Rua Bioscience obtains certification to manufacture medicinal CBD
Rua Bioscience has obtained certification to start manufacturing medicinal cannabis products. Photo / Supplied
Rua Bioscience, listed on NZX, has obtained certification from Medsafe to begin manufacturing its first cannabis-based medicinal product – a cannabinoid oil (CBD).
Good Manufacturing Practices (GMP) certification is the global standard for all pharmaceutical products and certifies that Rua can manufacture a product that is consistently safe and of acceptable quality.
Certification is a prerequisite for domestic and export sales.
Managing Director Rob Mitchell said it was a big milestone for Tairāwhiti-based Rua.
“GMP certification means we have come a long way to be allowed to manufacture products,” he said in a statement.
The next step is to submit a new medical cannabis product request to the Medicinal Cannabis Agency.
Once this process is completed, Mitchell expects to be able to supply products for the domestic market by early 2022.
Manufacturing will take place at Rua’s specially designed factory in Gisborne and the compounded CBD oil will be available in New Zealand as a prescription drug only.
Rua’s certification comes after a series of delays.
CBD oils are commonly prescribed in New Zealand for pain, epilepsy, and anxiety.
Germany is the world’s largest single market for pharmaceutical grade cannabis.
Clinicians can prescribe medicinal cannabis for a variety of conditions, many of which are covered by statutory health insurers.
Rua Bioscience shares debuted on the NZX a year ago at 70 cents, a premium of 20 cents or 40 percent over its issue price of 50 cents.
The stock last traded at 39 cents.
Unlisted medicinal cannabis company Helius Therapeutics was awarded the industry’s first GMP certificate by MedSafe in August.