The Therapeutic Goods Administration (TGA) has granted Cann Group a GMP license to manufacture therapeutic goods, which includes GMP testing at its Mildura facility (Mildura GMP Licence).
In combination with the licenses and permits issued by the Office of Drug Control (ODC) earlier this year, the Mildura GMP Licence enables Cann to manufacture Active Pharmaceutical Ingredients (API) and hard capsules and to conduct GMP-approved activities at the facility’s existing chemistry and microbiology laboratories.
This will allow the Company to produce API at the facility, manufacture Satipharm capsules for human therapeutic use, and perform in-house chemical, physical, and microbiological tests to demonstrate that products meet local and overseas regulatory requirements.
While manufacturing and testing activities had already commenced at Mildura following the licenses and permits issued by the ODC and the Victorian Department of Health, the Mildura GMP Licence will allow medicinal cannabis products manufactured at Mildura to be made available to patients via the TGA’s approved access pathways in Australia and (subject to approvals) for export markets.
Cann’s CEO, Mr. Peter Crock, said, “GMP licensing is the regulatory capstone of the Mildura facility, allowing us to cultivate, extract, manufacture, test, and supply finished products entirely in-house. With the license in place, we can now add additional GMP capabilities in response to market demands.”