Frutarom HealthActive Pharmaceutical Ingredient List

EFLA®pharmActive Pharmaceutical Ingredients

In the pharmaceutical-ingredients marketplace, quality and safety are topline concerns. As regulatoryframeworks grow stricter worldwide, herbal medicinal products demand assurance that the activepharmaceutical ingredients meet the highest standards.

Frutarom Health s herbal medicinal extracts not only meet those standards; they exceed them. Since theproduct line’s launch in 1968, its consistently high performance and quality have made extracts and Frutarom Health s active pharmaceutical ingredientsa reliable source and trusted partner across the industry.

This particular pharmaceutical orientated portfolio has the expertise to help our business partners build a sustainable natural Active Pharmaceutical Ingredient (API) supply chain, with documentation for its core products covering the 3.2.S quality chapter commonly known as Active Substance Master File (ASMF). The line’s core products fall within the Traditional Herbal Medicinal Products (THMP) regulatory framework.

With the documentation services and registration support of a global Regulatory Affairs Department on your side, we simplify your path to market.

Simplifying your path to market

Active Pharmaceutical Ingredients and therapeutic areas

Common Name ofHerbal Substance

ProductCode

Botanical Nameof Plant

Drug ExtractNative Ratio Reference / Substance Extraction

Medium

Bearberry leaf dry extract 2799 Arctostaphylos

uva-ursi 3,5 - 5,5 : 1 Arbutin (HPLC): batch specific

Ethanol 60%(V/V)

Bearberry leaf dry extract 850001 Arctostaphylos

uva-ursi 3,5 - 5,5 : 1 Arbutin (HPLC): 16 - 24 % (m/m) Ethanol 60%(V/V)

Devil’s claw root dry extract 1381

Harpagophytum procumbens DC; Harpagophytum zeyheri Decne

4 - 5 : 1 Harpagoside (HPLC): batch specific

Ethanol 60% (V/V)

Echinacea pressed juice dry extract 90894 Echinacea purpurea

Moench. 40 - 50 : 1

ß-1,2-D-Fructofuranosides (HPLC): ≥ 2.40 % (m/m);Alkylamides (HPLC): batch specific; Caffeic acid: batch specific

Ginseng root dry extract 90910 Panax ginseng C. A.

Meyer. 4 - 6 : 1 Ginsenoside Rg1 (HPLC): ≥ 0.75 % (m/m); Ratio Rg1/Rb1 calc.: ≥ 0.50

Ethanol 80% (m/m)

Ivy leaf dry extract 90151 Hedera helix L. 6 - 7 : 1 Hederacosid C (HPLC):≥ 10.0 % (m/m)

Ethanol 40%(m/m)

Ivy leaf dry extract 90001 Hedera helix L. 5 - 8 : 1 Hederacosid C (HPLC):≥ 10.0 % (m/m)

Ethanol 30% (m/m)

Passionflower herb dry extract 850027 Passiflora incarnata L. 6 - 7 : 1 Flavonoids (as vitexin)

≥ 4.0 % (m/m)Ethanol 60 %(V/V)

Pelargonium rootdry extract 2301

Pelargonium sidoidesDC; Pelargoniumreniforme Curt.

4 - 7 : 1Sum of umckalin and umcka-lin-7-sulphate as scopoletin in 100 mg: 0.06 - 0.36 mg

Ethanol 14%(V/V)

Peppermint leaf dry extract 850024 Mentha piperita L. 3 - 6 : 1 Rosmarinic acid: ≥ 0,5 % (m/m) Ethanol 40 %

(V/V)

Pumpkin seed dryextract 90940 Cucurbita pepo L. 21 - 36 : 1

Phenolic derivatives (photom.): 2.0 - 4.0 % (m/m);Cucurbitine (HPLC): ≥ 0.3 % (m/m)

Ethanol 60%(m/m)

Red vine leaf dryextract 90945 Vitis vinifera L. 4 - 6 : 1

Polyphenols (photom.):≥ 30.0 % (m/m);Anthocyanins (photom.):≥ 0.3 % (m/m);Trans-Resveratrol (HPLC):≥ 5 mg / 100 g

Water

Thyme herb dryextract 90633 Thymus vulgaris L.;

Thymus zygis L. 7 - 13 : 1Essential oil: 15-20 mg/kg Rosmarinic acid: batch specificThymol: 0.6% (m/m)

Water

Valerian root dry extract 850005 Valerianae off. 4 - 6 : 1 Sesquiterpenic acids, expressed

as valerenic acid (HPLC)> 0.4 Ethanol 60 % (V/V)

Flavors for pharmaceutical preparations

Enhance your innovation pipeline

The product catalogue comprises both phytopharmaceutical ingredients and selectedpharma flavors. Active pharmaceutical ingredients may taste bitter and/or irritate the mouth and throat and thus are aversive not only to children but also to many adults.

Flavors are commonly used in pharmaceutical oral solutions and oral suspensions to mask drug bitterness and to make the formulation more palatable. EFLA®pharm umbrella offers high quality flavors with long lasting profiles and masking properties.

EFLA®pharm - your partner for unique herbal solutions.Our capabilities, experience and flexibility position you and us in an optimum position to accelerate the development and commercialization of your herbal medicinal products.

Pharma Flavor Botanical Name of Plant Description

Seabuckthorn Flavor Hippophae rhamnoides Liquid flavor for pharmaceutical preparations

Cherryjuice Flavor Prunus avium Liquid flavor for pharmaceutical preparations

Orange Flavor Citrus sinensis Liquid flavor for pharmaceutical preparations

Lemon Flavor Citrus limon Powder flavor for pharmaceutical preparations

«Simplify pharma»

Expanded production capabilities& regulatory supportEFLA®pharm product line & Active Pharmaceutical Ingredients are manufactured under cGMP conditions.

An expanded range of pharmaceutical ingredients is manufactured in Germany and Slovenia. Both sites are equipped with state-of-the-art technologies and exacting quality systems. We are convinced that by using the synergies of the two production sites we will be able to provide excellent solutions.

Our Regulatory Affairs department is ready to support you with the data required for product registrations and can provide the available Active Substance Master Files for our pharmaceutical ingredients.

It is proof of Frutarom´s commitment to meet current phytopharmaceutical industry standards and exceed customer expectations.

Natural Solutions

Pharmaceutical Industry

Consumer

Frutarom Health

Regulatory Affairs

Health Authorities

health@frutarom.com

Contact usfor more information:

Any and all information, data or statements provided herein are subject to the provisions of this disclaimer. Frutarom does not make any representation, warranty or undertaking, express or implied, as to the accuracy, completeness or reasonableness of the information provided herein nor will Frutarom have any liability for the selection or use by the user of such information. It is acknowledged that all information, data or statements are provided “AS IS”. Frutarom expressly disclaims any responsibility for the suitability of the information provided for any specific or particular purposes intended by the user. All information provided herein refers solely to Frutarom’s products and therefore do not refer to any other finished products. Nothing contained herein shall release any users from evaluating the individual products as to their legal compliance. Any statement, warranties or the use of any finished products, containing Frutarom’s pro-ducts, are the sole responsibility of manufacturer or the marketer of such final products. Frutarom does not assume any liability or risk involved in the use or marketing of its products including without limitation the sale of any finished products, containing Frutarom’s products, to any consumers. The user of Frutarom’s products is solely responsible for compliance with all national or international legislation, regulation and/or standards applying to the sale, marketing, labeling and/or for any use of Frutarom’s products.

«Simplify pharma»

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Switzerland+41 44 782 64 64 USA+1 201 941 8777 Spain+34 968 89 28 55 Slovenia+386 2 788 87 32