Sovereign manufacturing capabilities for cannabis are being scaled up.
Sydney-based company Bioxyne, better known for its wholly-owned subsidiary Breathe Life Sciences, has become Australia’s first domestic manufacturer of pharmaceutical-grade cannabis pastilles.
While various medicinal cannabis products can be prescribed on a case-by-case basis for therapeutic purposes, the TGA has never approved a gummy product and there are no edible cannabis products on the Australian Register of Therapeutic Goods.
What the regulator has done, though, is give a Good Manufacturing Practice certification to Breathe Life Sciences.
“[We are] the first Australian manufacturer to complete a commercial production run of pharmaceutical grade [Good Manufacturing Practice]-certified THC gummies,” Bioxyne CEO Sam Watson said.
Breathe Life Sciences general manager Jason Stephens said it was a “significant milestone” for Australian pharmaceutical manufacturing and the country’s nascent medicinal cannabis industry.
To obtain a Good Manufacturing Practice licence, companies have to demonstrate compliance across areas like documentation, quality control and self-inspection.
Cannabis edibles only make up about 1% of the Australian cannabis market, but are projected to account for up to 20% by 2030 as popularity grows across the US and Canada.
Having already signed a two-year manufacturing and supply agreement with an Australian cannabis provider, Breathe Life Sciences will scale up its gummy manufacturing capacity from 2 million to 6 million per month.
It’s expected to rake in a minimum of $28 million from the deal.