Almost 12 months after lodging its application with the national Office of Drug Control, pharmaceutical manufacturing company IDT Australia (ASX: IDT) has been granted a licence to manufacture medicinal cannabis.
The licence authorises IDT to manufacture extracts and tinctures of cannabis and cannabis resin (drug) in accordance with its permits.
IDT is also permitted to supply the drug; package, transport, store, own and control the drug; and dispose or destroy the drug.
The company’s manufacturing and packaging facilities already have in place a Good Manufacturing Practices (GMP) licence issued by the Therapeutic Goods Administration.
The facilities also have the requisite Poisons Licensure for handling certain Schedule 8 and 9 drugs.
“A licence in our own right”
Chief executive officer David Sparling said the licence complements IDT’s existing pharmaceutical manufacturing capabilities and facilities.
“[Our] long history of manufacturing Active Pharmaceutical Ingredients (APIs) and Finished Dosage Forms fits well with the opportunities presently available to us in the medicinal cannabis space,” he said.
“Our API manufacturing abilities include precursor products such as cannabis resins and cannabinoids, while our finished dosage forms include tinctures, liquids and solid oral dose tablets and capsules for clinical trial and commercial applications.”
The company currently produces Temozolomide capsules for the treatment of adult patients with newly-diagnosed cancerous brain tumours, in conjunction with radiotherapy and then as maintenance treatment.
It also produces Pindolol tablets for the treatment of hypertension.
Mr Sparling said IDT was pleased to have finally secured the manufacturing licence.
“With our long established facilities and expertise in GMP [relating to] pharmaceutical manufacturing, a licence in our own right to manufacture medicinal cannabis products puts [us] in a very strong position in what is an exciting and rapidly growing global market,” he said.
Cann Group contract
Today’s announcement is in addition to an agreement which IDT entered into in August with Cann Group (ASX: CAN), which will see it provide manufacturing support relating to medicinal cannabis product formulations intended for supply to patients in Cann’s domestic and export markets.
Cann said it would continue moving towards the establishment of an enhanced product manufacturing capability with IDT, enabling production of value-added formulations which can be supplied to its customers under a five-year offtake agreement with Aurora Cannabis.
Equipment is being installed and commissioned at IDT to facilitate the manufacturing process.
At mid-afternoon, shares in IDT were trading 44.44% higher at $0.195, while shares in Cann were down 2.18% to $2.24.