AU: Grower granted GMP licence and inspected for another one

Cann Group has achieved an important regulatory milestone for the Company with the Therapeutic Goods Administration (TGA) granting to Cann a GMP licence to manufacture therapeutic goods for its Southern facility.

The Southern GMP Licence enables Cann to manufacture Active Pharmaceutical Ingredient (API) and medicinal cannabis products under cGMP conditions at its Southern facility for supply in Australia and overseas. This follows a significant upgrade of that facility which was substantially funded by the Company’s successful capital raise in July and August last year.

Dried cannabis flower products produced under the Southern GMP Licence are expected to be available for supply to patients under the TGA’s Special Access Scheme (SAS) and Authorised Prescriber (AP) scheme within the next few weeks.

Cann CEO, Peter Crock said: “Over the last 12 months, we have seen increasing demand for cGMP products from both domestic and international customers and have had pre-orders in place since late last year pending the granting of this licence. We are now able to service the needs of those customers. The granting of this licence is also another important achievement for Cann as we develop our integrated supply chain.”

In further regulatory updates, Cann’s Mildura facility was recently inspected by the TGA in respect of an application for a GMP licence to manufacture therapeutic goods and to undertake GMP testing at the Mildura site.

The Mildura GMP Licence will, once granted, enable Cann to manufacture cannabis extract (API) and Cann’s Satipharm CBD capsules. Additionally, the Mildura GMP Licence will allow
Cann to operate a GMP certified chemical, physical and microbiological laboratory for analytical testing of cannabis dried flower and various medicinal products and excipients, being a critical in-house capability enabling Cann to demonstrate that products meet local and overseas regulatory requirements.