Helius Therapeutics will soon launch THC-containing medicines, which are both grown and made in New Zealand.
This follows the country’s largest licensed medicinal cannabis company being issued a GMP (Good Manufacturing Practice) certificate by MedSafe to allow it to manufacture THC medicines.
“2022 has been a huge year for Helius. Reaching these milestones which allow us to bring more NZ-grown and made products to Kiwi patients,” says Carmen Doran, Chief Executive of Helius Therapeutics.
“Last week, we were able to announce GACP certification. Now we have obtained GMP certification for four more processes at our expansive East Auckland site. Such progress is a testament to the culture of teamwork Helius is building,” she says.
Helius first gained the GMP certification and a Licence to Manufacture Medicines in July 2021. Since that time, they have been the first company in NZ to launch products and provide NZ-made, NZ-grown products. Now they are the first in New Zealand to gain GMP certification for THC medicines.
Helius began the rigorous and complex journey for GMP certification as a start-up in 2018. Through an international recognition scheme, MedSafe’s latest approval also meets European standards, known as EU-GMP, opening future export possibilities for the 100% Kiwi-owned company.
“The GMP certification process has been exhaustive, and rightly so. We’re making medicines, so there is no room for cutting corners. Helius pulled together an internationally- experienced leadership team from both the pharmaceutical and medicinal cannabis industries to successfully achieve this level of compliance,” she says.
As a leader in New Zealand’s newest industry, Helius has worked alongside the regulators since the beginning to ensure patient safety.
Helius’ CEO, Carmen Doran, is a member of the New Zealand Medicinal Cannabis Council - the industry body committed to supporting the industry grow at home and providing high-quality exports to patients around the world.
“Helius has built the team and facilities to get the job done, motivated by an unwavering commitment to improving patients’ quality of life,” says Ms. Doran.
Helius leverages vertical integration from plant to patient. Operations connect cultivar breeding to yield optimization, precision extraction of high-value cannabinoids, next-generation medicine development, GMP production, plus academic and several scientific partnerships.
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