Pharma Portfolio - Biesterfeld

Pharma Portfolio

Active Pharmaceutical Ingredients

Pharmaceutical Excipients

Topical Ingredients

Extracts

Preservatives

2

Inhalt

Our Partners 4

Active Pharmaceutical Ingredients 5

Strategic APIs 5

Avesta Pharma 5Macrogol 5

Dow Corning™ 5Simethicone and Emulsion 5Dimethicone Fluid 6

Grillo Zinkoxid GmbH 6Zinc Oxide Pharma 6

Tereos Starch & Sweeteners 6Glucose Monohydrate Injectable Grade 6

Pharmaceutical Excipients 7

Avesta Pharma 7Macrogol 7

Tereos Starch & Sweeteners 7Starch 7Dextrose/Glucose 7Maltodextrin 8 Polyoles 8

Tereos Sugar France 8 Sucrose 8Sucrose With Functional Additives 9

CPKelco – Cellulose Derivative 9 Carmellose Sodium 9

CPKelco – Biogums 10Xanthan Gum 10 Pectine 10Carrageenan 10 Gellan Gum 10

Yung Zip 11 Sodium Starch Glycolate 11

Dow Corning™ 11Fluids 11 Volatiles and Cyclics 11Waxes 11 Blends 12Emulsifiers 12

Grillo Zinkoxid 12 Zinkoxid Pharma 12

DuPont Tate & Lyle 13 Propanediol 13

Various Excipients 13 Stearates 13 Petroleum Jellies 13

Topical Ingredients 13

Dow Corning™ 13Low Volatile Fluids 13Fluids 14Specialty Fluids 14Blends 14Waxes 15Emulsifier 15Resins 15

Extracts 16

Bio-gen Extracts 16Natural Extracts, Ingredients and Colours 16

Preservatives 16

Ueno Fine Chemicals Industry 16Parabens 16

Rasula Pharmaceuticals and Fine Chemicals 17Paraben Salts 17

4

Our Partners

5

Active Pharmaceutical Ingredients

Avesta Pharma

Dow Corning™

Strategic APIs

Product

Product

Product

Chlorhexidine Digluconate

Chlorhexidine Dihydrochloride

Methylphenobarbital

Methyl Nicotinate

BenzylnicotinatePotassium SulfoguaiacolateGuaifenesin

Tripelennamin HCl

Macrogol 3350

Macrogol 4000

Q7-2243 LVA, Simethicone USP

Antifoam M Compound

Q7-2587 30% Simethicone Emulsion USP7-9255 30% Simethicone Emulsion USP

• Active for laxatives• ICH Q7 GMP• EDMF Macrogol 3350/4000 available

• Active for prescription/OTC/medical device antiflatulents• Foam control in medical and pharmaceutical applications• Process aid for biofermentation

• ICH Q7 GMP• FDA registered production site

CAS

Description

Description

Use

Grade

Grade

Grade

18472-51-0

3697-42-5

115-38-8

93-60-7

94-44-078247-49-193-14-1

22306-05-4

Polyethylene glycol, PEG


Silicone antifoamLow volatile

Silicone antifoamLow volatileEmulsion containing 30% simethicone

Emulsion containing 30% simethicone

Antiseptic agentDisinfectant

DisinfectantTopical anti-infective agent

AnticonvulsantsSedativeRubefacientInflammationAnti-rheumaticExpectorantExpectorant

Antipruritic and antihistamine

BP/EP/NFCertificate of suitability (CEP)BP/EP/NFCertificate of suitability (CEP)

Simeticone EP Certificate of suitability (CEP)Simethicone USP, US-DMFSimeticone EPCertificate of suitability (CEP)Simethicone Emulsion USP

Simethicone Emulsion USP

Ph.Eur./ USPCertificate of suitability (CEP)REACHPh.Eur. Certificate of suitability (CEP)REACHPh.Eur.Certificate of suitability (CEP)Ph.Eur.

DAB 99 Ph.Eur./ USPPh.Eur./ USP Certificate of suitability (CEP)USP

Macrogol

Simethicone and Emulsion

6

Product

Product

Product

Q7-9120 Silicone Fluid 20 cSt 100 cSt 350 cSt 1.000 cSt 12.500 cSt

Zinc Oxide Pharma 4 API



Meridex™

Meridex™ PF

• Active for prescription/OTC/medical device antiflatulents• ICH Q7 GMP• FDA registered production site

• Pharmaceutical API• UV-protection, wound healing, antiseptic effect, antimicrobial effect• GMP certification in process (expected in Q4.2018)

• Parenteral nutrition, infusion solutions, haemodialysis (HD) and eritoneal dialysis (PD) • Matches key properties such as purity, flowability and product stability during processing

Description

Description

Description

Grade

Grade

Grade

Polydimethylsiloxane, PDMSDimethicone

High purity pharmaceutical zinc oxide99.995% ZnO



Glucose monohydrateTested on bacterial endotoxin(L.A.L test)Glucose monohydrateTested on pyrogens (Ph. Eur.)

Dimeticone EPCertificate of suitability (CEP)Dimethicone NF, US-DMF

EP/USP/BPCEP, ASMF in process (expected in Q4.2018)EP/USP/BPCEP, ASMF in process (expected in Q4.2018)EP/USP/BPCEP, ASMF in process (expected in Q4.2018)

Dextrose USP/NFGlucose Monohydrate EP

Dextrose USP/NFGlucose Monohydrate EP

Grillo Zinkoxid

Tereos Starch & Sweeteners

Zinc Oxide Pharma

Dimethicone Fluid

Glucose Monohydrate Injectable Grade

7

Avesta Pharma

Tereos Starch & Sweeteners

Product

Product

Product

Macrogol 200Macrogol 400Macrogol 3350

Macrogol 4000

Macrogol 6000Macrogols under development 300/600/1000/8000

Meritose Pharma

Mylose Pharma

Glucomalt Pharma

Glucodry G Pharma

Meritena 141 Pharma

• Solubility enhancer, non-alcohol diluent• Filler• ICH Q7 GMP

• Quality system based on IPEC-PQG GMP for pharmaceutical excipients• Solid dosage forms, direct compression, wet and dry granulation, capsules and powders• Liquid dosage forms, syrups, solutions, suspensions• Medicated confectionery, hard boiled candies, gums, chewing gums

• Quality system based on IPEC-PQG GMP for pharmaceutical excipients• Solid dosage forms, direct compression, capsules and powders• Medicated confectionery, hard boiled candies, gums, chewing gums

Description

Description

Description

Grade

Grade

Grade

Polyethylene glycol, PEGPolyethylene glycol, PEGPolyethylene glycol, PEG


Polyethylene glycol, PEGPolyethylene glycol, PEG

Dried D-glucose/dextrose powderDextrose monohydrateRange of specific particle sizesGlucose syrupDextrose equivalent and sugar spectrumGlucose syrupDextrose equivalent and sugar spectrumGlucose syrup spray-driedDextrose equivalent and sugar spectrum

Maize starch powder/Corn starch

NFEP/NFBP/EP/NFCertificate of suitability (CEP)BP/EP/NFCertificate of suitability (CEP)BP/EP/NFEP/NF

Glucose Monohydrate EPDextrose USP/NF

Glucose Liquid EPLiquid Glucose USP/NFGlucose Liquid EPLiquid Glucose USP/NFGlucose liquid spray-dried EP

Maize Starch EPCorn Starch NF

Pharmaceutical Excipients

Macrogol

Dextrose/Glucose

Starch

8

Product

Product

Product

Sucrose solution Compressuc® MS

Compressuc® PS

Alveosucre Fine GrainsPearl sugar 30Pure icing sugar Granulated sugars

Caster sugars

HPLE sucrose

Maldex Pharma

Maldex G Pharma

Merisorb Pharma

Merisorb SD Pharma

Merisorb BEC

Meritol Pharma

Maltilite Pharma

Maltilite P 200 Pharma

• Quality system based on IPEC-PQG GMP guidelines for pharmaceutical excipients• Solid dosage forms, direct compression, wet and dry granulation, capsules and powders• Liquid dosage forms, syrups, solutions, suspensions• Medicated confectionery, hard boiled candies gums, chewing gum• Clinical nutrition, baby food

• Quality system based on IPEC-PQG GMP for pharmaceutical excipients• Solid dosage forms, direct compression, wet and dry granulation, capsules and powders• Liquid dosage forms, syrups, solutions, suspensions• Medicated confectionery, hard boiled candies gums, chewing gum

Description

Description

Description

Grade

Grade

Grade

Perfectly clear solution, very low colour level Spray-dried sucroseAnhydrous, easily soluble in water Spray-dried sucroseAnhydrous, easily soluble in water Agglomerated sucroseAgglomerated sucrose Milled sucrose Screened sucrose Particle size 600-2000 µm Screened sucrose Particle size 250/400 µm Spray-dried sucrose

Spray-dried maltodextrin powderRange of specific particle sizesSpray-dried maltodextrin granulateRange of specific particle sizes

Crystallised sorbitol powder(min. 97 % D-sorbit) Range of specific particle sizesSpray-dried sorbitol powder(min. 97 % D-sorbit)Range of specific particle sizesSpray-dried sorbitol powder(min. 97 % D-sorbit)Bacterial endotoxin controlledCrystallising sorbitol syrupNon-crystallising sorbitol syrupD-Maltitol from maltitol syrupRange of specific maltitol contents and dry substancesD-Maltitol powder

Made from USP/NF SucroseUSP/NF Compressible Sugar

USP/NF SucroseEP SucroseEP SucroseEP SucroseEP SucroseEP Sucrose

EP Sucrose

USP/NF, EP, JP Sucrose

Maltodextrin EP, USP/NF

Maltodextrin EP, USP/NF

Sorbitol EP, USP/NF

Sorbitol EP, USP/NF

Sorbitol EP, USP/NF

Sorbitol Liquid (crystallising) EPSorbitol Liquid (non-crystallising) EPMaltitol Liquid EP

Maltitol EP

Tereos Sugar France

Sucrose

Polyoles

Maltodextrin

9

Product

Alveosucre Fine Grains with dextrinIcing sugar with starch Icing sugar with silica

• Quality system based on IPEC-PQG GMP for pharmaceutical excipients• Solid dosage forms, direct compression, wet and dry granulation, capsules, powders and sugar spheres• Liquid dosage forms, syrups, solutions, suspensions, dry syrups

Description Grade

Agglomerated sucrose + dextrin

Milled sucrose + starchMilled sucrose + silica

USP/NF Compressible Sugar

USP/NF Confectioner’s SugarComponents according to EP mo-nographs

Product

Cekol

• Tablet coating• Thickener and rheology modifier• Stabilisation of emulsions and suspensions

Description Grade

Carmellose sodium, CMCAvailable in a wide range of viscosity grades

Carmellose Sodium EP Carboxymethylcellulose NF

CPKelco – Cellulose Derivative

Sucrose With Functional Additives

Carmellose Sodium

10

Product

Genu® Pectin

• Gel forming agent• Textures from gels to structured fluids• Used as water-binding and film-forming agents

• Emulsion/suspension stabilisation• Buffer effect to pH 3-5• Ability to absorb and bind water

Description Grade

Pectin from citrus peelHigh ester pectin (DE >50%)Range of specific particle sizesAvailable in different viscosity grades

Pectin USP

Product

Product

Genugel® CG-130

Genuvisco® CG-131

Genuvisco® CG-129

Kelcogel® CG-LA

Kelcogel® CG-HA

• Gel forming agent• Thickener and rheology modifier• Stabilisation of emulsions, suspensions and foams

• Gel forming agent• Thickener and rheology modifier

• Fluid-gel forming agent • Controlled drug release formulations

Description

Description

Grade

Grade

Kappa-carrageenanFirm and brittle gelsIota-carrageenan Elastic and cohesive gelsLambda-carrageenan Viscous non-gelling solutions

Gellan gum (low acyl)Firm, non-elastic, brittle gelsGellan gum (high acyl)Soft, very elastic, non-brittle gels

Carrageenan NF

Carrageenan NF

Carrageenan NF

Gellan Gum NF

Gellan Gum NF

Product

Xantural® 11K

Xantural® 180

Xantural® 75

• Quality system based on IPEC-PQG GMP for pharmaceutical excipients• Thickener, rheology modifier or gel forming agent• Stabilisation of emulsions and suspensions• Controlled drug release formulations

Description Grade

Xanthan gum14 mesh/1,18 mm particle sizeXanthan gum80 mesh/180 µm particle size Xanthan gum200 mesh/75 µm particle size

Xanthan Gum EP/NF

Xanthan Gum EP/NF

Xanthan Gum EP/NF

CPKelco – Biogums

Pectine

Carrageenan

Xanthan Gum

Gellan Gum

11

Sodium Starch Glycolate

Product

Sodium Starch Glycolate (DST)Type A

• Superdisintegrant

Description Grade

Sodium carboxymethyl starch type A Sodium Starch Glycolate NF/EP/BP

Yung Zip

Fluids

Product

Product

Q7-9120 Silicone Fluid 20 cSt 100 cSt 350 cSt 1.000 cSt 12.500 cStST-Dimethiconol 40

Q7-9180 Silicone Fluid 0,65 cSt 1 cStST-Cyclomethicone 5-NFST-Cyclomethicone 56-NF

• Skin protectant• Solubiliser for hydrophilic actives

• Volatile carrier for sprays or semi-solid formulations• No cooling effect, non-stinging

Description

Description

Grade

Grade

Dimethicone, polymethylsiloxane (PDMS)

Short, hydroxy-terminated dimethicone

Hexamethyldisiloxane (0,65 cSt)Octamethyltrisiloxane (1 cSt)Cyclopentasiloxan (D5)Cyclopenta-/Cyclohexasiloxan(D5/D6)

Dimethicone NF, US-DMFDimeticone/Silicone Oil EP Certificate of Suitability (CEP)

For use in topical pharmaceutical applications

For use in topical pharmaceutical applicationsCyclomethicone NFFor use in topical pharmaceutical applications

Dow Corning™

Product

Silky Wax 10

• Semi-occlusive wax• Thickener for silicone-containing formulations• Water repellent

Description Grade

Stearyl alcohol and stearoxy trimethylsilane Melting point 53 °C


Volatiles and Cyclics

Waxes

12

Product

Product

Product

Product

Dimethiconol Blend 20

Silmogen Carrier

ST-Elastomer 10

Zemea® USP-NF Propanediol

Zinc Oxide Pharma 4 Excipient



Grillo UV ProTec®

Emulsifier 10

• Alternative to petroleum-based glycols and glycerin – naturally derived• Preservative-booster and moisturiser

• Emulsifier for W/O and W/Si emulsion (up to 80% water content)• Room temperature emulsification

• Pharmaceutical excipient• UV-protection, wound healing, antiseptic effect, antimicrobial effect• GMP certification in process (expected in Q4.2018)

Description

Description

Description

Description

Grade

Grade

Grade

Grade

Ultra-high viscosity silicone gum (6%) in non-volatile dimethiconeNon occlusive film formerUltra-high viscosity silicone gum (1%) in hexamethyldisiloxaneCarrier for spraysDimethicone crosspolymer (12%) in cyclo-meticone (D5)Thickener for silicone containing formulations

1,3-Propanediol

High purity pharmaceutical zinc oxide99.995% ZnOHigh purity pharmaceutical zinc oxide99.995% ZnOHigh purity pharmaceutical zinc oxide99.995% ZnOHigh purity pharmaceutical zinc oxide99.995% ZnONano-scale

Lauryl methicone copolyol




USP/NFNaturally derived

EP/USP/BP

EP/USP/BP

EP/USP/BP

EP/USP/BP


DuPont Tate & Lyle

Grillo Zinkoxid

Blends

Propanediol

Zinkoxid Pharma

Emulsifiers

13

Dow Corning™

Product

TI-1010 Fluids 0,65 cSt 1 cSt

• Solubiliser• Carrier• Spreading agent

Description Grade

Volatile dimethiconeLinear polydimethylsiloxane

For use in topical medical device applications

Topical Ingredients

Product

Magnesium Stearate

Calcium Stearate

Sodium Stearate Zinc StearateAluminium StearatePotassium StearateStearic Acid 50%/ 70%

• Tableting agent• Lubricant• Flowability agent

• Separating agent• Water repellent

Description Grade

Vegetable gradeFCCVegetable gradeFCCVegetable gradeVegetable gradeVegetable gradeVegetable gradeVegetable gradeFCC

Magnesium Stearate EP/NF

Calcium Stearate NF

Sodium Stearate EP/NFZinc Stearate EP/NF

Stearic Acid EP, USP/NF, JP, BP

Various Excipients

Product

Codex VaselineWhite Oils

• Petroleum jelly can be used as excipient or as API• Produced under GMP conditions

• Protective, healing, moisturising and soothing properties

Description Grade

Petroleum jellyParaffinum liquidum

EP, French Codex MonographEP, USP/NF, BP, French Codex Monograph

Low Volatile Fluids

Stearates

Petroleum Jellies

14

Product

Product

TI-2011 SPE Specialty Fluid

TI-2021 AMS Specialty Fluid

TI-3011 Gum Blend

TI-3021 Silicone Elastomer Blend

• Solubiliser and compatibiliser• Spreading agent• Non occlusive

• Emollient• Non occlusive• Improves substantivity

Description

Description

Grade

Grade

Water dispersible silicone polyetherPeg-12 dimethiconeCalculated HLB 12Caprylyl-modified trisiloxaneModerate volatility

Dimethicone and dimethiconolHigh molecular weight dimethiconoldispersed in a non-volatile carrierFilm forming agentDimethicone and dimethicone crosspolymerMixture of high molecular weightCross linked silicone (14%) in dimethicone5 cStRheology modifier





Product

TI-1050 Fluids 1,5 cSt

TI-1050 Fluids 5 cSt 10 cSt

TI-1050 Fluids 50 cSt 100 cSt 200 cSt 350 cSt 1.000 cStTI-1050 Fluids 12.500 cSt 30.000 cSt 100.000 cSt

• Non occlusive• Lubricant• Spreading agent

Description Grade

Volatile dimethiconeLinear polydimethylsiloxaneLow molecular weight dimethiconeLinear polydimethylsiloxaneNon-volatileIntermediate molecular weightdimethiconeLinear polydimethylsiloxaneNon-volatile

High molecular weight dimethiconeLinear polydimethylsiloxaneNon-volatile

For use in topical medical device applicationsFor use in topical medical device applications



Fluids

Specialty Fluids

Blends

15

Product

Product

Product

TI-7012 Solid Resin

TI-7021 Silicone Resin Blend

TI-4021 Semi-Occlusive Wax

TI-6021 W/O Formulation Aid

• Film former• Permeable barrier film• Long lasting film

• Excellent wash-off resistance• Non occlusive

• Structuring agent, semi occlusive• Helps rheology and texture modification• Broad compatibility with organic and silicone material

• Emulsifier for W/Si emulsion• Produces low viscosity emulsion• Cold or hot processing

Description

Description

Description

Grade

Grade

Grade

MQ resin polymerTrimethylsiloxysilicateSolventlessMQ siloxane resin diluted in a carrier fluidDimethicone and Trimethylsiloxisilicate

C30-45 Alkyldimethylsilyl polypropylsilses-quioxaneSilicone wax with added resin characterHigh melting point +/- 66 °C

PEG-10 dimethiconeSilicone polyether copolymerCalculated HLB 4





Resins

Emulsifier

Waxes

16

Product

Methylparaben

Ethylparaben

Propylparaben

Description Grade

Mehtylparaben for preservation

Ethylparaben for preservation

Propylparaben for preservation

Ph.Eur., USP, BP, NFREACHPh.Eur., USP, BP, NFREACHPh.Eur., USP, BP, NFREACH

PreservativesUeno Fine Chemicals Industry

Product

Lute-gen™

Zea-gen™

Beta Caro-gen™

TruBeet™FenuLean™

Garlixir™

Ultra-gen Omega™

Ultra Caro-gen™

Lycopene

Astaxanthin

Ginger Extract

MCT PowderBacopa

• Vegetarian, non-GMO• Suitable for softgel & hardgel capsule, tablets & colouring

Description Grade

Lutein from tagetes erecta in free % Ester formAvailable as oil, powder, beadlet, CWD powder & DC-gradeZeaxanthin from tagetes erectaAvailable as oil & powderNatural Beta-Carotene from blakeslea trispora Available as oil, powder & beadletStandardised Beetroot Extract 6% NitratesFenugreek Protein & FiberHigh protein, low fatAvailable as powder & flakesStandardised Garlic Extract (Lipid extracted)

Proprietary ingredient providing Omega-3/-6/-9, veganAvailable as oil & powderNatural mixed carotenoidsAvailable as oil & powderLycopene from blakeslea trisporaAvailable as oil & CWD-powderAstaxanthin from haematococcus pluvialisAvailable as oil & powderStandardised Ginger Root ExtractAvailable as powder, beadlet & oleoresinMedium Chained Triglycerides (Coconut)Bacopa monnieri extract 40% bacosides

DMF Clinical study: In vitro proliferative and telomere length analysisSolvent freeSolvent free

Solvent freeCross-over clinical study for satiety, hunger & fullness

In-vitro clinical study Solvent freeSolvent free

EU Novel Food

Technical Dossier

Solvent free Pesticide compliantSolvent freeUSP

ExtractsBio-gen Extracts

Parabens

Natural Extracts, Ingredients and Colours

17

Product

Sodium Methylparaben

Sodium EthylparabenSodium Propylparaben

Description Grade

Sodium Methylparaben for preservation

Sodium Ethylparaben for preservationSodium Propylparaben for preservation

Ph. Eur.REACHPh.Eur.Ph. Eur.REACH

Rasula Pharmaceuticals and Fine Chemicals

Paraben Salts

18

Notes

19

Imprint Published by: Biesterfeld Spezialchemie GmbH – HealthcareFerdinandstrasse 41 20095 Hamburg

Phone: +49 40 32008-0Fax: +49 40 [email protected]

Registered Office: Hamburg, Commercial Register: AG Hamburg, HRB 66970, VAT-No. DE 196 930 661Managing Directors: Peter Wilkes, Thomas Arnold

Our raw material information, data and graphics were obtained from the records of our raw material suppliers. Local availability of products might differ from country to country.

Disclaimer:We shall not be liable for the suitability of the goods for the purpose intended by Customer, unless the achievement of a certain outcome of the utilization was expressly incorporated into the contract. Our advice, information or recommendations regarding application shall be provided to the best of our knowledge. As the actual application is beyond our scope of influence, and as the circumstances of such application are not completely foreseeable, written and verbal indications, suggestions etc. can only be provided on a non-binding basis. They shall in particular not release Customer from the obligation to examine our products and goods for their suitability with regard to the intended processes and purposes.

Dr. Andreas LekebuschBusiness Manager HealthcareTel: +49 40 [email protected]

Patrizia WenzelProduct Manager Pharma Tel: +49 40 [email protected]

Nina HeldProduct Manager PharmaTel: +49 40 [email protected]

Contact

Biesterfeld Spezialchemie GmbH Ferdinandstrasse 41 20095 Hamburg Phone: +49 40 32008-0Fax: +49 40 32008-696www.biesterfeld.com S

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Pharma Portfolio - Biesterfeld

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