HYTN announces their new GMP Stability Program and the validation of their vape cartridges used in international markets.
Image | adobe.stock/pavelkant
In a recent press release, HYTN Innovations Inc. (HYTN) unveiled the launch of their new Good Manufacturing Practice (GMP) Stability Program, as well as the validation of their cannabis vape cartridges for international markets (1).
HYTN will be able to offer, “an initial six-month stability statement for its GMP-compliant vape products—an essential regulatory requirement for pharmaceutical and medical cannabis markets in most jurisdictions, including Germany, the United Kingdom, and Australia,” (1). Studies that are ongoing and non-accelerated will plan to extend those statements to 12 months. The hope is that this will help “validate long-term product stability for international markets,” (1). Through joint collaboration with the company’s GMP-licensed laboratory partner, the Stability Program is able to be organized.
The press release mentioned that, “In parallel with the launch of the Stability Program, HYTN has finalized the selection of a cartridge manufacturer and initiated comprehensive qualification and validation procedures, including equipment qualification and process validation, to ensure compliance with GMP standards for its ceramic coil 1g vaporizer cartridge. These efforts establish a foundation for global distribution while ensuring compliance with evolving regulations and market standards,” (1).
HYTN’s GMP product portfolio will have both live rosin and live resin cannabis vape products. An amendment was submitted for their existing licensing framework HYTN has with Health Canada so that they are able to include oil to be an approved dosage form (1).
In the press release, HYTN expressed (1), “The Company believes that these initiatives further position HYTN to meet the needs of global cannabis markets requiring GMP-certified products under strict regulatory frameworks.” The medical cannabis marketplace in Germany has been seeing a rise in growth through an increase in patient counts (1,2). Germany imported around 20,000 kilograms of cannabis in Q3 2024 which according to the press release, was more than double the country’s quarterly average before the cannabis reform in April 2024 (2). It helps show that there is a growing demand for cannabis that is made at the pharmaceutical-grade level (1).
References
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