CB21 Pharma, a leading pharmaceutical company focused on developing and marketing innovative cannabinoid-based treatments, is pleased to announce the successful completion of its certification audit for manufacturing plant-derived Dronabinol by the State Institute for Drug Control (SÚKL). This marks a significant milestone in the company’s efforts to expand its portfolio of medical cannabis-derived APIs for patients suffering from various medical conditions.
The certification audit, conducted by SÚKL, is a rigorous process that ensures compliance with the highest standards of quality, safety, and regulatory guidelines for the production of pharmaceutical ingredients. Passing this audit confirms that CB21 Pharma has met the stringent requirements for manufacturing Dronabinol (pure Delta-9-Tetrahydrocannabinol).
This compound is widely used to manage nausea and vomiting associated with chemotherapy, stimulate appetite in patients with AIDS-related wasting syndrome, and in various magistral formulas.
“We are proud to have successfully passed the SÚKL audit, which is a testament to our commitment to quality and regulatory compliance,” said Dr. Jan Storch, CEO of CB21 Pharma.
“This achievement is a significant step forward for CB21 Pharma as we continue to develop our portfolio of cannabis-derived APIs and market innovative treatments that leverage the therapeutic potential of cannabinoids. We are excited to bring Dronabinol to patients who may benefit from its effects and further strengthen our position as a leader in the cannabinoid-based pharmaceutical space.”
CB21 Pharma’s commitment to the concept of evidence-based medicine drives its development of cannabinoid-based pharmaceutical products. Through rigorous research and clinical trials, the company is focused on expanding treatment options in areas where cannabinoid therapy has demonstrated efficacy, including gynaecology, urology, proctology, dentistry, and psychiatry.
“With the successful inclusion of Dronabinol into our portfolio, CB21 Pharma is now well-positioned to expand its distribution APIs in both domestic and international markets, bringing this important therapeutic option to more patients in need,” said Boris Baňas, head of global substance sales.
