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Esomeprazole

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ACTIVE PHARMA INGREDIENTS

137 API Suppliers, 65 USDMF, 48 CEP/COS, 7 JDMF, 37 EU WC, 79 KDMF, 45 NDC API, 66 Listed Suppliers, $ API Reference Price

DEVELOPMENTS

4 Drugs in Development

4 Drugs in Development

INTERMEDIATES

14 Intermediates Suppliers

14 Intermediates Suppliers

FINISHED DOSAGE FORMULATIONS

912 FDF Dossiers, 92 FDA Orange Book, 464 Europe, 23 Canada, 86 Australia, 62 South Africa, 185 Listed Dossiers

DRUG PRODUCT COMPOSITIONS

CAPSULE, DELAYED RELEASE;ORAL - EQ 20MG BASE, CAPSULE, DELAYED REL PELLETS;ORAL - EQ 20MG BASE, CAPSULE, DELAYED REL PELLETS;ORAL - EQ 40MG BASE, FOR SUSPENSION, DELAYED RELEASE;ORAL - EQ 2.5MG BASE/PACKET, FOR SUSPENSION, DELAYED RELEASE;ORAL - EQ 20MG BASE/PACKET, FOR SUSPENSION, DELAYED RELEASE;ORAL - EQ 40MG BASE/PACKET, FOR SUSPENSION, DELAYED RELEASE;ORAL - EQ 5MG BASE/PACKET, TABLET, DELAYED RELEASE;ORAL - EQ 20MG BASE;375MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET, DELAYED RELEASE;ORAL - EQ 20MG BASE;500MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

RELATED EXCIPIENT COMPANIES

1 Minakem, 2 Evonik, 1 Rochem International Inc, 17 SPI Pharma, 2 Seqens, 8 DKSH, 3 Jai Radhe Sales, 6 Faran Shimi Pharmaceutical, 3 Boai NKY Pharmaceuticals Ltd, 1 Chynops Pharma, 12 Gangwal Healthcare, 4 Nanjing Well Pharmaceutical, 2 Pfanstiehl, 4 ACG Worldwide, 6 Actylis, 1 Aeon Procare, 2 Alcedo Pharmachem, 9 Anhui Sunhere Pharmaceutical Excipients Co.,Ltd, 30 BASF, 15 Corel Pharma Chem, 3 DFE Pharma, 3 Doshion Polyscience, 2 Finar, 11 Gangwal Chemicals, 13 Ideal Cures Pvt Ltd, 4 Ingredion Pharma Solutions, 19 Kerry, 4 Kima Chemical, 6 Lonza Capsugel, 11 Microlex e.U, 2 Nanjing Bold Chemical, 1 NEWEDGE Overseas, 2 Nomisma Healthcare, 2 Novo Excipients, 3 Pharmatrans-Sanaq, 6 Pluviaendo, 4 Prachin Chemical, 1 Qianhao Chemical (Hebei) Co., Ltd, 2 Qualicaps, 18 Roquette, 14 Seppic, 6 Shanghai Shenmei Pharmaceutical Technology Co., Ltd, 1 Shijiazhuang Huaxu Pharmaceutical, 10 Sigachi Industries, 3 The Dow Chemical Company, 2 Ulanqab Kema New Material, 2 Valens Pharmachem, 3 Vasa Pharmachem, 1 Vertellus

EXCIPIENTS BY APPLICATIONS

71 Fillers, Diluents & Binders, 69 Coating Systems & Additives, 43 Controlled & Modified Release, 38 Direct Compression, 32 Thickeners and Stabilizers, 30 Solubilizers, 26 Taste Masking, 25 Granulation, 24 Disintegrants & Superdisintegrants, 21 Lubricants & Glidants, 20 Co-Processed Excipients, 18 Film Formers & Plasticizers, 17 Chewable & Orodispersible Aids, 16 Topical, 16 Parenteral, 9 Emulsifying Agents, 9 Empty Capsules, 6 API Stability Enhancers, 5 Coloring Agents, 4 Vegetarian Capsules, 4 Surfactant & Foaming Agents, 4 Rheology Modifiers

DIGITAL CONTENT

16 DATA COMPILATION #PharmaFlow, 152 NEWS #PharmaBuzz

GLOBAL SALES INFORMATION

3 US Medicaid Prescriptions, 395 Finished Drug Prices, 16 Annual Reports

MARKET PLACE

67 APIs, 35 FDF Dossiers

PATENTS & EXCLUSIVITIES

2 US Patents, 44 Health Canada Patents

REF. STANDARDS & IMPURITIES

5 EDQM, 1 USP, 21 Others

ANALYTICAL

2 BioAnalytical Methods

2 BioAnalytical 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	Minakem	France	MINAKEM	28462	ESOMEPRAZOLE MAGNESIUM TRIHYDRATE	2014-07-08	Active	II	N/A
28/10/2024	Granules India Limited	India	GRANULES INDIA LTD	36556	ESOMEPRAZOLE MAGNESIUM TRIHYDRATE, USP	2021-12-24	Active	II	Complete	2023-05-26	2023-04-18

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CHEMISTRY

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ACTIVE PHARMA INGREDIENTS

137 API Suppliers

65 USDMF

48 CEP/COS

7 JDMF

37 EU WC

79 KDMF

45 NDC API

66 Listed Suppliers

$ API Reference Price

DEVELOPMENTS

4 Drugs in Development

INTERMEDIATES

14 Intermediates Suppliers

FINISHED DOSAGE FORMULATIONS

912 FDF Dossiers

92 FDA Orange Book

464 Europe

23 Canada

86 Australia

62 South Africa

185 Listed Dossiers

DRUG PRODUCT COMPOSITIONS

CAPSULE, DELAYED RELEASE;ORAL - EQ 20MG BASE

CAPSULE, DELAYED REL PELLETS;ORAL - EQ 20MG BASE

CAPSULE, DELAYED REL PELLETS;ORAL - EQ 40MG BASE

FOR SUSPENSION, DELAYED RELEASE;ORAL - EQ 2.5MG BASE/PACKET

FOR SUSPENSION, DELAYED RELEASE;ORAL - EQ 20MG BASE/PACKET

FOR SUSPENSION, DELAYED RELEASE;ORAL - EQ 40MG BASE/PACKET

FOR SUSPENSION, DELAYED RELEASE;ORAL - EQ 5MG BASE/PACKET

TABLET, DELAYED RELEASE;ORAL - EQ 20MG BASE;375MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

TABLET, DELAYED RELEASE;ORAL - EQ 20MG BASE;500MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

RELATED EXCIPIENT COMPANIES

1 Minakem

2 Evonik

1 Rochem International Inc

17 SPI Pharma

2 Seqens

8 DKSH

3 Jai Radhe Sales

6 Faran Shimi Pharmaceutical

3 Boai NKY Pharmaceuticals Ltd

1 Chynops Pharma

12 Gangwal Healthcare

4 Nanjing Well Pharmaceutical

2 Pfanstiehl

4 ACG Worldwide

6 Actylis

1 Aeon Procare

2 Alcedo Pharmachem

9 Anhui Sunhere Pharmaceutical Excipients Co.,Ltd

30 BASF

15 Corel Pharma Chem

3 DFE Pharma

3 Doshion Polyscience

2 Finar

11 Gangwal Chemicals

13 Ideal Cures Pvt Ltd

4 Ingredion Pharma Solutions

19 Kerry

4 Kima Chemical

6 Lonza Capsugel

11 Microlex e.U

2 Nanjing Bold Chemical

1 NEWEDGE Overseas

2 Nomisma Healthcare

2 Novo Excipients

3 Pharmatrans-Sanaq

6 Pluviaendo

4 Prachin Chemical

1 Qianhao Chemical (Hebei) Co., Ltd

2 Qualicaps

18 Roquette

14 Seppic

TABLET, DELAYED RELEASE;ORAL - EQ 20MG BASE;375MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons

TABLET, DELAYED RELEASE;ORAL - EQ 20MG BASE;500MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons