Amoxicillin Trihydrate

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ACTIVE PHARMA INGREDIENTS

107 API Suppliers, 40 USDMF, 31 CEP/COS, 5 JDMF, 2 EU WC, 40 KDMF, 20 NDC API, 4 VMF, 26 Listed Suppliers, $ API Reference Price

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108 Drugs in Development

INTERMEDIATES

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2 Intermediate Suppliers

FINISHED DOSAGE FORMULATIONS

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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TABLET;ORAL - 250MG;EQ 125MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET;ORAL - 500MG;EQ 125MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, FOR SUSPENSION;ORAL - 125MG/5ML;EQ 31.25MG BASE/5ML, FOR SUSPENSION;ORAL - 250MG/5ML;EQ 62.5MG BASE/5ML, TABLET;ORAL -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SUSPENSION;ORAL - 200MG/5ML;EQ 28.5MG BASE/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, FOR SUSPENSION;ORAL - 400MG/5ML;EQ 57MG BASE/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET;ORAL - 500MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET;ORAL - 875MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, FOR SUSPENSION;ORAL - 600MG/5ML;EQ 42.9MG BASE/5ML, CAPSULE, TABLET, CAPSULE, DELAYED REL PELLETS;ORAL - 500MG;500MG;30MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, FOR SUSPENSION;ORAL - 200MG/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, FOR SUSPENSION;ORAL - 400MG/5ML, TABLET, EXTENDED RELEASE;ORAL - 1GM;EQ 62.5MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET, EXTENDED RELEASE;ORAL - 775MG, CAPSULE, TABLET, CAPSULE, DELAYED RELEASE;ORAL - 500MG,N/A,N/A;N/A,500MG,N/A;N/A,N/A,20MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**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, 7 DKSH, 1 Pharm-RX Chemical, 3 Gangwal Healthcare, 1 Kirsch Pharma, 1 ACG Worldwide, 3 Actylis, 5 Anhui Sunhere Pharmaceutical Excipients Co.,Ltd, 8 BASF, 2 CD Formulation, 10 Corel Pharma Chem, 3 DFE Pharma, 1 Esteem Industries, 1 Finar, 6 Gangwal Chemicals, 4 Ideal Cures, 1 Ingredion Pharma Solutions, 10 Kerry, 2 Keval Exports, 3 Kima Chemical, 6 Lonza Capsugel, 8 Microlex e.U, 2 Nitika Pharmaceutical Specialities, 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, 3 Silverline Chemicals, 2 The Dow Chemical Company, 3 Vasa Pharmachem

EXCIPIENTS BY APPLICATIONS

39 Coating Systems & Additives, 22 Fillers, Diluents & Binders, 22 Thickeners and Stabilizers, 19 Controlled & Modified Release, 14 Disintegrants & Superdisintegrants, 11 Lubricants & Glidants, 10 Topical, 9 Granulation, 9 Direct Compression, 7 Rheology Modifiers, 7 Co-Processed Excipients, 6 Film Formers & Plasticizers, 5 Empty Capsules, 5 API Stability Enhancers, 5 Taste Masking, 5 Solubilizers, 4 Vegetarian Capsules, 4 Coloring Agents, 4 Emulsifying Agents, 4 Chewable & Orodispersible Aids, 1 Parenteral

DIGITAL CONTENT

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78 News #PharmaBuzz

GLOBAL SALES INFORMATION

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MARKET PLACE

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PATENTS & EXCLUSIVITIES

14 US Patents, 6 US Exclusivities, 2 Health Canada Patents

REF. STANDARDS & IMPURITIES

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ANALYTICAL

3 Analytical Methods

3 Analytical Methods

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USFDA APPLICATION NUMBER - 50754 / DOSAGE - TABLET;ORAL - 500MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
AMOXICILLIN(UNII: 804826J2HU) (AMOXICILLIN ANHYDROUS - UNII:9EM05410Q9)	AMOXICILLIN ANHYDROUS	875mg

Inactive Ingredients

Ingredient Name	Direct Rx	Dr Reddys Laboratories Inc	Proficient Rx LP
CELLULOSE, MICROCRYSTALLINE(OP1R32D61U)
CROSPOVIDONE (15 MPA.S AT 5%)(68401960MK)
CROSPOVIDONE(2S7830E561)
CROSPOVIDONE(68401960MK)
D&C RED NO. 30(2S42T2808B)
FD&C RED NO. 3(PN2ZH5LOQY)
HYPROMELLOSE 2910 (5 MPA.S)(R75537T0T4)
MAGNESIUM STEARATE(70097M6I30)
MICROCRYSTALLINE CELLULOSE(OP1R32D61U)
POLYETHYLENE GLYCOL, UNSPECIFIED(3WJQ0SDW1A)
POLYETHYLENE GLYCOLS(3WJQ0SDW1A)
SILICON DIOXIDE(ETJ7Z6XBU4)
SODIUM BENZOATE(OJ245FE5EU)
SODIUM CITRATE(1Q73Q2JULR)
SODIUM CITRATE, UNSPECIFIED FORM(1Q73Q2JULR)
SODIUM STARCH GLYCOLATE TYPE A POTATO(5856J3G2A2)
SODIUM(9NEZ333N27)
SUCROSE(C151H8M554)
TITANIUM DIOXIDE(15FIX9V2JP)
XANTHAN GUM(TTV12P4NEE)

Setid 286aa886 8a41 4cb6 85d5 7ba37b9b07d9 Applno 50754 Form Tablet Oral Dosage 500mg - Drug Product Composition: Amoxicillin Trihydrate