Somai wins EU-GMP certification for Portugal cannabis facility

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Somai Pharmaceuticals said it received European Union-Good Manufacturing Practice (EU-GMP) certification from the Portuguese health authority Infarmed.

The certification is an essential step to exporting cannabinoids for medical use to foreign markets.

The Lisbon, Portugal-based company, which claims to be the largest pharmaceutical cannabis product manufacturer in Europe, said the certification enables the company to execute its plan to own distribution channels in Australia and Germany.

Because Somai received the EU-GMP certification one week ago, the company said it has not yet exported any medical cannabis but plans to change that soon.

“We will be exporting to nine countries for the next few months: Germany, Australia, United Kingdom, Poland, Italy, Switzerland, Netherlands, Denmark, and Brazil,” CEO Michael Sassano told MJBizDaily via email.

“In addition, our (active pharmaceutical ingredients) are already being looked at in all those countries plus Albania, Malta, Luxembourg, Czechia, and US universities and R&D groups.”

Sassano said he isn’t concerned that the import market for medical cannabis products is currently small.

He expects recent recommendations to reschedule cannabis in the United States and Germany “will cause a world wide explosion in GMP cannabis which will prove Somai not only to be the right size, but potentially too small.”

Last week, Biden administration health officials officially recommended that the U.S. government reclassify marijuana from a Schedule 1 substance to Schedule 3 – the same category as Tylenol with codeine.

Germany is also following through with major – though scaled-back – reforms to cannabis regulation.

“EU-GMP pharmaceutical extracted products are the highest standard of global cannabis formulation sales, and can be imported and exported in all accepting countries and definitely all future markets,” Sassano said.

Somai’s new EU-GMP certification adds yet another competitor in the race to meet demand in a limited number of importing countries.

The import/export market for unapproved medical cannabis products consists of an outsized number of Canadian companies, but that might change as more international producers such as Somai come online with EU-GMP certification.

The export market is growing rapidly, though it’s starting from a small place.

Canadian companies, for instance, exported 160 million Canadian dollars ($118 million) worth of medical cannabis products in the 2022-23 fiscal year, which was about 50% more than the previous year’s total.

Australia, Israel and Germany were the top markets for Canada’s medical cannabis exporters that year.