicinal products (CBMPs) in the UK. The founders have demonstrated the ability and drive in the regulated markets to build a strong team resulting in Celadon going public on the AIM market of the London Stock Exchange in 2022. The company’s goal is to improve patient’s quality of life through the use of cannabis-based medicines, which are known to be effective in treating a variety of conditions, such as epilepsy, multiple sclerosis, and autism.
What is an Active Pharmaceutical Ingredient (API)
An Active Pharmaceutical Ingredient (API) is the component of a medication that produces the intended health effects on the body to treat a certain condition or disease. It is the core of the product that gives it its medicinal properties, and it is what makes a drug different from other competing drugs. Some examples of APIs are ibuprofen or paracetamol.
API can be produced by chemical synthesis, extraction from natural sources or biotechnology. The API is then incorporated into a finished product, such as a tablet, capsule or liquid (in the case of Celadon it’s in oil form), which is then packaged and labelled for distribution and use.
API is a crucial component in the development of any new drug, and manufacturers must meet strict regulatory requirements to ensure that the API is safe, effective and of the highest quality.
The necessity of Good Manufacturing Practice (GMP)
Good Manufacturing Practice (GMP) is a globally recognized set of guidelines and regulations for the manufacturing, testing and quality control of pharmaceutical-grade medicines and products.
The GMP rules are designed to ensure that pharmaceutical products are consistently produced and controlled to the quality standards appropriate for their intended use and are required for any new drug that leads to marketing authorization by the MHRA or FDA (Food and Drug Administration).
Placing strict GMP requirements on the manufacturing process, facilities, equipment, and personnel ensure the safety, efficacy and purity of any pharmaceutical products.
This way companies can ensure that their products are consistently manufactured to the highest quality standards, which helps to prevent contamination and protects the consumer from safety issues.
To sell high-THC medicinal cannabis in the UK, a GMP registration and a Home Office licence are required.
The company believes that this GMP registration and its ongoing R&D program make it a partner of choice for leading universities, government bodies and global pharmaceutical companies looking for cannabinoid R&D and drug development. This latest news from the Company leads the company to produce revenue returns.
In conclusion, Celadon Pharmaceuticals Plc has made history by becoming one of the few global pharmaceutical companies to receive GMP registration for the production of a new and high-THC cannabis Active Pharmaceutical Ingredient (API) which will lead to a new marketing authorisation for a prescription drug. Looking back at the history of the industry, it is evident that Celadon is following in the footsteps of its main competitor GW Pharmaceuticals. Celadon has the potential to become a multi USD $Billion stock in the next 12 months now that the company can finally produce the product for revenue or, there is every possibility that this company is raising the eyebrows of multinationals and a multi $billion acquisition could be at play. Based on industry analysis, this is a buy-and-hold stock ripe for the picking.
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