Professional Documents
Culture Documents
For over twenty years, we have built partnerships with our customers and with foreign manufacturers whose products we promote and distribute. From inception, Signet aligned its key focus to reflect a global perspective. Our goal was for Indian scientists and formulators to have access to raw materials and excipients available elsewhere in the world. With this in mind, we tied up with several major producers in USA, France, Germany, Japan and other countries. All are global leaders in their respective fields and today Signet proudly occupies a stellar position as Indias largest excipients distributing company. The following fundamentals have contributed to our success and steady growth. Customer Service: Close customer contact backed by well-trained and experienced team dedicated to every aspect pertinent to sales and personal service. Needs of timing, pricing, specifications and delivery are met in the best possible manner. Logistics Support: A management system that assures the right products in the right place at the right time. Careful strategic analysis of lead times, stock levels and pertinent costs that builds maximum efficiency into the supply chain. Technical Support: A team of qualified pharmaceutical personnel collaborating at all levels, whether it is introducing a new product, sampling, assistance in formulating or more complex issues involving our principals; Signet goes with you. Regulatory Support: Pharma industry operates in a regulatory environment. Whether it is for domestic markets or export areas, documents governing use, safety, etc. are a part of the process. GMP, DMF, TSE/BSE, GMO, OVI are just a few of them. Signet is committed to provide all that is available and required. We enjoy our legacy and reputation and continually look forward to deliver better and higher standards of service.
Contents
Index Application Guide
FMC BioPolymer Roquette Freres
Aqualon
(A division of Hercules Inc.)
BASF Aktiengesellschaft
1
Innophos Domo
4
CP Kelco
9
Rio Tinto Minerals (Luzenac)
17
Ferro Industrias Quimicas
25
29
Kronos International
33
Health & Beauty Solutions (Amcol) Specialty Minerals
39
41
Tereos Hanns G. Werner
43
Dead Sea Periclase
45
Scora
47
Cytec Industries
49
Stepan Co.
51
53
GumBase Co. Stearinerie Dubois
55
57
Lonza Musashino Chemical Laboratory
61
Glossary
63
65
67
69
71
73
77
79
81
Index
Company FMC BioPolymer Products
Avicel PH - Microcrystalline Cellulose (MCC) Avicel RC / CL - Microcrystalline Cellulose & Sodium CMC (Hydrocolloid) Avicel CE - Microcrystalline Cellulose & Guar Gum Ac-Di-Sol - Croscarmellose Sodium LustreClear LC 103 - Aqueous Film Coating System Aquacoat - Aqueous Dispersion for modified release Protanal - Alginate Protacid - Alginic Acid Marine Colloids - Carrageenan Protosan UP - Ultrapure Chitosan Salt Pronova UP / SL - Ultrapure / Sterile Sodium Alginate Sodium Hyaluronate Pearlitol C - Mannitol Crystalline Pearlitol SD / DC - Mannitol, Directly Compressible Kleptose - Betacyclodextrin Kleptose HPB - Hydroxy Propyl Betacyclodextrin Glycolys - Sodium Starch Glycolate Neosorb - Sorbitol Xylisorb - Xylitol Maltisorb - Maltitol Glucidex - Maltodextrin Lycoat - Peas Starch based aqueous film coating system ReadiLYCOAT - Ready-to-use, Aqueous film coating system Lycatab - Modified Starch Lycatab Mineral CC - Compound of Calcium Carbonate & Maize Starch G-D-L - Glucono Delta Lactone Lycadex PF - Injectable Dextrose Monohydrate Lycasin - Maltitol Solution Polysorb - Aqueous Solution of D-Sorbitol & Sorbitan Hi-Sweet - High Fructose Corn Syrup (HFCS) Starlac - Directly compressible Starch & Lactose compound Starch - Maize (Corn) / Potato / Wheat Nutriose - Soluble Fibre Roferose - Dextrose Monohydrate Tackidex - Dextrin Solulys AST - Corn-steep powder Pharmacoat - HPMC, Low viscosity Metolose SH - HPMC, High viscosity Metolose SM - Methyl Cellulose L-HPC - Low Substituted Hydroxy Propyl Cellulose HPMCP - HPMC Phthalate Aqoat - HPMC Acetate Succinate Ethyl Cellulose Pharm Klucel - Hydroxy Propyl Cellulose Natrosol - Hydroxy Ethyl Cellulose Blanose Sodium Carboxymethylcellulose (Na CMC) Kollidon - Povidone (PVPK 12PF, 17PF, 25, 30, 90F) Kollidon SR - Matrix Sustained Release Excipient Kollidon VA 64 - Copolyvidone (Vinyl Acetate Copolymer) Kollidon CL - Crosspovidone (Crosslinked PVP) Kollicoat - Aqueous Coating Systems for modified release Cremophor - Non-ionic surfactants Lutrol - PEG (Macrogol) / Poloxamer Solutol HS 15 - Macrogol-15-Hydroxystearate Ludipress - Advanced Excipient for direct compression Sicovit - Iron Oxide Soluphor P - 2-Pyrrolidone PVP Iodine - Povidone Iodine
Page
9
Novamatrix
15
Roquette Freres
17
25
29
BASF Aktiengesellschaft
33
Products
Celphere - Microcrystalline Cellulose Spheres Ceolus KG - Highly Compactible MCC PCS PC 10 - Partly Pregelatinised Starch Trehalose - Non-reducing Di-Saccharide Di-Tab - Dicalcium Phosphate Dihydrate, Granular A-Tab - Dicalcium Phosphate Anhydrous, Granular Tri-Tab - Tricalcium Phosphate Anhydrous, Granular Calipharm - Calcium Phosphate, Powder Lactochem - Lactose Monohydrate Lactopress - DC Lactose Xantural - Xanthan Gum Talc Luzenac Pharma
Page
39
Innophos
41
Domo CP Kelco Rio Tinto Minerals (Luzenac) Ferro Industrias Quimicas Kronos International Health & Beauty Solutions (Amcol) Specialty Minerals Tereos Hanns G. Werner Dead Sea Periclase
43 45 47
Synpro Stearates - Magnesium Stearate / Calcium Stearate / Zinc Stearate 49 Kronos 1171 Titanium Dioxide - Anatase & Superwhite Grade Magnabrite - Magnesium Aluminium Silicate Sturcal L - Heavy, Precipitated Calcium Carbonate Calopake - Extra Light, Precipitated Calcium Carbonate Compressuc - DC Sucrose Icing Sugar - Milled Sucrose Pharm-a-spheres - Sugar Spheres (Non-Pareil Seeds) Magnesium Oxide Magnesium Carbonate Magnesium Hydroxide Scoralite - Calcium Carbonate Magnesium Carbonate Magnesium Oxide Docusate Sodium (DSS) Stepanol - Sodium Lauryl Sulfate Medicated Chewing Gum Base / DC Chewing Gum Base DUB DUB DUB DUB DUB DUB DUB Microlub - Stearic Acid SE - Sucrose Esters MCT - Medium Chain Triglycerides GMS - Glyceryl Stearate DBS - Dibutyl Sebacate DBHG - Glyceryl Dibehenate PP - Hemi-synthetic Glycerides
51 53 55 57 61 63
Scora
65
67 69 71 73
77 79
Application Guide
Category Fillers and General Binders
Alveosucre A-Tab Avicel PH Calipharm Calopake Caster Sugar / Crystal Sugar Ceolus KG Compressuc Dextrose GC Di-Tab Glucidex Icing Sugar Lactochem Lactopress Ludipress Lycatab Magnesium Salts Maltisorb Neosorb PCS PC-10 Pearlitol Roferose Scoralite Starch Starlac Sturcal L Tackidex Trehalose Tri-tab Xylisorb Agglomerated Sucrose Dicalcium Phosphate Anhydrous, Granular Microcrystalline Cellulose (MCC) Calcium Phosphate Powder Extra Light, Precipitated Calcium Carbonate Screened Sucrose Highly Compactible MCC Directly Compressible Sucrose Directly Compressible Glucose Monohydrate Dicalcium Phosphate Dihydrate, Granular Maltodextrin Milled Sucrose Lactose Monohydrate DC Lactose Advanced Excipient for direct compression Modified Starch Magnesium Oxide / Magnesium Carbonate / Magnesium Hydroxide Maltitol Sorbitol Partly Pregelatinised Starch Mannitol Dextrose Monohydrate Calcium Carbonate of high purity Maize (Corn) / Potato / Wheat based Directly compressible Starch & Lactose compound Heavy, Precipitated Calcium Carbonate Dextrin Non-reducing Di-Saccharide Tricalcium Phosphate Anhydrous, Granular Xylitol 59 42 10 42 56 60 40 58 23 42 24 58 44 44 37 21 64 20 19 40 18 23 66 21 22 56 24 40 42 20
Product
Page
Granulating Binders
Klucel Kollidon Kollidon VA 64 Lycatab Lycatab DSH Metolose SH Metolose SM Pharmacoat Starch Hydroxy Propyl Cellulose Povidone (PVPK 25, 30, 90F) Copolyvidone (Vinyl Acetate Copolymer) Modified Starch Partially Hydrolyzed Maize Starch Hydroxypropyl Methyl Cellulose (HPMC - High Viscosity) Methyl Cellulose Hydroxypropyl Methyl Cellulose (HPMC - Low viscosity) Maize (Corn) / Potato / Wheat based 31 34 34 21 21 27 27 26 21
Glidants
Talc Luzenac Pharma Talc 48
Application Guide
Category Disintegrants
Ac-Di-Sol Glycolys Kollidon CL L-HPC Protacid Croscarmellose Sodium Sodium Starch Glycolate Crosspovidone (Crosslinked PVP) Low Substituted Hydroxypropyl Cellulose Alginic Acid 11 22 35 28 13
Product
Page
Colourants
Kronos 1171 Titanium Dioxide Sicovit Anatase & Superwhite Grade Iron Oxide 52 38
Fermentation aids
Solulys AST Soluten 50 Corn-steep powder Cellulose free, high vegetable protein 19 19
Application Guide
Category Lubricating agents
DUB DBHG DUB MCT DUB Microlub DUB SE Stepanol Synpro Stearates Talc Luzenac Pharma Glyceryl Dibehenate Medium Chain Triglycerides Stearic Acid Sucrose Esters Sodium Lauryl Sulfate Magnesium Stearate / Calcium Stearate / Zinc Stearate Talc 75 75 74 74 70 50 48
Product
Page
Mineral supplements
A-Tab Calipharm Calopake Di-Tab Lycatab Mineral CC Magnesium Salts Scoralite Sturcal L Tri-tab Dicalcium Phospate Anhydrous, Granular Calcium Phospate Powder Extra Light, Precipitated Calcium Carbonate Dicalcium Phospate Dihydrate, Granular Compound of Calcium Carbonate & Maize Starch Magnesium Oxide / Magnesium Carbonate / Magnesium Hydroxide Calcium Carbonate Heavy, Precipitated Calcium Carbonate Tricalcium Phospate Anhydrous, Granular 42 42 56 42 21 64 66 56 42
Nutritional supplements
Nutriose DUB MCT Soluble Fibre Medium Chain Triglycerides 22 75
Application Guide
Category Encapsulating agents
Aquacoat ECD 30 Crysmeb Ethyl Cellulose Kleptose Kleptose HPB Protanal Aqueous dispersion of Ethyl Cellulose Low MS Methyl Betacyclodextrin Ethyl Cellulose Pharm Betacyclodextrin Hydroxy Propyl Betacyclodextrin Alginate 12 23 30 23 23 13
Product
Page
Plasticizing agents
Cremophor DUB DBS DUB MCT Lutrol E Polysorb 85/70/00 Protanal Ester Hydrogenated Castor Oil Dibutyl Sebacate Medium Chain Triglycerides Polyethylene Glycol (PEG) / Macrogol Aqueous Solution of D-Sorbitol & Sorbitan Propylene Glycol Alginate 38 75 75 37 19 13
Solubilizing aids
Cremophor Crysmeb Docusate Sodium (DSS) DUB Microlub DUB SE Kleptose Kleptose HPB Lutrol F Soluphor P Solutol HS-15 Hydrogenated Castor Oil Low MS Methyl Betacyclodextrin Dioctyl Ester of Sodium Sulfosuccinate Stearic Acid Sucrose Esters Betacyclodextrin Hydroxypropyl Betacyclodextrin Poloxamer 2 - Pyrrolidone Macrogol - 15 - Hydroxystearate 38 23 68 74 74 23 23 37 36 38
Emulsifying agents
Cremophor A Docusate Sodium (DSS) DUB GMS DUB Microlub DUB SE Lutrol F Magnabrite Stepanol Synpro Stearate Macrogol - Cetostaryl Ether Dioctyl Ester of Sodium Sulfosuccinate Glyceryl Stearate Stearic Acid Sucrose Esters Poloxamer Magnesium Aluminum Silicate Sodium Lauryl Sulfate Sodium Stearate 38 68 75 74 74 37 54 70 50
Suspending agents
Avicel RC/CL Blanose Magnabrite Marine Colloids Metolose SH Metolose SM Natrosol 250 Pharm Protanal Xantural Microcrystalline Cellulose and Sodium CMC (Hydrocolloid) Sodium Carboxymethylcellulose (Na CMC) Magnesium Aluminum Silicate Carrageenan Hydroxypropyl Methyl Cellulose (HPMC - High Viscosity) Methyl Cellulose Hydroxy Ethyl Cellulose (HEC) Alginate Xanthan Gum 11 32 54 14 27 27 30 13 46
Application Guide
Category Stabilizing agents
D-L Malic Acid Protanal Ester Kollidon CL Malic Acid Propylene Glycol Alginate Crosspovidone (Crosslinked PVP) 78 13 35
Product
Page
Sweetening agents
Alveosucre Caster Sugar / Crystal Sugar Compressuc Flolys Hi-Sweet Icing Sugar Lycasin Maltisorb Neosorb Pearlitol Roclys Sucrose Solution Xylisorb Agglomerated Sucrose Screened Sucrose Directly Compressible Sucrose Dextrose syrup with extensive hydrolysis High Fructose Corn Syrup (HFCS) Milled Sucrose Maltitol Syrup Maltitol Sorbitol Mannitol Dextrose Syrup without extensive hydrolysis Liquid sucrose Xylitol 59 60 58 23 21 58 20 20 19 18 23 59 20
Thickening agents
Blanose DUB GMS Klucel Kollidon Lutrol F Magnabrite Marine Colloids Metolose SH Metolose SM Natrosol 250 Pharm Protanal Tackidex Xantural Sodium Carboxymethylcellulose (Na CMC) Glyceryl Stearate Hydroxy Propyl Cellulose Povidone (PVPK 25, 30, 90F) Poloxamer Magnesium Aluminum Silicate Carrageenan Hydroxypropyl Methyl Cellulose (HPMC - High Viscosity) Methyl Cellulose Hydroxy Ethyl Cellulose Alginate Dextrin Xanthan Gum 32 75 31 34 37 54 14 27 27 30 13 24 46
Suppository bases
DUB PP Synpro Stearate Hemi-synthetic Glycerides Sodium Stearate 76 50
Disinfectants
PVP Iodine Povidone Iodine 36
FMC BioPolymer
Microcrystalline Cellulose, Alginate, Carrageenan, Cellulose Gel and Coating Systems. For more than half a century, manufacturers around the world have turned to FMC BIOPOLYMER for the uncompromising performance and quality of these distinctive products. The very name FMC BioPolymer reflects the natural and renewable raw materials from which their products are derived and the polymer chains within the products that create strong and stable applications in the pharmaceutical industry. Apart from a very focussed customer service network, FMC BioPolymer offers partnerships to companies in developing new technologies, applications and other technical support. It has ISO certified manufacturing facilities in Europe, North America and Asia. Their commitment to product quality and functionality exists at every level - from raw material sourcing to manufacturing, process control, storage and shipping. It is one global producer that is different from all others.
High bulk density with fine Reduces powder stratification, helps mixing of fine particle size actives and facilitates making smaller tablets High bulk density with large particle size Avoids powder segregation, achieves good flow rates and can be used for high dose formulations to produce thin tablets
10
AVICEL RC/CL Microcrystalline Cellulose and Carboxymethylcellulose Sodium USP/NF, BP, JPE
Avicel RC/CL are water dispersible, spray-dried blends of microcrystalline cellulose and sodium carboxymethylcellulose used in preparation of pharmaceutical suspensions and emulsions. Usage of these products eliminate lengthy hydration time and provides long shelf-life stability. They act as viscosity regulators and modifiers thus preventing caking or sedimentation in suspensions. Grade Avicel RC-591 Avicel RC-581 Avicel CL-611 Description Spray dried, requiring low shear for dispersion Bulk dried, requiring high shear for dispersion Spray dried, requiring low shear for dispersion Application Provides a structured dispersion vehicle, acts as a protective colloid and facilitates dispersion Conventional suspending agent and dispersion aid Excellent for reconstitutable / dry suspensions
Cross linked Sodium CMC Highly effective in wet granulation & direct or Modified Cellulose Gum compression products, independent of tablet hardness with low use level and excellent stability. Best known super disintegrant that is effective intra and extra-granularly
11
An aqueous clear film coating All-in-one solvent free, clear conventional coating for tablets and other solid providing formulators with flexibility and resulting dosage forms in elegant, easy to swallow and taste masked finished forms
12
13
Gelcarin GP-812 Kappa Gelcarin GP-911 Kappa Viscarin GP-109 Viscarin GP-209 SeaSpen PF Lambda Lambda Iota
14
A business unit of FMC BioPolymer NovaMatrix is a newly created business unit of FMC BioPolymer. Their current products are special ultra pure grades of sodium alginates, chitosan salts & bases and sodium hyaluronates that satisfy functional and regulatory specifications. These are well-characterized and documented biopolymers and biomaterials for use in the development of novel drug delivery therapies, in the formation of biostructures for tissue engineering, wound healing, implants and advanced biotechnology applications. They also have proven properties suitable for parenteral administration of challenging drugs and implants.
15
16
Roquette Freres
ROQUETTE was founded in 1933 and ranks amongst the world's leading producers of starch derivatives and polyols for the pharma, food & cosmetic industry. It has a huge range of excipients and very specialized products that act as humectants, molecular encapsulation solutions, injectables, sweeteners, binders, diluents.... etc. Globally it has 13 production facilities manufacturing over 600 products and a sophisticated Research Centre at Lestrem, France where close to 350 scientists work, who are available to provide technical assistance to customers. Committed to strong customer service, Roquette have a world wide network of subsidiaries and agents.
Crystalline Mannitol
Grade Pearlitol PF (Mannitol PFG) Pearlitol 25 C (Mannitol 25) Pearlitol 50 C (Mannitol 35) Pearlitol 160 C (Mannitol 60) Description Pyrogen free Extra fine particle size Medium particle size Coarse particle size Application Diuretic-osmotic for injectable solutions Diluent, excipient for unstable actives & flash release, freeze drying carrier and sweetener with cooling effect
Agglomerated Mannitol
Grade Pearlitol 300 DC Pearlitol 400 DC Pearlitol 500 DC Description Fine particle size Medium particle size Coarse particle size Application Excellent diluent-binder for direct compression applications and in addition can be used as neutral carriers onto which active substances are poured or sprayed
18
GLUCONO-DELTA-LACTONE USP/NF
Grade G-D-L G G-D-L T Description Crystalline white powder, slightly sweet before developing an acid taste. Mean Diameter (m) G: 790; T: 330 Application pH acidity regulator, source of gluconate ions and increases the efficacy of preservatives
19
Xylisorb 700 / PFG Pyrogen free, coarse particle size Parenteral nutrition; used in combination with amino acids
ReadiLYCOATTM
Lycoat NG 73
20
Modified Starches
Grade Lycatab PGS Lycatab C
Application Excellent binder for wet granulation Versatile excipient optimised as a filler for hard gelatin capsules. Also used as a binder cum disintegrant for direct compression with self-lubricating property and as a binder for wet granulation Low viscosity, natural binder for wet granulation. Ready to use, easily dispersible, quickly soluble and no maturation time. It can also be directly incorporated in dry blends Direct compression of chewable calcium tablets with improved mouth-feel
Lycatab DSH
Lycatab Mineral CC
21
22
Crysmeb
Direct compression diluent with excellent compressability & flowability for tablets, sachets and capsule formulation Diluent for tablets, capsules and sachets Inhibiting sucrose crystallization, texturizer and bulk sweetener in syrups, lozenges, pastilles and pharmaceutical chewing gums
23
Note : Also available in IT grades which provides free flowing properties and better solubilization due to its particular physical structure.
24
26
4 15 400 4000
27
28
Aqualon
30
Klucel MXF Pharm (extra fine) 4000 - 6500 (2%) Klucel HF Pharm 1500 - 3000 (1%)
31
Substitution range 0,65 to 0,90 ** 0,80 to 0,95 1,15 to 1,45 1,12 to 1,21
Sodium content, % 7,0 - 8,9 9,2 - 9,3 10,4 - 12,0 10,2 - 10,8
32
BASF Aktiengesellschaft
BASF is the world's leading chemical company. As a transnational company, it maintains business relationships with customers in more than 170 countries and operates production facilities in 39 countries. BASF's association in India started way back in 1943. It's pharmaceutical involvement includes dozens of actives, excipients and vitamins. Excipients viz. Kollidon, Lutrol, Cremophor etc are familiar names even to students of pharmaceutical sciences. Over the years, several speciality products have been developed and today offer versatile choices to the modern day formulator. They maintain a close partnership with the industry.
34
Kollicoat IR White
Graft copolymer of To produce white tablets or with a colour premix for coloured 75% polyvinyl tablets. Used also for taste masking, appearance enhancing alcohol units and and protection of light sensitive actives 25% polyethylene glycol units with other additions form an instant release white coating system Coprocessed Provides excellent moisture protection and taste masking in product of Kollicoat addition to advantages of Kollicoat IR IR and PVA to form a homogenous powder
Kollicoat IR Protect
35
Sustained release, pH independent membrane coatings and matrix. Forms very flexible films without plasticizer and allows stable and reproducible drug release profiles. Also used for taste masking and moisture barrier applications pH-independent sustained release formulations (coating or matrix), taste masking and protective coatings
Kollicoat SR 30D
Aqueous dispersion of 27% polyvinyl acetate, 2.5% povidone & 0.3% sodium lauryl sulfate with solid content of 30%
36
Poloxamer USP/NF, EP
Grade Lutrol F 68 Lutrol M 68 Lutrol F 127 Lutrol M 127 Description Poloxamer 188 (Block polymer of 81% PEG and 19% PPG) New, micronized grade of F 68 with mean particle size of 50 m Poloxamer 407 (Block polymer of 73% PEG and 27% PPG) New, micronized grade of F 127 with mean particle size of 50 m Application Used as emulsifier, solubilizer, suspension stabilizer, thickener in liquids, orals, topicals, parenterals and for enhancing bioavailability in solid preparations Micronized grades avoids segregation of powder blends, gives a homogenous mixture of actives and excipients, which results in content uniformity concerns with tablets
Ludipress LCE
37
SOLUTOL HS 15 Macrogol-15-Hydroxystearate EP
Grade Solutol HS 15 Description Application
Well-tolerated, efficient solubilizer For manufacturing aqueous parenteral in aqueous systems for preparations with vitamins and other lipophilic injectables active pharmaceutical ingredients
Sicovit Yellow10 E 172 Yellow colour pigment Sicovit Black E 172 Sicovit Brown E 172 Black colour pigment Brown colour pigment
38
Ceolus KG-1000
50
40
Innophos
INNOPHOS is the worlds leading manufacturer of highquality calcium phosphates for the pharmaceutical and food industry. Since 1930 they have been manufacturing calcium phosphates in their Chicago Heights, USA plant which operates to the highest standards, most with ISO 9002 and GMP accreditation. Their client base includes some of the world's leading pharmaceutical companies and is testament to the value of it's consistent ability to supply the highest quality products. Innophos subscribes to the principles of sustainable development. To establish their position as the market leaders in calcium phosphates; they continue to add to their product line and have made repeated improvements in their products and their plant's manufacturing capability.
CALCIUM PHOSPHATE
Calcium Phosphates find wide applications in direct compression and wet granulation tableting. It has many positive characteristics as an excipient, including good compressibility, wide compatibility, stability and white colour. They are used as compressible filler, flow agents and as a source of calcium and phosphorous.
A-Tab
Tri-Tab
Tri-calcium phosphate anhydrous Direct compression granulation, glidant due to high surface area and carrier of actives. High calcium content nutritional products Tri-calcium phosphate anhydrous For wet granulation, higher density with similar benefits as Tri-Tab Tri-calcium phosphate Excellent for direct compression
Tri-calcium phosphate anhydrous In antacid and other formulations for neutralizing properties. Nutritional drinks and calcium / phosphorous fortifications
42
Domo
DOMO, a subsidiary of The Royal Friesland Foods, Holland is a leading global manufacturer of high quality pharmaceutical lactose. With 30 years experience and a commitment to supply the highest quality products; DOMO offers a broad range of conventinal as well as directly compressible lactose for a variety of pharmaceutical applications. DOMO's distinctive product range of anhydrous, spraydried and monohydrate lactose are manufactured in their FDA inspected state-of-the-art facilities in The Netherlands which meet the standards set by ISO 9001 and HACCP. Their excipients are tailored to meet strict requirements for applications such as tablets, capsules and sachets.
Spray Dried, DC Lactose Ideal for DC tabletting with excellent flow, high compressibility and enables good content uniformity Anhydrous, DC Lactose Improves stability of moisture-sensitive actives as well as their dissolution due to it's high intrinsic solubility
44
CP Kelco
More than 30 years ago, CP KELCO pioneered the commercialization of xanthan gum and developed KELZAN xanthan gum. Today, CP Kelco is the world leader in xanthan and other biopolymers produced by leading-edge fermentation technology. Their products, combined with an unsurpassed depth of technical expertise, bring unique functionality to a broad range of products and applications. With manufacturing facilities located in two continents, extensive processing technology, and research and development resources, CP Kelco have the ability to find the right solution for your specific product or processing needs.
46
Micronised grade
48
50
Kronos International
The KRONOS Group is one of the leading manufacturers of Titanium Dioxide with production facilities located in various European countries, Canada and the USA. All Kronos plants use modern, environment-friendly processes. Kronos have more than 80 years of experience in this industry. Besides being a world renowned supplier of Titanium Dioxide pigments for industrial applications, Kronos also produce a high purity grade for pharmaceuticals, cosmetics and foodstuffs having USP, BP and EU approval certification.
Kronos 1171 TiO2 E 171 Anatase grade, super white, fine particle size and bacteria controlled
52
Magnabrite K
Magnabrite S
Standard grade
Magnabrite F
Micro fine particle size grade Used as an inert low-bulk disintegrant, excellent for large tablets where the actives are the major weight and bulk of the tablet High stability grade Hydrates readily in warm or cold water producing high electrolyte stability
Magnabrite HS
54
Specialty Minerals
Minerals Technologies produce mineral-based and synthetic mineral products for healthcare and other industries. They have two subsidiaries - SPECIALTY MINERALS INC. and MINTEQ INTERNATIONAL. Specialty Minerals are the world's largest producer of Calcium Carbonate.
Calopake
56
Tereos
TEREOS, a part of the BeghinSay group was created in 2003 when two French market leaders got together. Tereos is today the world's second largest producer of sugar with plants in Europe, Africa and America. With 9000 employees and 26 plants; Tereos processes 10 million tons of beet and 10 million tons of sugar cane annually. For the pharmaceutical industry, Tereos offers a wide range of dry crystal sugars, liquid sugars and sugar specialities. Consistently pursuing its efforts to bring the best quality; Tereos has developed a perfect control over production and marketing of sucrose-based excipients.
Compressuc PS
Icing Sugar with Starch Milled Sucrose with corn starch added as anti-caking agent Icing Sugar with Silica Milled sucrose with colloidal silica added as fluidizing agent
58
Alveosucre with Dextrine Obtained by wet granulation of pure icing sugar with dehydrated glucose syrup additives Pearl Sugar 30 Obtained by successive screenings of sugar agglomerates
For applications requiring a dry excipient as a fixing medium. The irregular surface of the agglomerates and it's narrow particle size distribution allows highly homogenous and structured mixes
Liquid Sucrose
Grade Sucrose Solution Description Limpid, clear, viscous sugar syrup Application For syrups and coatings
59
Crystal Sugar N1 1350 1100 1600 m / 17 12 mesh Large sized without fine particles prevents agglomeration. Appreciated for its technical qualitites, especially for slow melting Crystal Sugar N1 2000 1750 2250 m / 11 9 mesh operations. Used for syrups, dry syrups and coating
60
Hanns G. Werner
The HANNS G. WERNER GMBH + Co. KG founded in 1952 and located in Germany is a manufacturer of exceptionally high quality neutral pellets (sugar spheres) and globuli sacchari (sugar globules). Their brand PHARM-A-SPHERES is known globally for superior quality sugar spheres confirming to USP/NF & EP monograph. Werners special manufacturing process enables ideal spherical shape, smooth-nonporous-solvent resistant surface and high mechanical stability to their sugar spheres.
62
Magnesium Carbonate BMC Light grade Magnesium Carbonate Heavy Heavy grade
64
Scora
Established in 1931, SCORA located in Caffiers, France is a specialist in calcium and magnesium derivatives. Their deep insight in the chemistry of calcium and magnesium, specialised dedicated equipments and unique production process enables Scora manufacture speciality products of the highest purity with exceptional properties particularly valued in the pharmaceutical and nutraceutical industry. Scoras products comply to USP/NF, EP, JP and are produced according to GMP rules.
Scoralite LL
Light grade, free flowing powder Used as a pH modifier, viscosity regulator and as a mineral supplement. Also used in the manufacture of antacids
66
Cytec Industries
CYTEC is the worlds leading supplier of Docusate Sodium (Dioctyl Ester of Sodium Sulfosuccinate - DSS), a versatile and highly effective anionic surfactant. Cytec manufactures pharmaceutical grade DSS products to the highest quality standards under cGMP, ensuring exceptional quality and performance for use as either active ingredients or excipients / formulating aids. They comply with USP & EP and are compatible with a broad range of active drugs. They meet worldwide recognised standards of quality, strength, purity and potency.
DSS Granular 85 % White crystalline with Sodium Benzoate powder DSS 50 % in Polyethylene glycol White to yellow, clear viscous liquid
68
Stepan Co.
STEPAN founded in 1932 is a global manufacturer of anionic surfactants, germicidal quaternary compounds and other speciality products that include flavours, emulsifiers and solubilizers. With headquaters in Illinois, USA it has twelve manufacturing locations worldwide and over 1500 employees. Stepans SLS (Sodium Lauryl Sulfate) is very popular in the pharmaceutical industry, is compliant with most pharmacopeias and has all regulatory approvals.
70
GumBase Co.
GUMBASE CO. founded in 1967 is a world leader in the manufacture of compressed powder gum base, chewing gum base and bubble gum base for the pharmaceutical, nutraceutical and confectionary industry. With headquarters in Italy it has sales in over 130 countries and delivers a range of more than 200 different gum base formulations supplied in five different shapes according to customer's requests on product pecularities. At GumBase Co. quality is a matter of constant dedication and improvements. It has achieved BRC (British Retail Consortium) certification which is a global standard that goes beyond other quality standards like HACCP and ISO
CPG
Specific gum base Absorption through oral mucosa, good distribution of developed for medicated active principles, easy & pleasant administration, chewing gums consumer controlled dosage and kinetics controlled active principle release. Directly compressible Product can be taken anywhere at any time as it does not chewing gum base require liquids for swallowing and is ready-for-use in powder enabling a cold emergencies. and dry process which protects delicate functional ingredients / actives.
* Available in flavours as well as without flavours. Conventional chewing gum base and Bubble gum base can also be provided.
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Stearinerie Dubois
Founded in 1820 in France, STEARINERIE DUBOIS develops, manufactures and sells a wide range of fatty acid esters specialities for the pharmaceutical, food and cosmetic industry. Their products coming from oleochemistry have outstanding properties and are used as lubricants, solubilizers, compressing agents, suppositories bases etc. With its plant located in Scoury, France; Stearinerie Dubois is committed to producing high quality products and has obtained the international ISO 9001 : 2000 certification. Their specialities comply to global pharmacopeias viz. USP/NF & EP, are exclusively of vegetable and/or synthetic origin and are widely used for tablets and granules, hard and soft capsules, solutions, creams and lotions, coating, suppositories etc.
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Lonza
Lonza SpA ( Polynt SpA), a division of the Swiss-based Alusuisse-Lonza group manufactures a broad range of additives, polymers and speciality chemicals for the pharmaceutical and food industry. With over 5300 employees and sales worth CHF 1.7 billion; it has several plants in Europe, UK and USA. Lonza manufactures Malic Acid by hydration of Maleic Anhydride at high temperature and pressure in their very modern plant in Bargamo, Italy with world class accredition.
Has the ability to enhance the Used in throat lozenges, cough syrups, effect of the aromas used to effervescent powders and tablets mask the undesirable tastes and smells of medicinals
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Glossary
Brand
Ac-Di-Sol Alveosucre Aqoat Aquacoat A-Tab Avicel CE Avicel PH Avicel RC/CL Blanose Calipharm Calopake Caster Sugar / Crystal Sugar Celphere Ceolus KG Compressuc Cremophor Crysmeb Dextrose Anhydrous PF Dextrose GC Di-Tab Docusate Sodium (DSS) DUB DBHG DUB DBS DUB GMS DUB MCT DUB Microlub DUB PP DUB SE Ethyl Cellulose Flolys G-D-L Glucidex Glycolys Hi-Sweet HPMCP Icing Sugar Kleptose Kleptose HPB Klucel Kollicoat IR Kollicoat MAE / EMM Kollicoat SR 30 D Kollidon Kollidon CL Kollidon SR Kollidon VA 64 Kronos 1171 Titanium Dioxide Lactic Acid Lactochem Lactopress Anhydrous 250 Lactopress Spray Dried 250 L-HPC Ludipress LustreClear LC 103
Product
Croscarmellose Sodium (Crosslinked Sodium CMC) Agglomerated Sucrose Hydroxypropylmethylcellulose Acetate Succinate (HPMCAS) Aqueous Dispersion for modified release Dicalcium Phosphate Anhydrous, Granular (DCPDA) Microcrystalline Cellulose and Guar Gum Microcrystalline Cellulose (MCC) Microcrystalline Cellulose and Sodium CMC (Hydrocolloid) Sodium Carboxymethylcellulose (Na CMC) Calcium Phosphate Precipitated Calcium Carbonate (Extra Light) Screened Sucrose Microcrystalline Cellulose Spheres Microcrystalline Cellulose (Ultracompactible) Directly Compressible Sucrose Non-ionic surfactant Low MS Methyl Betacyclodextrin Injectable Glucose Anhydrous Directly Compressible Glucose Monohydrate Dicalcium Phosphate Dihydrate, Granular (DCPD) Dioctyl Ester of Sodium Sulfosuccinate Glyceryl Dibehenate Dibutyl Sebacate Glyceryl Stearate Medium Chain Triglycerides Stearic Acid Hemi-synthetic Glycerides Sucrose Esters Ethyl Cellulose Dextrose Syrup Glucono Delta Lactone Maltodextrin Sodium Starch Glycolate High Fructose Corn Syrup (HFCS) Hydroxypropylmethylcellulose Phthalate Milled Sucrose Betacyclodextrin Hydroxy Propyl Betacyclodextrin Hydroxy Propyl Cellulose PVA and PEG graft co-polymer for instant release Methacrylic Acid Copolymer / Ethyl Acrylate Aqueous dispersion of PVA and PVP Povidone (PVPK, 12PF, 17PF, 25, 30, 90F) Crosspovidone (Crosslinked PVP) Matrix Sustained Release Excipient Copolyvidone Vinylacetate Copolymer Anatase & Superwhite Grade D-L Lactic Acid Lactose Monohydrate DC Lactose DC Lactose Low-Substituted Hydroxypropyl Cellulose Advanced Excipient for direct compression MCC & Carrageenan based Aqueous Film Coating System
Company
FMC BIOPOLYMER TEREOS SHIN-ETSU FMC BIOPOLYMER INNOPHOS FMC BIOPOLYMER FMC BIOPOLYMER FMC BIOPOLYMER AQUALON - HERCULES INNOPHOS SPECIALTY MINERALS TEREOS ASAHI-KASEI ASAHI-KASEI TEREOS BASF ROQUETTE ROQUETTE ROQUETTE INNOPHOS CYTEC STEARINERIE DUBOIS STEARINERIE DUBOIS STEARINERIE DUBOIS STEARINERIE DUBOIS STEARINERIE DUBOIS STEARINERIE DUBOIS STEARINERIE DUBOIS AQUALON - HERCULES ROQUETTE ROQUETTE ROQUETTE ROQUETTE ROQUETTE SHIN-ETSU TEREOS ROQUETTE ROQUETTE AQUALON - HERCULES BASF BASF BASF BASF BASF BASF BASF KRONOS MUSASHINO DOMO DOMO DOMO SHIN-ETSU BASF FMC BIOPOLYMER
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Brand
Lutrol E Lutrol F Lycadex PF Lycasin Lycatab Lycatab Mineral CC Lycoat Magnabrite Magnesium Carbonate Magnesium Hydroxide Magnesium Oxide Malic Acid Maltisorb Marine Colloids MedGumBase / CPG Metolose SH Metolose SM Metolose SR Natrosol 250 Pharm Neosorb Nutriose PCS PC-10 Pearl Sugar Pearlitol Pharmacoat Pharm-a-spheres Polysorb 85/70/00 Pronova UP / SL Protacid Protanal Protasan UP PVP Iodine ReadiLYCOAT Roclys Roferose Scoralite Sicovit Sodium Hyaluronate Solulys AST Soluphor Soluten 50 Solutol HS 15 Starch Starlac Stepanol Sturcal L Sucrose Solution Synpro Stearates Tackidex Talc Luzenac Pharma Trehalose Tri-Tab Xantural Xylisorb
Product
Polyethylene Glycol (PEG) / Macrogol Poloxamer Injectable Dextrose Monohydrate Maltitol Solution Modified Starch Compound of Calcium Carbonate and Maize Starch Peas Starch based Aqueous Film Coating System Magnesium Aluminium Silicate High Purity Magnesium Carbonate Spray Dried, DC Magnesium Hydroxide High Purity Magnesium Oxide D-L Malic Acid Maltitol Carrageenan Medicated Chewing Gum Base / DC Chewing Gum Base Hydroxypropyl Methylcellulose (HPMC - High viscosity) Methyl Cellulose (MC) Hydroxypropyl Methylcellulose (HPMC - Sustained Release grades) Hydroxy Ethyl Cellulose Sorbitol Soluble Fibre Partly Pregelatinised Starch Sucrose grains Mannitol / DC Manitol Hydroxypropyl Methylcellulose (HPMC - Low viscosity) Sugar Spheres (Non-Pareil Seeds) Aqueous Solution of D-Sorbitol & Sorbitan Ultrapure / Sterile Sodium Alginate Alginic Acid Alginate Ultrapure Chitosan Salt Povidone-Iodine Ready-to-use, Aqueous film coating system Dextrose Syrup Dextrose Monohydrate Calcium Carbonate of high purity Iron Oxide Pharma Grade Sodium Hyaluronate Corn-Steep powder 2-Pyrrolidone Cellulose free, high vegetable protein Macrogol-15-Hydroxystearate Maize (Corn) / Potato / Wheat Directly compressible Starch & Lactose compound Sodium Lauryl Sulfate Precipitated Calcium Carbonate (Heavy) Liquid Sucrose Synpro Stearates - Mg Stearate / Ca Stearate / Zn Sterate / Na Stearate Dextrin Talc Non-reducing Di-Saccharide Tricalcium Phosphate Anhydrous, Granular (TCP) Xanthan Gum Xylitol
Company
BASF BASF ROQUETTE ROQUETTE ROQUETTE ROQUETTE ROQUETTE HBS (AMCOL) DEAD SEA / SCORA DEAD SEA DEAD SEA / SCORA LONZA ROQUETTE FMC BIOPOLYMER GUMBASE CO. SHIN-ETSU SHIN-ETSU SHIN-ETSU AQUALON - HERCULES ROQUETTE ROQUETTE ASAHI-KASEI TEREOS ROQUETTE SHIN-ETSU WERNER ROQUETTE NOVAMATRIX FMC BIOPOLYMER FMC BIOPOLYMER NOVAMATRIX BASF ROQUETTE ROQUETTE ROQUETTE SCORA BASF NOVAMATRIX ROQUETTE BASF ROQUETTE BASF ROQUETTE ROQUETTE STEPAN SPECIALTY MINERALS TEREOS FERRO ROQUETTE RIO TINTO (LUZENAC) ASAHI-KASEI INNOPHOS CP KELCO ROQUETTE
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Warehouse:
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