Tetra Bio-Pharma wins a drug license to distribute REDUVO cannabinoid soft gel capsules in Canada
Tetra Bio-Pharma Inc (TSE:TBP) (OTCQB:TBPMF) (FRA:JAM1), a leader in cannabinoid-derived drug discovery and development, revealed that it has been granted a Health Canada Drug Establishment License (DEL) to distribute REDUVO cannabinoid soft gel capsules in Canada.
REDUVO is a synthetic THC-based soft gel capsule aimed as a therapy to combat severe nausea and vomiting associated with cancer chemotherapy. It is currently being assessed by Health Canada for the issuance of a Drug Identification Number (DIN). REDUVO, known as Marinol in the United States, has been approved as a regulated pharmaceutical drug by the US Food and Drug Administration since 1985.
READ: Tetra Bio-Pharma advances REDUVO cannabinoid soft gel capsules new drug submission file in Canada
“We look forward to working closely with our Contract Manufacturing Organization for the importation, warehousing, and dissemination of the THC pharmaceutical drug to pharmacies across Canada,” Tetra CEO Dr Guy Chamberland said in a statement.
“We stand by our commitment to launch our THC-based prescription drug to the Canadian market in late 2021,” he added.
On April 1, 2021, the company announced it had received a compliant rated GMP inspection by Health Canada. Subsequently, Health Canada finalized their regulatory assessment and determined that Tetra met all the requirements for the issuance of a DEL. In Canada, any company that intends to distribute drugs must obtain a DEL as per Health Canada regulatory requirements.
It is a comprehensive and stringent process to obtain a DEL approval as a company must demonstrate it meets strict quality control standards and procedures. In addition, a company that intends to distribute pharmaceutical drugs that contain cannabis must also obtain a Health Canada Cannabis Drug License (CDL). Only companies, such as Tetra Bio-Pharma with a Health Canada issued DEL are eligible to apply for a CDL.
Tetra said that it has submitted the CDL application to Health Canada.
Contact the author Uttara Choudhury at [email protected]
Follow her on Twitter: @UttaraProactive
Story by ProactiveInvestors
Source: http://www.proactiveinvestors.com/companies/news/948303/tetra-bio-pharma-wins-a-drug-license-to-distribute-reduvo-cannabinoid-soft-gel-capsules-in-canada-948303.html
Anyone can join.
Anyone can contribute.
Anyone can become informed about their world.
"United We Stand" Click Here To Create Your Personal Citizen Journalist Account Today, Be Sure To Invite Your Friends.
Please Help Support BeforeitsNews by trying our Natural Health Products below!
Order by Phone at 888-809-8385 or online at https://mitocopper.com M - F 9am to 5pm EST
Order by Phone at 866-388-7003 or online at https://www.herbanomic.com M - F 9am to 5pm EST
Order by Phone at 866-388-7003 or online at https://www.herbanomics.com M - F 9am to 5pm EST
Humic & Fulvic Trace Minerals Complex - Nature's most important supplement! Vivid Dreams again!
HNEX HydroNano EXtracellular Water - Improve immune system health and reduce inflammation.
Ultimate Clinical Potency Curcumin - Natural pain relief, reduce inflammation and so much more.
MitoCopper - Bioavailable Copper destroys pathogens and gives you more energy. (See Blood Video)
Oxy Powder - Natural Colon Cleanser! Cleans out toxic buildup with oxygen!
Nascent Iodine - Promotes detoxification, mental focus and thyroid health.
Smart Meter Cover - Reduces Smart Meter radiation by 96%! (See Video).