Clavulanate Potassium

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ACTIVE PHARMA INGREDIENTS

43 API Suppliers, 25 USDMF, 34 CEP/COS, 61 KDMF, 14 NDC API, 11 Listed Suppliers, $ API Reference Price

FINISHED DOSAGE FORMULATIONS

640 FDF Dossiers, 73 FDA Orange Book, 337 Europe, 105 South Africa, 125 Listed Dossiers

DRUG PRODUCT COMPOSITIONS

TABLET;ORAL - 250MG;EQ 125MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET;ORAL - 500MG;EQ 125MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, FOR SUSPENSION;ORAL - 125MG/5ML;EQ 31.25MG BASE/5ML, FOR SUSPENSION;ORAL - 250MG/5ML;EQ 62.5MG BASE/5ML, TABLET;ORAL - 875MG;EQ 125MG BASE, FOR SUSPENSION;ORAL - 200MG/5ML;EQ 28.5MG BASE/5ML, FOR SUSPENSION;ORAL - 400MG/5ML;EQ 57MG BASE/5ML, FOR SUSPENSION;ORAL - 600MG/5ML;EQ 42.9MG BASE/5ML, TABLET, EXTENDED RELEASE;ORAL - 1GM;EQ 62.5MG BASE

RELATED EXCIPIENT COMPANIES

1 Evonik, 5 Rochem International Inc, 13 SPI Pharma, 2 Seqens, 14 DKSH, 2 Jai Radhe Sales, 1 Pharm-RX Chemical, 5 Faran Shimi Pharmaceutical, 5 Boai NKY Pharmaceuticals Ltd, 9 Gangwal Healthcare, 6 Nanjing Well Pharmaceutical, 1 Pfanstiehl, 1 ACG Worldwide, 6 Actylis, 1 Aeon Procare, 1 Alcedo Pharmachem, 8 Anhui Sunhere Pharmaceutical Excipients Co.,Ltd, 1 Avesta Pharma, 31 BASF, 2 Clariant, 11 Corel Pharma Chem, 4 DFE Pharma, 2 Finar, 11 Gangwal Chemicals, 5 Ideal Cures Pvt Ltd, 3 Ingredion Pharma Solutions, 17 Kerry, 5 Kima Chemical, 6 Lonza Capsugel, 16 Microlex e.U, 1 Nanjing Bold Chemical, 2 Nomisma Healthcare, 3 Novo Excipients, 4 Pharmatrans-Sanaq, 6 Pluviaendo, 4 Prachin Chemical, 1 Qianhao Chemical (Hebei) Co., Ltd, 1 Qualicaps, 16 Roquette, 12 Seppic, 5 Shanghai Shenmei Pharmaceutical Technology Co., Ltd, 1 Shijiazhuang Huaxu Pharmaceutical, 11 Sigachi Industries, 4 The Dow Chemical Company, 1 Ulanqab Kema New Material, 1 Valens Pharmachem, 4 Vasa Pharmachem, 1 Vertellus

EXCIPIENTS BY APPLICATIONS

65 Fillers, Diluents & Binders, 51 Coating Systems & Additives, 38 Disintegrants & Superdisintegrants, 35 Direct Compression, 35 Thickeners and Stabilizers, 32 Controlled & Modified Release, 31 Solubilizers, 27 Granulation, 22 Topical, 21 Film Formers & Plasticizers, 21 Taste Masking, 18 Parenteral, 18 Lubricants & Glidants, 15 Chewable & Orodispersible Aids, 14 Co-Processed Excipients, 10 Rheology Modifiers, 9 Emulsifying Agents, 7 API Stability Enhancers, 6 Surfactant & Foaming Agents, 5 Empty Capsules, 4 Vegetarian Capsules, 4 Coloring Agents

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GLOBAL SALES INFORMATION

309 Finished Drug Prices, 5 Annual Reports

MARKET PLACE

49 APIs, 9 FDF Dossiers

REF. STANDARDS & IMPURITIES

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USFDA APPLICATION NUMBER - 50575 / DOSAGE - FOR SUSPENSION;ORAL - 250MG/5ML;EQ 62.5MG BASE/5ML

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
AMOXICILLIN(UNII: 804826J2HU) (AMOXICILLIN ANHYDROUS - UNII:9EM05410Q9)	AMOXICILLIN ANHYDROUS	400mg in 5
CLAVULANATE POTASSIUM(UNII: Q42OMW3AT8) (CLAVULANIC ACID - UNII:23521W1S24)	CLAVULANIC ACID	57mg in 5

Inactive Ingredients

Ingredient Name	Aurobindo Pharma Limited	A-S Medication Solutions LLC	Neopharma Inc	USAntibiotics, LLC
ACACIA(5C5403N26O)
ASPARTAME(Z0H242BBR1)
CELLULOSE, MICROCRYSTALLINE(OP1R32D61U)
CORN SYRUP(9G5L16BK6N)
HYPROMELLOSE 2910 (50 MPA.S)(1IVH67816N)
HYPROMELLOSE, UNSPECIFIED(3NXW29V3WO)
HYPROMELLOSES(3NXW29V3WO)
MAGNESIUM STEARATE(70097M6I30)
MANNITOL(3OWL53L36A)
MICROCRYSTALLINE CELLULOSE(OP1R32D61U)
ORANGE(5EVU04N5QU)
POLYETHYLENE GLYCOL(3WJQ0SDW1A)
POLYETHYLENE GLYCOL, UNSPECIFIED(3WJQ0SDW1A)
POLYETHYLENE GLYCOLS(3WJQ0SDW1A)
SACCHARIN SODIUM DIHYDRATE(SB8ZUX40TY)
SACCHARIN SODIUM(SB8ZUX40TY)
SILICON DIOXIDE(ETJ7Z6XBU4)
SODIUM STARCH GLYCOLATE TYPE A POTATO(5856J3G2A2)
SUCCINIC ACID(AB6MNQ6J6L)
TITANIUM DIOXIDE(15FIX9V2JP)
XANTHAN GUM(TTV12P4NEE)

Drug Product Composition: Clavulanate Potassium