US firm Vantage Hemp is closing in on Good Manufacturing Practice (GMP) certification after inking a deal with Medcan to import its pharmaceutical-grade CBD into Australia last year.
The Colorado-based firm said the TGA completed a four-day audit of its operations in August focused on compliance with the Pharmaceutical Inspection Co-operation Scheme (PIC/S) and TGO93.
Vantage said there were no critical observations noted during the inspection.
Chief Operating Officer Deepank Utkhede added: “As a result of the audit, Vantage is poised to receive its GMP certificate from the TGA in the coming months, cementing our status as a compliant, transparent, and reliable partner for companies seeking to navigate this complex landscape.”
The directors of Neurotech International have insisted there are “reasonable grounds to believe” the firm can continue as a going concern after independent auditor BDO flagged “material uncertainty” about its ability to do so in its FY23 annual report .
However, company directors insisted Neurotech could raise further working capital, citing previous successful raises, access funding via investments or grants, or scale down its operations to curtail expenditure “in the event capital raisings are delayed or insufficient cash is available to meet projected expenditure”.
Neurotech reported an operating loss of A$7.79 million for FY23, up from $3.36m the previous year. Cash outflows from operating activities were $6.32m, up from $2.96m in FY22, while it ended the year with cash on hand of $5.03m, up from $1.9m, and net assets of $3.96m, up from $1.43m.
Chairman Mark Davies said the company achieved several major milestones during the year, including the completion of a Phase I/II clinical trial and the initiation of a larger Phase II/III trial in Autism Spectrum Disorder (ASD), as well as a successful capital raise.
It also implemented a new ‘multiple shots on goal’ strategy including clinical trials of its NTI164 cannabinoid combination drug formulation in children with Paediatric Autoimmune Neuropsychiatric Disorders Associated with Streptococcal Infections (PANDAS) and Paediatric Acute-Onset Neuropsychiatric Syndrome (PANS).
UPDATE: Neurotech has completed patient recruitment for a Phase I/II clinical trial investigating the use of its NTI164 in female Rett Syndrome patients.
MediPharm Labs/Beacon Medical
MediPharm Labs has launched a range of GMP oils and inhalation cartridge products in Australia to be distributed under the Beacon Medical brand.
The oil portfolio comprises a high-CBD isolate, a balanced product and a THC-dominant full-spectrum oil made with Beacon’s flower strains.
The inhalation cartridges include flavour-forward options popular with patients in the Canadian market and strain-specific, full-spectrum cartridges using flower varieties already favoured by Beacon Medical patients.
The Canadian firm holds an Australian GMP licence from the TGA as well as GMP status from Health Canada and the US FDA.
Delivery of the inhalation cartridges to patients is underway, with the cannabis oils scheduled to ship from Canada this week.
Staff at Cann Group’s Mildura facility have recorded the single biggest inhalable-grade product yield to date. Propagated in late June, the crop was harvested last week.
General manager of Mildura Russell McGifford said the news was especially pleasing given the grading process has become increasingly stringent since the company’s previous best yield in late-2022.
He predicted the new record would be beaten again very soon.
“We’re expecting to see yields increase well over the next four to six weeks as we realise the benefits of the eight-tonne scale,” McGifford said.
“We’ve seen a solid upwards trend since July in yields and we’re well on track to beat further records in the coming months.”