Pharmaceutical and nutraceutical ingredients from Univar · Pharmaceutical and nutraceutical...
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Pharmaceutical and nutraceutical ingredients from Univar One network. A world of solutions.
Transcript of Pharmaceutical and nutraceutical ingredients from Univar · Pharmaceutical and nutraceutical...
Pharmaceutical and nutraceutical ingredients from Univar One network. A world of solutions.
www.univar.com/us
Pharmaceutical and nutraceutical ingredients from Univar
Univar has been connecting its customers to the world’s premier ingredient suppliers since 1924 We understand that each customer has unique needs requiring customized solutions. Our team of dedicated product specialists has the flexibility and knowledge to help you develop these solutions, improving total costs of operation while providing a secure source of supply.
To help our customers meet rapidly increasing cost pressures, Univar offers regulatory expertise and a suite of services, including:
⟩ Excipient supplier audits to IPEC GMP guidelines⟩ Product testing⟩ Regulated product packaging⟩ Change management notification⟩ Documentation and process change controls⟩ Lot control⟩ Container handling
Product Origin
Acetaminophen China
Aluminum hydroxide (Barcroft™) US
Aripiprazole US
Aspirin China
Benzocaine China
Benzocaine – micronized US
Brompheniramine maleate India
Caffeine China
Capsaicin Japan
Carbamazepine India
Cetirizine HCL India
Chlorpheniramine maleate India, Japan
Clopdrogrel bisulfate (Form I and II) India
Dexbrompheniramine maleate India
Dexchlorpheniramine maleate India
Dextromethorphan hydrobromide TBD
Diclofenac potassium China
Diclofenac sodium China, India
Diphenhydramine HCL China, Japan, India
Docusate sodium India
Doxycycline hyclate India
Doxylamine succinate India
Econazole nitrate China
Ferrous fumarate India
Fluconazole India
Product Origin
Guaifenesin India, China, India
Ibuprofen China
Ketaconazole India
Lidocaine India
Lidocaine HCL India
Magnesium hydroxide (Barcroft™) US
Metformin HCL India
Methocarbomol India
Miconazole nitrate China
Omeprazole India
Oxcarbazepine India
Oxymetazoline HCL India
Pantoprazole India
Pheniramine maleate India, Japan
Phenylephrine India
Phenyltoloxamine citrate India
Pyrilamine maleate India
Ranitidine HCL (Form I and II) India
Salicylamide India
Salicylic acid – micronized US
Sennosides Japan
Simethicone 30%, 100% US
Sodium salicylate US
Valproic acid India
Venlafaxine HCL India
Active pharma ingredients
Univar API Sourcing Sourcing globally for the pharmaceutical industry Our team at Univar Shanghai is central to our sourcing strategy in China and neighboring countries, working to develop relationships with bulk active and excipient suppliers to meet the GMP required by pharmaceutical companies in the US.
Univar has partnered with APAC Sourcing Solutions to focus on the important and growing Indian market, sourcing API products for the pharmaceutical, animal health and nutritional industries in the US and Europe.
APAC is tasked with forming strategic partnerships with key API manufacturers who will utilize Univar’s market reach to grow their presence in the US and Europe. APAC will also source specific product requests on Univar’s behalf from the most reputable Indian pharmaceutical companies.
APAC’s Managing Director has over 25 years of experience sourcing in the Indian pharmaceutical industry, and is supported by a team of chemists and business professionals all working together to support Univar’s sourcing presence in India.
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Product Manufacturer Origin
Carboxymethylcellulose Aqualon, CP Kelco Belgium, US
Carrageenan CP Kelco US
Cetyl alcohol Sasol, Cremer, Import US, US, Thailand
Diethanolamine Ineos, Equistar US
Glycerol stearates Stepan US
Isopropyl myristate Hallstar US
Isopropyl palmitate Hallstar US
Hypromellose (HPMC) Aqualon, Dow Belgium, US
Methylcellulose Aqualon, Dow Belgium, US
Mono- and diglycerides Kerry US
Monoethanolamine Ineos, Equistar US
Polysorbates Oxiteno Mexico
Silmogen carrier Dow Corning US
Sodium lauryl sulfate Stepan US
Sorbitan esters Oxiteno Mexico
ST-Dimethiconol Dow Corning US
Stearic acid (USP, EP, JP) Biogenix, Avantor US
Stearyl alcohol Sasol, Cremer, Import US, US, Thailand
Triethanolamine Ineos US
Xanthan gum CP Kelco US
Product Manufacturer Origin
Aspartame Contract Manufactured China
Compressible sugar (Di-Pac®) Domino US
Corn syrup ADM US
Dextrose Ingredion US
Ethyl vanillin Rhodia US
Fructose Tate & Lyle US
Maltitol Ingredion US
Mannitol SPI Pharma US
Menthol Penta Int'l India
Methyl salicylate Rhodia France
Sorbitol (crystalline) Ingredion US
Sorbitol (liquid) Ingredion US
Sodium saccaharin Productos Aditivos Spain
Sucrose Domino US
Vanillin Rhodia US
Xylitol Import China
Flavors and sweeteners
Thickeners, emulsifiers, surfactants, and carriers
Product Manufacturer Origin
Benzoic acid Avantor, Wuhan Youji, Columbus US, China, US
Benzyl alcohol Emerald Kalama US
Boric acid US Borax France
Butyl-, methyl-, propylparabens Ueno Japan
Phenol Blue Island US
Potassium sorbate Nutrinova, Nantong China
Propylene glycol Lyondell, Dow US
Sodium benzoate Emerald Kalama US
Sorbic acid Nutrinova, Mitsui China
Preservatives
Fillers, binders, disintegrants, and coatingsProduct Manufacturer Origin
Calcium carbonate Specialty Minerals US
Calcium carbonate DC SPI Pharma US
Calcium sulfate US Gypsum US
Carboxymethylcellulose (CMC) Aqualon, CP Kelco US
Carrageenan CP Kelco Belgium
Cetyl alcohol Sasol, Cremer, Import US, US, Thailand
Compressible sucrose Domino US
Dextrose Ingredion US
Dicalcium phosphate dihydrate – Di-Tab® and powder Innophos US
Dicalcium phosphate anhydrous – A-Tab® and powder Innophos US
Ethylcellulose Aqualon US
Glycerine P&G, Dow US, Germany
Gum acacia Colloides Naturels Africa
Lactose – USP / NF, EP, JP Kerry US
Hydroxyethylcellulose (HEC) Aqualon Belgium
Hydroxypropylcellulose (HPC) Aqualon US
Hypromellose (HPMC) Aqualon, Dow Belgium, US
Mannitol SPI Pharma US
Methylcellulose Aqualon, Dow Belgium, US
Polyethylene glycol (PEG) Dow, BASF US
Povidone (PVP) Nanhang China
Propylene glycol Lyondell, Dow US
Sodium starch glycolate Yung Zip Taiwan
Sorbitol Ingredion US
Stearyl alcohol Sasol, Cremer, Import US, US, Thailand
Talc MPSI, Avantor™ US
Triacetin TBD TBD
Tributyl citrate JBL, Vertellus Germany, US
Tricalcium phosphate – Tri-Tab® and powder Innophos US
Triethyl citrate JBL, Vertellus Germany, US
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Product Manufacturer Origin
Acetone Sun, Dow US
Acetonitrile Haltermann US
Benzyl alcohol Emerald Kalama US
Benzyl alcohol parenteral Emerald Kalama US
Butyl, ethyl, and propyl acetate Eastman, Celanese, Dow US
Butyl, ethyl, and propyl alcohol Eastman, Celanese, Dow US
Custom blends Multiple
Dimethylformamide BASF, Taminco US
DMSO Arkema France
Ethanol Equistar, MGP US
Hexane and heptane Exxon, Citgo, Conoco-Phillips, Shell US
Hexane and heptane hi-purity Conoco-Phillips, Haltermann US
Isopropyl alcohol – tech and USP Exxon, Dow, Shell US
Methanol Eastman, Avantor™, Import US, Import
Methyl acetate Eastman, Celanese US
Methyl ethyl ketone Exxon, Dow US
Methyl ISO butyl ketone Eastman US
Methylene chloride Dow US
MTBE Haltermann US
Sterile water (WFI) Microbix Canada
THF Lyondell, BASF US
Triethylamine BASF, Taminco US
Toluene / xylene Multiple US
Solvents
Lubricants and humectantsProduct Manufacturer Origin
CARBOWAX™ SENTRY™ polyethylene glycols Dow US
Calcium stearate Covidien US
Cetyl alcohol Sasol, Cremer, Import US, US, Thailand
Dimethicone NF, 35% Dow Corning US
Glycerine (synthetic) Dow Germany
Glycerine USP (natural) P&G US
Magnesium stearate Covidien, Nitika US, India
Mineral oil USP Penreco, Citgo US
Petrolatum Penreco US
Polyethylene and propylene glycol Dow, BASF, Huntsman US
Propylene glycol USP Lyondell, Dow US
Sodium stearyl fumarate (Lubripharm™ SSF) SPI Pharma Korea
Sorbitol Ingredion US
Sorbitan sorbitol solution (Sorbitol Special®) SPI Pharma US
Stearic acid Biogenix, Avantor US
Stearyl alcohol Sasol, Cremer, Import US, US, Thailand
Tributyl citrate JBL, Vertellus Germany, US
Triethyl citrate JBL, Vertellus Germany, US
Zinc stearate Covidien US
Acids, alkalis, buffers, and defoamersProduct Manufacturer Origin
ACES buffer Research Organics US
Acetic acid Eastman, Celanese US
ADA buffer Research Organics US
Amino acids (most) EMD, Research Organics US
Ammonium carbonate Keystone Universal US
Ammonium hydroxide Avantor US
AMP buffer Research Organics US
AMPD buffer Research Organics US
Benzoic acid Avantor, Wuhan Youji, Columbus US, China, US
Boric acid US Borax France
Calcium disodium EDTA (CA) Dow, BASF US
CAPS buffer Research Organics US
CHAPS buffer Research Organics US
CHES buffer Research Organics US
Citric acid JBL, Tate & Lyle US, Canada
Disodium EDTA (NA) Dow, BASF US
Fumaric acid Bartek, Tate & Lyle US, Canada
Glypure® (glycolic acid) DuPont US
HEPES buffer Research Organics US
Hydrochloric acid Regional (Tech), Avantor™ (NF) US
Lactic acid Purac US
Malic acid Tate & Lyle US
Medical antifoam C emulsion Dow Corning US
Medical antifoam A 100% Dow Corning US
Monobasic potassium phosphate Covidien US
Nitric acid Regional (Tech), Avantor™ (Reagent) US
Phosphate buffer Covidien US
Phosphoric acid ICL, Innophos, PCS US
Potassium citrate Tate & Lyle, JBL Europe, South America
Potassium hydroxide Oxy, Ashta US
Potassium phosphate Covidien US
Propionic acid Dow, BASF US
Simethicone emulsion 30% USP Dow Corning US
Sodium bicarbonate Church & Dwight US
Sodium borate Avantor™, US Borax US, France
Sodium carbonate Avantor™, JOST US
Sodium citrate Tate & Lyle, JBL Europe, South America
Sodium hydroxide Regional (Tech), Avantor™ (NF) US
Sodium lactate Purac, Ferro US
Sodium potassium acetates Covidien, Niacet, Jorchem US
Sodium phosphate Covidien US
Succinic acid powder Avantor US
Sulfuric acid Regional (Tech), Avantor™ (NF) US
Tartaric acid American Tartaric, Tartaric Chemicals US, Italy
Tris base Research Organics US
Tris buffers (various) Research Organics US
Tris HCl Research Organics US
VERSENE™ Dow US
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Univar’s Supplier Audit Library Univar’s innovative audit library can help your company navigate the supplier auditing process Comprehensive auditing of excipient suppliers can be a challenge for drug and nutritional supplement manufacturers. APIs and other high-risk areas are a priority for regulatory resources, often at the expense of regular excipient audits. But with a growing focus on the GMP compliance of excipient manufacturers, and increasing international adoption of the IPEC GMP guidelines, monitoring of excipient production is quickly becoming crucial: the FDA is expected to start conducting more frequent excipient reviews.
Since excipients are used in nearly every drug and / or nutritional supplement formulation, excipient manufacturers can be faced with an enormous volume of audit requests. Many have limited audit dates available – some have even begun to charge a fee to perform an audit for all but their largest customers.
Univar is in a unique position in the industry, representing a broad excipient portfolio from respected producers. We have contracted a certified third party to conduct audits of these major excipient partners, using the IPEC-PQG GMP Guide for Pharmaceutical Excipients. The audits are collected in our audit library and made available to our customers.
The library’s audit packages include the initial audit, observed non-conformances, and the excipient supplier responses. Audits began in Q3 2009, and completed audits are currently available to our customers. Audits will be scheduled on a three-year rotation – sooner if conditions warrant.
