Indena achieves another milestone: it’s the first global API manufacturer with European CEP certification for its CBD extract, which the company produces for clinical and commercial use.
The European Pharmacopoeia Certificate of Eligibility (CEP) is a document issued by the European Directorate for the Quality of Medicines (EDQM). It certifies the compliance of an active substance with the quality and safety specifications established by the European Pharmacopoeia.
This CEP certification underscores the high quality of Indena’s CBD and the company’s commitment to meeting the needs of customers worldwide seeking a quality- and safety- certified ingredient. Furthermore, Indena stands alone globally, as the only API manufacturer to have received this certification.
Indena previously received two key authorisations in 2021. The Italian Ministry of Health granted permission for the manufacture of cannabinoid-based cannabis extracts, while AIFA authorised the production of cannabidiol (CBD) for pharmaceutical use. Indena’s CBD is derived from the flowers and aerial parts of Cannabis sativa L. through extraction and isolation. The raw material is grown and processed in Italy. The company controls, certifies, and fully traces the supply chain, ensuring compliance with stringent Italian regulations. Indena’s rigorous management of the production chain was instrumental in securing authorisations from both Italian and European authorities.
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.
Cecilia Nastro, Regulatory Affairs Department, says: “This CEP certification represents a significant step forward for Indena. The extensive analytical work undertaken by our team, who meticulously examined our API and processes to meet the demanding standards of this European certification, demonstrates our commitment to delivering high-quality, reliable pharmaceutical ingredients. This achievement positions us well to meet the growing global demand for rigorously certified CBD products”.
Indena processes its hemp biomass in a pharmaceutical-grade facility authorised by AIFA and inspected by leading international regulatory agencies, including the FDA, KFDA, and PMDA. All production adheres to pharmaceutical Good Manufacturing Practices (GMP), reflecting Indena’s longstanding commitment to the highest quality standards, recognised by the international scientific community.
Cannabidiol (CBD) is an active pharmaceutical ingredient used in products approved for treating seizures associated with rare childhood epilepsy syndromes, including Lennox-Gastaut syndrome, Dravet syndrome, and tuberous sclerosis complex. CBD is also undergoing clinical development for other forms of epilepsy and is being studied for its therapeutic potential in schizophrenia, other psychiatric disorders, neurological diseases, and autoimmune/inflammatory conditions1.
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.
Indena’s Quercefit® is an innovative 100 % food-grade delivery system of quercetin based on Phytosome® technology, which optimises quercetin bioavailability (up to 20 times and in the range of a diet rich in vegetables and fruits) with dose linearity. It has been proven to be an effective natural help to manage early stage conditions of COVID-19, in combination with standard care.
Although the emergency due to the pandemic is luckily decreasing at a global level, COVID-19 continues to be the focus for several scientific analysis. Quercetin Phytosome® has been the object of several human studies in the last two years1 – the most recent one issued in January 20232 – which demonstrated that this ingredient, in combination with standard care, when used in early stage of COVID-19, could aid in ameliorating the early conditions and helps keeping the immune system strong, mildening the symptoms and optimising the timing of molecular test conversion from positive to negative.
The most recent study involved a larger group of subjects (100 subjects consisting of 50 people in the quercetin group and 50 ones in the control group) completing the preliminary data anticipated and published in 2021.
Antonella Riva, Head of Product Innovation and Development & LCM of Indena S.p.A, commenting the study “Quercetin as a possible complementary agent for early-stage COVID-19: Concluding results of a randomised clinical trial” by Di Pierro et al., explains: “This randomised clinical trial investigated the possible adjuvant effect of an oral quercetin supplementation in mild to moderately symptomatic COVID-19 outpatients. The results revealed that subjects who received quercetin in addition to standard care, cleared the virus better (tested negative for SARS-CoV-2) and had milder symptoms as compared to the people who received the standard care alone. Moreover, participants in the quercetin group also showed statistically significant improvement in the serum levels of inflammatory biomarker LDH. Also the outcomes of our last study then – adds Riva – suggest possible quercetin supplementation effectiveness in the early-stage mild to moderately symptomatic COVID-19 outpatients and may help in optimising the clearance of the SARS-CoV-2 infection, mildening of the symptoms and modulation/control of the host’s inflammatory response. The study also supports the safety of quercetin supplementation in subjects with COVID-19 which has an unpredictable and complex course and hence may be potentially used as an adjuvant alongside routine care in the management of mild to moderate symptoms of COVID-19”.
“We keep devoting resources to clinical research with the aim to get stronger and stronger scientific evidences about Indena’s ingredients. We’re very happy and proud to see such results from our Quercefit® and to give our contribution in helping people’s health which has had to face one of the most serious pandemics in recent years” adds Stefano Togni, Chief Commercial Officer of Indena S.p.A.
Quercetin, a flavonol not naturally present in the human body, is the most abundant polyphenol in fruits and vegetable and is widely used as a dietary supplement to boost the immune system and in general to promote a healthy condition. Quercetin is characterised by crucial pharmacological properties including, antioxidant and immune-protective effects, which allows it to be a potential candidate to support all unpleasant conditions.
1Di Pierro et al., Possible Therapeutic Effects of Adjuvant Quercetin Supplementation Against Early-Stage COVID-19 Infection: A Prospective, Randomized, Controlled, and Open-Label Study, International Journal of General Medicine 2021:14 2359–2366. https://www.dovepress.com/possible-therapeutic-effects-of-adjuvant-quercetin-supplementation-aga-peer-reviewed-fulltext-article- IJGM https://pubmed.ncbi.nlm.nih.gov/34135619/
Di Pierro et al., Potential Clinical Benefits of Quercetin in the Early Stage of COVID-19: Results of a Second, Pilot, Randomized, Controlled and Open-Label Clinical Trial, International Journal of General Medicine 2021:14 2807–2816. https://www.dovepress.com/potential-clinical-benefits-of-quercetin-in-the-early-stage-of-covid-1-peer-reviewed-fulltext-article-IJGM Rondanelli et al., Promising Effects of 3-Month Period of Quercetin Phytosome® Supplementation in the Prevention of Symptomatic COVID-19 Disease in Healthcare Workers: A Pilot Study 2022: 12 66 https://pubmed.ncbi.nlm.nih.gov/35054459/
2Di Pierro et al., Quercetin as a possible complementary agent for early-stage COVID-19: Concluding results of a randomized clinical trial, Front. Pharmacol. 13:1096853. doi: 10.3389/fphar.2022.1096853
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.
