Two new medicinal cannabis products containing THC have been verified as meeting the quality standard. New Zealand’s Medicinal Cannabis Agency publicly advised of the verification on 21 December 2022.
This follows Helius, a week earlier, being 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 NZ-grown, NZ-made medicinal cannabis products to Kiwi patients,” says Carmen Doran, chief executive of Helius Therapeutics.
The launch of two new medicines into the New Zealand market makes a total of four new medicines from Helius in 2022. It brings Helius’ portfolio of products to six.
“In mid-December, we were able to announce GACP certification, and since then, we’ve also obtained GMP certification for four more processes at our East Auckland site. Such progress is a testament to the culture of teamwork Helius is building,” she says.
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 Ms. Doran.
With the launch of these products, New Zealand patients now have access to NZ-made products across the spectrum of oral solutions. No longer do they have to rely on imported products that have had supply delays throughout 2022 and can be priced considerably higher.
The newly approved medicines have been developed at Helius’ expansive manufacturing site. Cannabinoids - the active compounds in the cannabis plant – have been extracted from dried flower also grown at Helius facility, enabling them to produce plant-to-patient solutions, all from under one roof.
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,” she says.
Ms. 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. Helius has worked alongside the regulators since the beginning to ensure patient safety.
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. We are motivated by an unwavering commitment to improving patients’ quality of life,” says Ms. Doran.
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