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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TABLET;ORAL - 250MG;EQ 125MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET;ORAL - 500MG;EQ 125MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, FOR SUSPENSION;ORAL - 125MG/5ML;EQ 31.25MG BASE/5ML, FOR SUSPENSION;ORAL - 250MG/5ML;EQ 62.5MG BASE/5ML, TABLET;ORAL -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- 400MG/5ML;EQ 57MG BASE/5ML, TABLET;ORAL - 500MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET;ORAL - 875MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, FOR SUSPENSION;ORAL - 600MG/5ML;EQ 42.9MG BASE/5ML, CAPSULE, TABLET, CAPSULE, DELAYED REL PELLETS;ORAL - 500MG;500MG;30MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, FOR SUSPENSION;ORAL - 200MG/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, FOR SUSPENSION;ORAL - 400MG/5ML, TABLET, EXTENDED RELEASE;ORAL - 1GM;EQ 62.5MG BASE, TABLET, EXTENDED RELEASE;ORAL -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- 500MG,N/A,N/A;N/A,500MG,N/A;N/A,N/A,20MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**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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Last Updated on PharmaCompass	Virtual Booth	Country	Holder	DMF No.	Subject	Submission Date	Status	Type	GDUFA DMF Review	GDUFA Review Date	GDUFA Payment Date
28/10/2024	Centrient Pharmaceuticals	Netherlands	CENTRIENT PHARMACEUTICALS NETHERLANDS BV	16950	AMOXICILLIN TRIHYDRATE (PURIMOX®)	2003-11-14	Active	II	Complete	2013-01-07	2012-12-20
28/10/2024	Centrient Pharmaceuticals	Netherlands	CENTRIENT PHARMACEUTICALS NETHERLANDS BV	25875	AMOXICILLIN TRIHYDRATE (PURIMOX)	2012-03-16	Active	II	Complete	2014-06-16	2014-03-05

Amoxicillin Trihydrate

Amoxicillin Trihydrate

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Browse all information

CHEMISTRY

Discover Molecule Insights

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

INTERMEDIATES

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

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

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

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

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