Indena

www.indena.com

Viale Ortles 12
Milan
I-20139
Italy

+39 0257 4961

Activities

Summary

Indena is the leading company dedicated to the identification, development and production of high quality active principles derived from plants, for use in the pharmaceutical and health food industries. Backed up by almost a century of botanical experience, the company holds more than 100 primary patents, has published more than 1000 scientific studies and co-operates with the world’s most prestigious universities and private research institutions. Indena employs about 800 staff, investing a significant amount of its annual turnover in research, making this activity the key to its success. Headquartered in Milan, Indena has 4 production sites and 5 international branches throughout the world and manages sales in more than 80 countries. The Company's experts communicate and interact constantly with the major international regulatory authorities and cooperate on the update of all the main pharmacopoeias.

Profile

THE IMPORTANCE OF R&D

Botanical derivatives find several applications in many fields, representing a rich source of new ingredients, mainly in the form of standardized extracts. Both the overall quality and human substantiation are essential to guarantee the necessary safety and efficacy profiles in the nutraceuticals field. As the demand for natural and herbal products grows, manufacturers and consumers are dedicating increasing attention to the available evidence supporting new ingredients offered in terms of benefits and safety.

The importance of investing in scientific research and bringing to the nutraceutical market botanical extracts supported by consistent scientific evidence comes clearly to light. Quality certifications have become a basic starting point for the main players in the market, where the real difference is made by the available scientific literature supporting that specific botanical extract: advanced human studies must be designed according to internationally recognized standard procedures and published in peer-reviewed scientific journals. This is the rigorous scientific approach that R&D Product Research guarantees to customers and consumers, and indeed what companies should be expecting their ingredient suppliers to provide every time they consider adopting an ingredient for a new formula.

At Indena, we have always been inspired by this approach in our research. In fact, we have developed a large number of ingredients with a distinctive high quality profile, starting with a state-of-the-art human study design with the aim of meeting and possibly exceeding market expectations, turning challenges into opportunities.

We have always followed a rigorous scientific approach in research and have leveraged this approach alongside our solid pharmaceutical background in the other markets in which we operate, developing biologically active ingredients for food supplements, as well as functional and medical products. All the ingredients Indena brings to the nutraceutical market have undergone a standardization process from the phytochemistry through formulation and their activity in terms of efficacy and safety is scientifically documented.

Indena knows that the use of every species of plant may have substantially different consequences on the results obtained at the end of the production process, in terms of active principles. Drawing on our extensive knowledge and proven skills, our researchers develop “premium” ingredients applying proprietary technology especially in term of process manufacturing. IP-covered solutions which are biologically validated with in vitro and human studies are our flagship: we do not settle just on generic botanical literature. We start from there, but for our original nutraceutical ingredients we trust our own and rely on ingredient-specific data.

The same rigorous quality is applied by the R&D Process Research in the development of new API and HPAPI. The phytochemical expertise was recently enlarged to semi-synthesis and total synthesis in order to offer turnkey solutions to pharmaceutical companies from the small scale to commercial batches. The availability of fermentation knowledges and dedicated plant allows to meet the most recent growth in this pharmaceutical field. Also in R&D Process Research IP-covered operations can be foresee.

Today, for the pharma business, Indena has further expanded its CDMO offer encompassing new services. In particular, a kilolab to handle semisynthetic and total synthetic APIs that require high containment (OEL of 20 ng/m3), a new multipurpose GMP pilot plant, a multipurpose fermentation suite and large-and-mid size spray dryers working with organic solvents.

In our R&D network unit, the Analytical Research is a mandatory pillar. Deep phytochemical extract profile and API identity are addressed with the most recent and sophisticated methods. R&D group is the flagship of the company boosting innovation always in the name of Quality.

THE IMPORTANCE OF QUALITY

Given the very complex nature of herbal ingredients, namely extracts of plant origin, the quality and reproducibility of their composition present a constant challenge to manufacturers.

Indena guarantees the quality and the consistency of extracts composition throughout a 30+ steps’ process – hence the Indena30® brand – which deeply touches all stages of the production, from cultivation to the finished product.

In addition, the Indena’s quality system comprises DNA analysis, being genomic identification part of its own DNA, for which the company is pioneering identification research.

With plant DNA analysis, Indena has added a fundamental element of certainty about the authenticity of its products. But the real challenge is to guarantee the quality and safety of botanical extracts: after years of smart research and investment, Indena’s quality system has developed a reliable method of genomic analysis of the extract itself.

Mirtoselect® - Indena’s bilberry extract largely used in pharmaceutical and nutraceutical products – is the first extract on which the company successfully performed a DNA test to pledge that bilberry extracts have the required specifications in terms of chemical components and declared pure botanical origin, Vaccinium myrtillus.

The method has 2 great strengths: robust results and fast analysis. Furthermore, thanks to the partnership with Hyris Ltd. and its portable tool bCUBE®, it’s very easy to apply. This allows partners, clients and end consumers to experience absolute certainty about the quality of Indena products. bCUBE® is a trademark of Hyris Ltd.

THE IMPORTANCE OF SUSTAINABILITY

Nature has always been for Indena both a source of inspiration and an essential resource. We have always been conscious of how important it is to preserve and regenerate the natural balance of every living source and for this we strictly follow laws, guidelines, procedures and programs with the aim of guaranteeing the safety of employees, safeguarding environment and biodiversity. These aims lie at the heart of the projects undertaken within the Sustainable Sourcing Program and dedicated to the communities involved in the collection of the many species that Indena markets. On the other side, the ever increasing effort to reduce the environmental impact of production sites has led to significant results in its main facilities, all certified ISO 14001 and ISO 18001.

OUR MAIN HF PRODUCTS

QUERCEFITTM – Quercetin Phytosome®

QUERCEFITTM is the patent pending food grade delivery system of quercetin from Sophora japonica L., japonica L., formulated with Phytosome® proprietary technology to optimize the biological absorption of the flavonoids, supporting the overall wellbeing in many conditions. Compared to the unformulated quercetin, bioabsorption and solubility are greatly optimized so it can be used at lower dosages retaining its efficacy.

VAZGUARDTM – Bergamot Phytosome®

VAZGUARD™ is a standardized extract from Bergamot - Citrus bergamia Risso et Poiteau (exclusively sourced from a specific part of Southern Italy) in the Phytosome® form, for cardiovascular health. In a randomized, double-blind, placebo controlled human study, VAZGUARDTM demonstrated to be extremely effective in supporting healthy blood levels through the optimization of total cholesterol, cLDL, cHDL, triglycerides, and glucose levels.

MERIVA® - Curcumin Phytosome® - The Life Guardian

MERIVA® is the 100% natural food grade delivery form of curcumin - Curcuma longa L. - utilizing Indena proprietary Phytosome® technology, based on dietary-grade adjuvants (lecithin), able to optimize the bioabsorption of the extract. MERIV is the most studied and documented curcumin bioavailable formulation. MERIVA® is overall supported by over 30 humanl studies in different conditions, involving 2000+ Individuals, confirming its high tolerabilityprofile.

CASPEROME® - Bioavailable Boswellic Acids

CASPEROME® is a purified mixture of triterpenoid acids from the gum resin of Boswellia serrata. Given the poor bioavailability of these compounds, Indena has formulated the extract with Phytosome® technology to optimize their absorption. Boswellia extracts have been demonstrated to be effective in the management of various inflammatory response functions. CASPEROME® has been shown to support muscoskeletal and gut health.

MIRTOSELECT® - Bilberry extract

MIRTOSELECT® - obtained from Vaccinium myrtillus L. berries - is the most studied bilberry extract in the market. The major applications investigated so far for MIRTOSELECT® are in the realms of vascular health and ophthalmology (retinal health), but different studies suggest a broader clinical profile for anthocyanins that encompasses memory improvement, cardiovascular health, metabolic health and more. More than 50 positive studies, including at least 25 controlled or double-blind studies, have validated the efficacy in vascular health of Indena’s bilberry extract.

UBIQSOME® - COQ10 Bioavailable

UBIQSOME® is the optimized delivery form of coenzyme Q10, formulated with the Phytosome® proprietary technology. UBIQSOME® is the first and only CoQ10 formulation on the market to have been tracked down from oral administration to its real and sole target: the inner space of cells, where it is needed.

MITIDOL® - Zingiber and acmella standardized extracts combination

MITIDOL® is a formulation of two standardized botanical extracts, namely Zingiber officinale and Acmella oleracea. The innovative composition exploits the properties of two traditionally used plants and has been proved to be effective as natural adjuvant in ache management.

PRODIGEST® - Artichoke leaf and ginger extracts

PRODIGEST® is a combination of 2 standardized ingredients: a lipophilic CO2 extract of ginger roots (Zingiber officinale Rosc.) and a unique extract of artichoke leaves (Cynara cardunculus L.) . This original synergy has been proven effective in managing digestive discomforts and gastric motility.

SILIPHOS® - Silybin Phytosome®

SILIPHOS® is a patented botanical derivative from Silybum marianum (L.) Gaertn. Commonly referred to as milk thistle, the plant has been used for centuries to address liver health. SILIPHOS® is an Indena Phytosome® ingredient in which silybin, one of the main bioactive constituents in milk thistle, is associated with phospholipids to significantly optimize bioabsorption. SILIPHOS® is a patented product specifically developed to tune silybin absorption and maintain a healthy liver.