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.
Living Wage is embedded within wider set of responsible pay practices aimed at creating equal opportunities and building a more inclusive society
Firmenich, one of the world’s largest privately-owned fragrance and taste companies, announces it has achieved living wage certification across all of its global operations. Firmenich is the second company in the world and the first in its industry to achieve this milestone, ensuring decent living standards for employees globally. Following a rigorous external assessment by Fair Wage Network, a widely recognised international NGO, the Group was awarded this pioneering certification three years ahead of its target completion date.
“I am very proud that Firmenich is one of only two companies worldwide to have succeeded in securing living wage certification,” said Gilbert Ghostine, CEO Firmenich. “As a critical pillar of our inclusive capitalism model, our progressive approach aims at creating a positive impact for all our stakeholders, and our employees are key to making us thrive as a responsible business. Ensuring that people, wherever they are, earn a living wage is a critical step towards building a more equitable and inclusive workplace and society. Fair Wage Network recognizes our concrete achievements in embedding fair compensation across our Group and I am particularly pleased this is raising the standard in our industry. I hope this inspires other organisations to join our efforts.”
“Firmenich continues to set the standard for excellence in the world of work, and our holistic strategy aims at securing equity and inclusion across the entire organisation. Building on achievements such as our EDGE certification, our no gender pay gap policy, equal representation on the Executive Committee, and a culture of diversity and inclusion, this certification will further strengthen Firmenich’s profile as a leading global employer,” said Mieke Van de Capelle, Chief Human Resources Officer at Firmenich. “Having reached this milestone already today, we will now further accelerate our efforts, partnering with suppliers to ensure that fair wage practices become the standard to do business together.”
The notion of a living wage is embedded within a wider set of responsible pay practices and principles already in place at Firmenich, such as fairness, equality and performance rewards. Living wage certification reinforces the Group’s equitable culture and helps to stimulate economic growth with benefits for its employees, and the wider community.
In 2021, Firmenich committed to providing a certified living wage to 100 % of employees globally by 2025. Having achieved this goal already today, Firmenich is engaged in driving strong practices on living wage across the value chain in collaboration with its customers and suppliers. Training for 100 major suppliers on human rights will include 10 new initiatives at source, including focus on women’s empowerment, education, human rights practices and living wage.
Firmenich is an active member in living wage initiatives, including the UN Global Compact Decent Work in Supply Chain platform; IDH (The Sustainable Trade Initiative); Sustainable Vanilla Initiative (SVI); and the Juice Covenant on the juice value chain. The Group has also been recognized by the United Nations Global Compact and will assume from June 2022 a global leadership position at the Labor and Decent Work Global Compact platform.
Tetra Pak has launched Tetra Pak® Plant Secure, a game-changing plant management service that delivers profitability improvements for customers.
The new service starts with a detailed audit of all the equipment and systems across the customer’s value chain. This analysis, combined with Tetra Pak’s deep knowledge of the industry and benchmark data on food manufacturing, enables its specialists to identify opportunities and implement improvements across the customer’s entire operation. All Tetra Pak Plant Secure contracts come with targets around operational expenditure reduction and capital expenditure optimisation.
Dennis Jönsson, President and CEO of Tetra Pak Group said: “Our investment in Industry 4.0 technologies such as artificial intelligence, automation and data velocity has enabled us to better-support our customers in the digital era. Tetra Pak Plant Secure is a great example of how we use new technology to broaden our perspective and deliver bottom-line benefits for our customers.”
Pilot projects have been carried out in the Americas and in Europe, delivering results that are above customer expectations. For example, an Americas-based dairy producer reduced operational costs by more than 10 % in the first year of implementation, and the project continues to deliver further savings.
Tetra Pak Plant Secure is being rolled out to all food and beverage companies around the world.
