Leading botanical extracts company to produce pharmaceutical grade CBD for the international market, using Italian biomass
Indena, a leading Italian company in international markets, has been authorised by the Italian Ministry of Health and Italian Medicines Agency (AIFA) to produce cannabinoid-based cannabis extracts. Indena will produce pharmaceutical grade cannabidiol (CBD) for the global market for clinical and commercial use.
Indena is the first company in Italy to receive authorisation from the Ministry of Health to manufacture cannabinoid-based cannabis extracts. The approval process continued and Indena has also received authorisation from the AIFA, making it one of the few companies in the world able to produce cannabidiol (CBD) for the pharmaceutical market. CBD is an active ingredient obtained by extraction and isolation from the inflorescences and aerial parts of hemp (Cannabis sativa L.).
With its 100 years of experience in the production of high-end botanical extracts, Indena is well placed to produce high purity CBD. The raw material will be grown and processed in Italy. The supply chain, which complies with the strict criteria set out in the Italian regulations, is controlled, certified and fully traced by the company. Indena’s traditional rigour in managing the production chain was a key factor in obtaining authorisation.
Indena uses registered varieties of hemp with a THC level of less than 0.2 % in accordance with European standards. It also guarantees a residual THC content of less than 0.02 %, well below the limits defined by the FDA (Food and Drug Administration) and by DEA (Drug Enforcement Administration). This approach enabled Indena to promptly submit the DMF (Drug Master File) for this product to the FDA.
“We have been working a long time for this outcome. It is the result of an intense and fruitful collaboration with the Ministry of Health and the AIFA, for the construction of a rigorous approval process to guarantee the safety and control of production, both of the raw material and of the active principle”, says Stefano Togni, Corporate Director for Business Development and Licensing of Indena SpA. “We are aiming at the international pharmaceutical markets. As an Italian company, we are proud to be able to make this totally Italian product of the highest quality available globally, an ingredient expected all over the world for its beneficial effects on a number of pathologies”.
The hemp biomass used by Indena is processed in a pharmaceutical plant that is regularly authorised by AIFA and inspected by the main international regulatory agencies (FDA, KFDA, PMDA and others). All production is carried out in compliance with pharmaceutical GMP (Good Manufacturing Practices), in line with the highest quality standards that the company has always applied which have been recognised by the international scientific community and consolidated over 100 years of business.
Cannabidiol (CBD) is an active pharmaceutical ingredient whose use is approved for seizures associated with some rare forms of childhood epilepsy (Lennox-Gastaud syndrome, Dravet syndrome and tuberous sclerosis complex), and in clinical development for other forms of epilepsy. Furthermore CBD is under clinical investigation for schizophrenia, and for its therapeutic potential in other psychiatric disorders, neurological or autoimmune/inflammatory based diseases1.
Once again, Indena’s focus on quality, scientific rigour and innovation has enabled it to receive recognition from Italy’s top pharmaceutical regulatory institutions. This will enable the company to produce an active principle for which there has been market demand for some time.
1C. Michael White, PharmD, A Review of Human Studies Assessing Cannabidiol’s (CBD) Therapeutic Actions and Potential, J Clin Pharmacol 2019, 59(7), 923-934.
Lightweight Containers, the Dutch company that produces the revolutionary kegs for beverages, is currently investigating the possibilities for their sixth production facility that will be located in Italy.
Anita Veenendaal, Chief Executive Officer of Lightweight Containers, says: “In our philosophy, offering customers the best possible service and support means that we have to be present in the local market. At this moment we are already present in Italy with warehouses and a sales team and soon with a brand new production plant. This plant will be our sixth; as we already produce in The Netherlands, United States, Germany, United Kingdom and Spain (2019).”
The company focusses on the environment in addition to the production of a quality product, a new production line in Italy will contribute to lowering environmental footprints even further. Together with One Circle, an initiative of Lightweight Containers, aimed at the collection and recycling of one-way kegs in general, the company is really making a big difference in leaving the world a better place.
European producers, emerging Mediterranean countries and large-scale retailers will meet to discuss one of the top fruit and vegetable products of the summer
With its production of peaches and nectarines of approximately 1,360,000 tonnes, Italy is now a leading European producer in the sector along with Spain. Consequently, a convention on peaches and nectarines will be held on the occasion of the 35th edition of Macfrut, to be held in Rimini from 9 to 11 May, promoted by the Macfrut trade fair and CSO Italy. On 9 May, the opening day of Macfrut, the European production forecasts for 2018 will be presented at a meeting with experts in the sector from leading producer countries in Europe – first and foremost Italy, Spain and Greece – and from emerging countries in the Mediterranean basin, with the participation of European large-scale retailers.
According to the data collected by CSO Italy, if we take a look at European production from 2000 to the present day, especially in the years marked by major crises in the industry, such as in the 2004-2005 period, it is evident that the production of peaches, clingstone peaches and nectarines in Europe had reached 4 million tonnes. Later, the European supply averaged around 3.6 million tonnes, with lows of 3.4 million tonnes, such as in 2016. As far as the Italian supply is concerned, the production of peaches for fresh consumption was + 10 % compared to 2016, at approximately 590,000 tonnes, whereas clingstone peaches showed + 24 % at almost 85,000 tonnes and +5 % was recorded for nectarines at about 690,000 tonnes. Following the trend of the other major producing countries in Europe, production in Spain increased by 9 %, France showed + 3 %, whereas Greece recorded a high percentage increase of + 53 % compared to its particularly poor production in 2016. In all major European countries, the expected supply for 2017 exceeded the previous year’s production by 16 %.
This year, for the first time since 2007, the production of peaches, nectarines and clingstone peaches reached 3.9 million tonnes, of which peaches and nectarines alone were equal to 3 million tonnes against 2.9 million tonnes in previous years. Spain played a major role in this rise: after producing a maximum capacity of about 1.2 million tonnes, it is now capable of producing 1.5 million tonnes. In fact, this significant increase is continuing, especially for doughnut peaches, which account for 50 % of total production in Spain. By contrast, in Italy the supply has dropped from 1.7 million tonnes to about 1.3 million tonnes due to the widespread removal of plants over the years, mainly in northern regions.
This is the issue at the heart of the recent peach crisis that has affected all of Europe.
Along with the increase in production in Europe, which leads to an imbalance between supply and demand, in the years when production is approaching its full potential, other factors are contributing to the crisis in this market: major unbundling of supply, high production costs, new competitors entering the market, competitive new products on the market and the ongoing Russian embargo. Last but not least, the economic problems linked to climate change, which for products such as peaches and nectarines – not intended to have a long shelf life – can significantly affect market trends.
All these themes will be discussed at the convention to be held at the Macfrut event, which will focus on current production trends in 2018. The availability of forecast data prior to harvesting is essential to peach production so that any necessary corrective measures can then be implemented.