Last month, Portugal’s government announced plans to establish a working group to explore the regulation of adult-use cannabis, with a conclusion expected by the end of the year.
While this latest development has placed the spotlight firmly on Portugal as one of the most exciting markets in the rapidly evolving European cannabis sector, it builds upon strong and long-standing foundations of progressive cannabis reform.
One firm that has long been an advocate of and investor in Portugal is SOMAÍ Pharmaceuticals, which recently secured EU GMP certification for its facility in the country’s capital.
Its CEO Michael Sassano explained to Business of Cannabis how the ‘well-informed regulator’ enabled his company to bring products to market in ‘under two years’.
GMP authorisation
SOMAÍ began construction on its 3,800 sq. m manufacturing and processing unit, one of the largest such facilities in Europe, in November 2021.
This came as the company received an ‘innovative products grant’ of €2.7m from the Portugal 2020 committee, a scheme launched with the European Commission aimed at funding ‘territorial policy goals that align with sustainability and inclusivity’.
At the time, SOMAÍ said this grant validated its ‘vision of and dedication to investing resources and introducing innovative technologies into the Portuguese market’.
Two years on and its commitment to the region has been validated once again. On August 25, 2023, Portugal’s National Authority for Medicament and Health Products (INFARMED) granted SOMAÍ’s Lisbon facility Part I and Part II EU GMP authorisation.
According to SOMAÍ, this will now enable the company to ‘manufacture, import, and export’ products to numerous markets, and represents a ‘significant step towards revenue generation’.
Mr Sassano explained that, alongside careful planning, Portugal’s welcoming and knowledgeable regulatory environment was key to enabling the rapid journey from construction to product launch.
“All factors were carefully considered when designing this multiphase project, which just finished phase 2. There was nothing left to guesswork,” he explained.
“And the fact that INFARMED is well informed about cannabis and its requirements was a huge factor in coming to Portugal. But also their knowledge of products, which will also speed our release of products. You want products in the market as fast as possible to reduce burn; planning and knowledgeable regulators will take you from start-up to launch equally as important.”
Road to revenue
In November 2022, a year after breaking ground, SOMAÍ began manufacturing in its facility following an initial inspection. According to the company, this has enabled it to ‘pre-sell’ over €6m in products to date.
“Currently, we are in soft launch, which requires registering products in our four main markets, expanding to eight. Our hard launch is at the end of Q1 2024, when we will have most of our initial 65 products ready, and the small remainder coming out in Q2. The excitement is already building.”
The four main markets SOMAÍ plans to target with its breadth of upcoming products include ‘extract magisterial markets like Germany, new extract markets like Poland’, alongside more advanced finished dosage form extract markets such as the UK and Australia.
“The latter are our target markets as countries like Germany, Poland, and Italy move to finished products. But there are many countries coming online that may be magistral or finished dosage forms, like France, Albania, Portugal, etc. We make products for today, tomorrow, and the future and will service emerging markets as they come,” Mr Sassano continued.
Alongside the certification from INFARMED, SOMAÍ also announced that it had successfully raised €5 million of new capital to fund its ambitious growth plans.
This is reportedly ‘going almost entirely to own sales and distribution’ in Germany and Australia alongside other ‘younger markets’.
After already spending on two phases of building and fully automated equipment lines, SOMAÍ says its goal is now on ‘revenue, and being number one in each market’.
Asked whether its lofty ambitions would include a break into the potentially upcoming Portuguese adult-use market, SOMAÍ suggested its current product offering already puts it in a strong position to capitalise on a consumer market if and when ‘markets shed the narcotics label’.
“We are a pharmaceutical manufacturer of the highest level and we are driven by the USA extract know-how and customer preference understanding for the future.
“Already, our vaporizer lines are on the border of medical versus OTC (recreational), and our 2024 chews line (gummies) are pharmaceutical grade with US taste profiling. If markets shed the narcotics label and move further to OTC, we will already be there with the most advanced products and installing hydrocarbon and other 2024 initiatives that will answer all your questions.”
