The TGA nod is the first ever in Australia. A breakthrough which gives MGC Pharma partner EXTRAX credibility, access and a huge head start into a unique market.
Note the date, the Therapeutics Goods Administration (TGA) has just approved Australias first ever CBD-based vape product.
The TGA gave European cannabis extracts company, EXTRAX, a partner of MGC Pharma (ASX:MXC), approval for its pre-filled vapes to be sold here in Australia, under Category 2: CBD dominant medicinal cannabis product as an unapproved therapeutic good, on valid prescription from a medical practitioner.
The EXTRAX vapes contain hemp extract with 80% cannabinoids, with MGC Pharma being the Australian importer and manufacturer.
EXTRAX is the brainchild of founder Alla Kuznetsova, a wellness and CBD specialist whos been involved in developing different herbal products based on cannabis extracts for over five years.
The blurb says all EXTRAX products are big on five core elements Balance, Calm, Dream, Elate, and Focus a process the company says provides balance and connection to mind, body and soul through natural herbal extracts.
Something Australians can now determine for themselves.
Todays TGA approval isnt just a landmark achievement for MGC Pharma and EXTRAX but also provides certified credibility for EXTRAX cannabis-based vape products as they look to enter other markets.
MGC Pharma says the approval is testament to the partnerships rigorous pharmaceutical standards which sees both companies gain first mover access into the significant Australian CBD vape market.
This is a great step for MGC Pharma and for EXTRAX, and has been achieved through the hard work and dedication of Nicole Godresse, our Global Sales Officer, says MGC Pharma CEO Roby Zomer.
As the importer and manufacturer of EXTRAX pre-filled vapes in Australia, this becomes the latest addition to MGC Pharmas extensive pharmaceutical and consumer product range.
Our range is growing in size and quality, and this heralds a new future of cannabis consumption both in-country and further afield, Zomer said.
MGC Pharma continues to ramp up its market presence across the world.
The company is currently building up its manufacturing and global distribution capacity in Europe, after completing its new production facility in Malta.
The opening of the new facility will create a European manufacturing hub for MXCs lead drug CimetrA, as well as for other liquid form dose medicines.
CimetraA is in late clinical development, and has been proven to contain anti-inflammatory properties that could fight COVID-19.
In the US, MGC Pharma works with distributor AMC Holdings to sell its products into the largest market in the world.
Under the partnership deal, AMC will seek to obtain the necessary US regulatory approval, and to commercialise CimetrA as quickly as possible in the country.
MGC Pharma has also been given the green light to import CimetrA into India, a crucial step to being granted Emergency Use Authorisation (EUA) for COVID-19 treatment.
Leading Indian pharmaceutical manufacturer Medopharm has been appointed to import and market CimetrA in India.
This article was developed in collaboration with MGC Pharma, a Stockhead advertiser at the time of publishing.
This article does not constitute financial product advice. You should consider obtaining independent advice before making any financial decisions.
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