Fidest – Agenzia giornalistica/press agency

Quotidiano di informazione – Anno 34 n° 316

Posts Tagged ‘health canada’

FSD Pharma Receives Cannabis Sales License from Health Canada

Posted by fidest press agency su martedì, 23 aprile 2019

FSD Pharma Inc. (CSE:HUGE) (OTCQB:FSDDF) (FRA:0K9) (“FSD” or the “Company”), announced today that its wholly-owned subsidiary FV Pharma Inc. has received its Sale for Medical Purposes license to sell cannabis under the Cannabis Act (Canada). The license went into effect on April 18, 2019.The license allows the current FSD facility to supply and sell cannabis products. The company anticipates receiving the amended sales license that will include the sale of dried and fresh cannabis flower in the near future.Dr. Raza Bokhari, Executive Co-Chairman and CEO congratulated the FSD Pharma team, shareholders and stakeholders on this much anticipated achievement. Dr. Bokhari stated, “Our sales license is a key development for FSD Pharma and a huge success and step forward for our Cobourg Facility.” “We have achieved this milestone thanks to the efforts of our dedicated team. We are exceptionally proud of this achievement and look forward to accelerating our efforts,” commented Dr. Sara May, President of FV Pharma Inc.Zeeshan Saeed, President and Founder, added, “The granting of our sales license allows FSD to serve the growing medicinal use markets in Canada. We intend to quickly scale up production at our current facility, while continuing to build out the plant to add additional grow capacity. In addition, our sales license opens the door for our partner Canntab Therapeutics to commence sales of its suite of novel cannabis oral dose delivery platforms, including CBD and THC capsules, in Canada and global markets. We expect that this will provide an immediate benefit to both parties, since FSD is entitled to a share of Canntab’s revenue from sales as a result of the collaboration and profit sharing agreement that we entered into this past fall.” Anthony Durkacz, Founder and Executive Co-Chairman of the board speaking on behalf of the FSD Pharma Board of Directors stated, “We are proud of the leadership at FSD Pharma. This industry is transforming very rapidly and the leadership has positioned the company well to generate top tier revenue from our medicinal grade cannabis production.”

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cGMP Compliance Status for Promethera Biosciences’ Production Site in Durham, NC Confirmed by Health Canada

Posted by fidest press agency su sabato, 1 settembre 2018

Promethera Biosciences SA, a global innovator in cell-based medicines and liver diseases, today announced that Health Canada has confirmed a cGMP compliance status for the company’s production facility in Durham, North Carolina. The Durham facility will be focused on achieving the goals of Promethera’s current strategic focus, developing and producing the starting material of HepaStem as a treatment for chronic liver disorders such as Non-alcoholic steatohepatitis (NASH) and Acute-on-chronic liver failure (ACLF). As part of this strategy, the company has decided on a full out-licensing of the Heparesc program to a commercial partner, and hence cancelled its New Drug Submission (NDS) before a final decision was reached by Health Canada in order to keep full negotiation flexibility with a future partner. “The confirmation of our Durham factory’s cGMP compliance status brings us a step closer to commercial capabilities for the production of our HepaStem treatment,” says John Tchelingerian, PhD, President & CEO of Promethera Biosciences SA. “HepaStem’s multiple mechanisms of action could be a potential alternative to reverse the NASH disease process forming a possible solution for the damage inflicted by advanced NASH or other chronic liver diseases that can lead to ACLF. With our new focus, we decided the time was right to bring in a commercial partner that would carry the Heparesc technology across the regulatory finish line.”“Our experienced manufacturing and quality teams in the US continue to work in line with very high-quality standards, as evident in our cGMP status confirmation, helping the site continue to play an important role in the overall group structure,” said Mark Johnston, Managing Director, Promethera Biosciences LLC.

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