Spectrum Therapeutics Australia (Spectrum), the medical division of Canopy Growth Corporation Australia (Canopy Growth), is pleased to announce that the Therapeutic Goods Administration (TGA) has approved the registration of its Storz & Bickel GmbH & Co. KG (Storz & Bickel) medical standard vapourisers and an update on local operations.
With a 22-year track record of breakthrough innovations, Storz & Bickel is widely recognised as the global leader in medically approved vapouriser design and manufacturing, most notably the Volcano(R) Medic and the Mighty(R) Medic. Storz & Bickel has spent the last two decades developing an automated and internationally certified factory, achieving ISO 13485(1) certification in 2009.
“Medicinal cannabis is not a one-size-fits-all approach,” said Ben Quirin, Asia-Pacific Managing Director, Canopy Growth, “so having a registered device available for patients is crucial to ensuring a range of products are available locally that meets the diverse needs of patients and can be administered safely with the support of their medical professional.”
Canopy, parent company of Storz & Bickel, launched its Spectrum Therapeutic Asia-Pacific Headquarters last year and is currently importing products from Canada, which have been tested to comply with TG093 standards, while the facility, located in Victoria, is retrofitted and licensed to meet Australian regulatory standards.
“Patient numbers are growing in Australia, we are seeing this in the SAS approval numbers. While we are currently importing our products from Canada, our first priority has always been to deliver locally produced medicinal cannabis products for patients,” says Quirin.
“We have secured the permits required to start construction, with the expectation of completion by first quarter 2020. Our completed facility will produce approximately 15,500 kg of dry flower per year which we will use to develop standardised and GMP-certified dried flower, oil and Softgel capsules.”
Here’s to Future Growth.
(1) An ISO 13485 certification means that the Storz & Bickel’s facilities have been scrutinised by external auditors and found to be compliant with all requirements needed to produce medical devices.