Amoxicillin Trihydrate

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ACTIVE PHARMA INGREDIENTS

77 API Suppliers, 44 USDMF, 30 CEP/COS, 6 JDMF, 3 EU WC, 41 KDMF, 22 NDC API, 4 VMF, 26 Listed Suppliers, $ API Reference Price

DEVELOPMENTS

23 Drugs in Development

23 Drugs in Development

INTERMEDIATES

2 Intermediates Suppliers

2 Intermediates Suppliers

FINISHED DOSAGE FORMULATIONS

1413 FDF Dossiers, 209 FDA Orange Book, 570 Europe, 113 Canada, 67 Australia, 153 South Africa, 301 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TABLET;ORAL - 250MG;EQ 125MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET;ORAL - 500MG;EQ 125MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, FOR SUSPENSION;ORAL - 125MG/5ML;EQ 31.25MG BASE/5ML, FOR SUSPENSION;ORAL - 250MG/5ML;EQ 62.5MG BASE/5ML, TABLET;ORAL -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- 400MG/5ML;EQ 57MG BASE/5ML, TABLET;ORAL - 500MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET;ORAL - 875MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, FOR SUSPENSION;ORAL - 600MG/5ML;EQ 42.9MG BASE/5ML, CAPSULE, TABLET, CAPSULE, DELAYED REL PELLETS;ORAL - 500MG;500MG;30MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, FOR SUSPENSION;ORAL - 200MG/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, FOR SUSPENSION;ORAL - 400MG/5ML, TABLET, EXTENDED RELEASE;ORAL - 1GM;EQ 62.5MG BASE, TABLET, EXTENDED RELEASE;ORAL - 775MG, CAPSULE, TABLET, CAPSULE, DELAYED RELEASE;ORAL - 500MG,N/A,N/A;N/A,500MG,N/A;N/A,N/A,20MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

RELATED EXCIPIENT COMPANIES

1 Rochem International Inc, 1 SPI Pharma, 2 Seqens, 5 DKSH, 1 Pharm-RX Chemical, 1 Faran Shimi Pharmaceutical, 7 Gangwal Healthcare, 1 ACG Worldwide, 3 Actylis, 5 Anhui Sunhere Pharmaceutical Excipients Co.,Ltd, 8 BASF, 10 Corel Pharma Chem, 3 DFE Pharma, 1 Finar, 6 Gangwal Chemicals, 5 Ideal Cures Pvt Ltd, 1 Ingredion Pharma Solutions, 15 Kerry, 3 Kima Chemical, 6 Lonza Capsugel, 8 Microlex e.U, 2 Nomisma Healthcare, 1 Novo Excipients, 2 Pharmatrans-Sanaq, 1 Pluviaendo, 3 Prachin Chemical, 1 Qianhao Chemical (Hebei) Co., Ltd, 1 Qualicaps, 11 Roquette, 6 Seppic, 3 Shanghai Shenmei Pharmaceutical Technology Co., Ltd, 9 Sigachi Industries, 2 The Dow Chemical Company, 3 Vasa Pharmachem

EXCIPIENTS BY APPLICATIONS

43 Coating Systems & Additives, 24 Controlled & Modified Release, 23 Fillers, Diluents & Binders, 20 Thickeners and Stabilizers, 15 Direct Compression, 15 Disintegrants & Superdisintegrants, 12 Lubricants & Glidants, 9 Granulation, 9 Topical, 8 Co-Processed Excipients, 7 Film Formers & Plasticizers, 5 Empty Capsules, 5 API Stability Enhancers, 5 Solubilizers, 4 Taste Masking, 4 Coloring Agents, 4 Emulsifying Agents, 4 Rheology Modifiers, 4 Vegetarian Capsules, 3 Chewable & Orodispersible Aids, 2 Parenteral

DIGITAL CONTENT

9 DATA COMPILATION #PharmaFlow, 75 NEWS #PharmaBuzz

GLOBAL SALES INFORMATION

1 US Medicaid Prescriptions, 545 Finished Drug Prices, 10 Annual Reports

MARKET PLACE

101 APIs, 44 FDF Dossiers

PATENTS & EXCLUSIVITIES

14 US Patents, 6 US Exclusivities, 7 Health Canada Patents

REF. STANDARDS & IMPURITIES

3 EDQM, 6 USP, 22 Others

ANALYTICAL

3 Analytical Methods

3 Analytical Methods

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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: Amoxicillin Trihydrate