Two new medical cannabis products with THC that meet the quality standard have been found. New Zealand’s Medicinal Cannabis Agency publicly advised of the verification on December 21, 2022.
This follows Helius, which a week earlier became the first New Zealand company to receive GMP certification to produce THC extracts and manufacture medicines containing THC.
“We are very pleased to bring more New Zealand-grown, New Zealand-made medicinal cannabis products to Kiwi patients,” says Carmen Doran, chief executive of Helius Therapeutics.
Helius will launch two new medicines in the New Zealand market in 2022, for a total of four new medicines. It brings Helius’ portfolio of products to six.
“We were able to announce GACP certification in the middle of December, and since then, we’ve gotten GMP certification for four more processes at our East Auckland site. Such progress demonstrates Helius’s commitment to teamwork, according to Doran. Helius is New Zealand’s only company to have GMP certification for the extraction and manufacture of CBD and THC medicines. What’s more, it is now one of two companies (the other being Nubu Pharma) that have six products verified as meeting the minimum quality standard in New Zealand.
The latest products will be exported in 2023 to Helius customers in Europe.
“The THC-containing products have had considerable interest internationally, with GMP-manufactured products gaining a lot of attention globally as the medical markets continue to grow.” “We have seen particular interest in balanced, full-spectrum medicinal cannabis formulations,” says Doran.
With the introduction of these products, New Zealand patients now have access to NZ-made oral solutions across the board. They no longer have to rely on imported goods, which have been hard to get throughout 2022 and often cost a lot more.
The newly approved medicines have been developed at Helius’ expansive manufacturing site. Cannabinoids, which are the active parts of the cannabis plant, have been taken from dried flower, which is also grown at the Helius facility. This lets them make solutions that go from the plant to the patient, all from the same place.
As a start-up in 2018, Helius began the long and hard process of getting GMP certification. Through an international recognition scheme, MedSafe’s latest approval also meets European standards, known as EU-GMP, opening up future export possibilities for the 100% New Zealand-owned company.
“The GMP certification process has been exhaustive, and rightly so. “We’re making medicines, so there is no room for cutting corners,” Doran says.
Doran says Helius pulled together an internationally experienced leadership team from both the pharmaceutical and medicinal cannabis industries to successfully achieve this level of compliance.
As the leader of New Zealand’s newest industry, Helius has worked with regulators from the start to make sure that patients are safe.
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.
“Helios has built the team and facilities to get the job done. “We are motivated by an unwavering commitment to improve patients’ quality of life,” says Doran.