Ingredient manufacturer Johnson Matthey (JM) has expanded its active pharmaceutical ingredient (API) and controlled substance offering with a new synthetic process for ‘ultra-pure’ cannabidiol (CBD).
According to JM, the completely synthetic method yields a free-flowing crystalline powder of CBD – a chemical compound derived from the cannabis plant.
“The process has been fully validated and a US DMF [drug master file] has been filed with the US Food and Drug Administration (FDA),” US commercial director of generic products and solutions, Kevin Hennessey, told us.
Manufacturing will take place at the firm’s API plant in West Deptford, New Jersey, where CBD will be made in multi-purpose reactors.
“JM is interested in supplying innovator and generic pharmaceutical companies for new drug application and abbreviated new drug application filings,” said Hennessey, adding that a majority of the interest in the technology has been observed in US and Canadian markets.
“JM is actively engaged in improving process efficiencies and scale to stay ahead of the growing CBD markets,” Hennessey added.
While CBD has attracted growing interest following FDA approval of GW Pharmaceuticals’ epilepsy treatment, Epidiolex – the first cannabis-derived drug to receive market authorisation in the US - Hennessey said there is potential to further expand focus beyond this key compound.
“JM is also focusing resources on the development of other cannabinoids that will go to help our innovator and generic pharmaceutical customers,” we were told.