bsc lieferprogramm pharma 2019 a4 uk rz - lindberg ......bromhexine hcl* guaifenesin* potassium...

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™ 6Simethicone and Emulsion 6Dimethicone Fluid 6

Grillo Zinkoxid GmbH 6Zinc Oxide Pharma 6

Tereos Starch & Sweeteners 7Glucose Monohydrate Injectable Grade 7

Omya 7Calcium Carbonate 7

Pharmaceutical Excipients 7

Avesta Pharma 7Macrogol 7

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

Tereos Sugar France 9 Sucrose 9Sucrose With Functional Additives 9

CPKelco – Cellulose Derivative 9 Carmellose Sodium 9

Omya 9 Co-processed Calcium Carbonate 9

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

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

Grillo Zinkoxid 12 Zinkoxid Pharma 12

DuPont Tate & Lyle 12Propanediol 12

KLK OLEO 13 Glycerin 13

Various Excipients 13 Stearates 13

Topical Ingredients 13

Dow Corning™ 13Low Volatile Fluids 13Fluids 14Specialty Fluids 14Blends 14Emulsifier 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

Strategic APIs

Product Name

Product

AnestheticLIDOCAINE BASELIDOCAINE HCLMETHYLPHENOBARBITAL*PROCAINE HCLROPIVACAINE HCL*AnticonvulsantCARBAMAZEPINE*VALPROIC ACID*AntifungalCLOTRIMAZOLE*UNDECYLENIC ACIDZINC UNDECYLENATEAntihistamineCHLORPHENIRAMINE MALEATEPHENIRAMINE MALEATEPROMETHAZINE HCLTRIPELENNAMINE HCLAnti-inflammatory/ Analgesic/ AntipyreticDICLOFENAC DIETHYLAMMONIUMDICLOFENAC FREE ACIDDICLOFENAC SODIUM*AntipsychoticPERAZINE DIMALONATERISPERIDONE*

Antiseptic/ DesinfectantCETRIMIDE*CETYLPYRIDINIUM CHLORIDE*CHLORHEXIDINE BASECHLORHEXIDINE DIGLUCONATE*CHLORHEXIDINE HCL*

CytostaticCARBOPLATIN*CYTARABINE*DACARBAZINE*ERLOTINIB HCLGEMCITABINE HCLIRINOTECAN HCLLETROZOLE*METHOTREXATEOXALIPLATINDiureticCHLORTHALIDONEXIPAMIDEExpectorantBROMHEXINE HCL*GUAIFENESIN*POTASSIUM SULFOGUAIACOLATELaxativeBISACODYL*Muscle relaxantCYCLOBENZAPRINE HClRheumatic/ RubefacientBENZYLNICOTINATEMETHYLNICOTINATEUlcer treatmentESOMEPRAZOLE SODIUMOMEPRAZOLE SODIUMPANTOPRAZOLE SODIUMUricosuricPROBENECIDVirostaticACYCLOVIR

Macrogol 3350

Macrogol 4000

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

*CEP available

Monograph

Description

Product Name

Grade

Monograph

BP/ EP/ USPBP/ EP/ USPBP/ EP/ USPEPBP/ EP/ USP

BP/ EP/ USPBP/ EP/ USP

BP/ EP/ USPBP/ EP/ USPBP/ EP/ USP

EPEPEPUSP

BPIHBP/ EP/ USP

DACEP

BP/ EPBP/ EP/ USPIHBP/ EP/ USPBP/ EP

Polyethylene glycol, PEG


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

BP/ EP/ USPBP/ EP/ USPBP/ EP/ USPIHBP/ EP/ USPUSPEP/ USPBP/ USPBP/ USP

EP/ IP/ USPIH

BP/ EPEP/ USPEP/ USP

BP/ EP/ USP

USP

DABBP/ EP

IHIHBP/ IH

EP/ USP

USP

Macrogol

6

Product

Product

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

Zinc Oxide Pharma 4 API



• 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 available• CEP request submitted, expected within 2019• EU-ASMF available

Description

Description

Grade

Grade

Polydimethylsiloxane, PDMSDimethicone

High purity pharmaceutical zinc oxide99.995 % ZnO



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)

Grillo Zinkoxid

Zinc Oxide Pharma

Dimethicone Fluid

Dow Corning™

Product

Q7-2243 LVA, Simethicone USP

Antifoam M Compound

Q7-2587 30% Simethicone Emulsion USP

• 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

Description Grade

Silicone antifoamLow volatile

Silicone antifoamLow volatile

Emulsion containing 30 % simethicone

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

Simethicone Emulsion USP

Simethicone and Emulsion

7

Avesta Pharma

Tereos Starch & Sweeteners

Product

Product

Product

Product

Meridex™

Meridex™ PF

Omyapure® 35-OG

Macrogol 200Macrogol 400

Macrogol 3350

Macrogol 4000

Macrogol 6000

Meritena 141 Pharma

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

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

• 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

Description

Grade

Grade Comments

Grade

Grade

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

Calcium carbonate

Polyethylene glycol, PEGPolyethylene glycol, PEG




Maize starch powder/Corn starch

Dextrose USP/NFGlucose Monohydrate EP

Dextrose USP/NFGlucose Monohydrate EP

EP / USP / JPCertificate of suitability (CEP)

Calcium supplementation, osteoporosis, antacidsICH Q7AISO 9001, 14001 , 22000 & OHSAS 18001 certified production site

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

Maize Starch EPCorn Starch NF

Tereos Starch & Sweeteners

Omya

Pharmaceutical Excipients

Macrogol

Starch

Glucose Monohydrate Injectable Grade

Calcium Carbonate

8

Product

Product

Maldex Pharma

Maldex G Pharma

Merisorb Pharma

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

Grade

Grade

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 sizesCrystallising sorbitol syrupNon-crystallising sorbitol syrupD-Maltitol from maltitol syrupRange of specific maltitol contents and dry substances

D-Maltitol powder

Maltodextrin EP, USP/NF

Maltodextrin EP, USP/NF

Sorbitol EP, USP/NF

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

Maltitol Liquid EP

Maltitol EP

Polyoles

Maltodextrin

Product

Meritose Pharma

Mylose Pharma

Glucomalt Pharma

Glucodry G Pharma

• 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

Description Grade

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

Glucose Monohydrate EPDextrose USP/NF

Glucose Liquid EPLiquid Glucose USP/NFGlucose Liquid EPLiquid Glucose USP/NF

Glucose liquid spray-dried EP

Dextrose/Glucose

9

Product

Product

Icing sugar with starch

Sucrose solution

Compressuc® MS

Compressuc® PS

Alveosucre Fine GrainsPearl sugar 30Pure icing sugar

Granulated sugars

Caster sugars

• 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

Description

Grade

Grade

Milled sucrose + starch

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

USP/NF Confectioner’s Sugar

Made from USP/NF Sucrose

USP/NF Compressible Sugar

USP/NF SucroseEP SucroseEP SucroseEP SucroseEP Sucrose

EP Sucrose

EP Sucrose

Tereos Sugar France

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

Sucrose With Functional Additives

Carmellose Sodium

Product

Omyapharm® 500-OG

Description Grade Comments

Co-processed excipi-ent based on calcium carbonate and tribasic calcium phosphate

EXCiPACTUS DMF under preparation

Binder for wet -, dry granulation and direct compression, hot melt extrusion, carrier, fast orally disintegrating tablets (ODTs)ISO 9001, 14001, 22000 & OHSAS 18001 certified production site

Omya

Co-processed Calcium Carbonate

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

Genuvisco® CG-129

Genugel® CG-130

Genuvisco® CG-131

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

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

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

Fluids

Product

Product

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

ST-Dimethiconol 40

Q7-9180 Silicone Fluid 0,65 cSt 1 cSt

ST-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

Grillo UV ProTec®

Zinc Oxide Pharma 4 Excipient



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• Complies with EU GMP guidelines

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 oxide 99.995 % ZnO High purity pharmaceutical zinc oxide99.995% ZnOHigh purity pharmaceutical zinc oxide99.995% ZnOHigh purity pharmaceutical zinc oxide99.995% ZnO

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

Product

Edenor® G 86 PH

Edenor® G 99.8 PH

• Pharmaceutical excipient• In cremes, ointments or juices

Description Grade

Glycerol, 1.2.3-Propantriol, Glycerin min. 85 %CAS: 56-81-5Glycerol, 1.2.3-Propantriol, Glycerin min. 99 %CAS: 56-81-5

EP/USP

EP/USP

Dow Corning™

KLK OLEO

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 Stearate

Stearic 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

Glycerin

Low Volatile Fluids

Stearates

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-volatile

Intermediate molecular weightdimethiconeLinear polydimethylsiloxaneNon-volatile

High molecular weight dimethiconeLinear polydimethylsiloxaneNon-volatile





Fluids

Specialty Fluids

Blends

15

Product

Product

TI-7012 Solid Resin

TI-7021 Silicone Resin Blend

TI-6021 W/O Formulation Aid

• Film former• Permeable barrier film• Long lasting film

• Excellent wash-off resistance• Non occlusive

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

Description

Description

Grade

Grade

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

PEG-10 dimethiconeSilicone polyether copolymerCalculated HLB 4




Resins

Emulsifier

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

ThymoPure

• 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 % bacosidesNigella Sativa extracts, standardized to Thymoquione

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

Solvent free

Solvent free

Cross-over clinical study for satiety, hunger & fullness

In-vitro clinical study Solvent free

Solvent free

EU Novel Food

Technical Dossier

Solvent free Pesticide compliantSolvent freeUSP

Solvent-free, non-GMO

ExtractsBio-gen Extracts

Parabens

Natural Extracts, Ingredients and Colours

17

Product

Sodium Methylparaben

Sodium Ethylparaben

Sodium Propylparaben

Description Grade

Sodium Methylparaben for preservation

Sodium Ethylparaben for preservation

Sodium 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 O

ctob

er 2

019

bsc lieferprogramm pharma 2019 a4 uk rz - lindberg ......bromhexine hcl* guaifenesin* potassium...

Documents