A WESTERN Australian medical cannabis company reached a key milestone last week when it was granted a Therapeutic Goods Administration (TGA) Good Manufacturing Practices (GMP) licence for its recently commissioned manufacturing facility in the South West.
Little Green Pharma (LGP) is the sole ASX-listed medicinal cannabis company with in-house capability to manufacture TGA GMP-grade medicinal cannabis flower and oil products from its own cultivated flower for delivery into Australian and higher-margin European markets.
The GMP licencing of the company's manufacturing facility is the culmination of a two-year regulatory strategy.
LGP now holds more than 20 State and Federal operating authorisations, allowing it to operate a fully in-house and vertically-integrated cannabis cultivation, production, manufacturing and wholesaling supply chain.
The company's broad suite of licences and authorisations gives it the flexibility to respond to changing market conditions, focus on higher-margin aspects of the product supply chain and react quickly to new market opportunities.
LGP managing director Fleta Solomon said the grant represented the culmination of LGP's long-term regulatory strategy and was a clear watershed moment for the company.
"The grant of this GMP licence differentiates the company as the only fully TGA and ODC-licensed and permitted medicinal cannabis company listed on the ASX with local Australian cultivation, manufacturing and wholesaling capacity, as well as brands in market," Ms Solomon said.
"This end-to-end capability allows us to more effectively manage costs, focus on higher-margin aspects of the supply chain and supply LGP-branded GMP-grade medicinal cannabis products into the highly regulated markets of the European Union."
Operating an in-house manufacturing capability avoids potential future congestion and competition for outsourced Australian manufacturing capacity and allows LGP to focus on reducing bottlenecks and identify further manufacturing cost efficiencies.
It will also facilitate expedited inspection and auditing by offshore distributors.
LGP plans to develop its capability to manufacture additional GMP-licensed cannabis products and other pharmaceutical formulations and potentially offer toll extraction and manufacturing services to other producers.
Ms Solomon said LGP was also the only ASX-listed medicinal cannabis company able to deliver higher-margin, TGA GMP-dried and processed medicinal cannabis flower and oil medicines into European markets, including Germany.
"Germany is the third largest medicinal cannabis market globally and is also currently wholly dependent on imports of medicinal cannabis products, with more than half of the market value derived from medicinal cannabis flower," she said.
"Only a handful of international manufacturers supply medicinal cannabis medicines into Germany."
The manufacturing facility was constructed with funding support from State government.