US-based Vantage Hemp is approaching Good Manufacturing Practice (GMP) certification following its agreement with Medcan to bring pharmaceutical-grade CBD into the Australian market last year.
The Colorado company said the TGA carried out a four-day audit of its operations in August, with a focus on compliance with the Pharmaceutical Inspection Co-operation Scheme (PIC/S) and TGO93.
Vantage confirmed that no critical observations arose 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."
Neurotech International
Neurotech International's board has maintained there are "reasonable grounds to believe" the company can keep operating as a going concern, after independent auditor BDO raised "material uncertainty" over its financial viability in the FY23 annual report.
Directors said Neurotech had the ability to raise additional working capital, pointing to its track record of successful raises, options to access funding through investments or grants, and the possibility of scaling back operations to reduce spending "in the event capital raisings are delayed or insufficient cash is available to meet projected expenditure".
Neurotech posted an operating loss of A$7.79 million for FY23, compared to $3.36m the year prior. Cash outflows from operating activities came in at $6.32m, up from $2.96m in FY22, while the company closed 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 noted that the company hit several significant milestones during the year, among them the completion of a Phase I/II clinical trial and the launch of a larger Phase II/III trial in Autism Spectrum Disorder (ASD), alongside a successful capital raise.
The company also adopted a new 'multiple shots on goal' strategy that includes 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 finished recruiting patients for a Phase I/II clinical trial examining the use of its NTI164 in female Rett Syndrome patients.
MediPharm Labs/Beacon Medical
MediPharm Labs has introduced a line of GMP oils and inhalation cartridge products to the Australian market, available through the Beacon Medical brand.
The oil range includes a high-CBD isolate, a balanced product, and a THC-dominant full-spectrum oil produced using Beacon's own flower strains.
The inhalation cartridge offering covers flavour-forward options that have proven popular with patients in Canada, as well as strain-specific, full-spectrum cartridges made with flower varieties already well-regarded among Beacon Medical patients.
The Canadian company holds an Australian GMP licence from the TGA, along with GMP recognition from Health Canada and the US FDA.
Inhalation cartridges are already being delivered to patients, while the cannabis oils are scheduled to depart Canada this week.
Cann Group
Workers at Cann Group's Mildura facility have achieved the highest single inhalable-grade product yield the site has ever recorded. The crop was propagated in late June and harvested last week.
Mildura general manager Russell McGifford said the result was particularly welcome given that grading standards have tightened considerably since the company's previous record yield in late 2022.
He anticipated the new benchmark would be surpassed again in the near term.
"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."
