MEDIPHARM Labs Australia has the green light it has been waiting for to commence local production.
MediPharm Labs Corp, a global leader in specialised, research-driven pharmaceutical-quality cannabis extraction, distillation and derivative products, has just announced that its Australian operation, based in Wonthaggi, has received an important enabling amendment to its Good Manufacturing Practice (GMP) Certification and Licence to Manufacture Therapeutic Goods.
The licence expansion, granted under Section 40B of the Australian Therapeutic Goods Act 1989 by the Therapeutic Goods Administration of the Australian Government’s Department of Health, provides MediPharm Labs with the ability to manufacture Active Pharmaceutical Ingredient (API) derived from cannabis and cannabis intermediates such as resins, extracts and isolates.
It can also manufacture medicinal cannabis finished products including oral liquids, soft-gel capsules and oil.
This is one of very few licenses of its kind for dedicated medicinal cannabis manufacture in Australia.
MediPharm Labs Australia is now poised to service the entire Australian patient population.
“This licence amendment paves the way for MediPharm Labs Australia to immediately begin using our facility as it was intended: to manufacture the highest quality APIs and finished medical cannabis formulations for our rapidly growing base of customers,” said Warren Everitt, CEO, Asia Pacific, MediPharm Labs.
“We are extremely proud of this achievement and the MediPharm Labs Australia team that made it happen as it reflects our longstanding commitment to GMP standards and pharma principles of production.”
MediPharm Labs Australia was certified by the Therapeutic Goods Administration as meeting GMP quality standards of practice and secured a Licence to Manufacture Therapeutic Goods in May 2020 and is already generating revenue.
MediPharm Labs Australia reported over $600,000 revenue in Q2 2020 from the final packaging of products, originally bulk manufactured in its Canadian headquarters, for sale to Australian customers.
As the Company’s Canadian facility was TGA GMP certified in late 2019, MediPharm Labs boasts a global pharmaceutical-quality supply chain that is qualified to serve emerging medical markets internationally.
“Whether we manufacture in Canada or now Australia, or a combination thereof, for our current worldwide demand, MediPharm Labs meets the most rigorous standards set out by established health authorities and this licence update serves as another reminder of that very important fact,” said Pat McCutcheon, Chief Executive Officer of MediPharm Labs.
MediPharm Labs plant in Wonthaggi features multi-phase supercritical CO2 extraction equipment, clean rooms and testing laboratories.
The Company also has capabilities to manufacture soft gels, oral liquids and oils and API. It was modelled on the Company’s state-of-the-art facility in Barrie, Ontario.