Amoxicillin Trihydrate

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ACTIVE PHARMA INGREDIENTS

75 API Suppliers, 44 USDMF, 30 CEP/COS, 5 JDMF, 3 EU WC, 40 KDMF, 22 NDC API, 4 VMF, 24 Listed Suppliers, $ API Reference Price

DEVELOPMENTS

22 Drugs in Development

22 Drugs in Development

INTERMEDIATES

2 API Suppliers

2 API Suppliers

FINISHED DOSAGE FORMULATIONS

1403 FDF Dossiers, 209 FDA Orange Book, 570 Europe, 113 Canada, 67 Australia, 153 South Africa, 291 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TABLET;ORAL - 250MG;EQ 125MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET;ORAL - 500MG;EQ 125MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, FOR SUSPENSION;ORAL - 125MG/5ML;EQ 31.25MG BASE/5ML, FOR SUSPENSION;ORAL - 250MG/5ML;EQ 62.5MG BASE/5ML, TABLET;ORAL -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- 400MG/5ML;EQ 57MG BASE/5ML, TABLET;ORAL - 500MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET;ORAL - 875MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, FOR SUSPENSION;ORAL - 600MG/5ML;EQ 42.9MG BASE/5ML, CAPSULE, TABLET, CAPSULE, DELAYED REL PELLETS;ORAL - 500MG;500MG;30MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, FOR SUSPENSION;ORAL - 200MG/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, FOR SUSPENSION;ORAL - 400MG/5ML, TABLET, EXTENDED RELEASE;ORAL - 1GM;EQ 62.5MG BASE, TABLET, EXTENDED RELEASE;ORAL -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- 500MG,N/A,N/A;N/A,500MG,N/A;N/A,N/A,20MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**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, 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 Disintegrants & Superdisintegrants, 15 Direct Compression, 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 Vegetarian Capsules, 4 Taste Masking, 4 Coloring Agents, 4 Emulsifying Agents, 4 Rheology Modifiers, 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

99 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 - 50725 / DOSAGE - FOR SUSPENSION;ORAL - 400MG/5ML;EQ 57MG 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	A-S Medication Solutions	Mylan Pharmaceuticals Inc.	NuCare Pharmaceuticals,Inc.	Preferred Pharmaceuticals Inc.	Preferred Pharmaceuticals, Inc.	Proficient Rx LP	A-S Medication Solutions LLC	Aurobindo Pharma Limited	Hikma Pharmaceutical	Hikma Pharmaceuticals USA Inc.	NorthStar Rx LLC	REMEDYREPACK INC.	Sandoz GmbH	Sandoz Inc
ANHYDROUS CITRIC ACID(XF417D3PSL)
ANHYDROUS TRISODIUM CITRATE(RS7A450LGA)
ASPARTAME(Z0H242BBR1)
BANANA(4AJZ4765R9)
CARAMEL(T9D99G2B1R)
CARBOXYMETHYLCELLULOSE SODIUM(K679OBS311)
CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORM(K679OBS311)
CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED(K679OBS311)
CELLULOSE, MICROCRYSTALLINE(OP1R32D61U)
CETYL ALCOHOL(936JST6JCN)
CHERRY(BUC5I9595W)
COLLOIDAL SILICON DIOXIDE(ETJ7Z6XBU4)
CROSCARMELLOSE SODIUM(M28OL1HH48)
CROSPOVIDONE (120 .MU.M)(68401960MK)
CROSPOVIDONE (15 MPA.S AT 5%)(68401960MK)
DEXTROSE(IY9XDZ35W2)
DEXTROSE, UNSPECIFIED FORM(IY9XDZ35W2)
ETHYLCELLULOSE, UNSPECIFIED(7Z8S9VYZ4B)
FD&C RED NO. 40(WZB9127XOA)
HYDROXYPROPYL CELLULOSE (1600000 WAMW)(RFW2ET671P)
HYPROMELLOSE 2910 (5 MPA.S)(R75537T0T4)
HYPROMELLOSE 2910 (50 MPA.S)(1IVH67816N)
HYPROMELLOSE, UNSPECIFIED(3NXW29V3WO)
HYPROMELLOSES(3NXW29V3WO)
MAGNESIUM STEARATE(70097M6I30)
MANNITOL(3OWL53L36A)
MICROCRYSTALLINE CELLULOSE(OP1R32D61U)
ORANGE(5EVU04N5QU)
POLYSORBATE 80(6OZP39ZG8H)
RASPBERRY(4N14V5R27W)
SACCHARIN SODIUM(SB8ZUX40TY)
SILICON DIOXIDE(ETJ7Z6XBU4)
SODIUM CITRATE(1Q73Q2JULR)
SODIUM CITRATE, UNSPECIFIED FORM(1Q73Q2JULR)
SODIUM LAURYL SULFATE(368GB5141J)
SODIUM STARCH GLYCOLATE TYPE A POTATO(5856J3G2A2)
SUCCINIC ACID(AB6MNQ6J6L)
TALC(7SEV7J4R1U)
TITANIUM DIOXIDE(15FIX9V2JP)
TRIETHYL CITRATE(8Z96QXD6UM)
XANTHAN GUM(TTV12P4NEE)

Drug Product Composition: Amoxicillin Trihydrate